District Court Holds That Even a Flawed Office Action Stops the Patent Term Adjustment Clock

13 November 2012 PharmaPatents Blog

In University of Massachusetts v. Kappos, the United States District Court for the District of Colombia held that an Office Action that was “fundamentally flawed” still stopped the Patent Term Adjustment (PTA) clock that was running against the USPTO under 35 USC § 154(b)(2)(A). The court distinguished this case from the Oncolytics case, where it was the USPTO itself who decided that a vacated Office Action would  not be counted for PTA purposes. This case indicates that it may be difficult to challenge PTA awards for A-type delay based on alleged inadequacies in an Office Action, or on other factual grounds.

Patent Term Adjustment

The PTA statute (35 USC § 154(b)) was created to compensate for delays in the patent examination process that can eat away at the effective term of the patent, now that patent term is measured from the earliest U.S. priority date rather than the patent grant date. The statute provides “guarantees” against different types of USPTO delays, and requires a day-for-day deduction of Applicant delays against USPTO delays.

“A” delay accrues when the PTO fails to act in accordance with set time frames (such as issuing a first Office Action within 14 months, issuing a second action or allowance within four months of a response, and issuing a patent within four months of the Issue Fee payment).

“B” delay accrues when the PTO fails to issue a patent within three years of the actual filing date of the patent application.

“C” delay accrues when the application is involved in an interference or appeal, or is subject to a secrecy order.

The issue in this case relates to the amount of A delay the patent should have been awarded for the USPTO’s failure to meet the time frames set forth in 35 USC §154(b)(1)(A).

The Patent at Issue

The patent at issue was U.S. Patent 7,625,559, directed to “Antibodies Against Clostridium Difficile Toxins and Uses Thereof.” The patent application was filed February 4, 2005, and granted December 1, 2009.

As characterized by the district court, the original claims addressed “three main embodiments of the invention — monoclonal antibodies that bind to C. difficile toxin A, or toxin B, or both toxin A + toxin B.”

The Office Action at Issue
The USPTO issued an Office Action on July 13, 2007, setting forth a Restriction Requirement that divided the application’s 80 claims into 10 groups, but did not “divide the claims based on ‘whether the antibody, or antigen binding portion thereof, could specifically bind to either C. difficile toxin A or toxin B,’” in accordance with the application.

The applicant filed a response on October 9, 2007, whereby they elected the subject matter of Group VIII for examination, canceled original claims 1-80, and added new claims 81-95, which were said to fall under elected Group VIII.

Although the applicant did not challenge the Restriction Requirement in the response, the applicant held several telephone interviews with the Examiner and Supervisor, asserting that the claims should have been restricted along the lines drawn in the application. Eventually it was agreed that the applicant would file a “Supplemental Response” to add back the original claims, and the Examiner would issue a new Restriction Requirement.

The Applicant filed a Supplemental Response on November 21, 2007. The Examiner issued an Office Action with a different Restriction Requirement on February 21, 2008. The Applicant responded, and prosecution proceeded to allowance and grant.

The District Court Decision 

The patentee argued that the first Restriction Requirement was so fundamentally flawed that it did not stop the fourteen month clock running against the USPTO for A delay purposes.

The question is whether, as a matter of law, when an applicant successfully convinces an Examiner to change a ruling contained in an Office action, regardless of whether it is classified as a vacatur, that renders the first Office action “a nullity for purposes of calculating A delay under Section 154(b)(1)(A).”

The USPTO disagreed with the patentee’s assertion that the first Restriction Requirement had been “vacated,” and that it should not be counted for PTA purposes.

The district court considered the plain language of the statute, and found that it squarely supported the USPTO’s position:

Under § 154(b)(1)(A), “A delay” is calculated based on the time that passes between the fourteen-month deadline and the mailing of the first Office action. The statute does not require that the first Office action be correct. The statute does not require that the first Office action ultimately stand, either completely unaltered or with only minor tweaks. The statute does not award additional A delay if an applicant successfully convinces the PTO that the Office action was erroneous. And the statute does not provide, either explicitly or implicitly, that an Office action, once taken, can be rendered a nullity

A Question of Fact or Law? 

The district court noted that while both the patentee and the USPTO had stated that no facts were in dispute,  both offered different characterizations of the prosecution history. The court cited the APA for the principle that its authority to overturn USPTO findings of fact is very limited:

Under the APA, the Court functions as an appellate authority addressing legal questions, … and only in rare circumstances, not present here, will the Court disturb the agency’s factual findings.

Indeed, as long as the USPTO’s factual findings are supported by “substantial evidence,” they will be upheld under APA review.

Clarifying the Record During Prosecution

In both the Supplemental Response after the first Restriction Requirement and the  Response to the second Restriction Requirement, the applicant described the first Restriction Requirement as being “vacated.” However, the court gave deference to the USPTO’s finding that the record did not indicate that the Examiner ever had indicated or agreed that the first Restriction Requirement was vacated. This decision indicates that such factual issues should be clarified and resolved with the USPTO, because they are not likely to be won in a district court challenge where a deferential standard of review will be applied.

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