Threshold of notice requirement for “A-delay” in PTA determination

| February 3, 2016

Pfizer Inc. v. Lee

January 22, 2016

Before:  Newman, DYK and O’Malley. Opinion by O’Malley. Dissenting opinion by Newman.


Appellants (Pfizer) challenged the district court’s decision that denied their motion for acquiring additional part of A-delay by excluding a withdrawn office action as non-event for the A-delay. CAFC affirmed the district court’s decision.

35 U.S.C. § 154(b)は出願後14カ月以内に「at least one of the notifications under section 132」(いわゆるオフィスアクション)が出願人に通知されない場合は、その遅れた分の特許期間延長を認める(PTAのA-delayと呼ばれる)。本件では、最初のオフィスアクションとしてリストリクション要求(クレームに複数の発明が記載されていると認定すると審査官は特定の発明を出願人に選択させる要求)が審査官から出された。ところが、発明分類から漏れた従属クレームがあったため、審査官は最初のリストリクション要求を取り下げて、訂正したリストリクション要求を出し直した。特許庁は、初回と訂正の2つのリストリクション要求の間の197日をPTAのA-delayとして加えることなく、最初のリストリクション要求の送達日に基づいてPTAの計算を行った。連坊地裁において、特許権者は訂正リストリクション要求の日を基準にPTAを計算するべきであり、197日の追加を主張した。連邦地裁は197日を認めない判決を出した。

CAFCは地裁の判断を支持した。CAFCの多数意見は、35 U.S.C. § 154(b)の要件を緩く解釈し、「at least one of the notifications under section 132」の内容が広い意味での拒絶原因(“the broad statutory basis for the rejection”)と、出願人が応答可能な程度の情報量(sufficient information)を提示している場合に該当するので、本件の最初のリストリクション要求は、35 U.S.C. § 154(b)が要求する「通知」であると判断した。従属クレームの欠落程度は、出願人が応答できないほどの不備ではなく、審査官とのやり取りの結果リストリクション要求が出し直されたが、これは審査での通常のやり取りの範囲内であり、最初のリストリクションが取り下げられたという事実だけをもってして、特許期間の延長を認めないという判断である。これに対して、Newman判事はオフィスアクションの不備は出願人の責任ではなく、あきらかに特許庁の責任であり、特許期間の延長を認めるべきとの反対意見を述べた。


I.  Background

35 U.S.C. § 154(b) awards “A-delay” as part of PTA in a case where “the issue of an original patent is delayed due to the failure of the Patent and Trademark Office to (i) provide at least one of the notifications under section 132 or … not later than 14 months after (I) the date on which an application was filed.”

Section 132 states: “Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application.”

On May 2, 2003, applicants (Wyeth later acquired by Pfizer) filed a patent application in PTO.

On August 10, 2005, an office action (a first restriction requirement) was mailed to the applicants.

On February 6, 2006, the applicants conducted a telephone interview to inform the examiner of a fact that certain dependent claims were omitted in the office action, and requested regrouping of one dependent clam into proper classification.

197 days after the mailing of the first restriction, on February 23, 2006, the examiner withdrew the first restriction and issued a corrected restriction requirement including the omitted claims.

In issuing a patent, the PTO did not count in PTA calculation the 197 days between the first restriction requirement and the corrected restriction requirement.

The district court denied Pfizer’s motion for correcting the A-delay period to add 197 days.

II.  Issue

The issue is whether the first restriction requirement qualifies as “at least one of the notifications under section 132” to stop the clock for the PTO-caused “A-delay. “ There is no dispute about the facts, but a “pure question of statutory interpretation.”

III. CAFC’s decision

CAFC held that the first restriction requirement met the notice requirement under 35 U.S.C. § 154(b) and Section 132.

As decided in Chester (Chester v. Miller), “Section 132 is violated when a rejection is so uninformative that it prevents the applicant from recognizing and seeking to counter the grounds for rejection” and “the PTO does not have to “explicitly preempt every possible response to a section 102 rejection.” Citing Chester, CAFC framed the issues as whether (i) the office action at issue informed the applicant of “the broad statutory basis for the rejection” and (ii) it was “sufficiently informative” to allow the applicant to counter the grounds for rejection.

Pfizer argued that the first restriction did not satisfy the notice requirement because six dependent claims were omitted examiner’s defined invention groups and withdrew the first restriction and therefore, the first restriction “should be treated as non-event.”

CAFC rejected the appellants’ argument, looking into the type of error made by the examiner and back and forth communications made between the examiner and the applicants. As to the type of error, the omitted claims are dependent claims, while the classification of all independent claims was not disputed and remained the same in the second restriction. CAFC held that the dependent claims “would naturally have been classified” to the invention groups for their independent claims, and the first restriction “did not require significant guesswork for the applicants.” CAFC found that the first restriction was sufficient informative.

In response to the second restriction, the applicants made a request to change the grouping of one of the omitted claims, and the examiner was persuaded to regroup the claim when the restriction was made final. Pfizer did not explained a reason why they could not suggest the proposed classification of the omitted dependent claims by responding to the first restriction requirement. CAFC viewed the course of prosecution as a normal back and forth process for the purpose of prosecution, and held: “viewed as a whole, the restriction requirement provided adequate grounds on which the applicants could ‘recogniz[e] and seek[] to counter the grounds for rejection.’”

In UMass (University of Massachusetts v. Kappos), CAFC held: “[w]hile the process of patent prosecution often involves changes in both the applicant’s and examiner’s positions, an examiner’s reissuance of an office action in response to an applicant’s suggestion does not automatically mean that an application has been ‘delayed’ for purposes of patent term adjustment.” CAFC distinguished UMass and this case from Oncolytics (In r: Patent) and Janssen (Janssen Pharmaceutica, N.V. v. Rea) in which “the examiner rescinded and replaced the issued restriction requirements without explanation and without prompting from the applicants” In these cases, additional PTA was awarded because the office action was considered “outside the normal ‘give-and-take process’ of patent prosecution.” According to CAFC, in the present case, the first restriction requirement was considered sufficient to trigger the “normal back and forth” process between the applicants and the examiner, and therefore, put the applicants on the notice.

Dissenting opinion

Newman dissented, noting that the 197-day delay actually occurred because of the “facially incomplete” initial restriction requirement and not because of applicants’ error at all, and this is the “admitted PTO-caused delay.”

Newman read the precedent cases differently, stating that the Chester court “held only that Section 132 does not require the PTO to state specifically that a prior art reference describes and enables claims rejected as anticipated” and did not concluded that “a less-than-complete Office action would comply with Section 132.” Newman’s view is that the facially incomplete Office action in this case was outside the normal give-and-take process of patent prosecution, and is different from UMass where an examiner withdrew a rejection or restriction as a result of applicants’ assertions.

Take Away

PTA calculations done by PTO look automatic and correct in most cases, but still need to carefully be checked by looking at the type of error and possible response to a withdrawn office action, if any.

Full Opinion

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