172期
2016 年 11 月 16 日
  北美智權官網 歷期電子報 / 訂閱電子報  
 
USPTO提案修訂IDS應呈報資訊實質關聯性定義要件
黃蘭閔/北美智權法規研究組

USPTO發布37 CFR 1.56、1.555修法提案,重點在於調整IDS應呈報資訊的實質關聯性(Materiality)要件定義,以符合Therasense案Federal Circuit聯席審判及相關判例揭示原則。儘管此次公告並非正式修法,從中可窺見USPTO如何解讀相關判例、對實質關聯性標準有何認知,仍具參考價值。

USPTO發布37 CFR 1.56、1.555修法提案[1],邀請公眾在2016年12月27日前回覆修改意見。綜觀此次提案內容,並不包括IDS呈報操作程序規則的變更,主要是為調整IDS應呈報資訊的實質關聯性(Materiality)要件定義,以符合先前判例揭示原則。儘管此次公告並非正式修法,從中仍可窺見USPTO如何解讀相關判例、對實質關聯性有何認知,因此仍值得留意。

依美國專利制度規則,專利申請人及Reexamination程序專利所有權人有義務呈報與發明內容可專利性實質相關的資訊,違反呈報義務可能被視為涉及不正行為(Inequitable Conduct),進而導致有效專利的專利權無法實施(Unenforceable)。但不正行為罪名成立需同時滿足兩大要件,即欺騙意圖,及未(如實)呈報的資訊具實質關聯性,而2011年5月25日美國聯邦巡迴上訴法院(US Court of Appeals for the Federal Circuit;簡稱Fed. Cir.)公告Therasense案聯席審判(en banc)判決結果[2],大幅拉高兩大要件的構成門檻。

2011年7月21日USPTO其實已發布修法提案[3],近兩個月的意見徵集期間,共收到24份書面回覆意見[4],其中不乏呈報程序修改提議,包括廢除呈報義務、讓呈報義務期間提前於繳領證費(Issue Fee)時終止、申請人傳送資訊予代理律師即視為已盡呈報義務、關聯案不需互提IDS呈報、限縮關聯案定義等,不過USPTO此次提案皆未採納,僅表示新提案不要求說明呈報文獻與發明內容的關聯,且該局目前正在研擬新辦法,希望能讓審查人員盡早收到關聯案引證清單、檢索結果等資訊,可是在新辦法公布之前,申請人仍應按現行法規以IDS呈報規定資訊。

此外,USPTO前次修法提案直接於條文點名Therasense案,但此次略有變動:一是不直接提及Therasense案,改以其判決中的But-For標準定義實質關聯性,取代現行法條的Prima Facie標準;二是判決中所提積極的惡質不法行為(affirmative egregious misconduct),不用以定義實質關聯性,但仍明文規定屬不予專利行為。

判斷一先前技術文獻是否構成But-For實質關聯性要件、是否為應呈報資訊,重點在於,採用優勢證據(Preponderance of the Evidence)標準的情況下,依專利說明書給予請求項最廣合理解釋(Broadest Reasonable Construction),若審查委員會因為知道存在這一先前技術文獻而否准該請求項,又或者說,若非審查委員不知道存在這一先前技術文獻,該請求項本來不應核准,那麼,這一先前技術文獻就構成了But-For實質關聯性要件,屬於應呈報資訊。

法院審理不正行為案件是否構成實質關聯性要件,其標準與USPTO IDS呈報義務的實質關聯性標準未必相同,但USPTO指出,歷來Fed. Cir.審理這類案件,都會參考USPTO IDS呈報義務的實質關聯性標準,因此USPTO改以Fed. Cir.所採標準定義IDS呈報義務的實質關聯性標準,自也理所當然。Therasense案判決已是Fed. Cir.聯席審判結果,其結論若真為後續的Fed. Cir.聯席審判或最高法院判決推翻,屆時USPTO將再考慮修訂法條文字,同時USPTO也承諾會透過MPEP公布該局對相關判例的理解。

而所謂積極的惡質不法行為,USPTO公告中整理了Therasense案判決教示及近年判例,大致包括以下類型:針對USPTO及法院蓄意計畫並小心執行的欺騙計畫、偽證、呈報不實證據、隱匿證據、提交明顯虛偽的宣誓書(Affidavit)、以不實方式對BPAI(PTAB前身)提出證據陳述、提交虛偽宣誓書(Affidavit)且未更正錯誤。但若單純只是未揭露先前技術文獻、未於宣誓書(Affidavit)提及先前技術、未更新Petition to Make Special,這些未作為本身還不算是積極的惡質不法行為。

以下是37 CFR 1.56(a)、(b)有關專利申請呈報義務的修法提案,37 CFR 1.555 Reexamination程序呈報義務也有類似的提案內容。

37 CFR

現行條文

修法提案

本次

前次

1.56(a)

A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b)-(d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:
(1) Prior art cited in search reports of a foreign patent office in a counterpart application, and
(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.

A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability under the but-for materiality standard as defined in paragraph (b) of this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b) through (d) and 1.98. However, no patent will be granted on an application in connection with which affirmative egregious misconduct was engaged in, fraud on the Office was practiced or attempted, or the duty of disclosure was violated through bad faith or intentional misconduct.
The Office encourages applicants to carefully examine:
(1) Prior art cited in search reports of a foreign patent office in a counterpart application, and
(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.

(無修改)

1.56(b)

Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.
A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.

Information is but-for material to patentability if the Office would not allow a claim if the Office were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction consistent with the specification.

Information is material to patentability if it is material under the standard set forth in Therasense, Inc. v. Becton, Dickinson & Co., F.3d (Fed. Cir. 2011). Information is material to patentability under Therasense if:
(1) The Office would not allow a claim if it were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction; or
(2) The applicant engages in affirmative egregious misconduct before the Office as to the information.

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