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。
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。
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。
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 The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application.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.
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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.
