Duty of Candor

The duty of candor is a legal obligation under 37 C.F.R. § 1.56 to disclose to the USPTO all information known to be material to the patentability of the claimed invention: STATUTORY BASIS: the duty is codified in 37 C.F.R. § 1.56; it is grounded in the equitable principle that the patent applicant must deal fairly with the USPTO, which must rely on the applicant's representations because it cannot independently investigate all facts; WHO HAS THE DUTY: (a) each inventor named in the application; (b) each attorney or agent who prepares or prosecutes the application; (c) every other person who is substantively involved in the preparation or prosecution of the application AND who is associated with the inventor, the applicant, or the assignee; 'substantively involved' includes people who: review the application, provide prior art, advise on claim scope, or participate in prosecution decisions; WHO DOES NOT HAVE THE DUTY: people who merely provide financial or administrative support without substantive technical or legal input; third parties who provide prior art to the applicant without being substantively involved in prosecution; SCOPE: the duty applies throughout the prosecution of the application — from filing until the application is granted or abandoned; MATERIAL INFORMATION: the duty requires disclosure of information that the individual KNOWS to be material; there is no duty to search for material information; INFORMATION DISCLOSURE STATEMENTS (IDS): the standard mechanism for fulfilling the duty of candor; an IDS lists prior art and other material information for the examiner to consider.

Materiality determines what must be disclosed — the standard has evolved with the Therasense decision: CURRENT STANDARD — THERASENSE (Fed. Cir. 2011, en banc): information is material if the USPTO would not have allowed the claim(s) BUT FOR the withheld reference or misrepresentation; this is the 'but-for' materiality standard; it requires that the information must establish a prima facie case of unpatentability — if disclosed, the examiner would have rejected the claim(s); PRE-THERASENSE STANDARD: the previous 'reasonable examiner' standard held that information was material if there was a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the claims; this was a broader standard that the Federal Circuit found led to overcrowding of IDS disclosures; THERASENSE EXCEPTION — AFFIRMATIVE EGREGIOUS MISCONDUCT: even under the but-for standard, if an applicant engages in 'affirmative egregious misconduct' (e.g., filing a false affidavit), the misconduct is material regardless of whether the claims would have been rejected; EXAMPLES OF MATERIAL INFORMATION: (1) a prior art reference that anticipates or renders obvious at least one claim; (2) contradictory data known to the inventor that undermines a patentability argument made to the examiner; (3) a prior art reference identified during a related litigation; (4) a rejection of a related foreign application based on specific prior art; (5) a claim construction by another court that contradicts the applicant's claim construction argument; NON-MATERIAL INFORMATION: cumulative information (prior art already cited by the examiner); information only tangentially related to the claims.

An IDS is the USPTO form for disclosing material information, fulfilling the duty of candor: FORM AND CONTENT: USPTO Form PTO/SB/08 (patent) or PTO/SB/08a/08b (non-patent literature); the IDS lists: (a) US patent documents (number and issue date); (b) US patent application publications; (c) foreign patent documents; (d) non-patent literature (journal articles, conference papers, product manuals); COPIES REQUIRED: applicant must submit copies of each cited document UNLESS: (a) the reference is a US patent or US published application (USPTO has its own copies); (b) the reference was previously considered by the USPTO in a related application and applicant states where; TIMELINESS — WHEN IDS IS FREE: an IDS filed before the earlier of: (a) the mailing date of a first office action on the merits; or (b) three months after the application filing date; no fee required; TIMELINESS — AFTER FIRST OFFICE ACTION: IDS filed after the first office action but before (a) the mailing of a notice of allowance OR (b) a statement that the claims have been allowed; requires a certification that each item was first cited or received after the filing of the first office action; TIMELINESS — AFTER NOTICE OF ALLOWANCE: an IDS may still be filed after a notice of allowance, but ONLY with: (a) payment of additional fee ($200 large entity); AND (b) certification that the information was first learned less than 3 months before filing; WITHOUT PROPER CERTIFICATION/FEE: an IDS filed outside the timeliness windows without the required certification or fee is NOT considered by the USPTO; the duty may not be satisfied.

Violation of the duty of candor with deceptive intent constitutes inequitable conduct, which renders the entire patent unenforceable: INEQUITABLE CONDUCT ELEMENTS (post-Therasense): (1) MATERIALITY: the withheld information or misrepresentation is material (but-for standard — patent would not have issued with the information); (2) DECEPTIVE INTENT: the person who made the disclosure decision did so with specific intent to deceive the USPTO; both elements must be proven by CLEAR AND CONVINCING evidence; THERASENSE TIGHTENED INTENT STANDARD: the Federal Circuit in Therasense eliminated the 'sliding scale' where a low materiality could be offset by high intent and vice versa; both elements must independently meet their thresholds; 'should have known' or gross negligence is insufficient — actual specific intent to deceive is required; ENTIRE PATENT UNENFORCEABLE: unlike invalidity (which can affect specific claims), inequitable conduct renders the ENTIRE PATENT unenforceable; even valid, non-obvious claims become unenforceable; INFECTIOUS UNENFORCEABILITY: related patents that share the inequitable conduct (same applicant, same attorney, same withheld prior art) may also be rendered unenforceable under the infectious unenforceability doctrine; DEFENSE STRATEGY: defendants in patent infringement cases assert inequitable conduct as an equitable defense; it requires a bench trial (not a jury); it is determined by the judge; DUTY SATISFIED BY IDS: filing an IDS that fully discloses the material information, even if the examiner ultimately allows the claims, satisfies the duty; the examiner's decision to allow after considering the information is the examiner's responsibility.

The duty of candor extends beyond the original prosecution and interacts with related proceedings: RELATED US APPLICATIONS: when a continuation, divisional, or CIP application is filed, applicants have a duty to disclose material information from the parent application that remains material; prior art cited in the parent is automatically considered; however, NEW material prior art discovered after filing the parent must be disclosed in the continuation; RELATED FOREIGN APPLICATIONS: when a patent application is filed in foreign countries, the following may be material to the US application: (a) rejections by foreign patent offices based on specific prior art; (b) claim amendments made in foreign applications to overcome rejections; (c) search reports from foreign offices identifying prior art; applicants should monitor foreign prosecution and file IDS submissions citing material foreign office actions; LITIGATION-DISCOVERED PRIOR ART: during litigation of related patents, parties may discover prior art that is material to pending applications in the same family; this art should be submitted to the USPTO in a timely IDS for any pending related applications; REEXAMINATION: during ex parte reexamination initiated by the patent owner, the duty of candor continues; the patent owner may not withhold material art from the reexamination proceeding; ANDA LITIGATION: pharmaceutical applicants facing ANDA litigation may discover prior art from Paragraph IV challengers that must be disclosed in pending divisional or continuation applications; PROACTIVE MONITORING: practitioners representing clients in patent-related litigation or licensing negotiations should implement procedures to identify and disclose material information discovered in those proceedings to the USPTO for pending applications.