Introduction

This Chapter deals with the duties owed toward the U.S. Patent and

Trademark Office by each individual who is associated with the preparation or

prosecution of the application. Each individual associated with the filing and

prosecution of a patent application, supplemental examination, or patent reexamination

has a duty to disclose to the Office all information known to that individual to be

material to patentability as defined in this section. These duties, of candor and good

faith and disclosure, have been codified in

37 CFR 1.56

and

37 CFR 1.555

, as

promulgated pursuant to carrying out the duties of the Director under Sections

2

,

3

,

131

, and

132

of Title 35 of the United States Code.

In some instances, the duty to disclose may constitute

correcting erroneous material information in the record. Effective September 16, 2012,

the America Invents Act (AIA) amended the patent laws to modify notable aspects of the

duty of disclosure. Specifically, the AIA eliminated the requirement that applicants

disclose that an error in a patent (e.g., change in inventorship) was made without any

deceptive intent before correction is permitted. See

35 U.S.C. 116

,

35 U.S.C.

251

, and

35 U.S.C. 256

. This does not negate,

however, the continuing obligation to practice candor and good faith in all dealings

before the Office.

On October 28, 2016, the Office issued a Notice of

Proposed Rulemaking proposing revisions to the materiality standard for the duty to

disclose information in patent applications and reexamination proceedings (duty of

disclosure) in light of the decision by the U.S. Court of Appeals for the Federal

Circuit (Federal Circuit) in

Therasense, Inc. v. Becton, Dickinson &

Co.,

649 F.3d 1276, 1288, 99 USPQ2d 1065 (Fed. Cir. 2011)(

en

banc

)

d a Notice of

Proposed Rulemaking proposing revisions to the materiality standard for the duty to

disclose information in patent applications and reexamination proceedings (duty of

disclosure) in light of the decision by the U.S. Court of Appeals for the Federal

Circuit (Federal Circuit) in

Therasense, Inc. v. Becton, Dickinson &

Co.,

649 F.3d 1276, 1288, 99 USPQ2d 1065 (Fed. Cir. 2011)(

en

banc

). Specifically, the Office is considering harmonizing the materiality

standard for the duty of disclosure to adopt the “but-for” materiality standard for

inequitable conduct as set forth in

Therasense

and adopted in

subsequent inequitable conduct cases, which will result in revisions to

37 CFR

1.56

and

37 CFR 1.555

. While these proposed

rule changes have not yet been finalized, it is still important for Office stakeholders

to recognize the split in how materiality may be considered within the Office and in the

courts. Some of the more instructive recent cases on inequitable conduct have been

incorporated in the discussion below to provide guidance on compliance with the duty of

disclosure regardless of the materiality standard.

On July 29, 2022, the Office issued a Federal Register

Notice reinforcing the importance of “duty of disclosure” and “duty of reasonable

inquiry”, and clarifying the scope of these duties as they relate to information and

statements material to patentability including, but not limited to, those received from

or submitted to the Food and Drug Administration (FDA) and other governmental agencies.

These duties apply during examination of patent applications, including continuation

applications, and after issuance during any post-grant examination or proceeding to

review the issued patent. See

Duties of Disclosure and Reasonable Inquiry

During Examination, Reexamination, and Reissue, and for Proceedings Before the Patent

Trial and Appeal Board,

87 FR 45764 (July 29, 2022).

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