Information Under 37 CFR 1.56(a)

37 CFR 1.56  Duty to disclose information material to patentability.

(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until the claim is cancelled or withdrawn from consideration, or the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claim that is cancelled or withdrawn from consideration need not be submitted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)

-

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.

*****

The language of

37 CFR 1.56

(and

37 CFR 1.555

)

emphasizes that there is a duty of candor and good faith which is broader than the duty

to disclose material information.

37 CFR 1.56

further states that “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.” Specifically, the duty of candor and good faith, and by

extension the duty to disclose, applies to positions taken by applicants or parties

involving the claimed subject matter.

If a party to a USPTO proceeding discovers that an

earlier position taken in a submission to the USPTO or another Government agency was

incorrect or inconsistent with other statements made by the party, the party must

promptly correct the record. See, e.g.,

In re Tendler,

Proceeding No.

D2013-17 (USPTO Jan

e, applies to positions taken by applicants or parties

involving the claimed subject matter.

If a party to a USPTO proceeding discovers that an

earlier position taken in a submission to the USPTO or another Government agency was

incorrect or inconsistent with other statements made by the party, the party must

promptly correct the record. See, e.g.,

In re Tendler,

Proceeding No.

D2013-17 (USPTO Jan. 1, 2014) (suspending a practitioner for four years for failure to

correct the written record after learning of inaccuracies in a declaration the

practitioner had filed). In the context of prosecution, an applicant must disclose to

the USPTO any information that 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. See

37 CFR

1.56(b)(2)

. Patent owners may bring information, including prior

art and incorrect or inconsistent positions, to the attention of the USPTO through

supplemental examination,

ex parte

reexamination, reissue

applications, or submissions under

37 CFR 1.501

. During prosecution,

third parties may have an opportunity to disclose information to the USPTO through third

party submissions under

37 CFR 1.290

and protests under

37 CFR

1.291

. After issuance, third parties may disclose information

directed to issued patents to the USPTO via submissions under

37 CFR 1.501

, or

in

ex parte

reexamination. A finding of “fraud,” “inequitable

conduct,” or violation of duty of disclosure through bad faith or intentional misconduct

with respect to any claim in an application or patent, renders all the claims thereof

unpatentable or invalid. See

MPEP § 2016

.

The Office strives to issue valid patents. The Office has both an

obligation not to unjustly issue patents and an obligation not to unjustly deny patents.

Innovation and technological advancement are best served when an inventor is issued a

patent with the scope of protection that is deserved

aim in an application or patent, renders all the claims thereof

unpatentable or invalid. See

MPEP § 2016

.

The Office strives to issue valid patents. The Office has both an

obligation not to unjustly issue patents and an obligation not to unjustly deny patents.

Innovation and technological advancement are best served when an inventor is issued a

patent with the scope of protection that is deserved. The rules serve to remind

individuals associated with the preparation and prosecution of patent applications of

their duty of candor and good faith in their dealings with the Office, and will aid the

Office in receiving, in a timely manner, the information it needs to carry out effective

and efficient examination of patent applications. Moreover, an incentive exists to

submit material information to the Office because it may result in enhanced patent

quality and may avoid later questions of materiality and intent to deceive.

The definition of materiality in

37 CFR 1.56

is intended to provide

the Office with the information it needs in order for the examiner to make a proper and

independent determination on patentability. The patent examiner should make the

patentability determination after considering the relevant facts properly of record in

the particular case.

37 CFR

1.56

states that each individual associated with the filing and

prosecution of a patent application has a duty to disclose all information known to that

individual to be material to patentability as defined in the section. Thus, the duty

applies to contemporaneously or presently known information. The fact that information

was known years ago does not mean that it was recognized that the information is

material to the present application.

The term “information” as used in

37 CFR 1.56

means all of the kinds

of information required to be disclosed and includes any information which is “material

to patentability.” Materiality is defined in

37 CFR 1.56(b)

and discussed herein

at

MPEP

§ 2001.05

The fact that information

was known years ago does not mean that it was recognized that the information is

material to the present application.

The term “information” as used in

37 CFR 1.56

means all of the kinds

of information required to be disclosed and includes any information which is “material

to patentability.” Materiality is defined in

37 CFR 1.56(b)

and discussed herein

at

MPEP

§ 2001.05

. In addition to prior art such as patents and

publications,

37 CFR

1.56

includes, for example, information on enablement, possible

prior public uses, sales, offers to sell, derived knowledge, prior invention by another,

inventorship conflicts, litigation statements, and the like. “Materiality is not limited

to prior art but embraces

any

information that a reasonable examiner

would be substantially likely to consider important in deciding whether to allow an

application to issue as a patent.”

Bristol-Myers Squibb Co. v. Rhone-Poulenc

Rorer, Inc.

, 326 F.3d 1226, 1234, 66 USPQ2d 1481, 1486 (Fed. Cir. 2003)

(emphasis in original) (finding article which was not prior art to be material to

enablement issue).

Patent examiners also have the ability to require

submission of information that may be reasonably necessary to properly examine or treat

a matter in a pending or abandoned application, but not necessarily “material to

patentability.”

37

CFR 1.105(a)(1)

. The information that must be submitted to comply

with a requirement for information under

37 CFR 1.105

may not be material to

patentability in itself under

37 CFR 1.56

, but it is necessary to

obtain a complete record from which a determination of patentability may be made. See

MPEP §

704.12(a)

. Therefore, when an examiner has a reasonable basis

to conclude that an individual identified under

37 CFR 1.56(c)

or any assignee has

information that would aid in the examination of the application or treatment of some

matter, the examiner may require submission of information that is not necessarily

material to patentability

ch a determination of patentability may be made. See

MPEP §

704.12(a)

. Therefore, when an examiner has a reasonable basis

to conclude that an individual identified under

37 CFR 1.56(c)

or any assignee has

information that would aid in the examination of the application or treatment of some

matter, the examiner may require submission of information that is not necessarily

material to patentability. This requirement could include statements made or information

submitted to other Government agencies such as the FDA. See

MPEP §

2015

. For example, when examining a claim directed to a

process of manufacturing a particular drug product that was effectively filed more than

one year after FDA approval of the drug product, an examiner may appropriately require

an applicant to submit to the USPTO information submitted to the FDA (e.g., in a New

Drug Application or Biologics License Application) on how the drug product was

manufactured.

The term “information” is intended to be all encompassing, similar to

the scope of the term as discussed with respect to

37 CFR 1.291(a)

(see

MPEP

§ 1901.02

).

37 CFR 1.56(a)

also states: “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.”

It should be noted that the rules are

not

intended

to require information

favorable

to patentability such as, for

example, evidence of commercial success of the invention. Similarly, the rules are not

intended to require, for example, disclosure of information concerning the level of

skill in the art for purposes of determining obviousness.

37 CFR

1.56(a)

states that the duty to disclose information exists until

the application becomes abandoned

d

to require information

favorable

to patentability such as, for

example, evidence of commercial success of the invention. Similarly, the rules are not

intended to require, for example, disclosure of information concerning the level of

skill in the art for purposes of determining obviousness.

37 CFR

1.56(a)

states that the duty to disclose information exists until

the application becomes abandoned. The duty to disclose information, however, does not

end when an application becomes allowed but extends until a patent is granted on that

application. The rules provide for information being considered after a notice of

allowance is mailed and before the issue fee is paid (

37 CFR 1.97(d)

)

(see

MPEP § 609.04(b),

subsection III

). The rules also provide for an application to

be withdrawn from issue:

(A) because one or more claims are unpatentable (

37 CFR

1.313(c)(1)

);

(B) for express abandonment so that information may be considered in

a continuing application before a patent issues (

37 CFR

1.313(c)(3)

); or

(C) for consideration of a request for continued examination (RCE)

under

37 CFR

1.114

(

37 CFR 1.313(a)

and

(c)(2)

). Note that RCE practice does not apply to utility

or plant applications filed before June 8, 1995 or to design applications. See

MPEP §

706.07(h)

.

See

MPEP

§ 1308

for additional information pertaining to withdrawal of

an application from issue.

In a continuation-in-part application, individuals covered by

37 CFR

1.56

have a duty to disclose to the Office all information known

to be material to patentability which became available between the filing date of the

prior application and the national or PCT international filing date of the

continuation-in-part application. See

37 CFR 1.56(e)

.

37 CFR

1.56

provides that the duty of disclosure can be met by submitting

information to the Office in the manner prescribed by

37 CFR 1.97

and

1.98

. See

MPEP § 609

et seq

tion known

to be material to patentability which became available between the filing date of the

prior application and the national or PCT international filing date of the

continuation-in-part application. See

37 CFR 1.56(e)

.

37 CFR

1.56

provides that the duty of disclosure can be met by submitting

information to the Office in the manner prescribed by

37 CFR 1.97

and

1.98

. See

MPEP § 609

et seq

. Applicants are provided certainty as to when information will

be considered, and applicants will be informed when information is not considered. Note,

however, if even a document was cited to or considered in a prior examination or related

Office proceeding, the Office may order reexamination based on the document if it raises

a substantial new question of patentability. See

MPEP § 2242

and

MPEP § 2258.01

.

37 CFR 1.555

provides for the duty

of disclosure in reexamination proceedings. For a discussion of information material to

patentability in a reexamination proceeding, see

MPEP § 2280

or

MPEP § 2684

. For

supplemental examination and any

ex parte

reexamination proceeding

ordered under

35 U.S.C. 257

, information material

to patentability is defined by

37 CFR 1.56

. See

37 CFR

1.625(d)(4)

and

MPEP §

2820

.