Supplemental Examination

35 U.S.C. 257

Supplemental examinations to consider, reconsider, or correct information.

(a) REQUEST FOR SUPPLEMENTAL EXAMINATION.—A patent

owner may request supplemental examination of a patent in the Office to consider,

reconsider, or correct information believed to be relevant to the patent, in

accordance with such requirements as the Director may establish. Within 3 months

after the date a request for supplemental examination meeting the requirements of

this section is received, the Director shall conduct the supplemental examination

and shall conclude such examination by issuing a certificate indicating whether

the information presented in the request raises a substantial new question of

patentability.

(b) REEXAMINATION ORDERED.—If the certificate issued

under subsection (a) indicates that a substantial new question of patentability is

raised by 1 or more items of information in the request, the Director shall order

reexamination of the patent. The reexamination shall be conducted according to

procedures established by chapter 30, except that the patent owner shall not have

the right to file a statement pursuant to section 304. During the reexamination,

the Director shall address each substantial new question of patentability

identified during the supplemental examination, notwithstanding the limitations in

chapter 30 relating to patents and printed publication or any other provision of

such chapter.

(c) EFFECT.—

(1) IN GENERAL.—A patent shall not be held

unenforceable on the basis of conduct relating to information that had not

been considered, was inadequately considered, or was incorrect in a prior

examination of the patent if the information was considered, reconsidered,

or corrected during a supplemental examination of the patent. The making of

a request under subsection (a), or the absence thereof, shall not be

relevant to enforceability of the patent under section 282.

f conduct relating to information that had not

been considered, was inadequately considered, or was incorrect in a prior

examination of the patent if the information was considered, reconsidered,

or corrected during a supplemental examination of the patent. The making of

a request under subsection (a), or the absence thereof, shall not be

relevant to enforceability of the patent under section 282.

(2) EXCEPTIONS.—

(A) PRIOR ALLEGATIONS.—Paragraph (1) shall

not apply to an allegation pled with particularity in a civil action,

or set forth with particularity in a notice received by the patent

owner under section 505(j)(2)(B)(iv)(II) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(j)(2)(B)(iv)(II)), before the date of

a supplemental examination request under subsection (a) to consider,

reconsider, or correct information forming the basis for the

allegation.

(B) PATENT ENFORCEMENT ACTIONS.—In an action

brought under section 337(a) of the Tariff Act of 1930 (19 U.S.C.

1337(a)), or section 281 of this title, paragraph (1) shall not apply

to any defense raised in the action that is based upon information

that was considered, reconsidered, or corrected pursuant to a

supplemental examination request under subsection (a), unless the

supplemental examination, and any reexamination ordered pursuant to

the request, are concluded before the date on which the action is

brought.

(d) FEES AND REGULATIONS.—

(1) FEES.—The Director shall, by regulation,

establish fees for the submission of a request for supplemental examination

of a patent, and to consider each item of information submitted in the

request. If reexamination is ordered under subsection (b), fees established

and applicable to

ex parte

reexamination proceedings

under chapter 30 shall be paid, in addition to fees applicable to

supplemental examination.

e Director shall, by regulation,

establish fees for the submission of a request for supplemental examination

of a patent, and to consider each item of information submitted in the

request. If reexamination is ordered under subsection (b), fees established

and applicable to

ex parte

reexamination proceedings

under chapter 30 shall be paid, in addition to fees applicable to

supplemental examination.

(2) REGULATIONS.—The Director shall issue

regulations governing the form, content, and other requirements of requests

for supplemental examination, and establishing procedures for reviewing

information submitted in such requests.

(e) FRAUD.—If the Director becomes aware, during the

course of a supplemental examination or reexamination proceeding ordered under

this section, that a material fraud on the Office may have been committed in

connection with the patent that is the subject of the supplemental examination,

then in addition to any other actions the Director is authorized to take,

including the cancellation of any claims found to be invalid under section 307 as

a result of a reexamination ordered under this section, the Director shall also

refer the matter to the Attorney General for such further action as the Attorney

General may deem appropriate. Any such referral shall be treated as confidential,

shall not be included in the file of the patent, and shall not be disclosed to the

public unless the United States charges a person with a criminal offense in

connection with such referral.

red under this section, the Director shall also

refer the matter to the Attorney General for such further action as the Attorney

General may deem appropriate. Any such referral shall be treated as confidential,

shall not be included in the file of the patent, and shall not be disclosed to the

public unless the United States charges a person with a criminal offense in

connection with such referral.

(f) RULE OF CONSTRUCTION.—Nothing in this section shall

be construed—

(1) to preclude the imposition of sanctions based

upon criminal or antitrust laws (including section 1001(a) of title 18, the

first section of the Clayton Act, and section 5 of the Federal Trade

Commission Act to the extent that section relates to unfair methods of

competition);

(2) to limit the authority of the Director to

investigate issues of possible misconduct and impose sanctions for

misconduct in connection with matters or proceedings before the Office; or

(3) to limit the authority of the Director to

issue regulations under chapter 3 relating to sanctions for misconduct by

representatives practicing before the Office.

35 U.S.C.

257(a)

provides that supplemental examination may be requested by the

patent owner to consider, reconsider, or correct information believed to be relevant to the

patent in accordance with requirements established by the Office. The information presented

in a request for supplemental examination is not limited to patents and printed

publications, and may include, for example, issues of patentability under

35 U.S.C. 101

and

112

. Within three months of the receipt of a request for

supplemental examination (meeting the requirements of

35 U.S.C.

257

including the requirements established by the Office), the Office

shall conduct a supplemental examination and conclude the supplemental examination

proceeding with the issuance of a supplemental examination certificate

ample, issues of patentability under

35 U.S.C. 101

and

112

. Within three months of the receipt of a request for

supplemental examination (meeting the requirements of

35 U.S.C.

257

including the requirements established by the Office), the Office

shall conduct a supplemental examination and conclude the supplemental examination

proceeding with the issuance of a supplemental examination certificate. The supplemental

examination certificate shall indicate whether the items of information presented in the

request raise a substantial new question of patentability.

If the supplemental examination certificate, issued under

35 U.S.C.

257(a)

, indicates that a substantial new question of patentability is

raised by one or more items of information in the request for supplemental examination, the

supplemental examination certificate will indicate that

ex parte

reexamination will be ordered by the Office. The resulting

ex parte

reexamination proceeding will be conducted according to

ex parte

reexamination procedures, except that the patent owner does not have the right to file a

statement pursuant to

35

U.S.C. 304

, and the basis of the

ex parte

reexamination is not limited to patents and printed publications. Each substantial new

question of patentability identified during the supplemental examination proceeding will be

addressed by the Office during the resulting

ex parte

reexamination

proceeding. See

35 U.S.C. 257(b)

.

35 U.S.C.

257(c)

specifies the effect of a supplemental examination under

35 U.S.C.

257(a)

and any resulting

ex parte

reexamination

under

35 U.S.C.

257(b)

on the enforceability of the patent.

35 U.S.C.

257(d)(1)

provides the Director with authority to establish fees for

filing a request for supplemental examination and for considering each item of information

submitted with the request. If

ex parte

reexamination is ordered under

35 U.S.C.

257(b)

,

35 U.S.C. 257(d)(1)

also establishes

that the fees applicable to

ex parte

reexamination must be paid in

addition to the fees for supplemental examination

(d)(1)

provides the Director with authority to establish fees for

filing a request for supplemental examination and for considering each item of information

submitted with the request. If

ex parte

reexamination is ordered under

35 U.S.C.

257(b)

,

35 U.S.C. 257(d)(1)

also establishes

that the fees applicable to

ex parte

reexamination must be paid in

addition to the fees for supplemental examination.

35 U.S.C.

257(d)(2)

provides the Director with authority to establish

regulations governing the requirements of a request for supplemental examination, including

its form and content.

In accordance with

35 U.S.C.

257(e)

, if the Office becomes aware, during the course of a

supplemental examination or

ex parte

reexamination ordered under

35 U.S.C.

257

, that a material fraud on the Office may have been committed in

connection with the patent that is the subject of the supplemental examination, the Office

shall refer the matter to the U.S. Attorney General, in addition to any other actions the

Office is authorized to take, including the cancellation of any claims found to be invalid

under

35 U.S.C.

307

as a result of

ex parte

reexamination ordered

under

35 U.S.C.

257

. The Office anticipates that such instances will be rare. The

Office regards the term

"material fraud"

in

35 U.S.C.

257(e)

to be narrower in scope than inequitable conduct as defined by

the U.S. Court of Appeals for the Federal Circuit in

Therasense, Inc. v. Becton,

Dickinson & Co.,

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

Nothing in

35 U.S.C. 257

precludes the imposition

of sanctions based upon criminal or antitrust laws (including 18 U.S.C. 1001(a)), the first

section of the Clayton Act, and section 5 of the Federal Trade Commission Act to the extent

that section relates to unfair methods of competition.

See

35 U.S.C.

257(f)(1)

. Section 12 of the AIA sets forth rules of construction,

providing that

35 U.S.C

011).

Nothing in

35 U.S.C. 257

precludes the imposition

of sanctions based upon criminal or antitrust laws (including 18 U.S.C. 1001(a)), the first

section of the Clayton Act, and section 5 of the Federal Trade Commission Act to the extent

that section relates to unfair methods of competition.

See

35 U.S.C.

257(f)(1)

. Section 12 of the AIA sets forth rules of construction,

providing that

35 U.S.C. 257

shall not be construed to limit the authority of the

Office to investigate issues of possible misconduct and impose sanctions for misconduct

involving matters or proceedings before the Office, or to issue regulations under

35 U.S.C.

32

or

35 U.S.C. 33

relating to sanctions for

misconduct by patent practitioners.

See

35 U.S.C.

257(f)(2)

and

35 U.S.C. 257(f)(3)

.

[top]