Requirements for Compliance and Consequences of Non-Compliance

[Editor Note: This section is not applicable to applications filed on or after

July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined

in

37

CFR 1.831(b)

. See

MPEP §§

2412

-

2419

for guidance on WIPO ST.26

requirements for applications filed on or after July 1, 2022.]

37 CFR

1.821(g)

requires compliance with the requirements of

37 CFR

1.821(b)

through

(e)

, as discussed above, if they are

not satisfied at the time of filing under

35 U.S.C. 111(a)

or at the time of

entering the national stage of an international application under

35 U.S.C. 371

,

within the period of time set in a notice requiring compliance. When applicant files an

amendment to comply with the requirements of

37 CFR 1.821(g)

and that amendment

adds or replaces a “Sequence Listing” and CRF copy thereof, the amendment must be

submitted in accordance with the requirements of

37 CFR 1.825

. Failure to provide a

proper reply in compliance with

37 CFR 1.825

will result in the

abandonment of the application. See

MPEP § 2426

. Extensions of time in

which to reply to a requirement under this paragraph are available pursuant to

37 CFR

1.136

. Note, however, that patent applications filed under

35 U.S.C.

111

on or after December 18, 2013, and international patent

applications in which the national stage commenced under

35 U.S.C. 371

on

or after December 18, 2013, may be subject to reductions in patent terms adjustment

pursuant to

37 CFR 1.704(c)(13)

if they are not in condition for examination

within eight months from the filing date or date of commencement, respectively. “In

condition for examination” includes compliance with

37 CFR 1.821

through

1.825

(see

37 CFR 1.704(f)

).

Provisional applications filed under

35 U.S.C. 111(b)

need not comply with

37 CFR 1.821

through

1.825

, however, applicants are

encouraged to file a “Sequence Listing” as defined in

37 CFR 1.821(c)

for ease of identification of the sequence information contained in the provisional

application

“In

condition for examination” includes compliance with

37 CFR 1.821

through

1.825

(see

37 CFR 1.704(f)

).

Provisional applications filed under

35 U.S.C. 111(b)

need not comply with

37 CFR 1.821

through

1.825

, however, applicants are

encouraged to file a “Sequence Listing” as defined in

37 CFR 1.821(c)

for ease of identification of the sequence information contained in the provisional

application.

If any of the requirements of

37 CFR

1.821(e)(3)

are not satisfied at the time of filing an

international application under the Patent Cooperation Treaty (PCT), and the application

is to be searched by the United States International Searching Authority or examined by

the United States International Preliminary Examining Authority, the applicant may be

sent a notice necessitating compliance with the requirements within a prescribed time

period. Where a sequence listing under

PCT Rule 13ter

is provided in reply

to a under

37 CFR

1.821(h)

, the sequence listing must be accompanied by a statement

that the information recorded in the ASCII plain text file under

37 CFR

1.821(e)(3)(i)

is identical to the sequence listing contained in

the international application as filed, or does not go beyond the disclosure in the

international application as filed, as applicable. Such a statement may be made by a

registered practitioner, the applicant, an inventor, or the person who actually compares

the sequence data on behalf of the aforementioned. Also, the ASCII plain text file under

37 CFR

1.821(e)(3)(i)

must be accompanied by the late furnishing fee, as

set forth in

37 CFR 1.445(a)(5)

. International

applications that fail to comply with any of the requirements of

37 CFR

1.821(e)(3)

will be searched and/or examined only to the extent

possible without the benefit of the information in computer readable form. See

PCT Administrative

Instructions Section 513(c)

text file under

37 CFR

1.821(e)(3)(i)

must be accompanied by the late furnishing fee, as

set forth in

37 CFR 1.445(a)(5)

. International

applications that fail to comply with any of the requirements of

37 CFR

1.821(e)(3)

will be searched and/or examined only to the extent

possible without the benefit of the information in computer readable form. See

PCT Administrative

Instructions Section 513(c)

.

The requirement to submit a statement that a submission in reply to the

requirement under

37

CFR 1.821(h)

does not go beyond the disclosure in the application

as filed or that the information recorded in the ASCII plain text file under

37 CFR

1.821(e)(3)(i)

is identical to the sequence listing contained in

the international application as filed is not the first instance in which the applicant

has been required to ensure that there is not new matter upon amendment. The requirement

is analogous to that found in

37 CFR 1.125

regarding substitute

specifications. When a substitute specification is required because the number or nature

of amendments would make it difficult to examine the application, the applicant must

include a statement that the substitute specification includes no new matter. The

necessity of requiring sequence information as an ASCII plain text file is similar to

the necessity of requiring a substitute specification and, likewise, the burden is on

the applicant to ensure that no new matter is added. Applicants have a duty to comply

with the statutory prohibition (

35 U.S.C. 132

and

35 U.S.C. 251

)

against the introduction of new matter.

The correction of errors in sequencing or any other errors that are

made in describing an invention are subject to the statutory prohibition

(

35 U.S.C.

132

and

35 U.S.C. 251

) against the

introduction of new matter.