Notification of a Failure to Comply

[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.]

With respect to the Office’s determination of compliance with the

sequence rules and the opportunities afforded applicants to satisfy the requirements of

the rules, applicants will be notified of easily detectable deficiencies early in the

application process. Applicants whose computer readable forms (which include a “Sequence

Listing” submitted as an ASCII plain text file under

37 CFR

1.821(c)(1)

and separate CRFs submitted under

37 CFR 1.821(e)

)

are not readable, or are missing mandatory elements, will be notified shortly after

receipt of the application by the Office. See

37 CFR

1.52(e)(9)

,

1.821(g)

, and

1.821(h)

.

The Office of Patent Application Processing (OPAP) will

mail a notice to applicant listing the requirements that have not been met and setting a

two month time period within which to comply with the sequence rules,

37 CFR 1.821

-

1.825

. Failure to comply with these requirements will result in

abandonment of the application under

37 CFR 1.821(g)

. Extensions of time

may be obtained by filing a petition accompanied by the extension fee under the

provisions of

37 CFR

1.136

. Applications will not be subject to examination on the

merits until a compliant “Sequence Listing” has been submitted, as jurisdiction remains

with Office of Patent Application Processing until compliance with the Notice to Comply

With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino

Acid Sequence Disclosures.

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

mitted, as jurisdiction remains

with Office of Patent Application Processing until compliance with the Notice to Comply

With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino

Acid Sequence Disclosures.

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

-

1.825

(see

37 CFR

1.704(f)

). Deficiencies of a more sophisticated nature will likely

only be detected by the examiner to whom the application is assigned. Applicant will be

notified of any errors or inconsistencies detected by the examiner in the next Office

action.

A notification of a failure to comply with the sequence rules will be

accompanied by a report of errors associated with any submitted computer readable form

(the

37

CFR 1.821(c)(1)

, the

1.821(e)(1)

or

1.821(e)(2)

submission). Any

inquiries regarding a specific computer readable form that has been processed by the

Office should be directed to the Sequence Systems Service Center (S3C) of the Scientific

and Technical Information Center. The S3C manages the Sequence Help Desk, and responds

to all questions or concerns, from both inside and outside the USPTO, related to

computer readable format sequence listing submissions. The S3C may be contacted at

571-272-2510 or via email at STIC-SSSCHelpdesk@uspto.gov.