Guidelines

I.    TEXT FILES SUBMITTED VIA THE USPTO PATENT ELECTRONIC FILING SYSTEM

A "Sequence Listing" under 37 CFR 1.821  through 1.825  may be submitted as an ASCII plain text file only in applications filed before July 1, 2022. The applicable filing date is either the filing date under 37 CFR 1.53  for applications submitted under 35 U.S.C. 111  or the international filing date under PCT Article 11 for applications submitted under 35 U.S.C. 371. For information on a "Sequence Listing XML" under 37 CFR 1.831  through 1.839  for applications filed on or after July 1, 2022, see subsection II below.

"Large Tables" (see 37 CFR 1.58(c) ), a "Computer Program Listing Appendix" (see 37 CFR 1.96(c) ), a "Sequence Listing" (see 37 CFR 1.821(c)(1) ), and a CRF of a "Sequence Listing" (see 37 CFR 1.821(e)(1)  or (e)(2) ), and "Large Tables" (see 37 CFR 1.58(c) ) may be submitted as ASCII text files via the USPTO patent electronic filing system. Each plain text file must be in compliance with ASCII and have a file name with a ".txt" extension. See 37 CFR 1.58(d)(4)1.96(c)(2), and 1.824(a)(3), which provide all requirements for the file name.

Further, the specification must contain an incorporation by reference statement of the material in the ASCII plain text file in a separate paragraph identifying the name of the ASCII plain text file, the date of creation, and the size of the ASCII text file in bytes (except for a "Sequence Listing" submitted in an international application (PCT) during the international stage regardless of whether the application is currently in the international stage or the national stage and a CRF of a "Sequence Listing" submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8)1.58(d)(5)1.77(b)(5)1.96(c), and 1.821(c)(1).

Form paragraphs 6.61.02 and 6.71.02 (reproduced in subsection II., below) may be used to indicate the need to add or amend an incorporation by reference statement for text files submitted via the USPTO patent electronic filing system.

A.    Information Specific to a "Sequence Listing"

The Office recommends that a "Sequence Listing" filed via the USPTO patent electronic filing system be submitted in an ASCII plain text file (37 CFR 1.821(c)(1) ). It is noted that while submission of the "Sequence Listing" as a PDF file (37 CFR 1.821(c)(2) ) or on physical sheets of paper (37 CFR 1.821(c)(3) ) is permitted, the inclusion of such would be part of the specification and would count toward the calculation for application size fee in accordance with 37 CFR 1.16(s). Should applicant file the "Sequence Listing" as a PDF file (37 CFR 1.821(c)(2) ) or on physical sheets of paper (37 CFR 1.821(c)(3) ) in an application submitted under 35 U.S.C. 111(a)  or file the "Sequence Listing" as a PDF file (37 CFR 1.821(c)(2) ) or on physical sheets of paper (37 CFR 1.821(c)(3) ) and not also as an ASCII plain text file (37 CFR 1.821(c)(1) ) in a national stage application submitted under 35 U.S.C. 371, a separate submission of a computer readable form (CRF) of the "Sequence Listing" would be required (37 CFR 1.821(e)(1)  or (e)(2) ). When a separate CRF is required under 37 CFR 1.821(e)(1)  or (e)(2), a statement that the sequence information contained in the CRF and the information in the "Sequence Listing" submitted as a PDF or on physical sheets of paper are identical is required (37 CFR 1.821(e)(1)(ii)  or 37 CFR 1.821(e)(2)(ii) ). It is noted that an applicant can no longer request a CRF transfer from a parent application when applicant submitted a "Sequence Listing" under 37 CFR 1.821(c)(2)  or 1.821(c)(3)  (see "Electronic Submission of a Sequence Listing, a Large Table, or a Computer Program Listing Appendix in Patent Applications", 86 FR 57035, 57038 (October 14, 2021)). Checker software that may be used to check a sequence listing for compliance with the requirements of 37 CFR 1.824  is available on the USPTO website at www.uspto.gov/Checker4.

In situations where an applicant is adding a "Sequence Listing" via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(a)  after the application filing date, the Office recommends submitting the "Sequence Listing" as an ASCII plain text file along with a request that the amendment be entered using an incorporation by reference statement (37 CFR 1.825(a)(2)(i) ). The "Sequence Listing" must be accompanied by a statement that the submission does not include any new matter which goes beyond the disclosure of the application as filed (37 CFR 1.825(a)(4) ) and a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) for all sequence data in the "Sequence Listing" in the application as originally filed (37 CFR 1.825(a)(3) ).

In situations where an applicant is filing an amendment to a "Sequence Listing" via the USPTO patent electronic filing system in accordance with 37 CFR 1.825(b), the Office recommends filing a replacement "Sequence Listing" as an ASCII plain text file where the applicant requests that the replacement "Sequence Listing" text file be entered using an incorporation by reference statement (37 CFR 1.825(b)(2)(i) ). The replacement "Sequence Listing" must be accompanied by: (1) a statement that the submission does not include any new matter (37 CFR 1.825(b)(5) ); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application (specification, claims, drawings) as originally filed for all amended sequence data in the replacement "Sequence Listing" (37 CFR 1.825(b)(4) ); and (3) a statement that identifies the location of all deletions, replacements, or additions to the "Sequence Listing" (37 CFR 1.825(b)(3) ). See generally 37 CFR 1.825.

For international applications that contain a disclosure of one or more nucleotide and/or amino acid sequences, PCT Rule 5.2(a)  requires a sequence listing as a separate part of the description. When filing a sequence listing in an international application (PCT) that was filed before July 1, 2022 using the USPTO patent electronic filing system, the sequence listing part of the description may be submitted either as a single ASCII plain text file with a ".txt" extension (e.g., "seqlist.txt") or as a PDF image file. Note that 100 megabytes is the size limit for submitting a sequence listing ASCII plain text file via the USPTO patent electronic filing system. See MPEP § 2422.03(a)(IV) for further information regarding filing a sequence listing in international applications via the USPTO patent electronic filing system.

B.    Application Size Fee

Any "Sequence Listing" or CRF of a "Sequence Listing" submitted as an ASCII plain text file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.821(c)  or (e), will be excluded when determining the application size fee required by 37 CFR 1.16(s)  or 1.492(j)  as per 37 CFR 1.52(f)(1)(i). A "Sequence Listing" submitted as a PDF image file via the USPTO patent electronic filing system will not be excluded when determining the application size fee.

Any "Computer Program Listing Appendix" submitted as an ASCII plain text file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.96(c)  will be excluded when determining the application size fee required by 37 CFR 1.16(s)  or 1.492(j)  as per 37 CFR 1.52(f)(1)(ii).

For "Large Tables" submitted as an ASCII plain text file via the USPTO patent electronic filing system, the "Large Tables" will be considered as part of the rest of the specification and drawings such that the paper size equivalent will be considered to be 75% of the number of sheets of paper present in the specification and drawings in the application when entered into the electronic file wrapper after being rendered by the USPTO patent electronic filing system. See 37 CFR 1.52(f)(2)  and MPEP § 607, subsection II.

C.    Size Limit for Text Files

One hundred (100) megabytes is the size limit for a "Sequence Listing" or a CRF of a "Sequence Listing" submitted as an ASCII plain text file via the USPTO patent electronic filing system; for nearly all other file types, 25 megabytes is the size limit. This includes a 25 megabytes size limit for ASCII plain text files for a "Computer Program Listing Appendix" and "Large Tables" (see 37 CFR 1.58(c)  and 1.96(c) ). This limit, however, may not prevent an entirely electronic submission. According to the Legal Framework for Patent Electronic System (www.uspto.gov/patents-application-process/ filing-online/legal-framework-efs-web ), a user may be able to break up a file of a ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ that is larger than 25 MB into multiple files that are no larger than 25 MB each and submit those smaller files via the USPTO patent electronic filing system. If the user chooses to break up a large ‘‘Computer Program Listing Appendix’’ or ‘‘Large Tables’’ file so it may be submitted electronically, the file names must indicate their order (e.g., ‘‘1 of X,’’ ‘‘2 of X’’). Files above the 25 MB limit for ‘‘Large Tables’’ and a ‘‘Computer Program Listing Appendix’’ (unless capable of being divided) and above 100 MB for a ‘‘Sequence Listing’’ must be submitted on read-only optical discs.

Submission of a ‘‘Sequence Listing’’ or a CRF of a "Sequence Listing" as an ASCII plain text file, if it exceeds 100 MB, cannot be divided like a submission of a ‘‘Large Table’’ or a ‘‘Computer Program Listing Appendix.’’ Thus, any "Sequence Listing" or CRF of a "Sequence Listing" greater than 100 MB must be submitted on read-only optical discs. If a user submits an electronic copy of a file that exceeds these size limits on a read-only optical disc(s), it is recommended that the read-only optical disc(s) be submitted via Priority Mail Express® from the USPS in accordance with 37 CFR 1.10, or hand delivery, on the date of the corresponding USPTO patent electronic filing system filing in accordance with 37 CFR 1.52(e)  if the user wishes the electronic copy to be considered to be part of the application as filed.

See MPEP § 2422.03(a)(III) et seq. for further guidance on "Sequence Listing" size limits. See the Legal Framework for Patent Electronic System (www.uspto.gov/patents-application-process/ filing-online/legal-framework-efs-web ) for additional information pertaining to limits on the number and size of files submitted via the USPTO patent electronic filing system. See also MPEP § 502.05.

II.    XML FILES SUBMITTED VIA THE USPTO PATENT ELECTRONIC FILING SYSTEM

A "Sequence Listing XML" may be submitted as a XML file with a ".xml" extension via the USPTO patent electronic filing system or as read-only optical discs in compliance with 37 CFR 1.52(e)  and 1.831(a). Such submission requires that applicant provide a statement in a separate paragraph that incorporates by reference the material in the XML file identifying the name of the XML file, the date of creation, and the size of the XML file in bytes (except that an incorporation by reference statement is not required for a sequence listing properly submitted as an XML file in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage). A "Sequence Listing XML" under 37 CFR 1.831  through 1.839  may be submitted as an XML file only in applications filed on or after July 1, 2022. See 2022 Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications To Implement WIPO Standard ST.26; Incorporation by Reference, 87 FR 30806 (May 20, 2022). The applicable filing date is either the filing date under 37 CFR 1.53  for applications submitted under 35 U.S.C. 111  or the international filing date under PCT Article 11  for applications submitted under 35 U.S.C. 371. For information on a "Sequence Listing" under 37 CFR 1.821  through 1.825  for applications filed before July 1, 2022, see subsection I above.

Applications filed on or after July 1, 2022 that contain disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b)  must provide such sequence information as a "Sequence Listing XML" submitted as an XML file (37 CFR 1.831(a) ), where the "Sequence Listing XML" complies with the requirements of 37 CFR 1.831 -1.834. The "Sequence Listing XML" may be filed via the USPTO patent electronic filing system using Patent Center which is available at www.uspto.gov/PatentCenter, and the "Sequence Listing XML" cannot be filed using EFS-Web.

In situations where an applicant is adding a "Sequence Listing XML" via the USPTO patent electronic filing system in accordance with 37 CFR 1.835(a)  after the application filing date, such as when a patent applicant receives a notice under 37 CFR 1.835(d)(1), to comply with the "Sequence Listing XML" regulations (37 CFR 1.831 -1.834 ), the applicant must submit the "Sequence Listing XML" as an XML file either via the USPTO patent electronic system or on read-only optical disc. Submission of a "Sequence Listing XML" after the filing date requires that the applicant provide: (1) a request to amend the specification to include an updated incorporation by reference statement of the material in the "Sequence Listing XML" (37 CFR 1.835(a)(2) ); (2) a statement that identifies the basis for the amendment with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all sequence data in the "Sequence Listing XML" in the application as originally filed (37 CFR 1.835(a)(3) ); and (3) a statement of no new matter (37 CFR 1.835(a)(4) ).

If the notice pursuant to 37 CFR 1.835(d)(1)  identifies an error in a previously submitted "Sequence Listing XML," or applicant needs to revise the "Sequence Listing XML," applicant can submit a replacement "Sequence Listing XML" along with: (1) a request to amend the specification to include an incorporation by reference statement of the material in the replacement "Sequence Listing XML" (37 CFR 1.835(b)(2) ); (2) a statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced "Sequence Listing XML" (37 CFR 1.835(b)(3) ); (3) a statement that identifies the basis for the additions, deletions, or replacements of the sequence information with specific references to particular parts of the application as originally filed (specification, claims, drawings) for all amended sequence data in the replacement "Sequence Listing XML" (37 CFR 1.835(b)(4) ); and (4) a statement of no new matter (37 CFR 1.835(b)(5) ). See generally 37 CFR 1.835.

A.    Application Size Fee

Any "Sequence Listing XML" submitted as an XML file via the USPTO patent electronic filing system that is otherwise in compliance with 37 CFR 1.831(a)  will be excluded when determining the application size fee required by 37 CFR 1.16(s)  or 1.492(j)  as per 37 CFR 1.52(f)(2)(i).

B.    Size Limit for XML Files

One hundred (100) megabytes is the size limit for a "Sequence Listing XML" submitted as an XML file via the USPTO patent electronic filing system.

III.    SUBMISSIONS ON READ-ONLY OPTICAL DISC

A read-only optical disc submitted under 37 CFR 1.52(e)  is a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased. A read-only optical disc must be one of a CD-ROM a CD-R, a DVD-R, or a DVD+R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R, DVD-R, and DVD+R are read-only optical discs that have recording medium only capable of writing once. CD-RW, DVD-RW, and DVD+RW types of media are not acceptable because they are erasable and rewriteable. Limiting the media types to CD-ROM CD-R, DVD-R, and DVD+R media will ensure the longevity and integrity of the data submitted. Additionally, the rules permit the use of DVD-R and DVD+R and non-self-extracting file compression (see 37 CFR 1.52(e)(3)(iii) ) to allow for higher-capacity read-only optical discs and to significantly reduce the number of physical media required to accommodate large files.

For "Large Tables," a "Computer Program Listing Appendix," a "Sequence Listing," or a CRF of a "Sequence Listing," the contents of each read-only optical disc must be in ASCII plain text file format. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII plain text files. While virtually any word processor may be used to view an ASCII plain text file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file. Also, each text file must have a file name with a ".txt" extension. See 37 CFR 1.58(d)(4)1.96(c)(2), and 1.824(a)(3)  (providing the requirements for the file name). For a "Sequence Listing XML," the contents of each read-only optical must be in XML file format, and if compressed, must be compressed in accordance with 37 CFR 1.834. A "Sequence Listing XML" must be encoded using Unicode UTF–8. All permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of the WIPO Standard ST.26 available at www.wipo.int/export/sites/ www/standards/en/pdf/03-26-01.pdf. Also, each XML file must have a file name with a ".xml" extension. See 37 CFR 1.834(a)  (providing the requirements for the file name).

Material on read-only optical disc(s) filed on the date that the application is accorded a filing date are generally to be treated as part of the originally filed disclosure even if the requisite "incorporation by reference" statement (see 37 CFR 1.77(b)(5) ) is omitted. However, in certain instances, the material on the read-only optical disc may not be treated as a part of the disclosure. For example, if a file is unreadable, it is treated as not having been submitted, and thus, it will not be treated as a part of the disclosure. It is noted that an incorporation by reference statement is not required for a "Sequence Listing" submitted as an ASCII plain text file or as an XML file (as applicable) in an international application during the international stage regardless of whether the application is currently in the international stage or the national stage. Also, an incorporation by reference statement is not required for a CRFs of a "Sequence Listings" submitted in compliance with 37 CFR 1.821(e). See 37 CFR 1.52(e)(8). The material on the read-only optical disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. If required, the incorporation by reference statement of the material on the read-only optical disc will need to be added via an amendment to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on the read-only optical disc. The examiner should require applicant(s) to insert this statement if it is omitted. See 37 CFR 1.58(h)1.96(c)(6)1.825(c), and 1.835(c). However, if the application would otherwise be in condition for allowance, the examiner may insert the statement by examiner’s amendment with a notice of allowance after receiving authorization from the applicant. See MPEP § 1302.04 and 37 CFR 1.121(g).

Each read-only optical disc must be compatible with PC or Mac® computers and with MS-DOS®, MS-Windows®, Mac OS®, or Unix®/Linux® operating systems. The files contained on each read-only optical disc must be in ASCII plain text format ("Computer Program Listing Appendix’’, ‘‘Large Tables’’ or "Sequence Listing") or XML file format ("Sequence Listing XML"). If the ASCII plain text file is compressed, the file must be compressed in accordance with 37 CFR 1.581.96, and 1.824. If the "Sequence Listing XML" file is compressed, the file must be compressed in accordance with 37 CFR 1.834. See 37 CFR 1.52(e)(3).

37 CFR 1.52(e)(4)  requires that each read-only optical disc must be enclosed in a hard case within an unsealed padded and protective mailing envelope and accompanied by a transmittal letter in accordance with 37 CFR 1.52(e)(4). The transmittal letter must include the following information: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) the operating system (MS-DOS®, MS-Windows®, Mac OS®, or Unix®/Linux®) used to produce the disc; and 6) the files contained on the read-only optical disc, including the name of the file, the size of the file in bytes, and the date of creation. Each read-only optical disc must have a permanent label affixed thereto on which the following information has been hand-printed or typed: 1) first-named inventor (if known); 2) title of the invention; 3) attorney docket or file reference number (if applicable); 4) application number and filing date (if known); 5) date on which the data were recorded on the read-only optical disc; and 6) disc order (e.g., "1 of X") if multiple read-only optical discs are submitted.

Read-only optical discs submitted to the Office will not be returned to the applicant and may not be retained as part of the patent application file. See 37 CFR 1.52(e)(6). Read-only optical discs containing submitted "Large Tables" or a "Computer Program Listing Appendix" must be submitted in duplicate and labeled as "Copy 1" and "Copy 2," respectively. See 37 CFR 1.58(i)  and 1.96(c)(7). Read-only optical discs submitted for a "Sequence Listing," CRF of a "Sequence Listing," or a "Sequence Listing XML" are not required to be submitted in duplicate because a "Sequence Listing," CRF of a "Sequence Listing," or a "Sequence Listing XML" is processed differently than "Large Tables" or a "Computer Program Listing Appendix".

If more than one read-only optical disc is required to hold all of the information, each read-only optical disc must have a label permanently affixed thereto with the disc order (e.g., "1 of X"). See 37 CFR 1.52(e)(5)  (includes other labeling requirements). Read-only optical disc(s) copies containing "Large Tables" and/or a "Computer Program Listing Appendix" should initially be routed to the Office of Patent Application Processing (OPAP), and read-only optical disc(s) discs containing a "Sequence Listing", a CRF of a "Sequence Listing", or a "Sequence Listing XML" Listings" should initially be routed to the Patent Legal Research Center (PLRC). Depending on the content in the read-only optical discs, the read-only optical discs will be checked by either OPAP or PLRC for viruses, readability, the presence of non-ASCII or non-XML files, and compliance with the file and disc labeling requirements. For "Large Tables" and a "Computer Program Listing Appendix" where duplicate disc copies are required, OPAP will retain one copy of the disc(s) and place the other copy in an artifact folder associated with the Office file wrapper. For a "Sequence Listing", a CRF of a "Sequence Listing", or a "Sequence Listing XML", PLRC loads the "Sequence Listing", the CRF of the "Sequence Listing", or the "Sequence Listing XML" into the USPTO’s Sequence Listing Information Control (SLIC) system, and the physical media may be retained by PLRC. In the event that a file is unreadable, then the USPTO will treat the submission as not ever having been submitted. See 37 CFR 1.52(e)(9). A file is unreadable if, for example, it is of a format that does not comply with the requirements of 37 CFR 1.52(e)(2), it is corrupted, or it is written onto a defective read-only optical disc. In such a case, OPAP will issue a notice indicating that the file is unreadable, and a replacement will be required.

Any amendment to the information on a read-only optical disc must be by way of a replacement read-only optical disc, in compliance with 37 CFR 1.58(g)  for "Large Tables", 37 CFR 1.96(c)(5)  for a "Computer Program Listing Appendix", and 37 CFR 1.825(b)  for a "Sequence Listing" or a CRF of a "Sequence Listing", and 37 CFR 1.835(b)  for a "Sequence Listing XML". See 37 CFR 1.52(e)(7). When the information is filed on a read-only optical disc initially, amendments cannot be made to the information using the USPTO patent electronic filing system, but instead must be made using a replacement read-only optical disc. The amendment should include a corresponding amendment to the description of the incorporation by reference statement in the specification when an incorporation by reference is necessary or present. A replacement read-only optical disc containing the amended file(s) must also contain all of the files of the original read-only optical disc that were not amended (if any). This will ensure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest electronic version of the file(s) provided in the replacement read-only optical disc.

The following form paragraphs may be used to notify applicant of corrections needed with respect to read-only optical disc submissions.

¶ 6.60.01    Read-only Optical Disc Requirements (No Statement that discs are Identical)

This application is objected to under  37 CFR 1.58(i)  for "Large Tables" or 1.96(c)(7)  for a "Computer Program Listing Appendix"  because it does not contain a statement in the transmittal letter that the two read-only optical discs are identical. Correction is required.

¶ 6.60.02    Read-only Optical Disc Requirements (No Listing in Transmittal Letter)

This application is objected to because it contains a data file on one or more read-only optical disc(s), however, the transmittal letter does not list for each read-only optical disc, the first named inventor(if known), the title of the invention, the attorney docket or file reference number (if applicable), the operating system used to produce the disc, a list of files contained on the read-only optical disc(s) including their names, sizes in bytes, and dates of creation, plus any other special information that is necessary to identify, maintain, and interpret the information on the read-only optical disc as required by  37 CFR 1.52(e)(4). A statement listing the required information is required.

¶ 6.61.01    Specification Lacking List of Read-only Optical Disc(s) and /or Associated Files

Portions of this application are contained on read-only optical disc(s). When portions of an application are contained on a read-only optical disc, the paper portion of the specification must identify the read-only optical disc(s) and list the files including the name of the ASCII text file, the date of creation, and the size of the ASCII text file on each of the read-only optical discs, or the name of the XML file, the date of creation of the XML, and the size of the XML on each read-only optical disc (as applicable). See   37 CFR 1.52(e). Read-only optical disc labeled [1]  is not identified in the paper portion of the specification with a listing of all of the files contained on the disc. Applicant is required to amend the specification to identify each disc and the files contained on each disc including ASCII text file name or XML file name (as applicable), the date of creation and the size of the ASCII text file or XML file (as applicable).

Examiner Note:

In bracket 1, insert the name on the label of the read-only optical disc.

¶ 6.61.02    Specification Lacking An Incorporation By Reference Statement for Read-only Optical Disc or Text File Submitted Via the Office Electronic Filing System

This application contains read-only optical disc(s) or text file(s) submitted via Electronic Filing System as part of the originally filed subject matter, but does not contain an incorporation by reference statement for the read-only optical discs or text files. See  37 CFR 1.77(b)(5)  and  MPEP § 502.05. Applicant(s) is required to insert in the specification an appropriate incorporation-by-reference statement that includes the name of the ASCII text file or XML file (as applicable), the date of creation, and the size of the ASCII text file or XML files (as applicable).

¶ 6.62    Data File on Read-only Optical Disc Not in ASCII File Format or XML File Format (only for a "Sequence Listing XML")

This application contains a data file on a read-only optical disc that is not in an ASCII file format or an XML file format (only for "Sequence Listing XML"). See 37 CFR 1.52(e). File [1]  is not in an ASCII format or XML format. Applicant is required to resubmit file(s) in ASCII format or XML format. No new matter may be introduced in presenting the file(s) in ASCII format or XML format.

Examiner Note:

1. This form paragraph must be used to indicate whenever a data file ("Large Table", "Computer Program Listing Appendix" or "Sequence Listing") is submitted in a non-ASCII file format. The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file may contain non-ASCII characters.

2. In bracket 1, insert the name of the file and whether the file is a non-text proprietary file format and/or contains non-ASCII characters.

The following form paragraphs should be used to respond to amendments which include amended or substituted read-only optical discs.

¶ 6.70.01    Read-only Optical Disc Requirements (Amendment Does Not Include Statement that Discs are Identical)

The amendment filed  [1]  is objected to under 37 CFR 1.58(i)  for "Large Tables" or 1.96(c)(7)  for a "Computer Program Listing Appendix" because it does not contain a statement in the transmittal letter that the two read-only optical discs are identical. Correction is required.

¶ 6.70.02    Read-only Optical Disc Requirements (No Listing in Transmittal Letter Submitted With Amendment)

The amendment filed  [1]  contains data on read-only optical disc(s). Read-only optical disc labeled  [2]  is not identified in the transmittal letter and/or the transmittal letter does not list for each read-only optical disc, the first named inventor(if known), the title of the invention, the attorney docket or file reference number (if applicable), the operating system used to produce the disc, a list of files contained on the read-only optical disc including their names, sizes in bytes, and dates of creation, plus any other special information that is necessary to identify, maintain, and interpret the information on the read-only optical disc as required by  37 CFR 1.52(e)(4). A statement listing the specified information is required.

Examiner Note:

1. Use this form paragraph when the transmittal letter does not include a listing of the files and required information.

2. In bracket 1, insert the date of the amendment.

3. In bracket 2, insert the name on the label of the read-only optical disc.

¶ 6.71.01    Specification Lacking List of Read-only optical Disc(s) and/or Associated Files (Amendment Filed With Read-only optical Disc(s))

The amendment filed  [1]  contains data on read-only optical disc(s). Read-only optical disc labeled  [2]  is not identified in the paper portion of the specification with a listing of all of the files contained on the disc. Applicant is required to amend the specification to identify each disc and the files contained on each disc including the ASCII text file name, the date of creation and the size of the ASCII text file on each of the read-only optical discs. See 37 CFR 1.52(e).

Examiner Note:

1. In bracket 1, insert the date of the amendment.

2. In bracket 2, insert the name on the label of the read-only optical disc.

¶ 6.71.02    Specification Lacking Incorporation By Reference Statement for Amended or Added Read-only Optical Disc or Text File or XML File

The amendment filed  [1]  amends or adds read-only optical disc(s) or text file(s) or XML file(s) (as applicable) submitted via the Patent Electronic Filing System, but does not include an incorporation by reference statement for the read-only optical discs or the text files or XML files (as applicable). Applicant is required to update or insert an appropriate incorporation by reference statement in the specification that includes the name of the ASCII text file or XML file (as applicable), the date of creation, and the size of the ASCII text file or XML file (as applicable). See 37 CFR 1.77(b)(5)   and  1.52(e)(8)  and MPEP § 502.05.

Examiner Note:

1. Use this form paragraph when a read-only optical disc or text file submitted via the Patent Electronic Filing System is filed with an amendment, but the required incorporation-by-reference statement is neither amended nor added to the specification.

2. In bracket 1, insert the date of the amendment.

¶ 6.72.01    Read-only Optical Disc Requirements (Discs Not Identical)

The amendment filed  [1]  is objected to under  37 CFR 1.58(i)  for "Large Tables" or 1.96(c)(7)  for a "Computer Program  Listing Appendix" because the two read-only optical discs are not identical. Providing a correct duplicate copy is required.

Examiner Note:

1. Use this form paragraph when the two read-only optical discs are not identical.

2. See also form paragraph 6.70.01 where the transmittal letter does not include a statement that the two read-only optical discs are identical.

¶ 6.72.02    Data File, Submitted With Amendment, on Read-only Optical Disc Not in ASCII File Format or XML File Format (only for a "Sequence Listing XML" submission)

The amendment filed [1] contains a data file on read-only optical disc that is not in an ASCII file format or an XML file format (only for a "Sequence Listing XML" submission). File [2] is not in an ASCII format or an XML file format. Applicant is required to resubmit file(s) in ASCII format or XML format as required by 37 CFR 1.52(e)(3)(iii). No new matter may be introduced in presenting the file(s) in ASCII format or XML format.

Examiner Note:

1. This form paragraph must be used whenever a data file ("Large Tables," a "Computer Program Listing Appendix," a "Sequence Listing," or a "Sequence Listing XML" (as applicable) is submitted in a non-ASCII file format or a non-XML file format (as applicable). The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file contains non-ASCII characters or fails to comply with the requirements for a "Sequence Listing XML" submitted under 1.52(e).

2. In bracket 1, insert the date of the amendment.

3. In bracket 2, insert the name of the file and whether the file is a non-text proprietary file format and/or contains non-ASCII characters and/or contains non-XML characters (as applicable).

¶ 6.72.03    Read-only Optical Discs Are Not Readable

The amendment filed [1] contains a data file on read-only optical disc that is unreadable. Applicant is required to resubmit the file(s) in International Organization for Standardization (ISO) 9660 standard and American Standard Code for Information Interchange (ASCII) format as required by 37 CFR 1.52(e)(2)  and 1.52(e)(3)(iii), respectively. No new matter may be introduced in presenting the file in ISO 9660 and ASCII format.

¶ 6.72.04    Read-only Optical Disc Contains Viruses

The amendment filed [1] is objected to because the read-only optical disc contains at least one virus. Correction is required.

¶ 6.72.05    Read-only Optical Disc Requirements (Missing Files On Amended Read-only Optical Disc)

The amendment to the application filed  [1]  is objected to because the newly submitted read-only optical disc(s) do not contain all of the unamended data file(s) together with the amended data file(s) that were on the original read-only optical disc. Since amendments to a read-only optical disc can only be made by providing a replacement read-only optical disc, the replacement disc must include all of the files, both amended and unamended, to be a complete replacement in accordance with 37 CFR 1.52(e)(7).

Examiner Note:

Use this form paragraph when a replacement read-only optical disc is submitted that fails to include all of the files on the original read-only optical disc(s) that have not been cancelled by amendment.

For greater detail on submission of a read-only optical disc in a "Sequence Listing", a "Sequence Listing XML," "Large Tables", or a "Computer Program Listing Appendix", see MPEP § 608.05(a)-(c).

608.05(a)    Submission of a "Computer Program Listing Appendix" [R-07.2022]

37 C.F.R. 1.96   Submission of computer program listings.

· (a) General. Descriptions of the operation and general content of computer program listings should appear in the description portion of the specification. A computer program listing for the purpose of this section is defined as a document that lists, in appropriate sequence, the instructions, routines, and other contents of a program for a computer. The program listing may be either in machine or machine-independent (object or source) language that will cause a computer to perform a desired procedure or task such as solving a problem, regulating the flow of work in a computer, or controlling or monitoring events. Computer program listings may be submitted in patent applications, as set forth in paragraphs (b) and (c) of this section.

· (b) Material which will be printed in the patent: If the computer program listing is contained in 300 lines or fewer, with each line of 72 characters or fewer, it may be submitted either as drawings or as part of the specification.

· (1) Drawings. If the listing is submitted as drawings, it must be submitted in the manner and complying with the requirements for drawings as provided in § 1.84. At least one figure numeral is required on each sheet of drawing.

· (2) Specification.

· (i) If the listing is submitted as part of the specification, it must be submitted in accordance with the provisions of § 1.52.

· (ii) Any listing having more than 60 lines of code that is submitted as part of the specification must be positioned at the end of the description but before the claims. Any amendment must be made by way of submission of a substitute sheet.

· (c) As an appendix that will not be printed: Any computer program listing may, and any computer program listing having over 300 lines (up to 72 characters per line) must, be submitted as an electronic document in ASCII plain text, whether submitted via the USPTO patent electronic filing system or on a read-only optical disc, in compliance with § 1.52(e). An electronic document containing such a computer program listing is to be referred to as a "Computer Program Listing Appendix." The "Computer Program Listing Appendix" will not be part of the printed patent. The specification must include an incorporation by reference of the "Computer Program Listing Appendix," in accordance with § 1.77(b)(5).

· (1) A "Computer Program Listing Appendix" must conform to the following requirements:

· (i) Computer compatibility: PC or Mac®;

· (ii) Operating system compatibility: MS–DOS®, MS-Windows®, Mac OS®, or Unix®/Linux®;

· (iii) Line terminator: ASCII CRLF or LF only; and

· (iv) Control codes: The data must not be dependent on control characters or codes that are not defined in the ASCII character set.

· (2) Each file must be named as *.txt, where "*" is one character or a combination of characters limited to upper- or lowercase letters, numbers, hyphens, and underscores and does not exceed 60 characters in total, excluding the extension. No spaces or other types of characters are permitted in the file name.

· (3) Each file containing a "Computer Program Listing Appendix" submitted via the USPTO patent electronic filing system must not exceed 25 MB, and file compression is not permitted.

· (4) A "Computer Program Listing Appendix" submitted in compliance with § 1.52(e)  must conform to the following requirements:

· (i) A separate read-only optical disc containing a "Computer Program Listing Appendix" must be submitted for each applicable application;

· (ii) Multiple computer program listings for a single application may be placed on a single read-only optical disc;

· (iii) Multiple read-only optical discs, containing one or more computer program listings, may be submitted for a single application, if necessary;

· (iv) Any computer program listing may, and a computer program listing having a nested file structure must, when submitted in compliance with § 1.52(e), be compressed into a single file using WinZip®, 7-Zip, or Unix®/ Linux® Zip;

· (v) Any compressed file must not be self-extracting; and

· (vi) A compressed ASCII plain text file that does not fit on a single read-only optical disc may be split into multiple file parts, in accordance with the target read-only optical disc size and labele