Federal Register / Vol. 86, No. 100 / Wednesday, May 26, 2021 / Proposed Rules 28301 DEPARTMENT OF COMMERCE comments. Attachments to electronic expected to have a minimal impact on comments will be accepted in ADOBE® applicants in general. Patent and Trademark Office portable document format or The USPTO encourages applicants to MICROSOFT WORD® format. Because file their patent applications via its 37 CFR Part 1 comments will be made available for USPTO patent electronic filing system and imposes a surcharge for non- [Docket No. PTO–P–2020–0032] public inspection, information that the submitter does not desire to make electronic filing of an original patent RIN 0651–AD48 public, such as an address or phone application (excluding reissue, design, number, should not be included in the plant, and provisional applications), as Electronic Submission of a Sequence comments. mandated by section 10(h) of Public Listing, a Large Table, or a Computer Visit the Federal eRulemaking Portal Law 112–29, September 16, 2011 Program Listing Appendix in Patent (Leahy-Smith America Invents Act). The Applications website (www.regulations.gov) for additional instructions on providing USPTO provides information (Legal AGENCY: United States Patent and comments via the portal. If electronic Framework for Patent Electronic Trademark Office, Department of submission of comments is not feasible System) concerning electronic filing via Commerce. due to lack of access to a computer and/ the USPTO patent electronic filing system on its website at www.uspto.gov/ ACTION: Notice of proposed rulemaking. or the internet, please contact the USPTO using the contact information patents-application-process/filing- SUMMARY: The United States Patent and below for special instructions. online/legal-framework-efs-web and in Trademark Office (USPTO or Office) section 502.05 of the Manual of Patent proposes to amend the rules of practice FOR FURTHER INFORMATION CONTACT: Examining Procedure (MPEP, Ninth to permit higher-capacity physical Mary C. Till, Senior Legal Advisor, Edition, Revision 10.2019). In media to be submitted to the USPTO. Office of Patent Legal Administration, particular, the USPTO patent electronic Patent applications for certain Office of the Deputy Commissioner for filing system permits submission of inventions require significant data in Patents, by email at Mary.Till@ ASCII plain text files (.txt) for American Standard Code for uspto.gov; or Ali Salimi, Senior Legal submission of a ‘‘Sequence Listing,’’ a Information Interchange (ASCII) text Advisor, Office of Patent Legal CRF of a ‘‘Sequence Listing,’’ ‘‘Large format to be submitted to the USPTO in Administration, Office of the Deputy Tables,’’ and a ‘‘Computer Program order to determine whether the Commissioner for Patents, by email at Listing Appendix.’’ Although a USPTO invention described in the patent [email protected]. Contact via patent electronic filing system application is patentable. When telephone at 571–272–7704 if further submission of such ASCII plain text submission of such data exceeds the instruction is needed for the submission files is preferred, it is possible that the USPTO’s patent electronic filing system of comments. system limitations of the USPTO patent capacity, direct submission would not SUPPLEMENTARY INFORMATION: electronic filing system may not accommodate large ASCII text files. be possible for a large data submission Background: In order to permit the Currently, in those circumstances, such in ASCII text format. To that end, the submission of large amounts of data in text files may be submitted on compact rules of practice are proposed to be patent applications where such a disc under 37 CFR 1.52(e), and images amended to provide applicants with the submission exceeds the capacity for of such text files may be submitted in ability to use physical media larger than filing via the USPTO patent electronic Portable Document Format (PDF) via the compact discs (CDs) for submission of filing systems, this rulemaking seeks to USPTO patent electronic filing system an electronic version of amino acid and expand the types of physical media that (except for a CRF of a ‘‘Sequence nucleotide sequence information, can be used for such a submission. The Listing’’ or a ‘‘Computer Program Listing information compiled in a large table, volume of applications in which such and information relating to a computer Appendix’’ having over 300 lines—these large amounts of data may need to be must be submitted on compact disc program listing. Additionally, changes submitted is a small fraction of the total regarding extraction of compressed data under 37 CFR 1.52(e)). The proposed number of applications that the USPTO changes to the rules of practice files, which had not been permitted in receives every year. Expanding the types pertaining to a ‘‘Sequence Listing,’’ a the past for certain submissions, would of physical media that can be used by CRF of a ‘‘Sequence Listing,’’ ‘‘Large be permitted if compliant with the these applicants achieves the intent Tables,’’ and a ‘‘Computer Program requirements of the proposed rules. with minimal changes to the USPTO’s Listing Appendix’’ would harmonize Other rules relating to certain obsolete processing of such large amounts of the rules for filing such documents in and non-secure methods of presenting data. electronic form with the requirements data would be eliminated. With respect to the submission of data and conditions set forth in the Legal DATES: Comments must be received by relating to biotechnology inventions, the Framework for Patent Electronic July 26, 2021 to ensure consideration. proposed rules would no longer permit System. The proposed changes do not ADDRESSES: For reasons of Government an applicant to rely on a previously alter the requirements and conditions efficiency, comments must be submitted submitted computer readable form set forth in the Legal Framework for through the Federal eRulemaking Portal (CRF) of required sequence information. Patent Electronic System. at www.regulations.gov. To submit The proposed rules thus ensure the Submission of ASCII plain text files: comments via www.regulations.gov, robustness of the data by requiring the Currently, electronic documents in enter docket number PTO–P–2020–0032 applicant to confirm that the data ASCII file format that are to become part on the homepage and click ‘‘Search.’’ presented is the correct information for of the permanent USPTO records in the The site will provide a search results the examiner to consider during the file of a patent application, page listing all documents associated examination process. Since the reexamination, or supplemental with this docket. Find a reference to this proposed rules will also permit an examination proceeding that exceed the document and click on the ‘‘Comment ASCII plain text file to serve as both the USPTO patent electronic filing system Now!’’ icon, complete the required sequence listing itself and the CRF of limits may be submitted on a compact fields, and enter or attach your the sequence listing, these changes are disc. Due to the limited storage capacity VerDate Sep<11>2014 18:54 May 25, 2021 Jkt 253001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\26MYP1.SGM 26MYP1 28302 Federal Register / Vol. 86, No. 100 / Wednesday, May 26, 2021 / Proposed Rules of compact discs, the USPTO is ‘‘Computer Program Listing Appendix’’ included in the specification, in proposing revisions to permit use of (unless capable of being divided) and accordance with 37 CFR 1.76, it should Digital Video Disc-Recordable (DVD–R above 100 MB for a ‘‘Sequence Listing’’ be noted that the USPTO does not or DVD+R). These higher-capacity read- will have to be submitted on read-only recognize a benefit or priority claim only optical discs, on which data is optical discs. Submission of a presented only in the specification for permanently recorded and cannot be ‘‘Sequence Listing’’ as an ASCII text file, patent applications filed on or after changed or erased, significantly reduce if it exceeds 100 MB, cannot be divided September 16, 2012. For these the number of physical media required like a submission of a ‘‘Large Table’’ or applications or patents issued from such to accommodate large files. a ‘‘Computer Program Listing applications, a benefit claim (37 CFR In the case of a ‘‘Sequence Listing,’’ Appendix.’’ Thus, any ‘‘Sequence 1.78) or priority claim (37 CFR 1.55) MPEP section 2422.03 indicates that if Listing’’ greater than 100 MB must be must be presented on an Application a new application is filed via the submitted on read-only optical discs. Data Sheet for an original application in USPTO patent electronic filing system Currently, such files cannot be order to be recognized by the USPTO. with an ASCII plain text file of a compressed; this can necessitate the use Sequence Listings: Any patent ‘‘Sequence Listing’’ that complies with of multiple CD–ROMs or CD–Rs. These application that contains unbranched the requirements of 37 CFR 1.824(a)(2) proposed changes to the rules of nucleotide sequences with 10 or more through (6) and (b), and the applicant practice will permit higher-capacity nucleotide bases or unbranched, non-D has not filed a ‘‘Sequence Listing’’ in a media as well as non-self-extracting file amino acid sequences with 4 or more PDF image file, the text file will serve compression. By permitting file amino acids, provided that there are at as both the paper copy required by 37 compression, material submitted on a least 10 ‘‘specifically defined’’ CFR 1.821(c) and the CRF required by read-only optical disc will be capable of nucleotides or 4 ‘‘specifically defined’’ 37 CFR 1.821(e). This concept is fitting on a single disc with the data amino acids, must contain a ‘‘Sequence expressly incorporated into these integrity remaining intact. Listing’’ and a CRF of the ‘‘Sequence proposed changes to the rules of The current rules of practice (37 CFR Listing.’’ Under the current rules, a practice.