Voglio sapere a riguardo di…

jbell on DSKJLSW7X2PROD with PROPOSALS

Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules The adopted version of Standard ST.26 is composed of eight documents, namely, the main body of the Standard, a first annex setting forth the controlled vocabulary for use with the main body, a second annex setting forth the Document Type Definition DTD for the Standard, a third annex containing a sequence listing specimen, a fourth annex setting forth the character subset from the Unicode Basic Latin Code Table, a fifth annex setting forth additional data exchange requirements for IPOs, a sixth annex containing a guidance document, and a seventh annex setting forth recommendations for the transformation of a sequence listing from Standard ST.25 format to Standard ST.26 format including avoiding adding or deleting subject matter. These materials can be found at http
www.wipo.int/export/sites/www/
standards/en/pdf/03-26-01.pdf. The main body of Standard ST.26 defines the disclosures of nucleotide and amino acid sequences in patent applications that must be presented in a sequence listing in XML format in the manner specified in the Standard. Specifically, as detailed in paragraph eight of the main body, a sequence listing must not include, as a sequence assigned its own sequence identification number, any sequences having fewer than ten specifically defined nucleotides, or fewer than four specifically defined amino acids. The main body establishes the requirements for representation of nucleotide and amino acid sequences and the requirements for the XML file format for a sequence listing. The first annex contains controlled vocabulary that provides nucleotide base codes, lists of modified nucleotides and their abbreviations, amino acid codes, and a list of modified amino acids and their abbreviations. In addition, the first annex provides defined feature keys and qualifiers used for nucleotide and amino acid sequences in the XML file for a sequence listing. This first annex specifically identifies qualifiers with language-dependent free text values that may require translation for national and regional procedures. The second annex provides the DTD setting forth the technical specifications to which a submitted Sequence Listing XML must conform. The third annex provides a specimen of a Standard ST.26 compliant sequence listing that shows a representation of an entire sequence listing in XML format. Annex IV
provides a table of the character subset from the Unicode Basic Latin Code that will be used for a Sequence Listing XML. Annex V provides guidance to WIPO member states on how certain
VerDate Sep<11>2014

16:39 Jul 02, 2021

Jkt 253001

sequence elements should be populated when data is exchanged with database providers. Annex VI, containing the guidance document, is provided to ensure that all applicants and WIPO
member states understand the requirements for inclusion and representation of sequence disclosures.
This guidance document was developed, in part, to address concerns raised in response to the USPTOs requests for comment in 2012 and 2016, mentioned above. The guidance document illustrates the requirements of selected paragraphs found in the main body of Standard ST.26 through specific examples of nucleotide and amino acid biological sequence data. Additionally, the document provides guidance on the manner in which biological sequence data is represented within a Standard ST.26 compliant sequence listing in XML format. Annex VII addresses the potential consequence of these requirements when transforming a compliant Standard ST.25 sequence listing to a Standard ST.26 sequence listing, and provides detailed guidance on avoiding added or deleted subject matter due to the additional requirements of Standard ST.26.
d. Benefits Transitioning from rules based on Standard ST.25 i.e., the current basis for the USPTO rules for Sequence Listings to rules based on Standard ST.26 will be beneficial to both patent applicants filing sequence listings and IPOs receiving applications containing disclosures of nucleotide and amino acid sequences. Standard ST.26
provides clear requirements as to what must be included in a sequence listing, and how sequences must be represented. For example, it standardizes the representation of modified nucleotide sequences and amino acid sequences as well as variants derived from primary sequences. Since Standard ST.26
contains a guidance document that illustrates the requirements for inclusion and representation of biological sequence data, patent applicants will have a clearer understanding of the requirements for presentation of biological sequence data in a compliant sequence listing under Standard ST.26. Additionally, since Standard ST.26 only allows XML
format, the potential for differences under the current rules between a sequence listing filed in paper/PDF
format and the required electronic CRF
will be eliminated. As a further benefit, IPOs of WIPO member states will no longer need to expend resources to process paper sequence listings and
PO 00000

Frm 00023

Fmt 4702

Sfmt 4702

35431

perform necessary checks on the contents of paper documents.
Unlike rules based on Standard ST.25, rules based on Standard ST.26 will allow patent applicants to file a single sequence listing with the USPTO with the exception of changes to comply with national language requirements that will be acceptable to the IPOs of WIPO
member states. Under Standard ST.25, IPOs have interpreted and enforced rules differently due to the imprecise language in the previous Standard. This has resulted in the frustrating situation where applicants generate sequence listings that may be accepted in one IPO
but not another.
Standard ST.26 was drafted to precisely define what must and must not be included in a sequence listing, and how sequences must be represented in a sequence listing. The Guidance document with illustrated examples in Annex VI of Standard ST.26 illustrates the application of the rules to real-world sequence disclosure examples, eliminating the possibility of misinterpretation by IPOs or applicants.
Due to the improved data structure of XML, transitioning from the current USPTO rules based on Standard ST.25
to rules based on Standard ST.26 will have the effect of increasing the quality of examination of patent applications containing biological sequence data since a more comprehensive search will be possible. Sequence listings submitted in accordance with Standard ST.26
allow for targeted searching of both sequence annotation and newly required sequence types, such as D-amino acids, nucleotide analogues, and linear portions of branched sequences. Finally, sequence listing submissions under rules based on Standard ST.26 will enhance public database content, as they include the sequence annotations e.g., feature keys and qualifiers used by database providers to describe biological sequence data. Standard ST.26
standardizes sequence variant presentation, annotation of modified and unusual residues, feature location descriptors, use of feature keys and qualifiers, organism names, and presentation of coding regions.
Incorporation by reference of Standard ST.26 into USPTO rules has the effect of promoting data exchange between USPTO and NCBI due to use of INSDC
identifiers required by database providers. The presence of additional data, as well as the enhanced compatibility to facilitate the exchange of data, will increase the value of database searches for biotechnology stakeholders that relate to nucleotide and amino acid sequences.

E:FRFM06JYP1.SGM

06JYP1