81 FR 74775 - Standard ST.26-Request for Comments on the Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language)
DEPARTMENT OF COMMERCE
Patent and Trademark Office Federal Register Volume 81, Issue 208 (October 27, 2016)
Patent and Trademark Office
Federal Register Volume 81, Issue 208 (October 27, 2016)
| Page Range | 74775-74777 | |
| FR Document | 2016-25968 |
[Federal Register Volume 81, Number 208 (Thursday, October 27, 2016)] [Notices] [Pages 74775-74777] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-25968] ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Patent and Trademark Office [Docket No.: PTO-P-2016-0039] Standard ST.26--Request for Comments on the Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible Markup Language) AGENCY: United States Patent and Trademark Office, Commerce. ACTION: Request for comments. ----------------------------------------------------------------------- SUMMARY: Patent applications that contain disclosures of nucleotide and/or amino acid sequences must contain sequence information in a separate part of the disclosure in a specified manner. The United States Patent and Trademark Office (Office) is seeking additional comments to obtain views of the public on the continuing international effort to revise the World Intellectual Property Organization (WIPO) standard for the presentation of nucleotide and/or amino acid sequences and the consequent changes to the United States rules of practice. The revised standard will be known as WIPO Standard ST.26. An interim version of WIPO Standard ST.26 was adopted in March 2016 by the Committee on WIPO Standards (CWS), but has not been implemented pending further consideration by the CWS. Since the adoption of the interim version, efforts have been undertaken to finalize WIPO Standard ST.26 and to improve its effectiveness once implemented. One aspect of that continuing effort is a proposed guidance document annex, which will include a variety of sequence disclosure examples, to ensure understanding and uniform application of standard requirements. Comments may be offered on any aspect of this effort, and in particular, (a) the comprehensiveness and clarity of WIPO Standard ST.26 and the proposed guidance document annex, and (b) the proposed authoring/validation tool for creation of a sequence listing in XML. DATES: Written comments must be received on or before December 27, 2016 to ensure consideration. No public hearing will be held. ADDRESSES: Comments concerning this notice should be sent by electronic mail message over the Internet addressed to [email protected]. Comments may also be submitted by mail addressed to: Mail Stop Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of Susan C. Wolski, Office of International Patent Legal Administration, Office of the Deputy Commissioner for International Patent Cooperation. Although comments may be submitted by mail, the Office prefers to receive comments via the Internet. The comments will be available for public inspection at the Office of the Commissioner for Patents, located in Madison East, Tenth Floor, 600 Dulany Street, Alexandria, Virginia, and will be available via the Internet (http://www.uspto.gov). Because comments will be made available for public inspection, information that the submitter does not [[Page 74776]] desire to make public, such as an address or phone number, should not be included in the comments. FOR FURTHER INFORMATION CONTACT: Susan C. Wolski, Office of International Patent Legal Administration, Office of the Deputy Commissioner for International Patent Cooperation, by telephone at (571) 272-3304, or by mail addressed to: Mail Stop Comments--Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313-1450, marked to the attention of Susan C. Wolski. SUPPLEMENTARY INFORMATION: 1. Background Information Patent applicants are currently required to submit biological sequence data in a standardized electronic format in accordance with WIPO Standard ST.25, both within the framework of the Patent Cooperation Treaty (PCT) (Annex C of the Administrative Instructions) and under most national and regional provisions. The Rules of Patent Practice in the United States (37 CFR 1.821-1.825) were amended to implement WIPO Standard ST.25 in July of 1998. See Requirements for Patent Applications Containing Nucleotide Sequences and/or Amno Acid Disclosures, 63 FR 29620 (June 1, 1998), 1121 Off. Gaz. Pat. Office 82 (June 23, 1998). WIPO Standard ST.25, which became effective in 1998 and has not been revised since that time, requires a flat file structure of numeric identifiers using a limited set of character codes. In October 2010, the CWS established a Task Force, designating the European Patent Organization as the lead, to draft a revised standard (WIPO Standard ST.26) for the filing of nucleotide and/or amino acid sequence listings in XML format. The Office issued a first request for comments on WIPO Standard ST.26 as drafted by the Task Force (see Request for Comments on the Recommendation for the Disclosure of Sequence Listings Using XML (Proposed ST.26), 77 FR 28541 (May 15, 2012), 1379 Off. Gaz. Pat. Office 106 (June 12, 2012)), following which the draft was revised in response to comments received. In March 2016, the reconvened fourth session of the CWS adopted an interim version of WIPO Standard ST.26, which had been initially considered at the fourth session of the CWS in May 2014. The interim version of WIPO Standard ST.26 contains an editorial note requesting that implementation be postponed until the recommendation for the transition from WIPO Standard ST.25 to WIPO Standard ST.26 is agreed on by the CWS at its next session to be held in 2017. Meanwhile, WIPO Standard ST.25 should continue to be used. The adopted interim version of WIPO Standard ST.26 is composed of six documents, namely, the main body of the standard, a first annex setting forth the controlled vocabulary for use with the sequence part of the standard, 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, and a fifth annex setting forth additional data exchange requirements for patent offices, and can be found here: http://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01.pdf. Since the adoption of the interim version, the main body, the controlled vocabulary, and the DTD have been further revised and updated. In addition, a sixth annex has been proposed; it would contain a guidance document that aims to ensure that all applicants and Intellectual Property Offices (IPOs) understand and agree on the requirements for inclusion and representation of sequence disclosures. In all, seven rounds of discussion have been completed since March 2011, and currently, the eighth round of discussion of the documents is ongoing. 2. Request for Comments The Office, leading the negotiations for the United States, is seeking public comment on WIPO Standard ST.26, as revised subsequent to the adoption of the interim version. To that end, the current revisions of the main body of the standard and its five annexes, as well as the newly proposed sixth annex, are available via the Office's Web site at http://www.uspto.gov/patent/laws-and-regulations/comments-public/2016-comments-standard-st26-presentation-nucleotide-and. Written comments may be offered on any aspect of WIPO Standard ST.26, its annexes, or the proposed authoring/validation tool. Comments are specifically requested on the following issues: (a) WIPO Standard ST.26 Main Body Since the first request for comments, the main body of WIPO Standard ST.26 has been revised, inter alia, to define a ``nucleotide'' to include nucleotide analogues and to provide further guidance on representation of nucleotide analogue sequences and variant sequences that have been disclosed as a single sequence with enumerated alternative variant residues at one or more positions. The Office invites comments on whether the main body of WIPO Standard ST.26 is sufficiently comprehensive and clear, and in particular welcomes suggestions to add details or clarify the language as appropriate. (b) Guidance Document One goal of the development of a WIPO Standard for sequence listings is to allow patent applicants to draw up a single sequence listing in a patent application that would be acceptable for the purposes of both international and national or regional prosecution worldwide. Any new standard should represent the maximum requirements for any sequence listing submission. The purpose of the guidance document is to ensure that all applicants and IPOs understand and agree on the requirements for inclusion and representation of sequence disclosures, such that this purpose is realized. The guidance document is composed of an introduction, examples, and a sequence listing in XML demonstrating representation of the exemplified sequences. The introduction defines terminology used in the document and discusses the questions raised for each example, namely, whether inclusion is required for a particular disclosed sequence, if inclusion of the sequence is permitted when it is not required, and the appropriate means of representation of sequences included in a sequence listing. Examples were chosen to illustrate various paragraphs of the main body and include 22 involving nucleotide sequences and 19 involving amino acid sequences. It is envisioned that the guidance document would be updated as necessary to include further examples to keep pace with technological advances. The Office invites comments on whether the guidance document is sufficiently comprehensive and clear, and in particular welcomes suggestions to add details or further examples as appropriate. (c) Authoring and Validation Tool Availability of an authoring tool in advance of the WIPO Standard ST.26 effective date is key to a successful transition from WIPO Standard ST.25. As envisioned, the authoring tool should be capable of intake of a sequence listing in WIPO Standard ST.25 format, and with additional input from applicant, create a sequence listing in WIPO Standard ST.26 format. Unfortunately, direct conversion from one standard to the other is not possible, due to numerous differences between the two standards, including inter alia, [[Page 74777]] the types of required sequences, representation and annotation of the sequences, and sequence data structure. The authoring tool should also prompt entry of all required data, prevent entry of sequences having fewer than ten specifically defined nucleotides or fewer than four specifically defined amino acids, inform as to the possibility of optional annotations, and allow use of only acceptable values or formats where applicable, thereby enhancing submission quality. A sequence listing in WIPO Standard ST.26 XML format is not as easily human-readable as its ST.25 counterpart; therefore, the tool should also provide a means for easily viewing both the in-progress and completed sequence listing. Because the authoring tool is expected to prompt entry of all required data and to allow use of only acceptable values or formats where applicable, a certain level of validation occurs as data is entered. The tool is further expected to include a separate validation function for use by both applicants and IPOs. WIPO Standard ST.25 provides for a single numeric identifier <223> per sequence to contain ``free text'' to describe sequence characteristics using non-language neutral vocabulary. Such ``free text'' is required to be repeated in the main part of the application description in the language thereof in a specific recommended section entitled ``Sequence Listing Free Text.'' Such repetition ensures that any ``free text'' will be translated together with the application description, precluding the need for separate translation of the sequence listing itself. In contrast, WIPO Standard ST.26 allows use of ``free text'' as the value for multiple different annotation qualifiers per sequence, and due to the absence of procedural requirements, repetition in the application is not required, although such a requirement under the PCT and by various IPOs is possible. In WIPO Standard ST.26, ``free text'' is limited to a few short terms indispensable for understanding a characteristic of a sequence, is preferably in the English language, and as part of the sequence data part of the sequence listing, must not exceed 1000 characters composed of printable characters from the Unicode Basic Latin code table. It is expected that most inventors providing sequence information are capable of providing ``free text'' in the English language. The Office invites comments on any aspect of the authoring tool, and in particular welcomes feedback on whether it is deemed necessary for the authoring tool to include a mechanism for automatic identification and extraction of any ``free text'' from sequence annotations to facilitate inclusion in the application description. Dated: October 21, 2016. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office. [FR Doc. 2016-25968 Filed 10-26-16; 8:45 am] BILLING CODE 3510-16-P
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DEPARTMENT OF COMMERCE The public uses this information ACTION: Request for comments.
collection to file requests related to
Patent and Trademark Office patent term extensions and SUMMARY: Patent applications that
reconsideration or reinstatement of contain disclosures of nucleotide and/or
Submission for OMB Review; patent term adjustments. The amino acid sequences must contain
Comment Request; Patent Term information in this collection is used by sequence information in a separate part
Extension the USPTO to consider whether an of the disclosure in a specified manner.
applicant is eligible for a patent term The United States Patent and Trademark
The United States Patent and Office (Office) is seeking additional
Trademark Office (USTPO) will submit extension or reconsideration of a patent
term adjustment and, if so, to determine comments to obtain views of the public
to the Office of Management and Budget on the continuing international effort to
(OMB) for clearance the following the length of the patent term extension
revise the World Intellectual Property
proposal for collection of information or adjustment.
Affected Public: Businesses or other Organization (WIPO) standard for the
under the provisions of the Paperwork presentation of nucleotide and/or amino
Reduction Act (44 U.S.C. Chapter 35). for-profits; not-for-profit institutions.
Frequency: On occasion. acid sequences and the consequent
Agency: United States Patent and changes to the United States rules of
Respondent’s Obligation: Required to
Trademark Office, Commerce. practice. The revised standard will be
Title: Patent Term Extension. obtain or retain benefits.
OMB Desk Officer: Kimberly R. known as WIPO Standard ST.26. An
OMB Control Number: 0651–0020. interim version of WIPO Standard ST.26
Form Number(s): N/A. Keravuori, email: Kimberly_R_
Type of Request: Renewal. Keravuori@omb.eop.gov. was adopted in March 2016 by the
Number of Respondents: 1,340. Once submitted, the request will be Committee on WIPO Standards (CWS),
Average Hours per Response: 1 hour publicly available in electronic format but has not been implemented pending
to 25 hours, depending upon the through reginfo.gov. Follow the further consideration by the CWS. Since
instrument used. instructions to view Department of the adoption of the interim version,
Burden Hours: 6,187 hours. Commerce collections currently under efforts have been undertaken to finalize
Cost Burden: $351,505.08. review by OMB. WIPO Standard ST.26 and to improve
Needs and Uses: The patent term Further information can be obtained its effectiveness once implemented. One
restoration portion of the Drug Price by: aspect of that continuing effort is a
Competition and Patent Term • Email: InformationCollection@ proposed guidance document annex,
Restoration Act of 1984 (Pub. L. 98– uspto.gov. Include ‘‘0651–0020 copy which will include a variety of sequence
417), which is codified at 35 U.S.C. 156, request’’ in the subject line of the disclosure examples, to ensure
permits the United States Patent and message. understanding and uniform application
Trademark Office (USPTO) to extend • Mail: Marcie Lovett, Records of standard requirements. Comments
the term of protection under a patent to Management Division Director, OCIO, may be offered on any aspect of this
compensate for delay during regulatory United States Patent and Trademark effort, and in particular, (a) the
review and approval by the Food and Office, P.O. Box 1450, Alexandria, VA comprehensiveness and clarity of WIPO
Drug Administration (FDA) or 22313–1450. Standard ST.26 and the proposed
Department of Agriculture. Only patents Written comments and guidance document annex, and (b) the
for drug products, medical devices, food recommendations for the proposed proposed authoring/validation tool for
additives, or color additives are information collection should be sent on creation of a sequence listing in XML.
potentially eligible for extension. The or before November 28, 2016 to DATES: Written comments must be
maximum length that a patent may be Kimberly R. Keravuori, OMB Desk received on or before December 27, 2016
extended under 35 U.S.C. 156 is five Officer, via email to Kimberly_R_ to ensure consideration. No public
years. The USPTO administers 35 U.S.C. Keravuori@omb.eop.gov, or by fax to hearing will be held.
156 through 37 CFR 1.710–1.791. 202–395–5167, marked to the attention ADDRESSES: Comments concerning this
Separate from the extension provisions of Kimberly R. Keravuori. notice should be sent by electronic mail
of 35 U.S.C. 156, the USPTO may in Dated: October 20, 2016. message over the Internet addressed to
some cases extend the term of an Marcie Lovett, seq_listing_xml@uspto.gov. Comments
original patent due to certain delays in may also be submitted by mail
Records Management Division Director,
the prosecution of the patent addressed to: Mail Stop Comments—
OCIO, United States Patent and Trademark
application, including delays caused by Office. Patents, Commissioner for Patents, P.O.
interference proceedings, secrecy Box 1450, Alexandria, VA 22313–1450,
[FR Doc. 2016–25951 Filed 10–26–16; 8:45 am]
orders, or appellate review by the Patent marked to the attention of Susan C.
BILLING CODE 3510–16–P
Trial and Appeal Board or a Federal Wolski, Office of International Patent
court in which the patent is issued Legal Administration, Office of the
pursuant to a decision reversing an DEPARTMENT OF COMMERCE Deputy Commissioner for International
adverse determination of patentability. Patent Cooperation. Although comments
The patent term provisions of 35 U.S.C. Patent and Trademark Office may be submitted by mail, the Office
154(b), as amended by Title IV, Subtitle prefers to receive comments via the
D of the Intellectual Property and [Docket No.: PTO–P–2016–0039]
Internet.
Communications Omnibus Reform Act The comments will be available for
Standard ST.26—Request for
of 1999, require the USPTO to notify the
sradovich on DSK3GMQ082PROD with NOTICES
Comments on the Recommended public inspection at the Office of the
applicant of the patent term adjustment Commissioner for Patents, located in
Standard for the Presentation of
in the notice of allowance and give the Madison East, Tenth Floor, 600 Dulany
Nucleotide and Amino Acid Sequence
applicant an opportunity to request Street, Alexandria, Virginia, and will be
Listings Using XML (eXtensible
reconsideration of the USPTO’s patent available via the Internet (http://
Markup Language)
term adjustment determination. The www.uspto.gov). Because comments will
USPTO administers 35 U.S.C. 154 AGENCY:United States Patent and be made available for public inspection,
through 37 CFR 1.701–1.705. Trademark Office, Commerce. information that the submitter does not
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![Federal Register / Vol. 81, No. 208 / Thursday, October 27, 2016 / Notices 74777
the types of required sequences, extraction of any ‘‘free text’’ from information. This helps the Department
representation and annotation of the sequence annotations to facilitate assess the impact of its information
sequences, and sequence data structure. inclusion in the application description. collection requirements and minimize
The authoring tool should also Dated: October 21, 2016. the public’s reporting burden. It also
prompt entry of all required data, helps the public understand the
Michelle K. Lee,
prevent entry of sequences having fewer Department’s information collection
than ten specifically defined Under Secretary of Commerce for Intellectual
Property and Director of the United States requirements and provide the requested
nucleotides or fewer than four Patent and Trademark Office. data in the desired format. ED is
specifically defined amino acids, inform soliciting comments on the proposed
[FR Doc. 2016–25968 Filed 10–26–16; 8:45 am]
as to the possibility of optional information collection request (ICR) that
BILLING CODE 3510–16–P
annotations, and allow use of only is described below. The Department of
acceptable values or formats where Education is especially interested in
applicable, thereby enhancing public comment addressing the
submission quality. A sequence listing DEPARTMENT OF EDUCATION
following issues: (1) Is this collection
in WIPO Standard ST.26 XML format is [Docket No.: ED–2016–ICCD–0116] necessary to the proper functions of the
not as easily human-readable as its
Department; (2) will this information be
ST.25 counterpart; therefore, the tool Agency Information Collection
should also provide a means for easily processed and used in a timely manner;
Activities; Comment Request; Student
viewing both the in-progress and (3) is the estimate of burden accurate;
Assistance General Provisions—
completed sequence listing. (4) how might the Department enhance
Satisfactory Academic Progress Policy
Because the authoring tool is expected the quality, utility, and clarity of the
to prompt entry of all required data and AGENCY: Department of Education (ED), information to be collected; and (5) how
to allow use of only acceptable values Federal Student Aid (FSA) might the Department minimize the
or formats where applicable, a certain ACTION: Notice burden of this collection on the
level of validation occurs as data is respondents, including through the use
entered. The tool is further expected to SUMMARY: In accordance with the of information technology. Please note
include a separate validation function Paperwork Reduction Act of 1995 (44 that written comments received in
for use by both applicants and IPOs. U.S.C. chapter 3501 et seq.), ED is response to this notice will be
WIPO Standard ST.25 provides for a proposing a revision of an existing considered public records.
single numeric identifier <223> per information collection.
Title of Collection: Student Assistance
sequence to contain ‘‘free text’’ to DATES: Interested persons are invited to General Provisions—Satisfactory
describe sequence characteristics using submit comments on or before Academic Progress Policy.
non-language neutral vocabulary. Such December 27, 2016.
‘‘free text’’ is required to be repeated in OMB Control Number: 1845–0108.
ADDRESSES: To access and review all the
the main part of the application documents related to the information Type of Review: A revision of an
description in the language thereof in a collection listed in this notice, please existing information collection.
specific recommended section entitled use http://www.regulations.gov by Respondents/Affected Public: State,
‘‘Sequence Listing Free Text.’’ Such searching the Docket ID number ED– Local, and Tribal Governments;
repetition ensures that any ‘‘free text’’ 2016–ICCD–0116. Comments submitted Individuals or Households; Private
will be translated together with the in response to this notice should be Sector.
application description, precluding the submitted electronically through the
need for separate translation of the Total Estimated Number of Annual
Federal eRulemaking Portal at http://
sequence listing itself. In contrast, WIPO Responses: 33,543,341.
www.regulations.gov by selecting the
Standard ST.26 allows use of ‘‘free text’’ Docket ID number or via postal mail, Total Estimated Number of Annual
as the value for multiple different commercial delivery, or hand delivery. Burden Hours: 1,470,256.
annotation qualifiers per sequence, and
Please note that comments submitted by Abstract: The Department of
due to the absence of procedural
fax or email and those submitted after Education (the Department) is making
requirements, repetition in the
the comment period will not be this request is for an extension of the
application is not required, although
accepted. Written requests for current approval of the policies and
such a requirement under the PCT and
information or comments submitted by procedures for determining satisfactory
by various IPOs is possible. In WIPO
postal mail or delivery should be academic progress (SAP) as required in
Standard ST.26, ‘‘free text’’ is limited to
addressed to the Director of the Section 484 of the Higher Education Act
a few short terms indispensable for
Information Collection Clearance of 1965, as amended (HEA). These
understanding a characteristic of a
Division, U.S. Department of Education, regulations identify the policies and
sequence, is preferably in the English
400 Maryland Avenue SW., LBJ, Room procedures to ensure that students are
language, and as part of the sequence
2E–347, Washington, DC 20202–4537. making satisfactory academic progress
data part of the sequence listing, must
not exceed 1000 characters composed of FOR FURTHER INFORMATION CONTACT: For in their program at a pace and a level
printable characters from the Unicode specific questions related to collection to receive or continue to receive Title
Basic Latin code table. It is expected activities, please contact Beth IV, HEA program funds. If there is lapse
that most inventors providing sequence Grebeldinger, 202–377–4018. in progress, the policy must identify
SUPPLEMENTARY INFORMATION: The how the student will be notified and
sradovich on DSK3GMQ082PROD with NOTICES
information are capable of providing
‘‘free text’’ in the English language. Department of Education (ED), in what steps are available to a student not
The Office invites comments on any accordance with the Paperwork making satisfactory academic progress
aspect of the authoring tool, and in Reduction Act of 1995 (PRA) (44 U.S.C. toward the completion of their program,
particular welcomes feedback on 3506(c)(2)(A)), provides the general and under what conditions a student
whether it is deemed necessary for the public and Federal agencies with an who is not making satisfactory academic
authoring tool to include a mechanism opportunity to comment on proposed, progress may continue to receive Title
for automatic identification and revised, and continuing collections of IV, HEA program funds.
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Document Created: 2016-10-27 01:52:28
Document Modified: 2016-10-27 01:52:28
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for comments. | |
| Dates | Written comments must be received on or before December 27, 2016 to ensure consideration. No public hearing will be held. | |
| Contact | Susan C. Wolski, Office of International Patent Legal Administration, Office of the Deputy Commissioner for International Patent Cooperation, by telephone at | |
| FR Citation | 81 FR 74775 |
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