EPO Increases Strictness of Examination of Sequence Listings |
|
Biotechnology Practice Note Historically, EPO Examiners have exercised some discretion when examining sequence listing for compliance with WIPO standard ST.25 (the international standard for sequence listings). However, the EPO is receiving increasing numbers of sequence listings which do not comply with the WIPO standard, to the extent that many sequence listings are very difficult to search and/or are meaningless. Therefore, the EPO has increased the strictness of its examination. In particular, sequence listings may now be objected to if the symbol ‘Xaa’, which is an abbreviation for ‘any amino acid’, is used incorrectly. Take, for example, SEQ ID No. 1: >SEQ ID No. 1 If, in SEQ ID No. 1, Ala (position number 5) can be replaced by Asn, Gln or Gly, i.e. the sequence contains a variable amino acid residue, it is not correct to state that the sequence is Met Lys Lys Ile Xaa and then to define Xaa as being any of Asn, Gln or Gly. This is because the paragraph 18 of the WIPO standard states that ‘Xaa’ can represent only a single amino acid. In order to comply with the WIPO standard: (i) the sequence should be represented as: Met Lys Lys Ile Ala Ile Ala Ala Ile Thr Ala Thr (ii) Ala (position number 5) should be defined as a ‘Variant’ using Numeric Identifiers <221> and <222> (iii) In order to define the Variant, Numeric Identifier <223> should be used to indicate that Ala may be replaced by Asn, Gln or Gly, for example using the following notation: /replace= “Asn” /replace= “Gln” /replace= “Gly” Likewise, other sequence features such as binding sites and amidation sites should be carefully indicated and defined using language neutral vocabulary in order to avoid the need to translate the sequence listing should the patent specification need to be translated. If a sequence listing does not comply with WIPO standard ST.25, the EPO is likely to object to the sequence listing and invite the applicant to file a replacement, usually within 2 months, and to pay a late fee of €200. For long sequence listings, preparing a replacement can be a time consuming, and therefore expensive, process. In some cases, the correction of a non-compliant sequence listing can take longer than the preparation of a replacement sequence listing from scratch. It is therefore most cost-effective to ensure that European patent applications and International (PCT) patent applications, that nominate the EPO as the International Searching Authority, are filed with a sequence listing that complies with WIPO standard ST.25. As other International Searching Authorities may follow the EPO’s lead, we recommend that all sequence listings are prepared in strict accordance with the WIPO standard. Withers & Rogers’ patent attorneys are familiar with WIPO standard ST.25 and would be pleased to prepare sequence listings that comply with the WIPO standard. Likewise, Withers & Rogers’ patent attorneys are happy to review sequence listings prior to filing. For more information, please contact a member of our Life Sciences & Chemistry team: http://www.withersrogers.co.uk/content/view/24/82/ Dr David Elsy |
| < Prev | Next > |
|---|