On 01.03.2021, the European Patent Office published a new revised version of the Guidelines for Examination in the European Patent Office (EPO). These Guidelines for Examination contain the instructions to be followed by the EPO in all first instance proceedings with regard to the practical and procedural aspects of the examination of European patent applications and patents under the European Patent Convention (EPC) and its Implementing Regulations (Rules). The new version of the Guidelines for Examination has already been announced in the Notice from the European Patent Office dated 25 January 2021. In the following, we summarize the changes that we consider most important for practice.
Part A of the Guidelines for Examination, concerning the formal examination of patent applications, now clarifies (see Section A-IV.1) that the term “earlier application” in Article 76(1) EPC and Rule 36 EPC is to be understood as a patent application filed at least one day before the divisional application. Thus, a divisional application cannot be filed on the same day as its parent application.
In Part C of the Guidelines for Examination, concerning procedural aspects of substantive examination, the Guidelines for Examination have been adapted, inter alia, to the abolished the possibility of waiving the right to receive a further communication under Rule 71(3) EPC(cf. Notice from the European Patent Office dated May 26, 2020), and chapters referring to the now unavailable waiver have been deleted.
With regard to Euro-PCT applications in which the applicant has subsequently corrected an erroneously filed element (description or claims) or parts thereof under Rule 20.5bis PCT during the international phase, and the international filing date has not been postponed, it is clarified that the EPO as designated/elected Office will consider as filing date only the date on which the complete correct documents were filed (cf. SectionC-III. 1.3). This rule will be particularly relevant for Euro-PCT applications for which the EPO was not itself competent as International Filing Office or International Searching Authority.
Due to the significance of this practice for any priority claims and the relevant state of the art in the examination procedure, the applicant concerned will in future be given the opportunity to file a written statement within 2 months after being requested to do so and to decide either:
- to continue with the original international filing date and to base the examination procedure also on the documents originally filed partially erroneously, or
- to proceed with the date on which the correct application documents were filed as the filing date, as well as to recognize the correct application documents as the original application documents for further proceedings.
This request can also be made proactively by the applicant within the 31-month period to avoid delaying the application process in the regional phase.
Further changes relate to telephone and personal consultation with the examination department, or the first examiner. These previously represented different categories with different regulations, which have now been combined and standardized into a single category “consultation” (cf. Section C-VII.2). A consultation should preferably be held as a videoconference, which allows, if necessary, the presentation of documents, the participation of other persons, and – in case of doubt – the verification of the identity of the persons participating. However, at the request of the applicant, consultations may also be conducted by telephone if the situation so requires. Oral statements made during a consultation that substantively address objections raised in an earlier communication may result in the examiner cancelling any running time limit. Furthermore, documents admissibly submitted by emailduring the consultation (see Section C-VII.3) may in fact be sufficient to preserve an ongoing deadline.
Another change in the Guidelines for Examination of practical importance concerns the treatment of requests for decisions according to the state of the file. Section C-IV.15.1 of the Guidelines now provides that if a request for oral proceedings is pending at the time the applicant files a request for decision according to the state of the file, the Examining Division will interpretthe request for decision according to the state of the file as an implicit withdrawal of the pending request for oral proceedings. Section C-IV.15.2 emphasizes that in a decision according to the state of the filefreshly presented arguments of the applicant in response to a communication of the Examining Division must be considered by the Examining Division by issuing either a regular reasoned decision or a further communication. The minutes of a consultation does not meet the standards of a communication under Article 94(3) and thus cannot be the basis of a decision according to the state of the file.
Part E of the Guidelines for Examination, concerning general procedural matters, has been updated, inter alia, with regard to conducting oral proceedings as a videoconference. In the light of theDecision of the President of the European Patent Office dated 17 December 2020 concerning oral proceedings by videoconference before examining divisionsare to be held by videoconference (see Section E-III.1). Oral proceedings before the Examining Division shall be held in person at the premises of the EPO only if there are serious reasons against holding the oral proceedings by videoconference.
For oral proceedings in opposition proceedings, oral proceedings may be held as a videoconference if the parties agree (see Section D-IV.3.2). However, due to the Decision of the President of the European Patent Office dated 10 November 2020 concerning the modification and extension of the pilot project for oral proceedings by videoconference before opposition divisions, oral proceedings before opposition divisions will be held by videoconference as ofJanuary 4, 2021 until at leastSeptember 15, 2021. Only if there are serious reasons against holding a videoconference in opposition proceedings, the oral proceedings will be postponed until after September 15, 2021.
However, serious reasons are likely to militate against a hearing by videoconference only in very exceptional cases. The Guidelines for Examination emphasize that such serious reasons include reasons relating to a participant to the oral proceedings as an individual (e.g. a proven visual impairment that prevents a representative from following oral proceedings on screen) and reasons related to the nature and subject-matter of the proceedings (e.g. where they involve the demonstration or inspection of an object where the haptic features are essential, to the extent that this is possible in accordance with the applicable provisions). Sweeping objections against the reliability of videoconferencing technology or the non-availability of videoconferencing equipment will, as a rule, not qualify as serious reasons in this regard.
If, exceptionally, applicants wish oral proceedings to be held before the Examining Division on the premises of the EPO, such a request must be filed as early as possible, preferably together with the request for oral proceedings. However, whether such a request is granted is at the discretion of the competent division. A rejection of such a request must be (briefly) substantiated by the Examining Division – irrespective of the time of filing the request. A rejection is not appealable (see Section E-III.2.2).
Furthermore, Section E-III.8.5.2 has been added to the Guidelines for Examination. This section concerns the filing of written submissions duringoral proceedings held as a videoconference. If oral proceedings are held as a videoconference, documents filed subsequently as referred to in Rule 50 EPC must be filed by emailWhere filed documents require signature, this signature may be applied to the attached document or to the text of the accompanying email. The signature must take the form of a string of characters or a facsimile signature. The string of characters which is selected by the signatories to provide evidence of their identity and of their intent to authenticate the message in question must clearly indicate the person’s name and position. The documents are to be sent to the email address indicated during the videoconference by the competent department.
Amended application documents must be submitted as attachments in PDF format and comply with the WIPO Standard for Filing and Processing in Electronic Form (Annex F). Where an attachment containing these amended application documents is not in PDF format or does not comply with the WIPO Standard or is illegible or incomplete, the party must be promptly informed during the videoconference. Where the deficiencies cannot be remedied during the videoconference or within the time limit set, that document (or that part of the document which is illegible or incomplete) is deemed not to have been received.No paper documents need be filed to confirm documents filed by email. All submissions made by email during a videoconference must be annexed to the minutes unless the exceptions under Rule 144 EPC apply.
Section E-III.11, concerning the technical aspects of oral proceedings held as a videoconference, has also been revised. In order to prepare for oral proceedings by videoconference, in addition to the summons, participants will receive an email confirming the date, time and the videoconference contact details to be used to establish the connection (in the form of a link or by other suitable means) and containing any further appropriate information, including on the organization of the videoconference. If the videoconference does not start at the agreed time, the Examining Division or Opposition Division will contact the representative or his/her office by telephone. If the connection cannot be established for technical reasons, the videoconference shall be terminated and a new summons to oral proceedings shall be issued.
Section E-VIII.1 of the Guidelines for Examination, which concerns the calculation of time limits, hasalso been restructured and supplemented. The Guidelines for Examination deal with extensions under Rule 134 EPC in a separate section, E-III.1.6.2, taking into account the contents of the Notice from the European Patent Office dated 22 October 2020 concerning the procedures and safeguards which apply under the EPC and the PCT in the event of outages of means of electronic filing and other online services. Accordingly, the extension of time limits under Rule 134(1) EPC also applies in cases where one of the means of electronic filing provided by the EPO under Rule 2(1) (currently Web-Form Filing, Online Filing (OLF), New Online Filing (CMS), ePCT and fax) is not available, regardless of any restrictions on the documents which may be filed by the means of electronic filing that suffered the outage. Also, Rule 134(2) EPC (general dislocation in the delivery or transmission of mail in a Contracting State) may now apply to a general breakdown of any of the means of electronic communication accepted by the EPO for the filing of documents. Furthermore, Section E-III.18.104.22.168explicitly lists the time limits falling within the scope of Rule 134 EPC and also mentions the cases in which the extension of time limits under Rule 134 EPC is not available.
Another practically relevant change in Part F of the Guidelines for Examinationhas found its way into Sections F-IV.4.3 and F-IV.4.4, whichconcern inconsistencies between the description and the patent claims (Article 84 EPC). Here, the practice of the examining divisions concerning the adaptation of the description to amended claims – which varies considerably across the divisions and also the fields of technology – has now been fundamentally revised. The Guidelines for Examination now explicitly require in Section F-IV.4.3that in cases where part of the subject-matter of the description and/or drawings is not covered by the claims, the description must be adapted to the claims in order to avoid inconsistencies between claims and description. Embodiments in the description which are no longer covered by the independent claims must be deleted (for example if the description comprises an alternative for at least one feature which is no longer covered by the amended claims) unless these embodiments can reasonably be considered to be useful for highlighting specific aspects of the amended claims. In such a case, the fact that an embodiment is not covered by the claims must be prominently stated (T 1808/06). Section F-IV.4.4 now clarifies that claim-like clauses must be deleted or amended prior to grant, in particular if the clauses are inconsistent with the claimed subject-matter or if it merely repeatonly repeat the claimed subject-matter in a very literal manner, which is now explicitly considered to be “an irrelevant and unnecessary reduplication […]” that do not fulfil the requirements ofRule 48(1)(c).
In Part G of the Guidelines for Examination, which concerns patentability, the sections on computer-implemented inventions and on inventions in the field of biotechnology have been revised and further clarified.
In Section G-II.3.6, which concerns computer programs excluded from patentability as such under Article 52(2) EPC, adjustments have been made in the light of recent case law. Section G-II.3.6.3 of the Guidelines for Examination now explains more clearly under which circumstances a data structure or data format may contribute to the technical character of the invention. Furthermore, the new section G-II.3.6.4 has been included, which concerns database management systems and information retrieval. There, the Guidelines for Examination include a remarkably clear statement that database management systems are technical systems installed on computers to perform the technical tasks of storing and retrieving data using various data structures for efficient data management. Thus, technical means are used in a process performed by a database management system, so that these processes are not excluded from patentability under Article 52(2) EPC.
The now well-established case law abouthuman stem cells that can be obtained without the consumption of human embryos are patentablehas found its way into the guidelines. Section G-II.5.2 now clarifies that pluripotent human stem cells including human embryonic stem cells, the use of such stem cells, or products derived therefrom, do not fall under the patenting prohibition of Article 53(a) and Rule 28(1)(c), if the application has a filing- or priority date on or after June 5, 2003, and if the technical teaching of the invention allows the use of parthenogenetically activated human oocytes(G-II.5.3).
Furthermore, sections G-II.5.3 and G-II.5.4 have been adapted to the recent case law on the exclusion of patentability of plant- and animal material, which can be produced exclusively by essentially biological processes (G 3/19). The new guidelines clarify that any material allowing regeneration of whole plants, such as cells, seeds, cuttings, etc., are also subject to the exclusion of patentability under Article 53b EPC, provided that the plants from which this material is derived can be exclusively obtained by means of an essentially biological process. However, this exclusion does not apply to patent applications and patents with a filing or priority date prior to July 1, 2017 (see G 3/19, OJ EPO 2020, A119).
In addition, a new Section G-II.5.6on patentability and examination of inventions in the field of antibody technology has been added to the new Guidelines for Examination. Here, an EPO internalantibody focused examination practice had been established, which is now enshrined in the new Guidelines for Examination. The Guidelines for Examination deal in particular with admissible structural/functional antibody definitions in claims, as well as the basis for an examination of inventive step in this field.A structural definition of a claimed antibody must reference at least all 6 CDR regions, which are the main mediators of antibody-antigen binding. Otherwise, the antibody patent claim would be objectionable under Article 84 EPC because it lacks an essential technical feature. Broader structural definitions of antibodies must be supported by experimental evidence.
To the extent that an antibody is defined by its target antigen or an epitope, the corresponding antigen/epitope must be referenced without open-ended formulations (such as definitions by broadsequence identity regions or open terms such as “comprising”), although negative features, in the sense of antigens or epitopes that are not bound by the antibody in question,are possible.
If solely functional features are used to claim an antibody, and the prior art discloses an antibody binding to the identical antigen, it is clarified that the burden of proof of novelty of the claimed antibodies lies with the applicant. It is also possible to define an antibody by means of product-by-process features, insofar as the general requirements of this claim category are fulfilled. However, to the extent that the referenced method is directed to an immunization of an animalwith an immunogen comprising a sequence that is not 100% identical to a defined sequence of the alleged antigen bound by the antibody, the claim does not meet the requirements of Article 84 EPC.
In section G-VI.7.1.1with regard to inventions of a second medical indication, the Guidelines for Examinationindicate the requirement whether a substance or a mixture of substances has a direct therapeutic effect as an active ingredient for a specific medical use due to its chemical properties. If it is a merely a physical property, such as a shielding effect of a substance of the use of a substance as a filler to protect sensitive tissue, such substance or mixture of substances is to be regarded as a device and not amenable to patenting under Article 54(5) (T 1758/15).