EPO Guidelines for Examination 2022

 

The EPO Guidelines for Examination are updated annually to take into account amendments to the EPC’s Implementing Regulations and decisions of the Board of Appeal and Enlarged Board of Appeal, and to reflect current practice at the EPO.

 

This week, the latest version of the Guidelines came into force (on 01 March 2022). Some of the major amendments to the Guidelines are summarized below.

 

Computer-Implemented Inventions

 

The Guidelines on patentability of computer-implemented inventions have been updated in accordance with last year’s decision G 1/19, particularly to provide some further clarification as to when a mathematical method and/or computer simulation contributes to the technical character of an invention (G-II, 3.3). Indeed, the guidelines relating to the patentability of simulation, design or modelling (G-II, 3.3.2) have been almost entirely rewritten.

 

The updated guidelines re-emphasise that steps of a claimed method that link to a physical object or system can provide a technical contribution. More particularly, it has been clarified how steps used to derive or predict the physical state of an existing real object from measurements of physical properties make a technical contribution. It is also noted that a technical contribution is provided by mathematical methods that exploit particular technical properties of a technical system to bring about a technical effect.

 

More interestingly, the update sets out how “purely numerical” simulations could provide a technical contribution. Such simulations must be adapted to a specific technical implementation (i.e., adapted to the technical/physical properties of the system running the simulation) or the data produced by a simulation must have an implicit or explicit “intended technical use” in order to contribute to the technical character of the invention.

 

Further down in the updated guidelines, a new example explains how data used to control an additive manufacturing device may make a technical contribution. Such data contributes to the technical character of an invention if it has an intended technical use and a technical effect is achieved when the data is used according to this technical use.

 

Some additional examples of applying the COMVIK approach to mixed-type inventions have been added, and a criticized example of a technical mathematical method has been removed. 

 

In our view, the general principle of computer-implemented inventions remains the same. Steps that are directed towards a technical or “real-life” purpose can contribute to a technical effect or technical character. The update to the Guidelines provides some welcome further examples and clarification on this point.

 

A further remark in the updated Guidelines is that any purported technical effect must be achieved over the whole scope of the claim (G-VII, 5.4.1). Claims must therefore be limited to only those embodiments that achieve the technical effect.

 

Biotechnological Inventions

 

Genetically Modified Animals

 

The Guidelines relating to the list of exceptions to patentability under Rule 28 EPC have been updated to clarify when the requirements of Rule 28(1)(d) EPC (relating to genetic modification) and Article 53(a) (relating to patentability of immoral inventions) are fulfilled (G-II, 5.3), in the context of genetic modification processes and genetically modified animals.

 

In an assessment under Rule 28(1)(d) EPC, a likelihood of suffering for animals resulting from the generic modification process and a likelihood of substantial medical benefit must be established. A correspondence between the suffering and the benefit must also be established on the balance-of-probabilities.

 

To comply with Article 53(a), a careful weighing up of these determined characteristics must be used.

 

Patentability of Antibodies

 

Some clarifying amendments have been made to the Guidelines regarding antibodies. The updated Guidelines explain how, when defining an IgG by structure, the IgG only needs to be defined by the number of CDRs required for its binding. However, the six sequences of its CDRs are still required unless it can be experimentally shown that one or more of these do not interact with the target epitope or concerns a specific antibody format allowing for epitope recognition by fewer CDRs.

 

Sequence Listings

 

In advance of the implementation of WIPO Standard ST .26 for sequence listings on 01 July 2022, the Guidelines relating to sequence listings now avoid references to specific standards (A-IV, 5). The updated Guidelines clarify that every sequence extending over the minimum length, including fragments of another disclosed sequence, must be listed in the sequence listing.

 

Further clarification has been provided as to when Rule 30 EPC applies and when sequence information may be late filed as a missing part under Rule 56 EPC.

 

Partial Priorities

The Guidelines relating to multiple priorities have been updated to include more detail on partial priority (F-VI, 1.5). Partial priority is defined as a situation in which only a part of the subject-matter encompassed by a generic “OR” claim is entitled to the priority date of an earlier application.

In an example added to the Guidelines, an application claiming the use of a composition defined in generic terms and claiming priority from an application that discloses the use of a specific composition encompasses a first alternative relating to the specific composition and a second alternative covering the remaining subject matter (i.e. all compositions encompassed by the generic terms except the specific composition of the first alternative). In this situation, priority can be claimed for the subject-matter of the first alternative, but not for that of the second alternative.

The updated Guidelines also clarify that, where a priority document and a still earlier application partially relate to the same invention, priority can only be validly claimed from the priority document for subject-matter that is not disclosed in the still earlier application.

 

Adaptation of the Description

Additional emphasis was introduced in the 2021 version of the guidelines on making the detailed description consistent with the subject-matter of the claims. These requirements have been updated (F-IV, 4.3).

Inconsistencies must be deleted from the description or marked as not falling within the subject-matter for which protection is sought. However, in borderline cases, the benefit of the doubt must be given to the applicant.

The Guidelines confirm that inconsistencies cannot be marked by the inclusion of a generic statement that refers to any embodiments not falling under the scope of the claims: statements must refer to specific embodiments. As before, unambiguous expressions must be used to mark inconsistencies (i.e. they cannot simply be referred to as “examples” or “aspects” instead of “embodiments”).

A further example of an inconsistency has been provided, namely the presence in the description of an alternative feature having a broader or different meaning than a feature of the independent claim and a feature that is demonstrably incompatible with an independent claim.

 

It has also been explained how described embodiments having additional features, where the combination of features in the embodiment is covered by an independent claim, and embodiments where one or more features of an independent claim are disclosed only implicitly, are not inconsistencies.