A sneak preview on the new EPO Guidelines for Examination 2024
A sneak preview on the new EPO Guidelines for Examination 2024
The new EPO Guidelines for Examination will enter into force on 1 March 2024. A draft version of the Guidelines can be previewed here. The main updates this year reflect the recent decisions from the Enlarged Board of Appeal (EBA) in G2/21 (Plausibility) and G 1/22 (and G2/22) (Priority). There are also updates on the sufficiency requirements for AI inventions, ways to define antibodies and acceleration of opposition proceedings in cases pending before the UPC.
The guidelines give instructions on the practices and procedures to be followed in the examination of European and international applications and patents in accordance with the European Patent Convention (EPC), the Patent Cooperation Treaty (PCT) and their Implementing Regulations.
The PCT-EPO Guidelines follow the same structure as the EPC Guidelines, minus Part D, which is omitted because there is no opposition, limitation or revocation procedure under the PCT. Each part conforms as closely as possible to the corresponding part in the EPC Guidelines but is adapted to the specifics of the PCT system.
What are the changes in the 2024 edition?
The EPO provided an overview of the changes in table form with major and minor changes indicated.
Two decisions of the EPO enlarged boards of appeal have a major impact on the examination practice before the EPO.
- Impact of G1/22 on Entitlement to priority (A-III-6.1[i])
Following G 1/22 (and G 2/22), Part A-III-6.1 has been updated to state:
"absent any substantiated indication to the contrary, there is a strong rebuttable presumption under the EPC that an applicant or joint applicants claiming priority in accordance with Art. 88(1) and Rule 52 are also entitled to the claimed priority. The burden of proof is shifted, and the examining division, opponent or third party challenging an applicant’s entitlement to priority has to prove that this entitlement is missing. Especially where an international application under the PCT is filed by joint applicants, including the priority applicant, but without naming the priority applicant as applicant for the European designation, the mere fact of the joint filing implies an agreement between the applicants allowing all of them to rely on the priority right, unless substantial facts indicate otherwise (see G 1/22 and G 2/22)".
The Guidelines have been amended to refer to the decision which involves a serious loosening of the previous formalistic practice applied by some Boards and Opposition Divisions by confirming that:
“The EPC does not set out any formal requirements for the transfer of the priority right (see G 1/22 and G 2/22)".
See also our earlier news on this decision.
2. Impact of G 2/21 on inventive step and evaluation of evidence (E-IV-4.1[ii], G-VII-5.2[iii] and G-VII--11)
G 2/21 (“Plausibility”) has been incorporated in the section on assessment of inventive step in Part G-VII, 5.2 and G-VII, 11 by implementation of the EBA’s conclusion that:
“It is also possible to rely on new effects submitted subsequently during the proceedings by the applicant, provided the skilled person, having the common general knowledge at the effective filing date in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention" (Part G-VII, 5.2)
and
“Any evidence submitted to prove a technical effect that can be taken into account for the assessment of inventive step is assessed in accordance with the principle of free evaluation of evidence. Such evidence may not be disregarded solely on the ground that it is post-published (G 2/21).” (Part G-VII, 11)
The Guidelines have been amended to refer to the decision but leave plenty of room for interpretation of what this all actually means to be confirmed in later Board decisions.
See also to our earlier news on this decision.
G 2/21 has further been incorporated in the section relating to the principle of free evaluation of evidence in Part E-IV, 4. As follows:
“The competent department has the power and the duty to assess whether the alleged facts are sufficiently established based on evidence. The proceedings under the EPC are governed by the principle of free evaluation of evidence. This principle allows, and requires, a competent department to decide according to its own discretion and conviction, by taking into account the entire content of the parties' submissions. There are no firm rules according to which certain types of evidence are, or are not, convincing. This does not mean that the evaluation of evidence may be arbitrary, rather the evidence must be assessed comprehensively and dutifully. The only decisive factor is whether the department is convinced of the truth of the factual allegation, i.e. how credible the department classifies a piece of evidence. To do this, the department must put all the arguments for and against a factual statement in relation to the required standard of proof. In doing so, the department remains bound by the laws of the logic and by probability based on experience. The department sets out in the decision the reasons for reaching its conclusions (G 2/21).
The principle of free evaluation of evidence may not be used to simply disregard an admissibly submitted piece of evidence that is relied upon by a party in support of an inference that is challenged and is decisive for the final decision, for example to prove the presence of a technical effect. Disregarding it as a matter of principle would deprive the party of a basic legal procedural right enshrined in Art. 113(1) and 117(1). For example, the mere fact that evidence is post-published is not a sufficient reason not to take it into account.” ( Part E-IV, 4)
3. Disclosure requirements for AI inventions (F-III-3[iv], G-II-3.3.1)
The amended guidelines also encompass a clarified practice relating to the disclosure requirements for AI and mathematical methods inventions requiring supporting data and examples akin to the disclosure requirements for inventions in the biotech field. This requirement has now been explicitly called out in the guidelines:
"Occasionally applications are filed in which there is a fundamental insufficiency in the invention in the sense that it cannot be carried out by a person skilled in the art [...] another example can be found in the field of artificial intelligence if the mathematical methods and the training datasets are disclosed in insufficient detail to reproduce the technical effect over the whole range claimed. Such a lack of detail may result in a disclosure that is more like an invitation to a research programme" (Part F-III-3)
and
"The technical effect that a machine learning algorithm achieves may be readily apparent or established by explanations, mathematical proof, experimental data or the like. While mere allegations are not enough, comprehensive proof is not required, either. If the technical effect is dependent on particular characteristics of the training dataset used, those characteristics that are required to reproduce the technical effect must be disclosed unless the skilled person can determine them without undue burden using common general knowledge. However, in general, there is no need to disclose the specific training dataset itself" (Part G-II-3.3.1)
Part A-III, 5.3 now also mentions that the EPO checks whether the designated inventor is a natural person thereby implementing recent case-law in J 8/20 (DABUS) that an AI cannot be designated as an inventor.
4. Antibodies (G-II-6.1 and 6.2)
Worthwhile to note are Parts G-II, 6.1 and 6.2, where amendments are included in relation to antibodies inventions as such and the assessment of inventive step of antibody inventions. Some passages related to the definition of antibodies via their epitopes have been deleted but still the reference to epitopes for claiming antibodies is now included in different passages. The reference to epitope for defining an antibody has been deleted in G-II, 6.1 and in previous section G-II, 5.6.1.6, but reformulated in section G-II, 6.1.3, explaining how antibodies can be defined based on their target antigens and other functional features:
“In addition to the functional definition by their target antigen antibodies can be further characterised by functional features defining their other properties; for example, the binding affinity, neutralising properties, induction of apoptosis, internalisation, inhibition or activation of receptors.
An antibody may also be claimed by reference to its epitope, i.e. the structurally defined part of the antigen that it specifically binds to. Claims are sometimes directed to antibodies defined by their ability to compete with a reference antibody which is disclosed for the first time in the application. However, this property will not normally be sufficient to identify antibodies in the state of the art. In such a case, a complete search cannot be carried out (B-VIII, 3) and an invitation under Rule 63(1) to indicate subject-matter for search is sent (B-VIII, 3.1).
In all these cases, in the absence of any indication to the contrary, it is to be assumed that a prior- art antibody binding the same target antigen will have the claimed functional properties. Therefore a novelty objection may be raised and the burden of proof lies with the applicant (cf. G-VI, 5).” (Part G-II, 6.1.3)
A new section has been added also to this Part G-II, 6.1.3:
“The application must enable the person skilled in the art to produce further antibodies having the claimed functional property without undue burden (cf F-III, 1 and 4). Furthermore, the functional definition must allow the skilled person to easily and unambiguously verify whether they are working inside or outside the scope of the claim. The claim should therefore normally include the relevant characteristics of the method used to determine and define the functional property (cf F-IV, 4.11).” ).” (Part G-II, 6.1.3)
The Guidelines have been updated to further clarify the circumstances in which these types of claims are permitted, including the sufficiency requirements and the burden of proof with respect to prior art antibodies in Part G-II-6.2:
“The subject-matter of a claim defining a novel antibody binding to a known antigen does not involve an inventive step unless a surprising technical effect is shown in the application or unless there was no reasonable expectation of success of obtaining antibodies having the required properties (cf G-VII, 13). Examples of surprising technical effects include an unexpected improvement over prior- art antibodies in one or more properties, such as therapeutic activity, stability or immunogenicity or an unexpected property not exhibited by prior- art antibodies. Inventive step is not acknowledged solely on the basis that an antibody is structurally different from the prior- art antibodies. Arriving at alternative antibodies exclusively by applying techniques known in the art is considered to be obvious to the skilled person. The fact that the structure of an antibody, i.e. its amino acid sequence, is not predictable is not a reason for considering the antibody as non-obvious (see T 605/14, section 24; T 187/04, section 11). Nevertheless, antibodies can be inventive if the application overcomes technical difficulties in generating or manufacturing the claimed antibodies. A novel type of functional antibody format may also be considered inventive.” (see Part G-II-6.2)
The updates to the Guidelines on antibodies also reflect Boards of Appeal case law in this field.
5. ST.26 sequence listings and divisionals (A-IV-5 and A-III, 13.2)
WIPO Standard ST.26 applies to divisional applications submitted on or after 1 July 2022. Consequently, if a Standard ST.25-compliant sequence listing is part of the parent application, it must be converted into one complying with WIPO Standard ST.26. To avoid the risk of adding and/or losing subject-matter, the EPO permits applicants, as a safeguard, to file the parent application's ST.25 sequence listing in PDF format as part of the divisional application. This practice, however, has the disadvantage that additional fee for pages in excess of 35 ("page fee") might be incurred. The EPO has recently upon request of epi decided to revise this practice. The Guidelines have been amended to mention this practice now further as follows:
“If nucleotide and amino acid sequences within the meaning of Rule 30(1) are disclosed in the European patent application, they are to be represented in a sequence listing that complies with WIPO Standard ST.26. WIPO Standard ST.26 is a worldwide standard that, in Annex VII, contains recommendations on how to prevent potential added or deleted subject- matter in sequence listings due to conversion from WIPO Standard ST.25 to WIPO Standard ST.26.” (Part A-IV, 5)
and
“Where the sequence listing of the parent application is in a format complying with WIPO Standard ST.25, it must be converted into one complying with WIPO Standard ST.26. To avoid the potential risk of adding and/or losing subject-matter due to conversion, applicants may additionally file the parent application's ST.25 sequence listing in PDF format as part of the divisional application. In such cases, the pages of the ST.25 sequence listing are excluded from the calculation of the additional fee for pages in excess of 35 ("“page fee"”).” (Part A-IV, 5.4)
This provision has now also been added to the Guidelines here:
“The pages of the request for grant (EPO Form 1001) and those forming part of a sequence listing within the meaning of Rule 30(1) are not counted, provided the sequence listing contained in the description is filed in XML format, in compliance with WIPO Standard ST.26 (see OJ EPO 2021, A97). By way of exception, an additional fee is not due either for a parent application's ST.25 sequence listing filed in PDF format as part of a divisional application (see OJ EPO 2023, A98, and A-IV, 5.4). If the application is filed by reference to a previously filed application, the pages of the certified copy are taken as the basis for the calculation, excluding the pages for the certification, for bibliographic data and any sequence listing in ST.25 format contained in the certified copy under Rule 40(3). If the application is filed without claims, the additional fee takes account of the pages of the first set of claims filed.” (Part A-III, 13.2)
6. Acceleration of opposition proceedings in cases of pending actions before the UPC (D-VIII-1.2)
The EPO recently announced new provisions for accelerating opposition proceedings and the Guidelines have been updated to reflect the latest notice:
"oppositions are to be given priority [...] if a party to the proceedings has submitted a reasoned request for accelerated processing in a case where an infringement action in respect of the European patent is pending before the Unified Patent Court or a national court of a contracting state, or if the EPO is informed by the Unified Patent Court, a national court or competent authority of a contracting state that infringement actions are pending" (Part D-VIII-1.2[v])
7. Adaptation of the description
Practitioners are currently awaiting a referral to the EBA to see if there is really a legal basis to force applicants to amend the description in line with the allowed claims (see our earlier post).
“the description of the patent may be examined for compliance with the requirements of Art. 84 only when, and then only to the extent that, an amendment of the patent introduces non-compliance with Art. 84. In particular, inconsistencies between the description and the claims resulting from amendments during opposition proceedings and casting doubt on the subject-matter for which protection is sought must be avoided" (Part D-V-5).
8. Other amendments
The section on enablement of a prior art document, previously in previous Part G-VI, 4 has been deleted.
New Part G-VI, 7 relating to selection inventions has been largely amended as may be read in detail in the version provided. We will detail this more soon.
Further, Part A-III- 12.1 was updated to include Georgia as a validation state.
The entering into force of the Unified Patent Court Agreement (UPCA), on June 1, 2023, giving rise to the birth of the European Patent with Unitary effect, brought amendments in General Part 8 and Part C-V, 2.1[vi], adding a section on the request for unitary effect.
Also to be noted is the addition of a new section in Part E-X, 7 concerning the procedures after expiry of the term of the European Patent.
Another major amendment in Part D-VII-4.3 relates to the abolition of the notification fiction in force since November 1, 2023, and its impact on the computation of time limits (Rule 131(2) EPC). This is the so called “10-days rule”, for which according to the previous wording of Rule 126(2) EPC it was assumed that documents sent by the EPO were received by the addressee on the 10th day following the date the document was entrusted to a postal service.
Also amendments are made in Part E-II, 2.3 and II, 2.4 to cover receipt of EPO notifications by postal services.
Part A-II was updated related to the filing of documents. Part A-X 10.2.6 relates to a new subsection related to refund of the appeal fee.
Further, as part of an initiative to harmonise and modernise the language used in the Guidelines Parts A, B and C have been rewritten in a simple, clear and consistent style using plain language. The other Parts will be tackled in the next two years. Furthermore, gender-neutral language has been implemented in all official languages across all parts of the Guidelines.
What are the major changes in the 2024 edition of the PCT-EPO Guidelines?
G 1/22 and G 2/22 also had their impact on the transfer of the priority right for Euro-PCT applications by virtue of similar changes made to Part A-VI, 1.6. New sections have been added on the form of documents in Part A-VIII, 2 and on the signature of documents, Part A-VIII, 3. In Part B, a new section II,6 has been added on the representation before the EPO as ISA or SISA.
Users Consultation
As a final note, and as every year, users also have the opportunity to provide feedback on these new editions in a consultation organised by the EPO. Comments can be submitted by 2 April 2024 and then anonymized for discussion between the members of the SACEPO Working Party on Guidelines in the first of their two annual meetings on 25 April 2024.
In case of any question, do not hesitate to contact us at info@dcp-ip.com.
[ii] Amended Guidelines part E
[iii] Amended Guidelines part G