Key points
- The only independent claim pending is directed to an "An anti-drug antibody immunoassay for the determination of the presence of an anti-drug antibody (ADA) ... in a sample comprising the following steps in the following order:"
- As a comment, perhaps the term "assay" indicates an activity, not a physical entity in this claim, as it seems to be defined solely by comprising "the following steps in the following order"
- The Examining Division rejected the application because "pages 20 to 28 of the description contained numbered claim-like clauses, and this gave rise to a lack of clarity within the meaning of Article 84 EPC."
- This is the description as filed i.e. of the PCT application published as WO2016071119A1 which contains under the caption "Specific embodiments of the invention" inter alia " A method for the determination of the presence of an anti-drug antibody against an effector function suppressed human or humanized drug antibody in a sample comprising the following steps in the following order ". There are also such statements for corresponding uses. The list of embodiments was placed basically just before the Examples.
- The Board: "The numbered embodiments listed on pages 20 to 27 of the description under the heading "Specific embodiments of the invention" cannot be mistaken for claims, since it is evident that they are a part of the description text, and they are not denoted as "claims", either. Rather, the description refers to them as embodiment, item, immunoassay, method or use."
- "Thus, there is no reason why the presence of the section "Specific embodiments of the invention" in the description should affect the clarity of the claims."
- The Board: "the entire section "Specific embodiments of the invention" relates to the same subject-matter (defined by the same method steps) as the current claims and may be taken to provide additional support for the claims in the description, as also required in Article 84 EPC (CLBA II.E.2.6). (underlining added)
- I think that the Board here says that the paragraphs at issue are fully consistent with the claims, which seems to be a highly fact-specific finding.
- "The decision under appeal also asserts that, independently of Article 84 EPC, there is a requirement for removing redundant subject-matter from the description, and that the section "Specific embodiments of the invention" comprises such redundant subject-matter. This objection is based on two approaches relying on the Implementing Regulations to the EPC (Article 78(1) EPC)."
- " As per Rule 42(1)(c) EPC (Rule 27(1)(d) EPC 1973 and Rule 27(1)(c) EPC 1973, before and as of 1 June 1991, respectively) the description must disclose the invention, as claimed, in such terms that the technical problem and its solution can be understood, and state any advantageous effects of the invention with reference to the background art. In line with the concept of a technical invention on which the EPC is founded, the first half-sentence requires the description to disclose how the invention can be understood as the solution to a technical problem."
- " However, in the absence of an objection of lack of unity under Article 82 EPC, this does not translate into a requirement to bring the description in line with claims intended for grant, and to remove passages of the description that disclose embodiments which are not claimed."
- As a comment, the reference to Article 82, lack of unity of invention is unclear to me.
- " A number of decisions have relied on Rule 48(1)(c) EPC as a potential legal basis for requiring the description to be adapted to the subject-matter as claimed. Nevertheless, on closer analysis, the wording and history of this provision suggest that this was not its intended purpose. The board agrees in this regard with the analysis provided in decision T 1989/18, Reasons 9 and 10."
- In T 1989/18, Board 3.3.04 reasoned that " Furthermore, points (a) to (c) of Rule 48(1) EPC are in the order of their offensiveness, ranking from high to low. This is reflected in paragraphs (2) and (3) of Rule 48 EPC. At the Munich diplomatic conference, there was general acceptance that the application should not be refused even if the application as filed contained statements or other matter contrary to "ordre public" or morality. Moreover, Rule 48(3) EPC remained optional (see Minutes of the proceedings of Main Committee I of the Munich Diplomatic Conference for the setting up of a European System for the Grant of Patents, document M/PR/I, No. 2225 to 2236). It is therefore difficult to conceive that the legislator intended to impose more severe sanctions on less offensive matter, in particular to provide a ground for refusal based on the inclusion of merely "irrelevant or unnecessary" matter (see also the doubts expressed in decision T 1065/99, point 7)."
- As a comment, I'm not convinced by this reasoning. First of all, the fact that the application should not be refused even if the application as filed contained statements or other matter contrary to "ordre public" or morality" may simply mean that the applicant can avoid the refusal by deleting the offensive statements. Moreover, Rule 48(2) and (3) seem to indicate an additional measure, in my view, namely omitting the offensive statements from the A publication, in addition to the general sanction of refusal of the patent application when not complying with Rule 48(1) EPC. These measures were added in the course of the drafting, suggesting in my view that they are additions to the general sanction of refusal of the application (see BR/135 e/71 p.25 / p.18 of the English Travaux to Rule 34 EPC; in view of BR/51 e/70 p.11 / p. 24 of the PDF; admittedly the Travaux are not very clear).
- Finally, the Board's observation in T 1989/18 that "according to the wording and history of Rule 48 EPC, it does not pertain to patent specifications" seems to ignore the fact that the entire chapter II of Part III Implementing Regulations pertains to "Provisions governing the application" but all these provisions are grounds for refusal so in a way they all aim at having a patent application that is ready for grant and hence suitable for the B1 publication.
2. Requirements of Article 84 EPC (main request)
2.1 The claims of a patent application define the matter for which protection is sought. Article 84 EPC requires this definition to be clear. This means that the claims must be clear in themselves for a person skilled in the art with common general knowledge of the technical field in question, without the need to refer to the description (T 412/03, Reasons 2.4.1). Article 84 EPC also requires the claims to be concise and be supported by the description.
2.2 The application documents according to the main request (see point IX. above) comprise a section entitled "Amended Claims", listing 12 claims in the version of 21 September 2018, and a description.
2.3 Nothing suggests that the current claims are not clear in themselves to a person skilled in the art.
Passage on page 20, line 17, to page 27, line 23, of the description
2.4 The numbered embodiments listed on pages 20 to 27 of the description under the heading "Specific embodiments of the invention" cannot be mistaken for claims, since it is evident that they are a part of the description text, and they are not denoted as "claims", either. Rather, the description refers to them as embodiment, item, immunoassay, method or use.
2.5 Thus, there is no reason why the presence of the section "Specific embodiments of the invention" in the description should affect the clarity of the claims.
2.6 As an additional remark, the Guidelines for Examination in the EPO (version of 11 November 2019), in point F-IV, 4.4, are inconsistent in that they acknowledge, on the one hand, that claim-like clauses may (or may not) give rise to a lack of clarity, but require, on the other hand, that such claim-like clauses must always be removed. If claim-like clauses in the description do not result in a lack of clarity of the actual claims, Article 84 EPC cannot provide the justification for removing them.
2.7 Moreover, the entire section "Specific embodiments of the invention" relates to the same subject-matter (defined by the same method steps) as the current claims and may be taken to provide additional support for the claims in the description, as also required in Article 84 EPC.
2.8 According to the decision under appeal (see page 7), the "specific embodiments" recited on pages 20 to 27 of the description belong to different claim categories (immunoassay, method or use) and this must result in either lack of clarity or lack of conciseness. This objection fails simply because Article 84 EPC relates to the claims and not to embodiments mentioned in the description.
Passage on page 9, lines 19 to 32, of the description
2.9 Since the passage on page 9, lines 19 to 32 is not in the section "Specific embodiments", the board accepts the appellant's explanation that this passage relates to more general aspects in the context of the invention.
2.10 Under the circumstances set out in points 2.1 to 2.9 above, the board does not see any reason for objection to the main request under Article 84 EPC.
3. Removal of "redundant" subject-matter (main request)
3.1 The decision under appeal also asserts that, independently of Article 84 EPC, there is a requirement for removing redundant subject-matter from the description, and that the section "Specific embodiments of the invention" comprises such redundant subject-matter. This objection is based on two approaches relying on the Implementing Regulations to the EPC (Article 78(1) EPC).
(a) The first approach relies on the reasoning in decision T 490/90 (Reasons 5), which in turn was based on Rule 27 EPC 1973.
(b) The second approach relies on Rule 48(1)(c) EPC.
3.2 Rule 42(1)(c) EPC
3.2.1 Decision T 490/90 merely stated that it did not seem questionable that the presence of claim-like clauses in the description did not satisfy the requirements of Rule 27 EPC. Rule 27 EPC 1973 corresponds to current Rule 42 EPC. The pertinent sub-paragraph would appear to be Rule 42(1)(c) EPC.
3.2.2 As per Rule 42(1)(c) EPC (Rule 27(1)(d) EPC 1973 and Rule 27(1)(c) EPC 1973, before and as of 1 June 1991, respectively) the description must disclose the invention, as claimed, in such terms that the technical problem and its solution can be understood, and state any advantageous effects of the invention with reference to the background art. In line with the concept of a technical invention on which the EPC is founded, the first half-sentence requires the description to disclose how the invention can be understood as the solution to a technical problem.
3.2.3 However, in the absence of an objection of lack of unity under Article 82 EPC, this does not translate into a requirement to bring the description in line with claims intended for grant, and to remove passages of the description that disclose embodiments which are not claimed.
3.2.4 In the present case, the passages on pages 20 to 27 of the description objected to by the examining division do not impair the understanding of the technical problem and its solution as set forth in the "Summary of the Invention" provided in the description on pages 2 to 8.
3.2.5 Thus, the main request meets the requirements of Rule 42(1)(c) EPC.
3.3 Rule 48(1)(c) EPC
3.3.1 Under Rule 48(1)(c) EPC, a European patent application must not contain any statement or other matter obviously irrelevant or unnecessary under the circumstances.
3.3.2 A number of decisions have relied on Rule 48(1)(c) EPC as a potential legal basis for requiring the description to be adapted to the subject-matter as claimed.
3.3.3 Nevertheless, on closer analysis, the wording and history of this provision suggest that this was not its intended purpose. The board agrees in this regard with the analysis provided in decision T 1989/18, Reasons 9 and 10.
3.3.4 As a consequence, Rule 48(1)(c) EPC cannot serve as a legal basis for the refusal of the present main request.
Order
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