Stricter conformity of patent specifications at the EPO
The European patent office (EPO) published new Guidelines for Examination (“Guidelines”), which came into force on 1 March 2021. A number of changes have been made to the Guidelines, the most significant of which concerns amending the description of a patent application to conform with allowed claims at the grant stage. This article reviews how the Guidelines have changed in this respect and what this means for practitioners responding to an objection from the examiner to “bring the description into conformity with the amended claims”.
Part of the subject matter of the description and/or drawings not covered by the claims
Typically, the claims of a European patent application will be amended at least once before the EPO considers them to be allowable. Often, amendments made to the claims during prosecution are in the form of limitations. As a result, some subject matter in the description, which fell within the scope of the claims as originally filed, may not fall within the scope of the allowed (limited) claims. Furthermore, even if the claims are not amended during prosecution, patent descriptions frequently contain subject matter that lies outside the scope of the claims.
Once the examining division has concluded that the claims on file are patentable it is typical for them to raise an objection that the description (and drawings) must be adapted to conform to the allowable claims, before a patent can be granted.
Guidelines F-IV, 4.3(iii) deals with the situation where part of the subject matter of the description and/or drawings does not fall within the scope of the allowed claims. This section of the Guidelines has been updated to recite that subject matter in the description and/or drawings that does not fall within the scope of the claims throws doubt on the scope of protection sought by the applicant, rendering the claims objectionable under Article 84 EPC (clarity), first and second sentences.
To avoid contravening Article 84 EPC, the description and/or drawings of a European patent application must be adapted in such a way that the scope of the claims is no longer in doubt. In effect, “embodiments in the description and/or drawings which are no longer covered by the independent claims must be deleted”. Embodiments that are not covered by the independent claims can only be retained in the description and/or drawings if “these embodiments can reasonably be considered to be useful for highlighting specific aspects of the amended claims”2. In such a case, the fact that an embodiment is no longer covered by the claims must be prominently stated in the description, e.g. using the wording “embodiment not covered by the claimed invention”2 next to the embodiment no longer covered.
Previously, it was seen as acceptable to include a generic statement, such as “embodiments not falling under the scope of the appended claims are to be considered merely as examples suitable for understanding the invention”, in the description, to meet the requirement of consistency between the claims and the description and drawings (i.e. to comply with Guidelines F-IV, 4.3(iii)). Such a generic statement avoided the need for extensive amendments to be made to the description prior to grant, reducing the burden on the applicant. Now, the EPO has decided that such generic statements are merely a repetition of Article 69(1) EPC and are insufficient to overcome an objection relating to an inconsistency between the claims and the description and/or drawings. The applicant must either delete embodiments not covered by the claims or prominently indicate the specific parts of the description and/or drawings no longer covered by the claims.
In addition amendments such as replacing “invention” with “disclosure” and “embodiment” with “example” that were previously considered to acceptably eliminate inconsistencies between the allowed claims and the description and/or drawings are no longer considered to comply with the requirement set out in Guidelines F-IV, 4.3(iii).
The amendment to Guidelines F-IV, 4.3(iii) concerning subject matter outside the scope of the allowed claims places a significant burden on the applicant. From now on, every embodiment disclosed in the description and/or drawings of an application will need to be reviewed, prior to grant, to see whether it falls within the scope of the allowed claims. Any embodiments falling outside the scope of the claims will then either need to be deleted or labelled as an “embodiment not covered by the claims”.
Technical features of the independent claims shall not be presented as optional
Guidelines F-IV, 4.3(iii) has also been amended to deal with the situation where features present in the independent claim(s) of the allowed claim set are presented as being optional in the description. This situation is also considered to render the claims objectionable under Article 84 EPC, first or second sentence1.
The updated Guidelines state that features required by the independent claims may not be preceded by terms such as “optionally”, “preferably”, “may” and “can” in the description. Such terms are considered to imply that said features are not essential to the invention, thereby contradicting the claims.
It follows that, where an independent claim has been amended during prosecution to incorporate features presented as optional in the application as filed, the description must be thoroughly reviewed prior to grant and any terms or phrases that imply the features incorporated into the independent claim are optional deleted.
Excluded subject matter under Article 53 EPC
Another topic affected by the amendments to Guidelines F-IV, 4.3(iii) is subject matter excluded from patentability under Article 53 EPC, which includes methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body.
Similar to subject matter not falling within the scope of the allowed claims, any subject matter in the description excluded from patentability under Article 53 EPC must be removed before grant. Alternatively, such subject matter must be reworded such that it does not fall under the exceptions to patentability or prominently marked as not being according to the claimed invention (i.e. marked with “embodiment not covered by the claims”)2.
The new requirement concerning subject matter excluded under Article 53 EPC will most likely affect: medical device inventions, which are typically disclosed together with corresponding methods of using the device; and applications concerning medicinal compositions, which often disclose methods of treatment using said compositions.
Rewording such that the subject matter does not fall under the exceptions is believed to refer to instances where the description discloses a method of treatment or diagnosis. For example, the description may recite “a method of treating disease X with composition Y is disclosed”. This passage can be reworded to “composition Y is suitable for use in the treatment of disease X”, i.e. converted to allowable subject matter under Article 54(4) or 54(5) EPC, to conform with the requirement laid down in updated Guidelines F-IV, 4.3(iii).
The “field of the invention” and “summary of the invention” sections must correspond to the amended set of claims
Guidelines F-II, 4.2, relating to the formal requirements of the description, has been amended to recite that the “field of the invention” and “summary of the invention” sections of the description should be amended to correspond to the amended claims.
It is most often necessary to amend the “field of the invention” section of the description when the application as filed contained independent claims in different categories (e.g. method and product claims) and during prosecution the claims in one or more of said categories have been cancelled. In such a case, the “field of the invention” section should be amended such that it no longer refers to the cancelled category of claims.
The “summary of the invention” section can be replaced with statements like “the invention is set out in the appended set of claims”, to meet the requirement of Guidelines F-II, 4.2. This avoids extensive rewriting of the “summary of the invention” section.
In effect, EPO practice concerning the “field of invention” and “summary of the invention” sections has not been altered by the updates made to the Guidelines. Applicants were already required to bring these sections of the description into conformity with the claims. Statements, such as “the invention is set out in the appended set of claims”, were already commonly-accepted by examiners.
Deletion of claim-like clauses
“Claim-like clauses” are typically added divisional applications at the filing stage to maintain all the subject matter from the parent application. They may also be included in PCT filings to generate multiply-dependent subject matter. The requirement to delete such clauses before grant is not new. However, Guidelines F-IV, 4.4 has been updated to provide reasoning for why such clauses must be deleted.
The Guidelines now recite that, if such clauses are inconsistent with the claimed subject matter, they lead to a lack of clarity as to the actual scope of protection sought by the applicant1. Furthermore, such clauses are considered to be an “irrelevant and unnecessary” duplication of the claims falling foul of Rule 48(1)(c) EPC .
Conclusion and practice
The new requirements place a significant additional burden on the applicant, who is now expected to more thoroughly review the description and/or drawings prior to grant and: a) remove or highlight any embodiments not falling within the scope of the claims; b) remove any terms implying features of the independent claim(s) are optional; and c) remove, highlight or reword any subject matter excluded from patentability under Article 53 EPC.
While such extensive amendment of the description and drawings is undesirable for the applicant in case it affects added matter or claim interpretation post-grant, the EPO considers such amendments to be necessary, to make it easier to determine the scope of the claims in infringement proceedings.
However, according to Article 69(1) EPC the description and drawings shall be used to interpret the claims, so clearly an enhanced adaptation of the description will have an impact on claim interpretation during opposition, infringement and revocation proceedings. On the one hand removing subject matter from the description may lead to a narrower claim interpretation which leads to a patent being held valid over the prior art; conversely the narrower interpretation may lead to a finding of non-infringement.
Newly introduced Guideline H-V, 2.7 makes it clear that failing to bring the description into conformity with the allowed claims as set out in Guidelines F-II, 4.2, F-IV, 4.3(iii) and F-IV, 4.4, when requested to do so, will result in a summons to oral proceedings for the applicant. However, it is yet to be seen whether this will be the case in practice.
Additionally in an effort to move applications forward, EPO examiners sometimes (helpfully) adapt the description themselves so that they can issue a notice of allowance. While both internal guidance and Guideline H-V, 2.7 attempt to dissuade examiners from making extensive amendments to the description and drawings of the allowed patent text it is possible that extensive amendments to the description and drawings of the text, requiring very careful review by the applicant, will become more common. We have found the EPO’s electronic (i.e. not hand-amended) patent texts to be somewhat inaccurate on occasion, and it is vital to check any amendments made by the examiner because once the text is approved by an applicant it is very difficult to correct any errors or omissions.
 Article 84 EPC: The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description.
 Guidelines F-IV, 4.3(iii).
 Decision T1808/06.
 Article 69(1) EPC: The extent of the protection conferred by a European patent or a European patent application shall be determined by the claims. Nevertheless, the description and drawings shall be used to interpret the claims.
 Article 53 EPC: European patents shall not be granted in respect of:
(a) inventions the commercial exploitation of which would be contrary to “ordre public” or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;
(b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;
(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.
 Article 54(4) and (5) EPC:
(4)Paragraphs 2 and 3 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art.
(5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.
 Guidelines F-II, 4.2.
 Guidelines F-IV, 4.4.
 Rule 48(1) EPC: The European patent application shall not contain:
(a) statements or other matter contrary to “ordre public” or morality;
(b) statements disparaging the products or processes of any third party or the merits or validity of the applications or patents of any such party. Mere comparisons with the prior art shall not be considered disparaging per se;
(c) any statement or other matter obviously irrelevant or unnecessary under the circumstances.
 Guidelines F-II, 7.4.
This article is for informational purposes only and does not constitute legal advice. Please, therefore, get in touch with your usual Forresters Attorney if you need further advice.