Disclaimer Practice at the EPO

Summary

Special conditions apply under European practice when making an amendment that involves a negative claim limitation (a disclaimer). 

A disclaimer of subject-matter that was originally disclosed in the application as an embodiment of the invention is known as a “disclosed disclaimer”. In Decision G2/10[1] the EPO’s Enlarged Board of Appeal ruled that disclosed disclaimers are allowable in principle.  However, a disclosed disclaimer will only be permitted if the subject-matter remaining in the claim is “directly and unambiguously disclosed” in the application as filed.  A case-specific “technical assessment” is necessary to decide whether this requirement has been met.

In its earlier decision G1/03[2], the Enlarged Board also outlined some exceptional situations where it may be allowable to disclaim subject-matter that was not disclosed at all in the original application (an “undisclosed disclaimer”).  It is not as yet entirely clear whether or not an undisclosed disclaimer in accordance with G1/03 should be subjected to the same “technical assessment” as a disclosed disclaimer.  That issue is the subject of a pending referral to the Enlarged Board of Appeal (G1/16).

Background

A disclaimer is a negative claim feature.  Its effect is to exclude some specific subject-matter from the scope of a claim.

Where a claim of an application as filed contains a disclaimer this generally does not cause problems under European practice (provided that the scope of protection sought is clear). However, like any other amendment, introduction of a disclaimer into a claim after filing must be examined to confirm that it does not add subject-matter to the application[3].

It is unusual for an application as filed to contain explicit support for a negative claim feature (e.g. “[Invention] preferably does not include [Disclaimed subject-matter]”). Much more commonly, the intended disclaimer will not have been disclosed in the original application at all (an undisclosed disclaimer) or will have been originally disclosed as an embodiment of the invention (a disclosed disclaimer).  Under these circumstances a careful assessment will be required to determine whether introduction of the disclaimer is permissible.

G2/10: Assessment of “disclosed disclaimers”

In this Decision, the EPO’s Enlarged Board of Appeal considered whether there is an impermissible addition of subject-matter when an amendment is made to include a disclaimer that was originally disclosed as an embodiment of the invention.  The Decision arose due to a conflict in the Board of Appeal case law.  For example, in Decision T1102/00 it was suggested that subject-matter could only be excluded if it was expressly disclosed as subject-matter to be excluded from protection.  On the other hand T1107/06 suggested a more liberal approach, whereby it was permitted to disclaim subject matter which had been disclosed in the application as filed as an embodiment of the invention.

The Enlarged Board rejected the two extreme positions.  Thus, it was held that there is no absolute bar on the use of a disclosed disclaimer.  However, the Board also held that a disclosed disclaimer cannot be assumed to be always allowable. 

The Enlarged Board emphasised that a disclosed disclaimer should not be permitted if the subject-matter remaining in the claim after the introduction of the disclaimer is not “directly and unambiguously disclosed”.  Further, the Board ruled that “[d]etermining whether or not that is the case requires a technical assessment of the overall technical circumstances of the individual case under consideration, taking into account the nature and extent of the disclosure in the application as filed, the nature and extent of the disclaimed subject-matter and its relationship with the subject-matter remaining in the claim after the amendment”.

It is therefore clear that assessment of a disclosed disclaimer must have regard to the specific facts of the application at issue.  The detailed reasoning in G2/10 is complex and it is not always fully clear how the required “technical assessment” will be implemented by the Examining Divisions, Opposition Divisions and Boards of Appeal at the EPO.  Nonetheless, the following general observations do emerge:

  • Where a generally worded claim embraces many specific embodiments of an invention, and the disclosed disclaimer is based on a single such embodiment (e.g. the subject-matter of one of a number of working Examples), this is likely to be allowable.  That is because the subject-matter remaining in the amended claim does not contain new “technical information” or result in the “singling out” of other embodiments that were not specifically disclosed in the original application.
  • On the other hand, a disclosed disclaimer will not be allowed if it results in an amended claim that has special technical characteristics not disclosed in the original application or in which particular combinations of features have been singled out in a manner not disclosed in the original application.  That is because the subject-matter in the amended claim would then contain new “technical information” compared with the originally filed application.

The practical examples set out in the attached Annex may assist with understanding the nature of the technical assessment envisaged in G2/10.

G1/03: Assessment of “undisclosed disclaimers”

In this Decision, the EPO’s Enlarged Board of Appeal outlined the following exceptional circumstances where an undisclosed disclaimer could be permitted:

  1. to restore novelty over disclosure in an earlier unpublished European application citable for novelty only in accordance with Article 54(3) EPC;
  2. to restore novelty over an “accidental anticipation” contained in a prior art document; an anticipation is “accidental” if it is so unrelated to and remote from the claimed invention that the person skilled in the art would never have taken it into consideration when making the invention;
  3. to disclaim subject-matter that is excluded from patentability for non-technical reasons (e.g., a method of medical treatment).

The Enlarged Board added the following conditions:

  1. The disclaimer should not remove more than is necessary either to restore novelty or to disclaim subject-matter excluded from patentability for non-technical reasons.
  2. A disclaimer which is or becomes relevant for the assessment of inventive step or sufficiency of disclosure adds subject-matter contrary to Article 123(2) EPC.
  3. claim containing a disclaimer must meet the requirements of clarity and conciseness of Article 84 EPC.

New referral to the Enlarged Board of Appeal

Prior to G2/10, assessment of an undisclosed disclaimer typically involved firstly identifying that one of the exceptional circumstances (a)-(c) applied, and then checking for compliance with the additional conditions (i)-(iii).

However, the discussion in G2/10 implies that an undisclosed disclaimer in accordance with G1/03 ought to be subjected to the same “technical assessment” as a disclosed disclaimer.  Several Technical Board of Appeal decisions issued since G2/10 have followed this approach[4].  However, not all Technical Boards of Appeal have subjected undisclosed disclaimers in accordance with G1/03 to the “technical assessment” test[5]. In view of this divergence in the case law, the Technical Board of Appeal in T437/14[6] has referred the following questions to the Enlarged Board of Appeal (pending referral G1/16): 

  1. Is the standard referred to in G2/10 for the allowability of disclosed disclaimers under Article 123(2) EPC, i.e. whether the skilled person would, using common general knowledge, regard the subject-matter remaining in the claim after the introduction of the disclaimer as explicitly or implicitly, but directly and unambiguously, disclosed in the application as filed, also to be applied to claims containing undisclosed disclaimers?
  2. If the answer to the first question is yes, is G1/03 set aside as regards [exceptions (a)-(c) listed above]?
  3. If the answer to the second question is no, i.e. if [exceptions (a)-(c) listed above] apply in addition to the standard referred to in G2/10, may this standard be modified in view of these exceptions?

The Enlarged Board will therefore now consider these questions, and we expect a decision to be reached by the second half of 2018.  Until then, we would advise against introducing new undisclosed disclaimers during pre-grant examination or post-grant opposition proceedings at the EPO.  The EPO has announced[7] that it will stay pre-grant examination and post-grant opposition proceedings in which the final decision depends entirely upon the outcome of G1/16.

Summary

Amendments involving disclaimers require thorough consideration under European practice.  Disclosed may be permissible under appropriate circumstances.  Undisclosed disclaimers were also considered allowable under appropriate circumstances until the recent pending referral G1/16 to the Enlarged Board of Appeal, following which the allowability of undisclosed disclaimers is uncertain.  In any event, careful analysis of the facts of the case at issue is essential, so that the best decision can be made about whether to introduce a disclaimer into a claim or to seek an alternative, albeit potentially more restrictive, positive claim limitation.

January 2017

Annex: Practical Examples Involving Assessment of Disclaimers

Claim Desired disclaimer Disclosure of disclaimer Allowable?
Chemical compound defined using general formula Single compound falling within scope of general formula As an embodiment of the invention in the application Likely to be allowable as a G2/10 disclosed disclaimer, particularly if the disclaimed compound is only one of many compounds specifically disclosed in the application as filed (no new “technical information”)
Chemical compound defined using general formula Single compound falling within scope of general formula No disclosure in application No - undisclosed disclaimer not allowable unless an exceptional circumstance of G1/03 applies
Chemical compound defined using general formula Single compound falling within scope of general formula Disclosed in a novelty-only prior art document citable under Article 54(3) EPC Likely to have been allowable as a G1/03 undisclosed disclaimer.  Situation now unclear in view of pending referral G1/16. If G1/16 endorses the strict view of the referring Technical Board of Appeal, then the disclaimer would probably be found to add subject matter.
Chemical compound defined using general formula, for use in treating cancer Single compound falling within scope of general formula Disclosed in a prior art document as a dye compound Likely to have been allowable as a G1/03 undisclosed disclaimer against an “accidental anticipation”. Situation now unclear in view of pending referral G1/16. If G1/16 endorses the strict view of the referring Technical Board of Appeal, then the disclaimer would probably be found to add subject matter.
Chemical compound defined using general formula, for use in treating cancer Single compound falling within scope of general formula Disclosed in a prior art document as an analgesic No - not an “accidental anticipation” according to current Board of Appeal case law and so not an acceptable G1/03 undisclosed disclaimer
Chemical compound defined using general formula, for use in treating cancer Single compound falling within scope of general formula Disclosed in a prior art document as an analgesic; also disclosed as an embodiment of the invention in the application May be allowable as a G2/10 disclosed disclaimer
Method of reducing weight of a human subject Therapeutic (i.e., non-cosmetic) method of reducing weight of a human subject No disclosure in application Likely to have been allowable as G1/03 undisclosed disclaimer as disclaimer of “therapeutic method” is for purely non-technical reasons. Situation now unclear in view of pending referral G1/16.
Chemical compound where substituent A is methyl, ethyl or propyl and substituent B is methyl, ethyl or propyl Chemical compound where at least one of substituents A and B is either ethyl or propyl As an embodiment of the invention in the application Unlikely to be allowable under G2/10, because disclaimer results in “singling out” of the compound where A is methyl and B is methyl
Chemical compound where substituent A is methyl, ethyl or propyl and substituent B is methyl, ethyl or propyl Chemical compound where at least one of substituents A and B is either ethyl or propyl

Disclosed in a novelty-only prior art document citable under Article 54(3) EPC

Likely to have been allowable as a G1/03 undisclosed disclaimer.  Situation was unclear following G2/10, because disclaimer might not have passed “technical assessment” of G2/10.  Situation remains unclear in view of pending referral G1/16, but if G1/16 endorses the strict view of the referring Technical Board of Appeal, then the disclaimer would very probably be found to add subject matter.

[1] http://www.epo.org/law-practice/case-law-appeals/pdf/g100002ex1.pdf

[2] http://www.epo.org/law-practice/case-law-appeals/pdf/g030001ex1.pdf

[3] Article 123(2) EPC prohibits amendments that introduce new subject-matter to an application after filing.  This provision is interpreted extremely strictly by the EPO.

[4] See, for example, T2464/10, T1870/08 and T1176/09.

[5] See, for example, T74/11.

[6] https://www.epo.org/law-practice/case-law-appeals/pdf/t140437ex1.pdf.  The referring Technical Board of Appeal in T437/14 stated that, in its view, most undisclosed disclaimers would not pass the “technical assessment” of G2/10.

[7] http://www.epo.org/law-practice/legal-texts/official-journal/2016/12/a105/2016-a105.pdf

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