EP 3 484 437 B1 relates to a tooth paste including zinc and blue dye or pigment.
Brief outline of the case
The OD decided that claim 1 as granted and of AR1-6 wre offending Art 53(c). The patent was maintained according to AR7.
The claims of AR7 were restricted to a dentifrice composition wherein the zinc salt is zinc lactate, was reformulated as a composition for use under Art 54(5).
Both proprietor and opponent appealed.
The board confirmed that claim 1 as granted and of AR1-6 were offending Art 53(c).
The patent proprietor filed amended description pages for the MR and AR1-6, deleting paragraphs [0067]-[0075] of the patent as granted, as well as new AR12-17, which correspond to AR1-6, except for the introduction of the qualification of the defined uses and method as “cosmetic”.
AR7-11 were offending Art 123(3), and AR12-17 were not admitted under Art 13(2) RPBA.
The patent was thus revoked.
The proprietor’s point of view
The amendments to the description addressed the objection regarding paragraphs [0067]-[0075], first raised in the board’s communication under Art 15(1) RPBA.
The purpose of whitening the tooth surface as defined in the claims as granted and in AR1-6 related to a purely cosmetic effect resulting from the combination of the defined blue dye and the zinc salt.
This effect did not require brushing and was not necessarily linked to therapy. In particular, any inherent antibacterial activity of a zinc salt would not necessarily result in a therapeutic effect..
According to established jurisprudence, CLBA, 11th edition, 2025, I.B.4.5.2, the exclusion from patentability under Art 53(c) for therapeutic methods applied to a claimed non-therapeutic use only if such use is inseparably associated with a therapeutic effect.
The definition of the subject-matter of AR7-11 in the format of Art 54(5), as a whitening dentifrice composition for use in a method of whitening a tooth surface, did not contravene Art 123(3), since the subject-matter thereby defined was, in accordance with G 2/08. Reasons 5.10.4, limited to the specified use. The considerations in T 1635/09 concerned reformulation in the Swiss-type format and did not apply to AR7-11.
The opponent’s point of view
The amendments to the description and AR12-17 should, in the absence of exceptional circumstances, not be admitted under Art 13(2) RPBA.
The uses and method involving a dentifrice for whitening a tooth surface in a human or animal, as defined in the claims as granted and in AR1-6, were inseparably linked to a therapeutic effect resulting from the presence of the zinc salt in the dentifrice.
Moreover, the claims encompassed embodiments in which the whitening of the tooth surface results from the removal of plaque or tartar. This represented a therapeutic effect associated with the use of a dentifrice and specifically intended to be encompassed by the claims, as illustrated by paragraphs [0067]-[0075] of the patent.
The change of category from the use and method claims of the patent as granted to claims directed to compositions for use in a method of whitening a tooth surface in AR7-11 contravened Art 123(3). The principles set out in G 2/08 did not address such a change of category.
The board’s decision
The amendments to the description
The amendments concerned the deletion of paragraphs [0067]-[0075] of the patent. These paragraphs describe that the dentifrice compositions optionally include one or more further active materials for the prevention or treatment of a condition or disorder of hard or soft tissue of the oral cavity, for treatment of a physiological disorder or condition, or for providing a cosmetic effect, including dental abrasives and anti-tartar agents.
The board observed that, while the disclosed effect of whitening a tooth surface appears, per se, to be purely cosmetic and not in all circumstances inseparably linked to a therapeutic effect, the uses and method as defined in the granted claims of the patent and in AR1-6 do not exclude therapy.
The embodiments set out in paragraphs [0067]-[0075] appear to suggest that the claimed uses and method may encompass, or coincide with, methods falling under Art 53(c).
The mere deletion of paragraphs [0067]-[0075] from the description is not suitable to overcome this objection, since the claims define a whitening dentifrice composition in an open manner and those paragraphs merely specify conventional additional ingredients for such compositions.
The board decided therefore not to admit the amendments to the description into the appeal proceedings.
Subject matter excluded from patentability under Art 53(c)
According to established jurisprudence, CLBA, 11th ed., 2025, I.B.4.5.2, if the scope defined by the wording of a claim encompasses a use directed to a non-therapeutic effect which is inseparably associated with a therapeutic effect, such a use is excluded from patentability under Art 53(c).
Notably, G 1/03, Reasons 2.4.1, explains in this context that it may happen that a general claim comprises embodiments which fall under an exception to patentability, whereas the rest is patentable, and that, in such a case, the introduction of a disclaimer is allowable.
The purpose of whitening the tooth surface as defined in the claims concerns the use of a whitening dentifrice composition which is defined in an open manner to comprise a blue dye and a zinc salt.
The defined uses of this whitening dentifrice composition are therefore not confined to a purely cosmetic effect resulting from the deposition of the blue dye. Rather, they encompass embodiments in which the whitening effect, defined as the purpose of the claimed uses, results at least partially from the removal of plaque or tartar.
In such embodiments, the defined whitening effect is inseparably linked to the therapeutic or prophylactic effect of plaque or tartar removal conventionally associated with the use of a dentifrice composition, as illustrated by paragraphs [0067]-[0075]. These embodiments are not excluded from the scope of granted claims 1 and 8, which therefore encompass subject-matter excluded from patentability under Art 53(c). The same applies to claim 13 as granted.
Comments
The present decision reminds of T 290/86, Blendax. In this decision, the board held that, if the claimed invention is not directed solely to a cosmetic effect, but is also necessarily defining a treatment of the human body by therapy as well, such a claim is excluded from patentability, at the time under Art 52(4), now Art 53(c)..
Cleaning teeth has a cometic and a therapeutic effect which cannot be distinguished from each other. Simply adding the qualification “cosmetic” does not limit the claim to such an application, especially if the description makes clear that next to a cosmetic effect a therapeutic effect is not excluded.
Although the board did not admit the AR in which paragraphs [0067]-[0075] were deleted, the deletion could be objected under Art 123(2) as the skilled person would receive a new technical information when comparing the claim encompassing cosmetic and therapeutic uses.
It could also be objected to under Art 123(3) as the deletion of paragraphs [0067]-[0075], would enlarge the protection as therapeutic uses would not any longer be covered by the claims.
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