T 0589/01 (Artificial tanning compositions/PROCTER & GAMBLE) 16-12-2005

Summary of Facts and Submissions

I. The respondent is proprietor of European patent No. 0 752 842 ("the patent") which was granted with effect from 11 November 1998 on the basis of European patent application No. 95 912 039.5 (International application No. PCT/US95/02641) filed on 3 March 1995, claiming priority from an earlier US application on 29 March 1994 (Serial No. 219 053). The patent relates to artificial tanning compositions having improved stability. Claims 1 to 9 as granted read as follows:

"1. An artificial tanning composition having improved stability comprising:

(a) from 0.1% to 20% dihydroxyacetone,

(b) from 0.025% to 5% of a salt selected from the group consisting of metabisulfite salts, sulfite salts, hydrogen sulfite salts, and mixtures thereof, and

(c) a topical carrier.

2. A composition according to Claim 1 wherein said metabisulfite, sulfite, and hydrogen sulfite salts are selected from alkali metal salts, alkaline metal salts, ammonium salts, and mixtures thereof, preferably wherein said metabisulfite, sulfite, and hydrogen sulfite salts are selected from sodium salts, potassium salts, ammonium salts, and mixtures thereof.

3. A composition according to Claim 1 wherein said salt is a metabisulfite salt, preferably wherein said metabisulfite salt is selected from alkali metal metabisulfite salts, alkaline metal metabisulfite salts, ammonium metabisulfite salts, and mixtures thereof, more preferably wherein said metabisulfite salt is selected from sodium metabisulfite, potassium metabisulfite, ammonium metabisulfite, and mixtures thereof, and most preferably wherein said metabisulfite salt is sodium metabisulfite.

4. A composition according to Claim 3 comprising from 0.05% to 5% of said metabisulfite salt, preferably from 0.05% to 1% of said metabisuflte salt, more preferably from 0.1% to 1% of said metabisulfite salt, and most preferably 0.25% of said metabisulfite salt.

5. A composition according to Claim 4 comprising from 2% to 7% dihydroxyacetone, preferably from 3% to 6% dihydroxyacetone.

6. A composition according to Claim 1 wherein said composition further comprises from 0.5% to 20% of a sunscreen selected from 2-ethylhexyl N,N-dimethyl-p-aminobenzoate, 2-ethylhexyl p-methoxycinnamate, octocrylene, octyl salicylate, oxybenzone, 2-phenyl- benzimidazole-5-sulfonic acid, 4,4´-methoxy-t-buyl-dibenzoylmethane, 3-(4-methylbenzylidene) camphor, 3-benzylidene camphor, 4-N,N-(2-ethylhexyl)methylamino-benzoic acid ester with 4-(2-hydroxyethoxy)dibenzoyl- methane, titanium dioxide, zinc oxide, iron oxide, and mixtures thereof.

7. A composition according to Claim 1 wherein said composition further comprises from 0.1% to 10% of an amino acid or pharmaceutically acceptable salt thereof selected from alanine, valine, leucine, isoleucine, proline, methionine, phenylalanine, tryptophan, glycine, serine, threonine, cysteine, tyrosine, asparagine, glutamine, lysine, arginine, histidine, and mixtures thereof, preferably wherein said composition further comprises from 0.1% to 10% of an amino acid or a pharmaceutically acceptable salt thereof selected from lysine, arginine, histidine, and mixtures thereof, and more preferably wherein said composition further comprises from 0.1% to 10% of an amino acid or a pharmaceutically acceptable salt thereof selected from L-lysine, L-lysine hydrochloride, L-lysine dihydrochloride and mixtures thereof.

8. The use of a composition in the manufacture of a medicament for providing an artificial tan to human skin said composition comprising an effective amount of a composition according to any of Claims 1 to 5 and 7.

9. The use of a composition in the manufacture of a medicament for providing an artificial tan to human skin and protecting human skin from the harmful effects of ultraviolet radiation comprising an effective amount of a composition according to Claim 6."

II. Opposition was filed by the present appellant on 9 August 1999 calling for the patent to be revoked as regards claims 1 to 6 and 8 and 9 on grounds of lack of novelty under Article 54(3)and (4) EPC over the state of the art according to citation (2).

III. Of the numerous documents and other pieces of evidence introduced into the first instance opposition proceedings the following are referred to in the present decision:

(2) EP-A-0 622 070, filing date 19 April 1994;

(3) Priority Document (DE 4 314 083 of 29 April 1993) of citation (2);

(2/3) Content of (2) entitled to the priority (3);

(4) "Ullmanns Encyklopadie der Technischen Chemie", 4. neubearbeitete und erweiterte Auflage, Band 12, Verlag Chemie GmbH, Weinheim/Bergstrasse, 1976, S. 564-565;

(5) "Dihydroxyaceton for cosmetics", Merck, May 1988;

(6) W. Umbach, "Cosmetics and Toiletries - Development, Production and Use", Ellis Horwood Ltd., Chichester, 1991, pp. 106-108;

(7) Cosmetics & Toiletries 107 (1992) 133, 147, 148

(8) W092/17159;

(9) W093/16683;

(11) EP-A-0 425 324.

IV. The opposition division, in a decision pronounced at the close of the oral proceedings on 30 January 2001, with written reasons notified on 15 March 2001, rejected the opposition. The essence of the reasoning in the opposition division's decision was as follows:

(a) The disclosure of citation (2) which was entitled to the priority date was comprised in the state of the art under Article 54(3) and (4) EPC. In this respect it was noted in the decision under appeal that Application Examples ("Anwendungsbeispiele") A to F described at pages 5 to 10 of (2) were not entitled to claim priority from the priority document (3) and were thus entitled only to the European filing date of 19 April 1994.

(b) In the impugned decision it was recalled that both citation (2) in claim 6 and the priority document (3) in corresponding claim 9 disclosed powder mixtures, containing 45-99% by weight, preferably 80-90% by weight of a compound having skin-tanning properties, preferably dihydroxyacetone (hereinafter referred to as DHA), 0.1-50% by weight, preferably 1-20% by weight of an agent which forms sulfite ions, preferably a metal sulfite salt or a metal bisulfite salt, and 0.1-5% by weight of a stabilising agent, relative to the total amount of said powder mixtures. It was also recalled that (2/3) taught the use of such powder mixtures for the preparation of artificial cosmetic tanning compositions comprising a topical carrier and that the artificial tanning compositions were present in (2/3), inter alia, in the form of milks, lotions, creams, emulsions, or aerosols.

It was further mentioned in that decision that Examples 1 to 12 of (2/3) described powder mixtures, comprising as the relevant active ingredients 89.5 g DHA and 10 g sodium sulfite or sodium disulfite (Examples 1 to 4) or 98 g DHA and 10 g sodium sulfite or sodium disulfite (Examples 5 to 12), and their use for the preparation of artificial tanning compositions.

(c) However, the decision under appeal left no doubt that (2/3) certainly did not explicitly refer to the specific amounts (weight percentages) of either DHA or the sulfite salt present in the final artificial tanning compositions disclosed in (2/3). As regards novelty, the crucial question to be considered was thus, in the opposition division's judgment, whether or not the opponent (appellant) was correct in its contention that the skilled person would have recognised artificial tanning compositions comprising both DHA and the sulfite salt in the specific amounts (weight percentages) claimed in claim 1 of the patent (see I above) as being clearly and unequivocally implied by the disclosure of (2/3), if this disclosure was interpreted in the light of the references in citations (4) to (9) and (11) to conventional artificial tanning compositions comprising DHA in amounts of, for example, 2% to 5% by weight or 3% to 6% by weight.

(d) The opposition division mentioned in the decision under appeal that none of the cited documents (4) to (9) and (11) disclosed the specific combination of DHA and a sulfite forming agent (sulfite salt) as the active principle of artificial tanning compositions and concluded therefrom that the amount (weight percentage) of DHA recited in claim 1 of the attacked patent could not be considered as clearly implied by the disclosure of the prior art of (2/3), even if this disclosure was interpreted in the light of the disclosures of documents (4) to (9) and (11).

The opposition division concluded further that the particular weight ratios of DHA to the sulfite salt, which could be derived from Examples 1 to 12 of powder mixtures in (2/3), were not necessarily maintained essentially constant when these powder mixtures of (2/3) were converted into cosmetically acceptable artificial tanning compositions. It followed that, even if the amount of DHA was considered as a feature which for the skilled person was implicit in what was explicitly disclosed in (2/3), the amount (weight percentage) of the sulfite salt recited in claim 1 of the patent could also not be inferred directly and unequivocally from the disclosure in (2/3). The opposition division thus found that the disclosure of (2/3) did not prejudice the maintenance of the patent as granted.

V. An appeal against this decision was filed on 21 May 2001, with the appeal fee being paid at the same time. The statement of grounds of appeal was filed by facsimile of 13 July 2001,received by the EPO on 14 July 2001.

VI. On 30 January 2002, the respondent (patent proprietor) filed a reply to the appellant's statement of grounds of appeal.

VII. By a letter dated 10 August 2004, the appellant filed further submissions, including the following citations:

(12) JP-A-05/30031 and English translation; since the correctness of the translation has never been called in question by the parties, in this decision reference is made to this translation;

(13) R. G. Harry, "Cosmetic Materials", Volume 2, 1963, 178-179;

(14) Kosmetikverordnung, "Bundesgesetzblatt für die Republik Österreich", 16 August 1990.

VIII. In advance of the oral proceedings, the respondent submitted with its letter of 15 November 2005 further observations, including auxiliary requests I to IV. Both parties were represented at the oral proceedings held before the board of appeal on 16 December 2005.

IX. The appellant's arguments in writing and during oral proceedings, in so far as they are relevant to the present decision, may be summarised as follows:

(1) The state of the art according to (2/3) disclosed powder mixtures containing DHA and a sulfite forming agent, e.g. a metal sulfite salt or a metal bisulfite salt. In (2/3) it was also disclosed that said powder mixtures were preferably used for conversion into artificial cosmetic tanning compositions. With respect to the novelty of the claimed subject-matter in the patent, the only question to be answered was thus whether or not the specific amounts (weight percentages) of both DHA and the sulfite agent recited in claim 1 of the patent were features which for the skilled person were implicit in what was explicitly disclosed in (2/3). In contrast to the finding of the opposition division in the impugned decision, the appellant was of the opinion that the relevant amounts of both components should be regarded as implied by the disclosure of (2/3), in the light of the skilled person's knowledge of the state of the art according to citations (4) to (9), (11), (13) or (14).

(2) As regards the amount (weight percentage) of DHA present in artificial tanning compositions disclosed in (2/3), the appellant essentially argued that the prior art of (2/3) related to the use of the powder mixtures in the manufacture of cosmetic compositions useful for providing an artificial tan to the human epidermis ("zur Bräunung der menschlichen Epidermis"). It further argued that, as it was evident that in the compositions of (2/3) the active agent having skin-tanning properties was DHA, the reference in (2/3) to the intended use or purpose of the known cosmetic compositions ("for providing an artificial tan to human epidermis") had to be construed as including a definition in general terms of the amount of DHA present in artificial tanning compositions disclosed in (2/3). This definition related to amounts of DHA required to produce a tanned appearance, i.e. an artificial tan to human skin and, accordingly, to amounts normally present in conventional artificial self-tanning compositions such as those disclosed in documents (4) to (9). These documents provided evidence that conventional self-tanning compositions normally contained DHA in an amount up to 5% by weight, preferably from 2 to 5% by weight or from 3 to 6% by weight.

(3) In the appellant's opinion, the disclosure of citation (11) was particularly relevant for determining the available information content of the disclosure of (2/3). Since (2/3) contained in the introductory portion of the description a reference to prior-art document (11) which disclosed compositions intended for imparting to the skin an artificial colouration similar to the colouration resulting from natural tanning, the disclosure of (11) could and would be used, in the appellant's opinion, by those skilled in the art to interpret the general definition of the amount of DHA ("for providing an artificial tan to human epidermis") present in artificial tanning compositions disclosed in (2/3). It was stated in the cited document that the specific artificial tanning compositions disclosed in (11) contained 0.1 to 10%, preferably 1 to 6% DHA (see page 3, lines 5 to 8; claims 3 and 4); in the examples of (11) the use of amounts of DHA of 2%, 3%, and 5% by weight were explicitly disclosed. In the appellant's opinion, the state of the art of (11) was so close to the claimed subject-matter in the patent as to give the skilled person a direct pointer to the amounts of DHA normally used in artificial tanning compositions and that the specific amounts of DHA exemplified in (11) might accordingly be considered as much part of the disclosure of (3/2) as though implicitly contained therein. The claimed range of the amount (weight percentage) of DHA was thus without novelty.

(4) As regards the amount (weight percentage) of the agent which forms sulfite ions present in the artificial tanning compositions disclosed in (2/3), the appellant argued that, by indicating the specific amount of both DHA (89.5 g or 98 g) and the sulfite forming agent (10 g) present in the powder mixtures described in Examples 1 to 12 of (2/3), the weight ratio of DHA to the sulfite forming agents was also explicitly disclosed for the powder mixtures described in these examples. The appellant drew therefrom the following conclusion: if a skilled person was converting a powder mixture disclosed in the above-mentioned examples of (2/3) into a final cosmetic self-tanning composition and, in doing so, ensured or selected a specific value for the amount (weight percentage) of DHA in that final composition, then the amount (weight percentage) of the sulfite forming agent in that composition could easily be calculated from the known weight ratio of DHA to the sulfite forming agent. [In this respect, the appellant put forward a calculation showing that, if the weight ratio of DHA to the sulfite forming agent was 8.95:1 (see Examples 1 to 4 of (2/3)) and the amount of DHA in the self tanning composition of (2/3) was selected to be, for example, 5% be weight, then the calculated amount (weight percentage of the sulfite forming agent would be (5:8.95) = 0.56%]. The appellant's final conclusion was that since the amount of DHA in the cosmetic self-tanning composition was implicitly disclosed in (2/3) (see (3) above), the amount of the sulfite forming agent was necessarily also disclosed. Accordingly, the disclosure of (2/3) prejudiced the maintenance of the patent on the grounds of lack of novelty.

(5) In the appellant's opinion, there could be no doubt that citation (12) disclosed compositions falling within the scope of present claim 1 and was thus also prejudicial to the novelty of the claimed subject-matter in the patent. The appellant requested that, in view of the relevance of the disclosure of (12) to the legal validity of the Patent, citation (12) should be taken into consideration by the board, in spite of its filing at this late stage in the proceedings (see VII above).

X. The respondent disagreed, relying essentially on the following arguments:

(6) The respondent did not deny that the state of the art according to (2/3) disclosed powder mixtures comprising DHA and sulfite ions. It also agreed that the cited documents suggested using such powder mixtures as intermediate products for the preparation of cosmetic compositions intended for imparting to the human skin an artificial colouration or tan (see (2), page 3, lines 11 to page 4, line 5; (3), top of page 5 to page 6, line 22 ). However, the respondent emphasised that (2/3) failed to disclose any specific example of an artificial tanning composition and also failed to disclose either explicitly or by implication the amount (weight percentage) of at least one of DHA or the sulfite salt contained in the known artificial tanning compositions of (2/3). The respondent also drew attention to the fact that in the course of the proceedings before the first instance and again in the statement of the grounds of appeal the appellant itself had admitted that the prior art of (2/3) was entirely silent about the amount of DHA and likewise the amount of the sulfite salt present in the artificial tanning compositions of (2/3). In this context the respondent repeated that, according to well-established legal principles, laid down in the consistent case law of the boards of appeal, the subject matter of a claim lacked novelty over a prior-art document only if each and every feature of the subject-matter claimed could be inferred directly and unequivocally from that prior-art document in isolation. As this was clearly not the case here, for this reason alone, the present appeal had to be dismissed.

(7) The appellant's allegation that the specific amount (weight percentage) of DHA present in the final artificial tanning compositions of (2/3) was part of the technical teaching implicitly derivable form the disclosure of (2/3), if this disclosure was interpreted in the light of the available information content of any of citations (4) to (9), (11), (13) or (14), was based, in the respondent's opinion, on a clear misinterpretation of the relevant case law of the boards of appeal. The same applied to the appellant's further allegation that, once the amount (weight percentage) of DHA in the tanning compositions of (2/3) was given, it was then only a trivial matter of calculation to determine the amount (weight percentage) of the sulfite salts in said compositions from the weight ratio of DHA to the sulfite salts in the powder mixtures disclosed as intermediate products in Examples 1 to 12 of (2/3).

As regards the appellant's first allegation, this did not, in the respondent's judgment, take account of the fundamental legal principle that, for a prior-art document to be novelty-destroying, all elements of the subject-matter claimed must be disclosed in that single document. This principle had been confirmed by a vast number of decisions by the boards of appeal of the EPO. In this connection the respondent noted that in the first instance proceedings reference was already made to decision T 153/85 (OJ EPO 1988, 1) which held that "when assessing novelty, the disclosure of a prior document must be considered in isolation" (see especially Headnote III).

As regards the appellant's second allegation, this did not pay attention to the equally fundamental legal principle that a prior art disclosure was not prejudicial to novelty, unless the subject-matter claimed can be inferred directly and unequivocally from that disclosure. The latter was not the case here, as shown below.

(8) None of the publications (4) to (9), (11), (13) or (14) cited by the appellant in the first instance opposition or the subsequent appeal proceedings disclosed artificial tanning compositions comprising a mixture of DHA and sulfite salts and thus none represented relevant prior art in relation to the claimed subject-matter in the patent. Contrary to the appellant's view, the disclosure of citation (11) - insofar as it related to the concentration of DHA in artificial tanning compositions - could not be combined with the teaching of (2/3). In (2/3) it was clearly stated that (11) related to specific adjuvants, which were added to enhance the artificial self-tanning effect of DHA (see (2), page 2, lines 14 and 15; (3), page 1, last paragraph). Contrary to the appellant's assertions, citation (11) was clearly not cited in (2/3) to supplement the disclosure of (2/3) by indicating certain specific DHA concentrations in artificial tanning compositions.

(9) The appellant's assertions that DHA was generally used in the artificial tanning compositions disclosed in the cited documents only in amounts (weight percentages) of up to 5% or 6%, because the use of larger amounts (weight percentages) of DHA in artificial tanning compositions was prohibited by national law or regulations in certain countries such as Austria [see (5); (14)] or Switzerland [see (5)], were in themselves contradictory. Citation (ll), for example, to which the appellant specifically referred, disclosed artificial tanning compositions containing DHA in an amount of up to 10% (see claims 3 and 4). All the documents cited by the appellant clearly demonstrated the broad variation in the amounts of DHA conventionally used in artificial tanning compositions.

(10) The opposition division was entirely correct in its opinion that the incomplete disclosure of (2) and (3) could not be supplemented by reference to (11) or to any other prior art document, as a lack of novelty objection must be based on a single document only. The contrary conclusion maintained by the appellant was based on the following two assumptions (a) and (b) for which no basis could be found in the disclosure of the patent:

(a) the assumption that the concentration of DHA in the novel tanning compositions provided by the patent must be the same as the concentration of DHA in conventional artificial tanning compositions comprising only DHA, in the absence of sulfite salts; there was, however, absolutely no basis for this assumption. Interactions between DHA and other components of the claimed new compositions might produce, for example, an enhanced or reduced self-tanning effect, or a reduction in toxicity, or any other effects and might thus require the use of DHA in higher or lower concentrations than previously used to achieve the desired self-tanning effect;

(b) the assumption that the weight ratio of DHA to the sulfite salts provided for powder mixtures in (2/3) was necessarily maintained constant when an artificial tanning composition was produced from these powder mixtures; this assumption neglected, for example, what was an obvious option in the present case, namely that the weight ratio of DHA to the sulfite ions could be altered or adjusted by the addition of a certain amount of either sulfite salt or DHA, as required, when formulating the powder mixtures of (2/3) into a final artificial cosmetic tanning composition.

(11) The fact that the appellant had based its objections of lack of novelty on a number of assumptions demonstrated clearly, in the respondent's opinion, that the claimed subject-matter was not directly and unambiguously derivable from the cited state of the art.

(12) Citation (12) was allegedly published in December 1993 and thus represented prior art under Article 54(2) EPC. Whereas the patent related to compositions to be applied to the skin, citation (12) related to compositions to be applied to the hair and, accordingly, to a different technical field. It was even entirely uncertain whether or not any of the compositions disclosed in (12) were suitable for application to the skin. In contrast to the claimed composition in the patent, the compositions of (12) consisted of two distinctly different and separate agents (a) and (b) which were applied to the hair one after the other. Since the late filed citation (12) was not even prima facie relevant to the question of novelty in the present case, it should not be allowed into the proceedings.

XI. The appellant requested that the decision under appeal be set aside and that the patent be revoked.

The respondent requested that the appeal be dismissed (main request), or that the patent be maintained in amended form on the basis of one of the auxiliary requests I to IV filed by letter dated 15 November 2005.