T 0269/02 (Sunblock agents/SUN SMART, INC.) 20-07-2005

Summary of Facts and Submissions

I. This appeal is against a decision of the opposition division posted on 9 January 2002 to revoke European patent No. 0 585 239 ("the patent") entitled "Visible transparent UV sunblock agents and methods of making same". The patent was granted to the appellant with effect from 23 September 1998 in response to European patent application No. 92 906 777.5, filed on 4 February 1992 and claiming two US priorities of 5 February 1991 (Serial No. 65 16 96) and 22 June 1991 (Serial No. 704250).

II. The sole ground for revocation was that claim 1 as granted contained subject-matter which extended beyond the content of the application as originally filed (Articles 100(c) and 123(2) EPC).

III. The application as filed (International application No. PCT/US92/00860, published under the PCT as WO 92/13517) contained inter alia claims directed to (emphasis added by the board):

"1. A substantially transparent topical sunblock formulation for shielding skin from ultraviolet radiation, said formulation comprising a substantially visibly transparent agent for absorbing ultraviolet radiation which is relatively physiologically inert, said agent dispersed within a substantially colorless dermatologically suitable liquid carrier in at least an amount sufficient to shield substantially all of said skin over which said formulation is applied from hazardous effects of ultraviolet radiation.

2. The transparent sunblock formulation of claim 1 wherein said ultraviolet absorbing agent comprises a plurality of visibly transparent particles of zinc oxide.

4. The transparent sunblock formulation of claim 2 wherein said ultraviolet absorbing agent comprises a plurality of substantially pure micronized particles of zinc oxide having an average particle diameter of less than about 0.2 microns.

5. The transparent sunblock formulation of claim 2 wherein said ultraviolet absorbing agent comprises a plurality of substantially pure, substantially optically perfect particles of zinc oxide having an average particle diameter of between about 1-100 microns, wherein said particles have a substantially smooth outer surface and are relatively free of internal fractures and imperfections.

9. The transparent sunblock formulation of claim 1 wherein said ultraviolet absorbing agent comprises a plurality of particles of a visibly transparent uv absorbing glass with an average particle diameter of between about 0.01-100 microns, said particles having a substantially smooth outer surface and being relatively free of internal fractures and imperfections.

12. The transparent sunblock formulation of claim 1 wherein said ultraviolet absorbing agent comprises a plurality of particles having a diameter ranging between about 0.01-100 microns formed from a visibly transparent plastic and at least one UV stabilizer compound.

15. The transparent sunblock formulation of claim 1 wherein said dermatologically suitable liquid carrier is selected from among SD alcohol, lanolin, glyceryl stearate, cocoa butter, sorbitan sesquiolate, propylene glycol, mineral oil, isopropyl myristate, petrolatum, acrylic polymers and mixtures thereof.

16. The transparent sunblock formulation of claim 15 wherein said substantially transparent ultraviolet absorbing agent is dispersed within said liquid carrier in the form of an emulsion."

IV. The patent as granted contained 18 claims. In this decision specific reference will be made to independent claim 1 and dependent claim 2 as granted; these claims read as follows:

"1. A transparent topical sunblock formulation for shielding skin from ultraviolet radiation, comprising a visibly transparent agent for absorbing ultraviolet radiation which agent is physiologically inert, said agent being one of

(a) a plurality of visibly transparent micronized particles of zinc oxide having an average particle diameter of less than 0.2 µm and containing less than 20 ppm lead, less than 3 ppm arsenic, less than 15 ppm cadmium, and less than 1 ppm mercury;

(b) a plurality of visibly transparent particles of zinc oxide having an average particle diameter of between 1 - 100 µm and containing less than 20 ppm lead, less than 3 ppm arsenic, less than 15 ppm cadmium, and less than 1 ppm mercury;

(c) a plurality of visibly transparent UV absorbing crystal glass with a bandgap energy of about 400 nm and an average symmetrical particle diameter of between 0.01 - 100 µm, said particles having a smooth outer surface and being free of internal fractures and imperfections; or

(d) a plurality of visibly transparent plastic spheres having a diameter ranging between 0.01 - 100 µm and having incorporated in said plastic at least one UV stabilizer compound,

said agent being dispersed within a dermatologically compatible carrier in an amount effective to shield skin over which said formulation is applied from hazardous effects of ultraviolet radiation.

2. The topical formulation according to claim 1, wherein said dermatologically compatible carrier is selected from SD alcohol, lanolin, glyceryl stearate, cocoa butter, sorbitan sesquioleate, propylene glycol, mineral oil, isopropyl myristate, petrolatum, acrylic polymers or mixtures thereof.

V. Oppositions to the grant of the patent were independently filed by six parties (opponents I to VI; present respondents I to VI). The opponents requested revocation of the patent in part or in toto, variously invoking the following grounds:

(i) lack of novelty (Articles 100(a) and 54 EPC);

(ii) lack of inventive step (Articles 100(a) and 56 EPC);

(iii) insufficient disclosure (Articles 100(b) and 83 EPC); and also

(iv) added subject-matter (Articles 100(c) and 123(2) EPC).

VI. The essence of the reasoning in the opposition division's decision to revoke the patent was as follows:

[A] In the introductory portion of the decision under appeal it was recalled that in the granting procedure claim 1 was amended, inter alia, by deleting the features "substantially colorless" and "liquid", both these features relating to the carrier wherein the visibly transparent agent for absorbing ultraviolet radiation of the claimed sunblock formulation is dispersed (see III above: claims 1 as originally filed vs. IV above: claim 1 as granted).

[B] With reference to the disclosure at lines 10-14 on page 7 of the application as filed, the opposition division considered that the original disclosure of the claimed subject-matter did not stipulate that the carrier was necessarily colorless and concluded that deletion of this feature from claim 1 as amended did not contravene Article 123(2) EPC.

[C] As regards deletion of the feature "liquid" in claim 1, the opposition division did not, however, follow the proprietor's (appellant's) argument that this feature was implicitly disclosed in claim 1 as granted, in particular, if claim 1 was interpreted in the light of dependent claim 2 (see IV above). In this respect the opposition division noted that claim 2 included, for example, cacao butter, which was clearly a solid carrier at room temperature. It further noted that the objections under Articles 100(c) and 123(2) EPC were directed to claim 1 as such and that the features of dependent claim 2 accordingly imposed no real limitation or restriction on the nature of the carrier in claim 1. Since claim 1 as granted was entirely silent as to the physical state of the carrier, it had to be construed as including both solid and liquid carriers. The opposition division also did not accept the proprietor's (appellant's) argument that sunblock formulations were mandatorily liquid, as such formulations in the form of lipsticks, gels or creams were clearly feasible.

[D] Finally, the repeated statements in the description to the effect that "a visibly transparent sunscreen is obtained if substantially pure micronized particles of zinc oxide are dispersed in a dermatologically suitable liquid carrier" (see eg page 13, lines 21-27) made it, in the judgment of the opposition division, entirely clear that the use of a liquid carrier was essential for obtaining transparency. The conclusion was that the use of a carrier in "liquid" form was an essential technical feature of the claimed invention and its omission resulted in a clear contravention of Article 123(2) EPC.

VII. In its statement setting out the grounds of appeal, the appellant requested that the amended set of claims filed with the notice of appeal dated 7 March 2002 be substituted for those rejected by the opposition division. The amended claims were identical with those before the opposition division, with the sole exception that claim 1 had the term "liquid" reinstated in relation to the carrier present in the claimed transparent sunblock formation. Claim 1 as amended read as follows, with the sole amendment compared to claim 1 as granted highlighted by the board in bold italic letters:

"1. A transparent topical sunblock formulation <...... see claim 1 as granted..................>,

said agent being dispersed within a dermatologically compatible liquid carrier in an amount effective to shield skin over which said formulation is applied from hazardous effects of ultraviolet radiation."

VIII. In advance of the oral proceedings, scheduled to take place on 20 July 2005, the appellant additionally filed an auxiliary request. Claim 1 of this auxiliary request is the same as that of the main request (see VII above). Dependent claim 2, however, has been amended so as to delete the following compounds from the list of suitable carriers in claim 2 as granted: lanolin, glyceryl stearate, cocoa butter petrolatum and acrylic polymers. Amended claim 2 of this request read as follows:

"2. The topical formulation according to claim 1, wherein said dermatologically compatible carrier is selected from SD alcohol, sorbitan sesquioleate, propylene glycol, mineral oil, isopropyl myristate or mixtures thereof."

IX. The appellant and all respondents I to VI were represented at the oral proceedings. At the beginning of the hearing, the board expressed the preliminary opinion that neither the reinstatement of the term "liquid" into claim 1 nor the omission of the feature colorless gave rise to any objections. It expressed, however, ex officio certain reservations under Articles 100(c) and 123(2) EPC as to the support of claim 1 before it in the application as filed, in particular as far as embodiments (b) and (c) of claim 1 were concerned (see IV and VII above). Following several submissions of all parties and further discussion as to the support of claim 1 before the board (see VII above) in the application as filed, the appellant requested a short break for deliberation, which was allowed.

X. After the break, the appellant abandoned the previous requests and filed, as its new main and sole request, an amended set of thirteen claims. Claim 1 of this request reads as follows, with the amendments compared to claim 1 as granted highlighted in bold italics below:

"1. A transparent topical sunblock formulation for shielding skin from ultraviolet radiation, comprising a visibly transparent agent for absorbing ultraviolet radiation which agent is physiologically inert, said agent being one of

(a) a plurality of visibly transparent micronized particles of zinc oxide having an average particle diameter of less than 0.2 µm and containing less than 20 ppm lead, less than 3 ppm arsenic, less than 15 ppm cadmium, and less than 1 ppm mercury,

(b) a plurality of substantially optically perfect, visibly transparent particles of zinc oxide having an average particle diameter of between 1 - 100 µm and containing less than 20 ppm lead, less than 3 ppm arsenic, less than 15 ppm cadmium, and less than 1 ppm mercury, wherein said particles have a substantially smooth outer surface and are relatively free of internal fractures and imperfections;

[former embodiment (c) deleted]

or

(c) a plurality of visibly transparent plastic spheres having a diameter ranging between 0.01 - 100 µm and having incorporated in said plastic at least one UV stabilizer compound,

said agent being dispersed within a substantially colorless dermatologically compatible liquid carrier in an amount effective to shield skin over which said formulation is applied from hazardous effects of ultraviolet radiation."

Dependent claims 2 to 7 are identical with those as granted; as a consequence of the deletion of former embodiment (c) in claim 1 of the patent as granted, dependent claims 8 to 12 as granted, relating to specific embodiments of item (c) in claim 1 as granted, have also been deleted and dependent claims 13 to 18 as granted have accordingly been renumbered claims 8 to 13.

XI. The arguments of the appellant as submitted in writing and during the oral proceedings, so far as relevant to this decision, can be summarised as follows:

[1] As regards the appeal based on the amended claims filed together with the notice of appeal (see VII above), it was recalled by the appellant that the contested decision was made on the sole ground that the patent contained subject-matter which extended beyond the scope of the application as originally filed (Articles 100(c) and 123(2) EPC). More specifically, only the deletion of the term "liquid" in relation to the carrier present in the transparent sunblock formulations of the invention was considered by the opposition division as an inadmissible broadening of the claims. The appellant submitted that the appeal as initially filed was thus a remedial appeal in that it sought to obviate the sole issue which had given rise to the adverse finding in the decision under appeal revoking the patent.

[2] The amended claims on which the appeal was initially based had the term "liquid" reinstated in claim 1 in relation to the carrier present in the claimed transparent sunblock formulations. Consequently, the appellant had had a legitimate expectation that the ground of objection which gave rise to the decision to revoke the patent had been overcome by the clearly allowable reinstatement of the term "liquid" in claim 1 and that thus the appealed decision would be set aside in its entirety. The appellant also argued that, given the narrow ambit of the decision under appeal, this course of action was appropriate; any further issues, including the newly raised clarity and insufficiency objections raised by the respondents at the appeal stage in respect of the term "liquid" reinstated in the amended claims, should be addressed after the case has been remitted to the opposition division for further consideration.

[3] As regards the appeal based on the further amended set of claims 1 to 13 filed during the oral proceedings before the board (see X above), the appellant submitted that this set of claims had been filed in reply to the objections and reservations under Articles 100(c) and 123(2) EPC which the board and the respondents expressed at the beginning of the hearing about the possible non-compliance of embodiments (b) and (c) in claim 1 and deletion of the feature "liquid" relating to the carrier with the requirements of Article 123(2) EPC. It also submitted that the new and sole request was presented with the clear intention to set aside the concerns expressed by the board and respondents for the first time during the hearing.

[4] The appellant pointed out that it addressed in its newly filed request the board's and the respondents' reservations and observations in a direct manner and without raising subsidiary issues which were not considered at the oral proceedings either before the opposition division or the board and which were not addressed in the decision under appeal. In doing so, the appellant sought (i) to deal with the single issue raised in the decision under appeal, namely that the deletion of the term "liquid" from claim 1 during the prosecution of the application constituted "added subject-matter" and was thus in breach of Articles 100(c) and 123(2) EPC, and (ii) to additionally take account of the objections and reservations expressed at the hearing before the board.

[5] The appellant submitted that the amended set of claims filed during the oral proceedings before the board was fully supported by the disclosure of the application as filed and satisfied the requirements of Article 123(2) and (3) EPC. As regards the alleged inconsistency between the disclosure at page 9, lines 14-17 (" which are essentially free of internal fractures and/or other physical imperfections, and which have a relatively smooth outer surface") and present claim 1 ("wherein said particles have a substantially smooth outer surface and are relatively free of internal fractures and imperfections), the appellant argued that the expressions "relatively" and "substantially" had, in its opinion, essentially the same meaning in the context they were used. It also argued that the wording of embodiment (b) in present claim 1 was identical with that used in original claim 5 and, accordingly, supported by the application as filed.

[6] The appellant did not agree to the respondents' contention that it was necessary to consider the newly raised clarity and insufficiency objections at the oral proceedings before the board in order to decide whether the amended claims were formally allowable. Thus, the new objections of clarity and insufficiency were, in the appellant's opinion, not only issues of formal allowability but also substantive objections. Moreover, the arguments now submitted by the respondents in these respects had never been raised before the opposition division, despite the appellant's submission during the examination and opposition proceedings that the claims should be implicitly read as including the term "liquid" which was only at this late stage of the proceedings objected to. Consequently, if the board were to consider the newly raised arguments of the respondents at this stage and decide against the appellant, then it would be deprived of its fundamental right of appeal.

[7] However, if the board was minded to consider the issues of clarity and sufficiency, then it was the appellant's position that present claims 1 to 13 met the requirements of Articles 83 and 84 EPC. In the appellant's opinion, it was clearly explained in the description what was meant by substantially optically perfect particles which have a substantially smooth outer surface and are relatively free of internal fractures an imperfections and detailed methods were given in the description how such particles could be produced. Moreover, those skilled in the art of formulating sunblock compositions would readily understand the meaning of the term "liquid" in claim 1 and would have no problem in selecting a suitable dermatologically compatible liquid carrier. With regard to those compounds listed in claim 2, it would be clear to those skilled persons that where the compounds listed in that claim were not liquids per se they must be formulated as liquid dispersions or emulsions. In answer to a question from the board, the appellant explicitly declared that sunblock formulations per se, independent of their physical state (solid or liquid at ambient conditions), were covered by the present claims. Moreover, in a further answer to a question of the board the appellant agreed that, for example, a colorless lipstick when forming a transparent film on application to the skin fell within the scope of present claim 1.

[8] As regards the request for apportionment of costs and the objection of respondent III to the timing of the submission of the amended claims filed together with the notice of appeal (see VII above), the appellant maintained that, by filing these amendments, it responded fully to the objections under Article 123(2) EPC in the contested decision, on the basis of a reasonably held belief that no further amendment of the claims was necessary in order to comply with this article (see also the remarks in [1] and [2] above). The appellant asserted that it had no intention either to delay the proceedings or to obtain a procedural tactical advantage by not having filed the amended set of claims having the feature "liquid" reinstated in claim 1 already during oral proceedings before the opposition division. On the contrary, the appellant held that it had filed the amended set of claims at the appeal stage as soon as possible already with the notice of appeal, hoping thereby that it would be possible to avoid the need for oral proceedings and to accelerate the proceedings.

XII. The arguments presented by the respondents in their written submissions and at the hearing before the board, insofar as these are relevant to the present decision, can be summarised as follows:

[9] Some of the respondents pointed out that neither claim 1 nor claim 5 as originally filed referred to the specific ranges of the trace metals contained in the particles of zinc oxide according to embodiment (b) in claim 1 in order to conclude that the combination of the specific ranges of the trace metals with the technical features added to embodiment (b) in amended claim 1 filed during the oral proceedings (see X above) lacked appropriate support in the application as filed and, accordingly, contravened Article 123(2) EPC.

[10] The respondents also noted that the discrepancy between the description and present claim 1 resulting from the fact that the terms "relatively" an "substantially" were interchanged in the description as originally filed and in present claim 1 (see for more details X[5] above) could give rise to an objection under Articles 84 and 123(2)EPC. In this respect it was argued that, if the basis for an amendment to a claim were to be found in the description, that amendment should be incorporated verbatim into the claim.

[11] In this context it was also submitted by the respondents that no one could definitely exclude that in the present case the term "relatively" was broader than the term "substantially". If this was the case present claim 1 containing the feature "relatively free of internal fractions and imperfections" would be objectionable under Article 123(3) EPC.

[12] Contrary to the appellant's submissions, the respondents' clarity and insufficiency objections were clearly appropriate to these appeal proceedings and indeed needed to be considered, since the appellant was proposing a claim which introduced certain features not present in any of the granted claims. It was thus necessary to decide whether the claims as a whole were formally allowable. Included within this assessment was the question of whether the claims as amended were clear.

[13] The amendment made by the appellant to include the term "liquid" in claim 1 rendered this claim unclear and thus was a contravention of Article 84 EPC. In particular, there was no definition of the term "liquid" anywhere in the patent, nor was there any indication of the condition under which the desired carrier should be considered to be "liquid" or not. It was however well known that the physical state of a substance, whether solid, liquid or gas, depended upon the conditions to which the substance was subjected, one such condition being temperature. However, as the patent failed to specify such conditions, or indeed any other parameter by which the substance could be judged to be a "liquid" , the term "liquid" was patently unclear.

[14] The situation was worsened by the fact that a number of the carriers listed in claim 2 were not "liquid" at "room temperature", whatever that might be. For instance, lanolin had a melting point of about 40ºC and glyceryl stearate (glyceryl monostearate) of 56-58ºC and both were therefore in solid form at room temperature. Petrolatum was available in various forms, typically as a waxy solid having a melting point of 45-48ºC. Claim 2 also included acrylic polymers, but failed to define the molecular weight of these polymers. High molecular weight acrylic polymers might well be solid at "room temperature".

[15] In view of the fact that the patent failed to define what is meant by the term "liquid", and failed to include any working examples, it was also unable under Article 83 EPC to provide adequate instructions to the skilled person as to how to formulate a composition as defined in claim 1.

[16] In addition, the specific materials listed in claim 2 might generally also be used in sunblock formulations, many of them were not suitable for use as a carrier for the visibly transparent agent and were used for completely different purposes. For example, glyceryl stearate and sorbitan sesquioleate were emulsifiers, cacao butter and petrolatum were emollients and acrylic polymers were thickeners. It was inconceivable that all of the aforementioned materials could be used as a liquid carrier, for example, for zinc oxide in sunblock formulations. It was impossible for the skilled person to tell whether or not the use of the aforementioned materials in a transparent sunblock formulation fell within the present claims. The present specification taught that in order to obtain transparency it was essential that the carrier was in liquid state. But to what temperature that liquid state actually related, it was impossible to tell from the disclosure of the invention in the patent specification.

[17] The respondents also mentioned that the appellant had argued in the proceedings before the opposition division that the claims only covered liquid sunblock formulations, i.e. that in order to obtain transparency a liquid carrier must be employed and that the final formulation must also be liquid. However, the present claims were not limited to liquid sunblock formulations. It was possible to employ a liquid carrier and still end up with a non-liquid sunblock formulation, for example by the use of additional thickeners. A lipstick for example could be solid and still have been formed from one or more liquid ingredients.

[18] As regards the request for apportionment of costs, respondent III submitted that, in relation to the timing of the appellant's amended claim filed together with the notice of appeal, it should be noted that the objection raised under Article 123(2) EPC was raised by it in its initial opposition statement. Accordingly, the appellant was given sufficient opportunity during the protracted written proceedings and at the oral proceedings before the opposition division to amend its claims to alleviate the problem under Article 123(2) EPC. However, the appellant chose not to do this, with the result that the patent was revoked on the ground of Article 123(2) EPC, rendering necessary the present appeal proceedings which will deal solely with the issue of amendment. Therefore the appellant's conduct had been far from exemplary, with the result that it has to be questioned whether it should be allowed to amend its claims at this stage in the proceedings. Thus, if the appeal were to be allowed, and the case remitted to the opposition division, the appellant should be made to bear the costs incurred as a result of the present appeal proceedings.

XIII. The appellant requested that the decision under appeal be set aside and that the patent be maintained on the basis of the set of claims filed in the oral proceedings, and that the case be remitted to the first instance for further prosecution.

The respondents requested that the appeal be dismissed.

Respondent III also requested an apportionment of costs.

The appellant requested that the request for an apportionment of costs be refused.