T 0952/92 (Prior use) 17-08-1994

Reasons for the Decision

1. Novelty: issues raised

1.1 The first main issue in this appeal is whether the prior sale of Supersolve by Koch-Light Laboratories Limited deprives any claims of any of the patent proprietor's requests of novelty, and if so, which claims.

In this connection certain matters are not in dispute between the parties. First, the process step in claim 1 (that "phosphoric acid esters have been neutralised"), which make this claim a "product-by-process claim", is not a distinguishing feature for the product per se. In the board's view this process feature is irrelevant to the issue of novelty.

Furthermore, as set out in the notice of opposition and supported by evidence filed at the same time, the product Supersolve was sold in the United Kingdom from 1980 onwards, and therefore before the priority date of the patent in suit.

Furthermore, as set out in the notice of opposition and supported by the declaration by Mr Huggett, the product Supersolve had a composition within claims 1, 2, 4 and 5 of the main request. In particular, the mixture which was sold contained GAFAC PE 510 surfactant, which according to documents D2 and D3 is a mixture of mono and di-esters of phosphoric acid. According to Mr Huggett's declaration the mixture was neutralised with aqueous ammonia (having a pKa of between 5 and 12), so that it contained a mixture of mono- and di-phosphate salts.

However, claim 3 of the main request requires that "the organic phosphoric acid ester is neutralised with an organic amine", and Supersolve did not have a composition falling within such claim.

1.2 During the proceedings before the opposition division, the opponent originally submitted in the notice of opposition that such claims 1, 2, 4 and 5 lacked novelty simply having regard to the fact that Supersolve had been sold before the priority date and had had a composition falling within such claims. In reply, however, the patent proprietor submitted inter alia that such fact (ie "the mere availability of a product satisfying the claims") does not destroy the novelty of such claims, because it is "a prior use which does not allow a skilled person to find out how the product can be made". In response to this, the opposition division issued a communication in which the opponent was "requested to comment in detail on the question whether it would have been possible to analyze (Supersolve) prior to the priority date of the contested patent". In connection with this question, the patent proprietor filed the declaration by Dr Gevers, which supported the patent proprietor's view that the chemical composition of the Supersolve product was "too complex to allow skilled persons to analyse it without undue experimentation"; and the opponent filed the declaration by Dr Taylor, as well as the letter from Dr Kremer, supporting the opponent's view that it would have been possible to analyse Supersolve before the priority date.

Before the opposition division the patent proprietor relied primarily upon decisions T 93/89 (OJ EPO 1992, 718) and T 461/88 (OJ EPO 1993, 295), as well as decision T 206/83 (OJ EPO 1987, 5), in support of contentions to the effect that there was no motivation for a skilled person to analyse Supersolve and furthermore that such an analysis would not have been possible without an undue burden of experimentation, and was not possible with a reasonable investment of time and money.

Since the issue of the opposition division's decision, the Enlarged Board has issued its opinion G 1/92 (OJ EPO 1993, 277), which overruled the finding in decision T 93/89 that "If the composition of a commercially available product can be established only by a chemical analysis, the ingredients of the product have not been made available to the public unless there was reason for experts to investigate it".

1.3 In the light of the Enlarged Board's opinion G 1/92, during the appeal proceedings the patent proprietor raised a number of questions as to what has to be proved by an opponent in a case such as the present, in order to establish lack of novelty of a claimed invention having regard to the prior sale of a product having a composition in accordance with the claimed invention. These questions can be summarised as follows:

(i) Is it necessary for an opponent to prove that a skilled person could have analysed without undue burden the product which was sold before the priority date, and could thereby have known that the composition of such product was in accordance with claims of the patent, in order to establish lack of novelty of such claims?

(ii) Is it necessary for an opponent to prove that a skilled person could have carried out a complete analysis, without undue burden, of the product which was sold, and to be able to reproduce such product exactly without undue burden, in order to establish lack of novelty of the claimed invention?

(iii) As a factual matter, has it been established by the opponent in the present case that Supersolve could have been analysed before the priority date so as to prove lack of novelty of the claimed invention?

1.4 In relation to questions (i) and (ii) above, the patent proprietor requested that if the present board did not intend to decide, or hesitated to decide, in favour of his submissions, questions along the following lines should be referred to the Enlarged Board of Appeal under Article 112(1)(a) EPC:

(a) "Is the chemical composition of a product made available to the public by virtue of the availability to the public of that product when said chemical composition could be determined by analysis of the product, but not without undue burden?"

(b) "Does the availability to the public of a product, the chemical composition of which could not be determined so completely as to allow reproduction of the said product, nevertheless destroy the novelty of an invention if at least the presence of the essential elements of said invention could be determined from the product?"

(c) "What are the considerations which should be taken into account when determining whether a prior sold product could have been analysed and reproduced 'without undue burden'?".

The opponent did not object to questions such as set out above being referred to the Enlarged Board of Appeal, if the present board thought it appropriate to do so.

2. Novelty - main request: legal issues

The main legal question in this case is: what was "made available to the public" and therefore part of the state of the art for the purpose of Article 54(2) EPC, by reason of the prior sale of Supersolve?

To answer this question, as well as the other related questions set out in paragraph 2.3 above, it is necessary to consider briefly the relevant legal background.

2.1 In the first place it appears to be very well established in the case law of the boards of appeal that for a claimed invention to have been "made available to the public" in the sense of Article 54(2) EPC before the relevant filing date, information equivalent to the claimed invention must have been accessible to a skilled person. As stated by the Enlarged Board in decisions G 2/88 and G 6/88 (OJ EPO 1990, 93 and 114), "The word "available" carries with it the idea that, for lack of novelty to be found, all the technical features of the claimed invention in combination must have been communicated to the public, or laid open for inspection". Similarly in opinion G 1/92 (OJ EPO 1993, 277), the Enlarged Board stated that "Where it is possible for the skilled person to discover the composition or the internal structure of the product ... then both the product and its composition or internal structure become state of the art", and that "It is the fact that direct and unambiguous access to some particular information is possible which makes the latter available ...".

Furthermore, in opinion G 1/92 the Enlarged Board emphasised that "Article 54(2) EPC does not make any distinction between the different means by which any information is made available to the public. Thus, information deriving from a use is governed in principle by the same conditions as is information disclosed by oral or written description".

In other words, the disclosure of a written description is the information which a skilled person can learn by reading it, the disclosure of an oral description is the information that a skilled person can learn by hearing it, and the disclosure of a product which has been used is the information that a skilled person can learn from it, either visually or by analysis for example.

Thus whatever the means of disclosure (written description, oral description, use, etc.), availability in the sense of Article 54(2) EPC involves two separate stages: availability of the means of disclosure, and availability of information which is accessible and derivable from such means.

Furthermore, whatever the means of disclosure, as indicated in the passage of opinion G 1/92 quoted above, a question may arise in any particular case as to what is "directly and unambiguously" derivable from such means. Both the result of reading a written description and the result of an analysis may be relatively unclear. This is a question of degree.

It follows from the above that in the board's view the opposition division was correct to inquire into the possibility of analysis of Supersolve.

2.2 The further question to be considered (paragraph 1.3 above, question (i), and paragraph 1.4 above, question (a)) is whether the line between what is available to the public by analysing a prior used product and what is not so available is determined by the criterion of what can be derived from such an analysis "without undue burden". In this connection the patent proprietor relied upon the following passage in opinion G 1/92: "Where it is possible for the skilled person to discover the composition or the internal structure of the product and to reproduce it without undue burden, then both the product and its composition or internal structure become state of the art" (emphasis added). The patent proprietor submitted that the phrase "without undue burden" governed both the "discovery" of the composition or internal structure and its reproduction, and relied upon the official German translation as published in the Official Journal, which, it was submitted, made this clear.

The official text of opinion G 1/92 is English and, in the board's view, it is therefore the English text of the opinion which has to be interpreted, without reference to the translated German text, which is legally irrelevant; the wording of the German text may have resulted from a misunderstanding by the translator of the intention underlying the English text.

In the board's view the above-quoted passage of the opinion is not entirely clear as a matter of grammar, since the phrase "without undue burden" could qualify just the reproduction of the product, or it could qualify both the discovery of its composition or internal structure and its reproduction. In support of the latter interpretation, the patent proprietor submitted that the analysis of the composition of the product went together with the possibility of reproducing it, and that since both analysis of the product and the possibility of reproducing it were necessary for the composition of the product to have been "made available", the phrase "without undue burden" necessarily applied to both analysis and reproduction.

In the board's view it must first be noted that the questions which were referred to the Enlarged Board and which were the subject of opinion G 1/92 did not raise the question of the applicability of the concept "without undue burden". The referred questions concerned whether it was necessary for particular reasons to be identified which would cause a skilled person to analyse a prior used product or to search for information from such a product; as mentioned in paragraph 2.2 above, such referred questions arose from the finding in decision T 93/89 that the composition of a prior used product is not "made available to the public" unless there are reasons for a skilled person to analyse it.

Thus the reference in opinion G 1/92 to "without undue burden" in the above-quoted passage was not strictly necessary for providing an answer to the referred questions, and therefore cannot have been intended to alter or add to the existing law concerning what constitutes "the state of the art".

The concept of reproduction of a product "without undue burden" is traditionally associated with the question of "sufficiency" of a description of an invention in a patent specification: that is, whether the invention which is the subject of the patent has been described in the patent specification "in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art" (Article 83 EPC). In this context, the skilled person knows what it is that he is trying to reproduce: namely, the subject-matter which is claimed in the patent and which is therefore to be protected by the patent, and the invention which has been disclosed in the description of the patent. Thus in this context, the phrase "without undue burden" is an explanation of the words "sufficiently clear and complete" in Article 83 EPC.

The concept of reproducibility "without undue burden" has also been extended by analogy to cases concerning novelty, where a prior document describes a product such as a chemical compound which is the subject of a claim in a patent. As held in decision T 206/83 (OJ EPO 1987, 5), such a description of a product does not render the product "available to the public", and thus does not destroy the novelty of such a claim, if a skilled person is unable to make the product, using his common general knowledge and "without undue burden" (in other words, in the absence of an "enabling disclosure").

However, the extension of application of the concept "without undue burden" from reproduction of what has been described in a prior document to the discovery of what is not yet known about a previously sold product (namely, its composition or internal structure) would involve very different considerations, and the board does not accept either that that was intended by the Enlarged Board of Appeal in opinion G 1/92, or that it is legally correct.

Thus in the present case the patent proprietor argued that because the product Supersolve only had mediocre properties and was "nothing special", it followed that the cost of analysing Supersolve would far outweigh any benefit that could be expected from such analysis, and for this reason the carrying out of an analysis of Supersolve would be an undue burden on the skilled person. In the board's view, such an approach to the determination of novelty is essentially equivalent to the approach set out in decision T 93/89, which was overruled in opinion G 1/92, for example in the following passage: "It is the fact that direct and unambiguous access to some particular information is possible, which makes the latter available, whether or not there is any reason for looking for it".

The board does not accept the further submission of the patent proprietor to the effect that the criterion of analyzability of a prior used product without undue burden has always been applied by the boards of appeal, as evidenced for example by decision T 406/86, which is referred to in and implicitly approved by opinion G 1/92, and in which it was held that the composition of a product is "made available" if it can be "determined without any difficulty" by chemical analysis. Such a finding is not the same as saying that, for the composition of a product to be "made available" it must be analyzable "without undue burden".

In the board's view, to apply the concept of "without undue burden" to the determination of the composition or internal structure of a prior used product which cannot be ascertained visually (for example by analysis) would introduce a subjective element into the determination of novelty, which was specifically rejected by the Enlarged Board in opinion G 1/92 (see paragraph 2.1). On the contrary, following what is stated in such opinion as quoted above, in the board's view it is the fact that direct and unambiguous access to information concerning the composition or internal structure of a prior used product is possible, for example by means of analysis, which makes such composition or internal structure "available to the public" and thus part of the state of the art for the purpose of Article 54(2) EPC. If such an analysis is possible in accordance with the known analytical techniques which were available for use by a skilled person before the relevant filing date, the composition or internal structure thereby is available to the public.

This conclusion is in accordance with what was stated in decision T 406/86, referred to above, and is also in accordance with the principles set out in paragraph 2.1 above. In particular, the analysis by a skilled person of a product which has per se been "made available to the public" by means of prior sale for example, using available analytical techniques, can be considered as equivalent to the reading by a skilled person of a written description in a document which has per se been "made available to the public". The likelihood or otherwise of such a skilled person either reading such a written description, or analysing such a prior sold product, and the degree of burden (ie the amount of work and time) involved in such reading or analysing, is in principle irrelevant to the determination of what constitutes the state of the art.

2.3 The next question to be considered (paragraph 1.3 above, question (ii), and paragraph 1.4 above, question (b)) is whether, if the composition of a prior used product is to be "made available", a complete analysis of such product must be possible, so that, as submitted by the patent Proprietor, such product could have been exactly reproduced. This requirement was said to follow in particular from the statement in paragraph 1.4 of opinion G 1/92 that "An essential purpose of any technical teaching is to enable the person skilled in the art to manufacture or use a given product ..." (ie to be able to reproduce it), and that "Where such teaching results from a product put on the market, the person skilled in the art will have to rely on his general technical knowledge to gather all information enabling him to prepare the said product" (emphasis added).

While this board agrees that on a strict literal interpretation, this paragraph of the opinion in isolation could be understood to mean that a complete analysis of a marketed product, sufficient to enable it to be exactly reproduced, is necessary if the composition of the product is to become part of the state of the art, nevertheless, bearing in mind also that this paragraph is only indirectly related to answering the questions which were referred by the President of the EPO to the Enlarged Board, in the board's view having regard also to the previous case law of the boards of appeal, such a literal interpretation was not what was intended by the Enlarged Board.

According to the established jurisprudence of the boards of appeal, the novelty of a claimed invention is destroyed by the prior disclosure (by whatever means) of an embodiment which falls within the claim. Thus in the board's view, the novelty of a claimed invention is destroyed by the prior use of a product, for example, sale of a product, if an analysis of a product using available analytical techniques is such as to inform the skilled person of an embodiment of the product which falls within the claim of the patent. The board therefore does not accept the patent proprietor's submissions to the effect that a complete analysis of a prior used product must be possible, so as to enable an exact reproduction of such product, in order to destroy the novelty of the claimed product.

3. As to questions (a) and (b) in paragraph 1.4 above which were put forward by the patent proprietor for possible referral to the Enlarged Board of Appeal, the board decided not to refer such questions, because in the board's view the answers to the questions which are discussed and set out above follow clearly from previous case law of the boards of appeal, whereas the answers to such questions which were put forward by the patent proprietor, although perfectly arguable as such, are contrary to such previous case law and appear also to be contrary to the main gist of opinion G 1/92.

In view of the answers to questions (a) and (b) as set out above, question (c) in paragraph 1.4 does not arise.

4. As to question (iii) set out in paragraph 1.3 above, the factual question to be answered in the present case is essentially as follows: has the opponent established that Supersolve could have been analysed before the priority date of the opposed patent, using known analytical techniques which were available for use by a skilled person at that time, so as to inform such skilled person that the composition of Supersolve was in accordance with the invention claimed in the opposed patent?

4.1 The declaration of Dr Taylor, an expert in the field of analytical chemistry, describes with reference to published articles analytical procedures that a skilled person would have followed in the analysis of Supersolve, using techniques available before the priority date of the patent-in-suit. Thus, according to the declaration, after the removal of the volatile components of the Supersolve which could be identified by their boiling points, an elemental analysis or inductively coupled plasma (ICP) source spectrometry of the residue would have indicated the presence and the amount of phosphorus in the residue; high pressure liquid chromatography (HPLC) or gas chromatography (GC) of the residue would have identified 2,5-diphenyl oxazole (PPO) and 1,4-bis (o-methylstyryl) benzene (bis-MSB) which are commonly used scintillant in the art; and a 31P NMR at a relatively higher pH would have indicated the presence of monoester and diester of phosphates since at higher pH the resonance shifts of the two species are quite distinct. Moreover, according to the declaration, using a cation-exchange column all the cations including ammonium would have been separated and then identified by classical means.

Similarly, in the declaration of Dr Emsley, an expert in the field of analytical chemistry and the chemistry of phosphorus, it is stated that using inductively coupled plasma source (IPC) spectrometry and Fourier Transform (FM) 31P NMR, it would have been possible to measure the amount of phosphorus and also identify mono-and diester of phosphorus in Supersolve. Also, according to the declaration, the pH of a solution of phosphate esters would have indicated that they were not in the free acid form.

In the declaration by Dr Gevers, an expert in the field of chemical analysis by chromatography and spectroscopy, it is stated that whereas an identification of solvents and non ionic surfactant in Supersolve would be straight forward, an isolation, and therefore, identification of all the surfactants present in the Supersolve would be complicated and time-consuming. Moreover, according to the declaration, the amount of phosphorus present is at the detection limit of elemental analysis and a 31P NMR analysis to detect the presence of phosphates would require a comparison with more than 150 known phosphate surfactants under identical conditions. With regard to the cations present in Supersolve, it is stated by Dr Gevers that although identification of cations would be possible, it would be impossible to tell which cation originally belonged to which anion or whether the cations were added as inorganic salts or bases, so that it was not possible to conclude whether salts of surfactants or a mixture of acids, bases and/or salts was used to compose Supersolve.

Although the patent proprietor does not disagree with Dr Taylor's final conclusion that it would have been possible in 1983 to carry out an analysis of Supersolve, it nonetheless disputes that (a) an elemental analysis would have automatically revealed the presence of phosphorus, since the skilled person had no reason to expect its presence in an LSC mixture, and (b) that an average analytical laboratory would have possessed around the year 1983 all of the advanced equipment and apparatus necessary to perform the analysis according to Dr Taylor's suggestion. Referring to the Declaration by Dr Gevers, it has been further submitted by the patent proprietor that (c) a complete analysis of the Supersolve would be so complicated and time consuming that it would be impossible in practical terms.

4.2 As to submission (a), the board considers that it was well within the competence of a skilled person to identify the presence of phosphorus by subjecting the Supersolve residue (after the evaporation of volatile components) to an elemental analysis. Also in the board's view, the use of Fourier Transform 31P NMR technique (which has been known since the 1960's) in the case of dilute solutions would have sufficiently enhanced weak signals so that it would have been possible to identify the presence of mono- and diesters of phosphates in Supersolve, as explained by Dr Taylor and Dr Emsley in their declarations. Concerning the submission by Dr Gevers that it was not possible to conclude whether phosphoric acid esters or a mixture of phosphoric acids, bases and/or salts was used to compose Supersolve, this is not relevant to the issue of novelty in the present case. As to the possibility of identification of solvent and scintillators in Supersolve, this has not been disputed by Dr Gevers, and the board is also of the view that isolation and identification of solvent Pseudocumene would have been possible by evaporation, whereby Pseudocumene would have boiled at its boiling point of 168 C, whereas the HPLC or GC technique would have identified the presence of PPO and bis-MSB which are commonly used scintillators in the art.

4.3 As to submission (b), the board considers that it is irrelevant whether or not all the necessary analytical equipment was were available in one laboratory. What is crucial is whether all the necessary equipment and techniques were available to a skilled person before the relevant date so that he was able to inform himself of the composition of the Supersolve to the extent that the composition was in accordance with the claimed subject-matter. In the present case the board is satisfied that this is so for the above reasons.

4.4 As to submission (c), as already stated in paragraph 2.3 above, the board does not accept that a complete analysis of Supersolve is required to take away the novelty of the claimed subject-matter, but merely an analysis which is sufficient to inform a person skilled in the art that Supersolve had a composition falling within the terms of the claimed subject-matter. As discussed in paragraph 4.2 the board is satisfied that in the present case such an analysis of Supersolve was possible.

5. Thus, the board considers that in the present case all the necessary means and analytical methods were available to the notional skilled person at the priority date of the patent in suit which allowed him to identify Supersolve as a product falling within the scope of claim 1 of the main request. Therefore, in the board's judgment, the subject-matter of claim 1 of the main request lacks novelty within the meaning of Article 54 EPC.

6. Novelty - auxiliary request 1

The LSC mixture according to claim 1 of this request is distinguished from Supersolve in that the phosphoric acid esters have been neutralised but not with ammonia, as in the case of Supersolve. The mixture as a result contains cations of an alkaline material other than those of ammonia. The subject-matter of claim 1 is thus new.

7. Inventive step - auxiliary request 1 ...

8. For these reasons, in the board's judgment, the LSC mixture according to claim 1 of auxiliary request 1 was not obvious to a person skilled in the art and therefore involves an inventive step within the meaning of Article 56 EPC.