T 0409/91 - Sufficiency of disclosure vs. support by the desciption - #13

Citation rank: 13
No. of citations: 205

T 409/91 looked at the relationship between sufficiency of disclosure (Art. 83) and support by the description (Art. 84). It found that both are interrelated, because they both express the same principle, namely that the scope of protection should be commensurate with the contribution that the invention makes to the prior art (point 3.5 of the reasons).

Claim 1 of the application in dispute read:

"Distillate fuel oil boiling in the range 120 C to 500 C which has a wax content of at least 0.3 weight% at a temperature of 10 C below the Wax Appearance Temperature, the wax crystals at that temperature having an average particle size less than 4000 nanometres."

Claims 2 to 5 defined smaller upper limits of the particle size down to 1000 nanometres. It was claimed by the applicant that the small size of the wax crystals reduced the undesired "cold clogging" otherwise observed with wax crystals in fuel oils.

Only one way of obtaining "wax crystals at that temperature having an average particle size less than 4000 nanometers" was disclosed in the application as-filed, namely a process which produced wax particles having an average particle size of 1200 nm. No way of obtaining wax crystals of 1000 nm (as claimed in claim 5) was disclosed.

The Examination Division refused the application for two reasons: Firstly they found that claim 1 was insufficiently disclosed, because the invention could not be carried out within the whole area claimed, i.e., no method was disclosed yielding a particle size of less than 1200 nm. Secondly, the Examination considered that the claim did not meet the requirement of Art. 84, first sentence, in combination with Rule 29(1) EPC1973 (now Rule 43(1)), so that the claim as a whole did not define (state all the essential elements of) the matter for which protection was sought (i.e. the fuel oil) in terms of technical features.

The Appeal Board analysed the application and concluded that for obtaining the inventive small wax crystals, the presence of certain "additives", which were disclosed in the description and present in all of the "examples", were indeed necessary to obtain the inventive small wax crystals. The Board hence considered the presence of such additives was an "essential feature" of the invention, which was missing in the claims. With reference to T 133/85 they stated that a technical feature which is described and highlighted in the description as being an essential feature of the invention, must also be a part of the independent claim or claims defining this invention (point 3.3 of the reasons). The claims thus infringed Art. 84 EPC.

The Board also found that the claims lacked sufficiency of disclosure (Art. 83) for very similar reasons. The Board stated:

"Although the requirements of Article 83 and Article 84 are directed to different parts of the patent application, since Article 83 relates to the disclosure of the invention, whilst Article 84 deals with the definition of the invention by the claims, the underlying purpose of the requirement of support by the description, insofar as its substantive aspect is concerned, and of the requirement of sufficient disclosure is the same, namely to ensure that the patent monopoly should be justified by the actual technical contribution to the art." (point 3.5 of the reasons)

The Board judged that the reasons why the claims were insufficiently disclosed in this case were in effect the same as those that lead to their infringing Art. 84 EPC, namely that the invention extends to technical subject-matter not made available to the person skilled in the art by the application as filed,. In particular, as was not contested by the appellant, no information was given to perform the claimed invention successfully without using the structurally defined "additives".

The Applicant argued that the claims were sufficiently disclosed, for the reason alone that the application disclosed one way of carrying out the invention. However, the Board did not accept this. They stated:

"... the Board does not accept the appellant's submission that sufficiency should be acknowledged simply because one way of performing the invention was disclosed. In the Board's judgement, the disclosure of one way of performing the invention is only sufficient within the meaning of Article 83 EPC if it allows the person skilled in the art to perform the invention in the whole range that is claimed ...".

As a consequence, the appeal was dismissed.

Remark: It remarkable that the Board in this case considered the invention to be insufficiently disclosed, although the required features for obtaining the small wax crystals (i.e., the required "additives") were disclosed in the description. The argument frequently made by applicants and proprietors, that it is sufficient for complying with Art. 83 that the description taught how to carry out the invention, is hence not always correct. If essential features are missing in a claim, the claim effectively extends to embodiments that are not accessible with the information given in the patent/application (namely those embodiments that do not employ the essential features), and therefore the invention as defined by the claims - as a whole - is insufficiently disclosed.

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Headnote:

The questions of sufficiency and of support by the description are questions of fact which have to be answered on the basis of the available evidence having regard to the balance of probabilities in each individual case. Although the requirements of sufficient disclosure of the invention (Art. 83 EPC) and support by the description (Art. 84 EPC) are related to different parts of the patent application, they give effect to the same legal principle that the patent monopoly should be justified by the technical contribution to the art. Therefore, the extent to which an invention is sufficiently disclosed is also highly relevant for the answer to the question of support (points 3.3 to 3.5 of the Reasons).

The full text of the decision can be found here.


Quotes from decisions citing T 409/91 can be found here.

T 0435/91 - Sufficiency of disclosure over the whole area claimed - #26

Citation rank: 26
No. of citations: 140

T 435/91 is concerned with the question of sufficiency of disclosure in cases where the invention relates to a chemical composition and is, in part, defined by functional features. T 435/91 holds that sufficiency of disclosure is not given, if the patent discloses only isolated examples falling under the functional definition of the claim, but does not disclose a technical concept fit for generalisation so that the skilled person can achieve the envisaged result without undue difficulty within the whole ambit of the claim containing the functional definition.

Claim 1 of the underlying opposition case related to:

"An aqueous detergent composition comprising a gel, characterised in that the gel is wholly or predominantly in hexagonal liquid crystal form, and comprises:

(a) [...]

(b) an additive which is a water-soluble non-micelle-forming or weakly micelle-forming material capable of forcing the surfactant system (a) into hexagonal phase, the additive being nonionic or of the same charge type as the surfactant (a)(i); and

(c) [...]"

There was no dispute that the skilled person could establish whether or not a detergent composition was in a hexagonal form or not. Furthermore, it was not disputed among the parties that the worked examples in the description of the patent were feasible. Thus it is clear that the patent discloses at least one way to carry out the invention and that it is possible to determine whether or not any particular composition meets the definition of the invention as set out in claim 1.

There was, however, dispute as to whether or not the subject matter of claim 1 could be carried out by skilled person, because one of its essential technical features, the "additive" (b), was defined only by its function.

Regarding the requirement for sufficient disclosure of structurally vs. functionally defined inventions, the Board stated:

"In the board's judgment, the criteria for determining the sufficiency of the disclosure are the same for all inventions, irrespective of the way in which they are defined, be it by way of structural terms of their technical features or by their function. In both cases the requirement of sufficient disclosure can only mean that the whole subject-matter that is defined in the claims, and not only a part of it, must be capable of being carried out by the skilled person without the burden of an undue amount of experimentation or the application of inventive ingenuity." (point 2.2.1 of the reasons, emphasis added)

The Board thus held that the disclosure relating to both, functionally and structurally defined inventions, must be such that the skilled person can carry out the invention over the entire scope of what is claimed.

Regarding the special case of functionally defined inventions, the Board held:

"The peculiarity of the "functional" definition of a component of a composition of matter resides in the fact that this component is not characterised in structural terms, but by means of its effect. Thus this mode of definition does not relate to a tangible component or group of components, but comprises an indefinite and abstract host of possible alternatives, which may have quite different chemical compositions, as long as they achieve the desired result. Consequently, they must all be available to the skilled person if the definition, and the claim of which it forms a part, is to meet the requirements of Article 83 or 100(b) EPC. This approach is based on the general legal principle that the protection covered by a patent should correspond to the technical contribution to the art made by the disclosure of the invention described therein, which excludes the patent monopoly from being extended to subject-matter which, after reading the patent specification, would still not be at the disposal of the skilled person (see also points 3.4 and 3.5 of decision T 409/91, OJ EPO 1994, 653)." (point 2.2.1 of the reasons, emphasis added)

The Board thus  investigated whether in the case at hand, the description contained sufficient information to fulfil the above requirement for sufficient disclosure. In this respect, the patentee had admitted during the oral proceedings that it was not possible to identify, on the basis of the information contained in the patent, other compounds than those specifically mentioned in the description, which could reasonably be expected to bring about the desired effect defined in feature (b).

The Board concluded that the definition of the "additive" in feature (b) amounted more to an invitation to launch a research program than to a clear definition of a feature of the claimed detergent composition.

Therefore, the Board held that the invention defined in claim 1 was not sufficiently disclosed.

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Headnote:

The disclosure of an invention relating to a composition of matter, a component of which is defined by its function (in the present case an additive which forces a detergent composition into the hexagonal liquid crystal phase), is not sufficient if the patent discloses only isolated examples, but fails to disclose, taking into account, if necessary, the relevant common general knowledge, any technical concept fit for generalisation, which would enable the skilled person to achieve the envisaged result without undue difficulty within the whole ambit of the claim containing the "functional" definition (point 2.2.1 of the reasons).

The full text of the decision can be found here.

Quotes from decisions citing T 435/91 can be found here.

T 0019/90 - The "Onco mouse" - #45

Citation rank: 45
No. of citations: 101

The case underlying T 19/90 was one of the most controversial patent cases that the instances of the EPO ever had to deal with. It concerned the so-called "onco mouse", a genetically modified laboratory mouse, which was genetically modified to have a predisposition to develop cancer. The onco mouse could be used as a test subject for testing anti-cancer drugs.

The application contained a claim 1 directed to a method of producing a "transgenic non-human mammalian animal", and independent product claim 17 directed to the genetically modified "non-human mammalian animal" itself.

The patent application was refused by the Examination Division. The grounds given for refusal were that the application did not meet the requirements of Articles 53(b) EPC (exclusion from patentability of "plant and animal varieties") and 83 EPC (insufficiency of disclosure).

Regarding insufficiency of disclosure, the Examining Division found it unlikely that the invention (which was demonstrated to work only in a single species, namely in mice) would work over the entire claimed scope, i.e., also in species having a very different "genetic make-up", such as apes and elephants. The Examining Division concluded that the requirements of Art. 83 EPC were not fulfilled.

Regarding the exclusion from patentability of "plant and animal varieties" under Art. 53(b) EPC, the Examining Division considered that it must have been the legislators intent not only to exclude "animal varieties" from patentability, but to exclude "animals" in general. The Examining Division therefore decided that Art. 53(b) EPC was infringed.

The Board of Appeals took a different view.

Regarding insufficiency of disclosure, the Board conceded that the claims were significantly broader than what was demonstrated to work in the examples. They stated:

"However, the mere fact that a claim is broad is not in itself a ground for considering the application as not complying with the requirement for sufficient disclosure under Article 83 EPC. Only if there are serious doubts, substantiated by verifiable facts, may an application be objected to for lack of sufficient disclosure.

Although the Examining Division was right in saying that certain non-human mammals other than mice have very different numbers of genes and different immune systems, it does not necessarily follow that the invention cannot be carried out on such animals. On the contrary, at least one source (Palmiter & Brinster, Ann. Rev. Genet. 1986, 20; 465-499) suggests that those skilled in the art might very well be able to carry out the invention on non- human mammals other than mice. Nor is the Board itself aware of any verifiable facts which could cast serious doubt on the possibility for a skilled person to carry out the invention as claimed." (point 3.3 of the reasons)

The Board concluded that - in the absence of substantiated, verifiable facts to the contrary - the invention was sufficiently disclosed.

Regarding the exclusion from patentablity of plant and animal varieties under Art. 53(b), the Board also did not agree with the Examining Division. The Board pointed out that Art. 53(b) EPC was an exception, and exceptions should generally be "narrowly construed" (point 4.5 of the reasons). They argued that Art. 53(b) clearly referred to "animal varieties", "races animales" and "Tierarten", and nothing suggests that in reality "animals" (in general) were meant to be excluded.

As a consequence, the Board concluded that Article 53(b) EPC was not infringed and the case was remitted to the Examining Division for further prosecusion.

Remark: When the patent proceeded to grant, seventeen (17) parties filed an opposition against it. The oppositions were i.a. based on Art. 53(a) (exclusion of inventions contrary to "ordre public" or morality). The patent was maintained in amended form by the Opposition Division. That decision was again appealed (T 315/03). The Appeal Board remitted the case back to the Oppostion Division with an order to maintain the patent in further amended form. At that stage, however, the proprietor decided not to file translations of the amended claims and not to pay the required fees under Rule 58 EPC1973. The patent was revoked, more than 20 years after its filing date.

Further remark: While the controversial nature of this case clearly lies in its aspect regarding the exclusions from patentability (Art. 53(a)/(b)), that aspect is not the reason why T 19/90 made it to the present top-100 list. Interestingly, the vast majority of citations of T 19/90 concern other aspects of the decision, namely its statement that insufficiency-objections must be based on "serious doubts, substantiated by verifiable facts".

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Headnote:

1. The exception to patentability under Article 53(b) EPC applies to certain categories of animals but not to animals as such.
2. In particular in the case of genetic manipulation of animals involving, as in this case, the insertion of an activated oncogene, there are compelling reasons to consider the provisions of Article 53(a) EPC in relation to the question of patentability.

T 0182/89 - Sufficiency of disclosure - Examination of all grounds of opposition by OD - #72

Citation rank: 72
No. of citations: 66

In T 182/89 the opponent opposed the patent under Art. 100(a) (inventive step) and Art. 100(b) (sufficiency of disclosure). The ground of Art. 100(b) was based on experiments done by the opponent, in which they tried to reproduce the invention, but failed.

In the first instance, the opposition division (OD) decided at oral proceedings that the invention was insufficiently disclosed and revoked the patent under Art. 100(b), without commenting on Art. 100(a). The patentee appealed.

1. Sufficiency - burden of proof
Upon reviewing the arguments under sufficiency, the Board found that they were so weak that - had the ground of sufficiency of disclosure been the sole ground asserted against the patent - the opposition would have been inadmissible. It would have failed to provide substantiated grounds for opposition, as required by R. 55(c) EPC1973 (now R. 76(2) EPC2000). The Board pointed out that, if the ground of insufficiency of disclosure is put forward by an opponent, it is upon him to show that the disclosure of the invention is indeed insufficient (reference was made to T 182/89 in this regard).

2. Examination of all grounds of opposition
In the case at hand, the opponent's main line of attack was the one under inventive step. The ground of sufficiency was merely an add-on, and not really pursued in appeal. In this situation, the Board criticised the OD for having only decided on sufficiency, and for not having dealt with the ground of lack of inventive step. The Board stated:

"3.1 In the present case, the Board can see no justification for the Opposition Division not having decided the question of inventive step at the oral proceedings before it, this being the only ground on which in reality both Opponents intended to rely. While there may be cases in which it is sensible for an Opposition Division only to decide upon one of several grounds of opposition which have been alleged, and to say nothing in its decision about the other grounds of opposition which were alleged, in the Board's view the circumstances of the present case as set out above make it plain that this is not such a case."

Comment:
Some of the points made in T 182/89 regarding the opposition procedure were taken up and mostly confirmed by G 9/91 ("Power to examine") and G 10/91 ("Examination of opposition-appeals"). Nowadays, the latter two decisions should be consulted regarding the nature and principles of the opposition procedure.

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Headnotes:

I. In order to establish insufficiency, the burden of proof is upon an opponent to establish on the balance of probabilities that a skilled reader of the patent using his common general knowledge would be unable to carry out the invention. A mere statement that one of several examples in a patent has been repeated once "exactly as described" without obtaining exactly the results claimed in the patent is in principle inadequate to discharge that burden (Decisions T 292/85 (OJ EPO 1989, 275) and 281/86 (OJ EPO 1989, 202) followed).
II. 1. The purpose underlying the relevant provisions of the EPC requires that an Opposition Division should normally decide at the same time all grounds of opposition which have been both alleged and supported (as required by Rule 55(c) EPC) in the notice of opposition; and that it should not decide potential grounds of opposition which have not been alleged in the notice of opposition.
2. If a notice of opposition contains allegations as to grounds of opposition which are not supported as required by Rule 55(c) EPC, such allegations in principle should be rejected on the same basis as if they were inadmissible under Rule 56(1) EPC.
3. In principle, Article 114(1) EPC should not be interpreted as requiring the Opposition Division or a Board of Appeal to investigate whether support exists for grounds of opposition which have not been properly supported by an Opponent, but should be interpreted as enabling the EPO to investigate fully the grounds of opposition which have been both alleged and properly supported as required by Rule 55(c) EPC.

The full text of the decision can be accessed here.

T 0292/85 - "At least one way of carrying out the invention" - #74

Citation rank: 74
No. of citations: 65

The invention in T 292/85 related to a biological invention and the claims included certain functionally defined elements, which covered various modifications, mutants, etc., which were not yet known or readily available at the time of filing.

The examning division decided in first instance that the claim was insufficiently disclosed, because the claims contradicted a suggested requirement that "all embodiments within the claims should be reproducible at will by the skilled person without having to make an invention".

The Board, however, considered that such a requirement does not exist under the EPC (see Reasons 3.1.2). The Board  referred to T 68/85 in which the possibility of using functional terminology in claims was approved if "such features cannot otherwise be defined more precisely without restricting the scope of the invention" and their reduction to practice was not an undue burden. This general principle would also apply to the field of biotechnology.

Regarding the terms "bacteria", "regulon" and "plasmid", which were characterised in the claims by their functions, the Board observed:

"What is also important in the present case is the irrelevancy of the particular choice of a variant within the functional terms "bacteria", "regulon" or "plasmid". It is not just that some result within the range of polypeptides is obtained in each case but it is the same polypeptide which is expressed, independent of the choice of these means. A term of this kind must, of course, be clear and enable the skilled person to find suitable specimens without undue difficulty. In the present application enough choice is available, although some vehicles and hosts are preferred for practical reasons." (Reasons 3.1.3)

The Board also stated that it would not be detrimental to sufficiency of disclosure, if some variants falling under the claims (e.g. certain combinations of bacteria, plasmids and regulons) were not operable, as long as there are suitable variants known to the skilled person through the disclosure or common general knowledge which provide the same effect for the invention.

It must be acknowledged, however, that there is an inherent conflict between the "one-way-of-carrying-out-the-invention" principle of T 292/85 and a statement in T 266/85, saying that

"... substantially any embodiment of the invention, as defined in the broadest claim, must be capable of being realised on the basis of the disclosure."

Which concept to apply seems to lie in the nature and circumstances of the particular case. In practical opposition cases, the standpoint a party takes seems to depend entirely on whether the party is the proprietor or the oppnent.

The difference between the inventions underlying T 292/85 and T 266/85 is that in T 292/85 all variants of the functionally defined "bacteria", "plasmids" and "regulons" resulted in the same product (i.e., the same polypeptide; see quote from Reasons 3.1.3, above), whereas in T 266/85 the variants were simply different chemical compositions falling under a broad generic claim (i.e., not the same product).

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Headnote:

1. An invention (here: biological) is sufficiently disclosed if at least one way is clearly indicated enabling the person skilled in the art to carry out the invention. Then the non-availability of some particular variants or unsuitability of some unspecified variants of a functionally defined component feature of the invention is immaterial to sufficiency as long as there are suitable variants known to the skilled person through the disclosure or common general knowledge which provide the same effect for the invention. The disclosure need not include specific instructions as to how all possible component variants within the functional definition should be obtained (cf. point 3.1.5 of the Reasons).

T 0014/83 - Non-working embodiments not necessarily mean insufficient disclosure - #89

Rank: 89
No. of citations: 59

T 14/83 is concerned with sufficiency of disclosure. It is often cited for its ruling that sufficiency of disclosure is not to be judged on the basis of the claims alone, but that the description and drawings need to be taken into account. For example, T 291/89 cites T 14/83 as follows:

"As regards sufficiency of disclosure the Board wishes to point out that this question has to be judged not merely on the basis of claims but also on the basis of the description: cf. decision T 14/83, OJ EPO 1984, 105."

In more specific cases, T 14/83 is cited for saying that it is not necessarily detrimental to sufficiency of disclosure, if some of the examples given in a patent/application fail, although these examples are carried within parameter ranges defined in the claim in question. Occasional failure is not detrimental, if it takes e.g. only takes some additional experiments to convert failure to success, as long as these experiments do not involve inventive step. For example, T 583/93 states (in the original language):

"Wie in T 14/83 (ABl. EPA 1984, 105) festgestellt wurde, beeinträchtigt das gelegentliche Mißlingen eines beanspruchten Verfahrens nicht dessen Ausführbarkeit im Sinne des Artikels 83 EPÜ, wenn es z. B. nur einiger Versuche bedarf, um den Fehlschlag in einen Erfolg zu verwandeln; diese Versuche müssen sich allerdings in vertretbaren Grenzen halten und dürfen keine erfinderische Tätigkeit erfordern (Entscheidungsgründe Nr. 6, 1. Absatz)."

In the case underlying T 14/83, the claim at issue related to a polymerisation process in which a monomer is polymerised with a multifunctional co-monomer, wherein the resulting prolymer product has a "gel content" of 10-80% and a "polymerisation degree" of greater than 1000. The claim also defined ranges for two process parameters, namely the reaction temperature (0-50°C) and the "amount of polyfunctional co-monomer" (0.01-10%).

From various examples in the description it followed that even if the temperature and the "amount of the polyfuctional co-monomer" were held in the claimed ranges, the resulting product did not in all cases fulfill the claimed product requirements in terms of "gel content" and "polymerisation degree". The examination division, in the contested decision, was of the opinion that this resulted in a lack of sufficiency (Art. 83 EPC).

The Board, however, found that one should not judge claim 1 solely on the basis of its own wording, but one should take the content of the entire application into account (see above). In particular, the Board found that Tables 1 and 2 (which contained process parameters and resulting product properties) should have been taken into account. After making a very detailed analysis  of the numbers given in Tables 1 and 2, the Board concluded that the skilled person could deduce certain rules, which rules would then allow the skilled person to purposefully modify process parameters so as to convert failure to success, i.e., make products having the claimed properties.

Specifically, the Board in T 14/83 states in the Reasons:

"7. The resins obtained in runs 8, 13 and 14 present too low a gel content. The practical rules set out above offer the expert two correcting measures therefor: (i) increase of the amount of the polyfunctional comonomer as the result of which the polymerization degree of the "soluble fraction" declines, or (ii) decrease of the polymerization temperature whereby the "polymerization degree" goes up. According to what is wanted the polymerization degree can be simultaneously affected in contrary directions. The matter is similar in the runs No. 17 and 18 where the soluble fraction of the resin has too low an average polymerization degree. To redress this undesired result two possibilities also exist: (iii) diminishing the amount of the polyfunctional comonomer whereby the gel content declines consequentially, or (iv) decreasing the temperarature, which entails a consequential increase of the gel content. Finally, run 12 shows that the resin presents too high a gel content and too low an average polymerization degree of the soluble fraction. In that case only one remedy can be applied to correct the result. Operating as set out in case (iii) above will diminish the gel content and simultaneously increase the polymerization degree. In conclusion, it is clear that the expert who carried out the claimed processes strictly in accordance with the instructions and occasionally missed the desired target at the first attempt would be able to bring about the desired composition of the resin quickly and reliably by having recourse to the said empirical rules disclosed in the description of the present specification."

Based on this analysis, the Board concluded that the skilled person had sufficient guidance to successfully perform the invention, and that the claimed polymerisation method was thus sufficiently disclosed.

By way of a comment, it seems to me that T 14/83 puts a limit on a different concept developed by Appeal Boards, namely the "over-the-whole-area-claimed" concept, according to which sufficiency of disclosure is only present, if the invention can be performed over the whole area claimed (Case Law Book II.C.4.4). This concept, however, has always been in conflict with a further concept developed by the Boards, namely the concept of (at least) "one way of carrying out the invention" being sufficient to fulfill the requirement of Art. 83 EPC (CLB II.C.4.2). (I must confess that I never really understood when which of the two concepts is to be applied.)

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Headnotes:

1. The question whether an invention has been disclosed sufficiently clearly and completely is not to be decided solely on the basis of the content of the claims. If a chemical invention involves the task of manufacturing a product with certain measurable properties (e.g. gel content or degree of polymerisation of a copolymer), and this task is performed by means of a process involving several variables, then the means of its performance are to be regarded as sufficiently disclosed within the meaning of Article 83 EPC if, encountering occasional lack of success notwithstanding strict adherence to the prescribed limits of those variables, clear information, contained in the description, regarding the effects of individual variables on the properties of the product enables the person skilled in the art to bring about the desired properties quickly and reliably in such an event.
2. If teaching thus disclosed cannot be defined in a claim precisely enough to rule out occasional failure, such a claim is not to be objected to, provided it is possible to deduce from the description the action to be taken - which also cannot be precisely defined - by way of fine tuning of the variables.

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T 0609/02 - No second medical use claim based on speculation - #92

Rank: 92
No. of citations: 56

T 609/02 deals with second-medical-use claims and looks at how much experimental evidence is required to make the second-medical-use claim is sufficiently disclosed.

Second-medical-use claims seek to protect the use of known substances or compositions for a new medical purpose. Under the EPC1973 second-medical-use claims had to be formulated in the "Swiss-type" format ("use of compound X for the manufacture of a medicament against disease Y"). Under the EPC2000 the a purpose-limited-substance-claim format ("substance X for treating disease Y") must be used.

Since second-medical-use claims confer valuable protection for new pharmaceutical treatment schemes, and research in this area is expensive and slow, applicants tend to file speculative patent applications claiming a second-medical-use way before hard data of the respective substance in the specific medical indication claimed is available. Arguably, the invention is not ready at this point.

The Board in T 609/02 looked at the following claim:

"6. The use of a steroid hormone or steroid hormone analogue as identified by the method of claims 1 to 5, which fails to promote transcriptional activation of glucocorticoid receptor or retinoic acid receptor genes, for the preparation of a pharmaceutical for the treatment of AP-1 stimulated tumor formation, arthritis, asthma, allergies and rashes."

The Board noted correctly that the claim - on top of being a second-medical-use claim - was also in the controversial "reach-through claim" format (see EPO Guidelines F-III, 9). The "reach-through" issue, however, could be left aside, because the claim was not allowable for other reasons.

Specifically, the Board noted that the patent specification only described a study of the "interplay" between the steroid hormone/steroid hormone receptor complex regulating the transcription of steroid hormone-responsive genes and the AP-1 protein regulating the transcription of AP-1 responsive genes. The Board stated that the patent specification, however,

"... provides no evidence at all relating to the invention in claim 6: no steroid hormone is identified as binding to the hormone receptor in such a way that the so-formed complex will disrupt AP-1 stimulated transcription and at the same time fail to promote steroid hormone regulated transcription; no data of any kind are presented indicating that such an hormone (if it were identified) could have an impact on any of the listed specific diseases." (point 5 of the reasons)

Only later, the applicant provided post-published evidence showing that steroid hormones such as needed to carry out the use according to claim 6 were later structurally identified and that they, indeed, have an effect on AP-1 stimulated transcription. They argued that on the basis of the disclosures of these post-published documents, by carrying out the claimed invention, one would necessarily obtain pharmaceutical compositions since it was by following the teachings of the patent in suit that the post-published results had been obtained. Consequently, in the appellant's opinion, sufficiency of disclosure had to be acknowledged.

The Board disagreed. They stated:

"Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent. The general principle that the extent of monopoly conferred by a patent should correspond to, and be justified by, the technical contribution to the art, has to be kept in mind (eg. decision T 409/91, OJ EPO 1994, 653)." (point 8 of the reasons)

In other words, sufficiency of disclosure is a requirement that must be fulfilled at the time of filing. No patent should be granted on the basis of mere speculation that a possible second-medical-use exists. Post-published evidence that the second-medical-use indeed exists cannot cure the fundamental deficiency of lack of sufficient disclosure.

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Headword:

If the description of a patent specification provides no more than a vague indication of a possible medical use for a chemical compound yet to be identified, later more detailed evidence cannot be used to remedy the fundamental insufficiency of disclosure of such subject-matter.

T 0608/07 - Ambiguities in the claim (sufficiency vs. clarity) - rank #97

Rank: 97
Number of citations: 55

This appeal against a decision of an opposition division in case deals with the question of whether and when difficulties in determining the scope of the claim, i.e., ambiguities, are to be regarded a clarity issue (not a ground of opposition) or as pointing towards insufficiency of disclosure (a ground of opposition, Art. 100(b)).

An earlier decision, T 256/87, held that - in order to be able to carry out an invention - the skilled person must know whether a certain embodiment "falls within the forbidden area of the claim" or not. Otherwise, the invention could not be carried out in a targeted manner.

Since then, T 256/87 has been used by opponents to interpret a clarity issues as a lack of sufficieny. Also the respondent/opponent in T 608/07 made a similar attack under Art. 100(b) against the claims at issue.

The claims in T 608/07 defined a polymerisation process, in which two "incompatible catalysts" were used. The description provided a definition of the term "incompatible catalyst", which was, i.a., based on a comparison of the average molecular weights of the polymers that were produced by each of the catalysts. The numerical value of the average molecular weight of a polymer, however, depends on how the average molecular weight is calculated. Specifically, it plays a significant role whether the weight average molecular weight (Mw) is used, or whether the number average molecular weight (Mn) is used. The opponent showed that using the number average mean molecular weight, two tested catalysts were to be regarded as "compatible", whereas using weight average molecular weight, the same two catalysts were "incompatible". The respondent/opponent argued that this resulted in a situation where the skilled person could not carry out the invention.

Under the specific circumstances of the case, the Board found that the skilled person would readily understand the expression "molecular weight" to mean weight average molecular weight. The alledged difficulty in deciding whether one operates "within the forbidden area of the claim" therefore did not exist.

However, the Board added a general statement on the "forbidden-area" concept of T 256/87. The Board stated:

"2.5.2 The issue of insufficiency dealt with in T 256/87 and the present case is an insufficiency which arises through ambiguity. Although the board accepts that, depending upon the circumstances, such an ambiguity may very well lead to an insufficiency objection, it should be born in mind that this ambiguity also relates to the scope of the claims, ie Article 84 EPC. Since, however, Article 84 EPC is in itself not a ground of opposition, care has to be taken that an insufficiency objection arising out of an ambiguity is not merely a hidden objection under Article 84 EPC. It is the conviction of this board that for an insufficiency arising out of ambiguity it is not enough to show that an ambiguity exists, eg at the edges of the claims. It will normally be necessary to show that the ambiguity deprives the person skilled in the art of the promise of the invention. It goes without saying that this delicate balance between Article 83 and 84 EPC has to be assessed on the merits of each individual case."

In other words, not in every case where there is ambiguity in the claims, this can be translated into insufficiency of disclosure. Only where the ambiguous feature concerns the core of the invention, as opposed to the "edges of the claims", then an objection under Art. 83/100(b) may be justified.

Since then, the question of whether ambiguity in the claims is a matter of clarity or sufficiency of disclosure had frequently been debated in opposition proceedings.

A recent decision (T 2290/12, mentioned in the EPO's 2017 Case Law Report, Suppl. Publ. 3 of the OJ) has summarised the debate and concluded that the "forbidden area" concept of T 256/87 has only been followed in four decisions, whereas the approach of T 608/07 was applied in more than 20 cases. The Board in T 2290/12 stated that the "forbidden area" concept "appeared to have been dropped".

The "forbidden area" concept, however, is not dead. In T 1914/11 the Board found that difficulties in determining the "transient pH in the mouth" of a subject resulted in insufficiency of disclosure. The patent was revoked under Art. 100(b). More recently, in T 626/14, difficulties in measuring the thickness of a "fluffy absorbent core", which was a parameter used to define the invention, rendered claim 1 insufficiently disclosed.

Generally, however, ambiguities in patent claims are nowadays more likely to be regarded a matter of clarity than insufficient disclosure.

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Headnote:

none

The full text of the decision can be found here.

T 0226/85 - Trial and error vs. sufficiency of disclosure ("Stable bleaches") - #100

Rank: 100
Number of citations: 54

This is the first decision on our list of the 100 most cited Board of Appeal decisions of the EPO. It just made it to the list. Appeal T 266/85 was filed against the decision of the opposition division upholding European patent No. 9942 unamended.

The independent claim at issue related to a "pourable scouring cleanser composition", which was defined in terms of certain structural features (viz. structure and relative amounts of its essential components), but also by the following functional feature:

"... the composition showing a loss of no more than half the initial available chlorine in a storage period of 30 hours at 50°C and being capable of suspending abrasive without allowing a layer of unsuspended material to settle for 1 month at 37°C."

The opponent filed experimental evidence showing that the functional features were difficult to meet, e.g., when the composition does not contain perfume, a component which was present in all examples disclosed in the patent, while perfume was not included as a an essential feature of the invention in claim 1.

The Board firstly found that, for sufficiency of disclosure to be given,

"substantially any embodiment of the invention, as defined in the broadest claim, must be capable of being realised on the basis of the disclosure" (point 2 of the reasons).

With respect to the difficulties of obtaing stable suspensions, when no perfume component was present in the composition, the Board remarked:

"5. If the presence of perfume is, as suggested, not an essential feature of the invention but only a circumstance which may influence the effect of the essential features and thereby their proper adjustment, the skilled person must be in the position to readjust the composition in case he wishes to exclude the perfume from the same. In view of the fact that he could rely on his common general knowledge even to rectify errors or fill gaps in the instructions (cf. T 171/84, "Redox Catalyst" OJ 4/1986, 95), his knowledge in this respect is also assumed to be applicable when he tries to repeat specific examples or to prepare other embodiments falling within the scope of the claim. It appears that there is no advice available from the such sources, or from the instructions of the patent to enable the skilled person to steer the formulation towards success in such situations. For instance, no trend is recognisable for other components when examples with or without the perfume component are compared." (point 5 of the reasons)

The Board stated that

"a reasonable amount of trial and error is permissible when it comes to the sufficiency of disclosure in an unexplored field or, - as it is in this case -, where there are many technical difficulties" (point 8 of the reasons).

However, since there was no guidance in the description of how to obtain compositions meeting the structural requirements of claim 1, which compositions also met the stability criteria expressed as functional features, the Board concluded that the invention was insufficiently disclosed.

As a result, the positive decision of the opposition division was set aside and the opposed patent was revoked.

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Headword:

Even though a reasonable amount of trial and error is permissible when it comes to the sufficiency of disclosure, e.g. in an unexplored field or, - as it is in this case - , where there are many technical difficulties, there must then be available adequate instructions in the specification or on the basis of common general knowledge which would lead the skilled person necessarily and directly towards the success through the evaluation of initial failures or through an acceptable statistical expectation rate in case of random experiments (following decision T 14/83, "Vinylchloride resins", OJ EPO 1984,105).

The full text of the decison can be accessed here.