T 1911/08 – Not Accidental

This appeal was filed against the revocation of the patent under consideration.

Claim 1 of the main request before the Board was a Swiss-type claim for a medicament for treating a great variety of disorders stretching from migraine to schizophrenia, Parkinson’s and stroke.  Claim 48 was directed at a compound for use as medicament. It contained a disclaimer which is referred to as “disclaimer (vi)” in the following passage where the Board examined  the allowability of the disclaimer under A 123(2):

[3.2] Disclaimer (vi) […] was introduced in response to a novelty objection raised under A 54(2) EPC with respect to document D6.

It is not in dispute that this disclaimer relates to an “undisclosed disclaimer” in the sense of decision G 1/03 [2, 1^st §], that is, it does not have a basis in the application as filed. However, the parties disagree on whether document D6 can be viewed as being an “accidental anticipation” and, accordingly, as providing the basis for an allowable disclaimer under A 123(2), as set out in decision G 1/03 [hn2.1;2.2].

Therefore, in the present instance, it has to be decided whether document D6 is an accidental anticipation as defined in decision G 1/03, that is, whether “it is so unrelated to and remote from the claimed invention that the person skilled in the art would never have taken it into consideration when making the invention” (see [hn2.1]).

[3.3] The patent in suit relates heterocyclic compounds of general formula (I) that are effective as NMDA NR2B antagonists, and accordingly are disclosed as being useful in the treatment of a number of diseases associated with this pharmacological activity, namely, pain, migraine, depression, anxiety, schizophrenia, Parkinson’s disease, and stroke […].

Document D6 also relates to heterocyclic compounds of overlapping general formula (I), and a number of the specific compounds listed in Table 1 fall within this area of overlap. The compounds according to document D6 are disclosed as being well tolerated by plants and having favourable toxicity to warm-blooded species, and being highly suitable for controlling animal pests, for controlling endoparasites and ectoparasites in the field of veterinary medicine, and for controlling harmful fungi […]. Further details of the use in the field of veterinary medicine are disclosed […], including the possibility of oral administration to animals.

[3.4] The appellant argued that the biological pathway by which compounds acted should constitute the boundary between accidental and non-accidental anticipation, since, in modern mechanism-based research, the skilled person, that is, the medicinal chemist, would only take into account compounds interacting with the same receptor as a starting point for drug development.

The board cannot agree with this analysis for the following reason:

The ultimate aim of the pharmaceutical industry is the development of drugs capable of treating specific diseases. Therefore, in the present instance, where the patent in suit relates to the field of pharmaceuticals, the skilled person cannot merely be defined as being a medicinal chemist, but rather as being made up of a team covering the full range of disciplines required for drug discovery and development. High-throughput screening may be an important and integral part of this process. However, it will be equally important to establish whether candidate drug compounds have potentially favourable properties with respect to safety, toxicity, pharmacokinetics and metabolism. Therefore, the disclosure in document D6 that specific structures under consideration have favourable toxicity properties and are suitable for oral administration to animals would be considered to be valuable information to be taken it into consideration by the skilled person when making the present invention.

The board therefore agrees with the conclusion reached in T 134/01 [2.3], namely, that a further document belonging to the field of pharmaceuticals is not to be considered as being an accidental anticipation within the meaning of the decision G 1/03, that is, even if it does not relate to the same illness or biological pathway as the patent or application in suit.

In decisions T 739/01 [3.5], T 580/01 [2.4] and T 639/01 [3.2], the relevant prior art documents related to the treatment of the same illness as the patent or application in suit and were considered to be non-accidental anticipations. However, it does not follow that, had they related to a different illness, they would have been regarded as being accidental. Indeed, decisions T 739/01 [3.4-5] and T 580/01 [2.3-4] emphasise that “the patent in suit relates to the technical field of medicaments”, as does the relevant prior art.

[3.5] The further arguments advanced by the appellant are also not considered to be persuasive:

It is true that, for the purpose of patent protection of a medical application of a substance, a pharmacological effect observed in vitro may be accepted as sufficient evidence of a therapeutic application. However, this is only true if this observed effect directly and unambiguously reflects such a therapeutic application (cf. e.g. T 241/95 [4.1.2]). Indeed, as is further stated in decision T 241/95 [hn1], “the discovery that a substance selectively binds a receptor ... still needs to find a practical application in the form of a defined, real treatment of any pathological condition in order ... to be considered as an invention eligible for patent protection”.

Moreover, the appellant’s narrow problem-based approach to defining accidental disclosure focuses on an analysis of the problem to be solved. However, this was specifically rejected in decision G 1/03 [2.2.2]:

“Even less decisive, as an isolated element, is the lack of a common problem, since the more advanced a technology is, the more the problem may be formulated specifically for an invention in the field. Indeed, one and the same product may have to fulfil many requirements in order to have balanced properties which make it an industrially interesting product. Correspondingly, many problems related to different properties of the product may be defined for its further development. When looking specifically at improving one property, the person skilled in the art cannot ignore other well-known requirements. Therefore, a “different problem” may not yet be a problem in a different technical field.”

Finally, the appellant questioned the relevance of the disclosure of document D6 to pharmaceutical applications. As outlined above under point [3.3], the use in the field of veterinary medicine is disclosed in this document as one of three fields of application. Moreover, a whole section is devoted to dosages and formulations suitable for this use […], and an example is included relating to antiparasitic use […]. Therefore, it cannot be accepted that the disclosure of a veterinary use only qualifies as “a passing reference”. Moreover, since document D6 envisages oral administration to animals, there seems no basis for the contention of the appellant that the reference to a favourable toxicity in warm-blooded species was not of relevance to pharmaceutical applications. Finally, […] the diseases claimed in the patent in suit cannot be seen as being exclusively human-specific. Moreover, animal models are frequently used in research into human diseases. Therefore, information derived from the former is also of relevance to the latter.

[3.6] Accordingly, the main request […] must be rejected, since the incorporation of disclaimer (vi) into the respective claims 48 to 50 contravenes the provisions of A 123(2).

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T 759/10 – Normal Development

This decision deals with an appeal against the revocation of the opposed patent.

Claim 1 of the main request read as follows:

1. A texturizing composition comprising a texturizing agent and a hardstock, the texturizing composition having substantially the same physical properties as hardstocks, characterized in that the texturizing agent consists essentially of one or more phytosterol fatty acid esters, one or more phytostanol fatty acid esters or their mixtures, and in that the texturizing composition comprises at least 70% of the texturizing agent. (my emphasis)

According to the Opposition Division (OD), while the originally filed application provided support for a texturizing agent comprising and consisting of stanol/sterol esters, a texturizing agent consisting essentially of stanol/sterol esters was not clearly and unambiguously disclosed. Such a feature could also not be considered to be inherently supported by the combination of the terms “comprising” and “consisting of”, because the technical meaning of the term “consisting essentially of” was different from that of these two terms.

The patent proprietor filed an appeal. In case the Board was unwilling to allow its requests, it requested the Board to refer the following questions to the Enlarged Board (EBA):

1. In order for amendment of the term “comprising” to “consisting essentially of” to be in accordance with A 123(2), is it necessary for the term “consisting essentially of” to be found expressis verbis in the application as filed?

2. If the answer to question 1 is no, is it nevertheless necessary to consider whether the term “consisting essentially of” is directly and unambiguously derivable from the content of the application as originally filed?

3. If the answer to question 2 is yes, is the term “consisting essentially of” considered directly and unambiguously derivable from the term “comprising” itself, such that no new subject-matter is introduced by an amendment of the term “comprising” to the term “consisting essentially of”?

Here is what the Board had to say:

Amendments - A 100(c)

[3.1] Claim 1 of the main request contains the feature that the texturizing agent “consists essentially of one or more phytosterol fatty acid esters, one or more phytostanol fatty acid esters or their mixtures” (in the following denoted “stanol/sterol esters”). This feature differs from the corresponding feature in claim 1 as originally filed in that the term “consists essentially of” has been substituted for the term “comprises”. It was a matter of dispute between the parties whether this amendment infringed A 100(c).

[3.2] The term “consists essentially of” in claim 1 of the main request implies that apart from the stanol/sterol esters, only certain types and amounts of other components may be present in the texturizing agent, namely those types and amounts that do not materially affect the essential characteristics of the texturizing agent (see the interpretation of the term “consisting essentially of” in e.g. T 472/88 [3]).

[3.3] The application as filed does not contain any explicit disclosure of the term “consisting essentially of” or the possibility that the texturizing agent, apart from the stanol/sterol esters, contains certain types and amounts of other components that do not materially affect its essential characteristics.

It has therefore to be examined whether there is a clear and unambiguous implicit disclosure in the application as filed for the amendment from “comprises” to “consists essentially of”.

[3.4] As has been set out above, claim 1 as originally filed and page 10, lines 20-22 of the application as filed disclose texturizing agents comprising the stanol/sterol esters.

The appellant argued that the term “comprising” encompassed three alternatives, namely (i) “comprising”, (ii) “consisting of” and (iii)”consisting essentially of”, and each of these alternatives would immediately come to the skilled person’s mind when reading the term “comprising”. The term “comprises” is therefore by itself already a sufficient basis for the term “consists essentially of”.

The board cannot accept this argument as each term has a different technical meaning, namely (i) that any further component can be present (“comprises”), (ii) no further component can be present (“consists of”) and (iii) specific further components can be present, namely those not materially affecting the essential characteristics of the texturizing agent (“consists essentially of”). Therefore the skilled person is not at liberty to choose whichever of the three terms he wishes when reading the term “comprises”.

Consequently, the reference to texturizing agents comprising stanol/sterol esters in the application as filed does not provide a clear and unambiguous disclosure of the feature “consists essentially of”.

[3.5] Apart from the disclosure of texturizing agents comprising the stanol/sterol esters, the remaining part of the application as filed refers to texturizing agents consisting of these esters. Reference is made in particular to the following passage on page 8, lines 2-4 as filed:

“The process comprises substituting, for at least a portion of the hardstock, a texturizing agent consisting of fatty acid esters of sterols, fatty acid esters of stanols or mixtures of these” (emphasis added).

As has been set out above, the term “consisting of” has a different technical meaning than the term “consisting essentially of” in that it excludes the presence of any components other than the stanol/sterol esters. The reference to texturizing agents consisting of stanol/sterol esters in the application as filed therefore does not provide a clear and unambiguous disclosure of the feature “consists essentially of” either.

[3.6] Apart from the above disclosures, the passage on page 12, line 29 to page 13, line 7 of the application as filed appears to be relevant with regard to the composition of the texturizing agent. This passage describes the preparation of stanol fatty acid esters (as the texturizing agent) from (i) a fatty acid ester or a fatty acid ester mixture, (ii) a stanol and (iii) an interesterification catalyst. This reaction results in a mixture of stanol fatty acid esters and further fatty acid esters, which mixture can either be purified or can be applied as such. This preparation process is further illustrated by way of a specific example on page 15, lines 1-30, where the preparation of stanol fatty acid esters is described starting from vegetable oil stanol and erucic acid rapeseed oil methyl ester (a fatty acid ester) and resulting in a blend of stanol fatty acid esters and erucic acid rapeseed oil methyl ester. The conversion rate of the esterification process is described to be higher than 99% (page 15, line 29). Apart from the stanol fatty acid esters and erucic acid rapeseed oil methyl ester, the resulting reaction mixture thus possibly contains additionally some unreacted stanol starting material (due to conversion below 100%). This reaction mixture can be used as such or after removal of the erucic acid rapeseed oil methyl ester by vacuum distillation (page 15, lines 24-27).

These disclosures imply that apart from the stanol esters, the texturizing agent may contain some additional fatty acid esters and some unreacted stanol. According to the appellant, these disclosures provide a basis for the term “consists essentially of” in claim 1 of the main request. The term “consisting essentially of” is however not restricted to additional fatty acid esters or unreacted stanol but clearly covers in general any types and amounts of further components that do not materially affect the essential characteristics of the texturizing agent. The specific reference to additional fatty acid esters and unreacted stanol in the application as filed thus does not provide a clear and unambiguous disclosure of the feature “consists essentially of” in claim 1 of the main request.

[3.7] The amendment of the term “comprises” in claim 1 as originally filed to the term “consists essentially of” thus infringes A 100(c).

The main request has therefore to be refused. […]

Request for referral to the EBA of Appeal (EBA)

[5] The appellant requested that, in the event of any of the main request or auxiliary requests 1 and 2 not being granted, three questions be referred to the EBA (in the following “referral questions”) as a divergence existed between, on one hand, decisions T 472/88 and T 975/94 and on the other hand T 868/04 and T 725/08. The appellant in particular argued that in T 472/88 and T 975/94 the respective boards considered the amendment of the term “comprises” to “consists essentially of” to be generally allowable as the term “consists essentially of” was narrower than “comprises”, while in T 868/04 and T 725/08 the respective boards concluded that in the absence of either an explicit or an implicit disclosure of the term “consists essentially of”, such an amendment extended beyond the content of the application as filed.

[5.1] In T 472/88 [4] the board considered the requirements of A 123(2) to be met for a claim containing a number of amendments, one of which was the replacement of the terms “comprising” by the term “consisting essentially of”. The board cited several passages of the application as filed as a basis for the amendments but from inspection of the application in the public file (the cited passages are not quoted in the decision), it appears that the passages are not concerned with the amendment of “comprises” to “consisting essentially of” but with the other amendments. Rather, it therefore appears to be the case that the board considered the term “comprises” by itself to be a sufficient basis for the amendment from “comprising” to “consisting essentially of”: see point [4], penultimate paragraph. In T 975/94 [1.1], it was decided that the amendment of “comprises” to “consists essentially of” met the requirements of A 123(2) as the term “consists essentially of” was narrower in meaning than the term “comprises”, so that no new subject-matter was introduced by this amendment. No further explanation as regards this amendment is present in the decision.

The present board therefore agrees with the appellant that the two boards in decisions T 472/88 and T 975/94 appear to have considered the term “comprises” by itself to be a sufficient basis for the term “consists essentially of”.

[5.2] However, since these two decisions, the jurisprudence of the boards has further developed, in particular by way of the two later decisions of the EBA in G 2/98 and G 1/03.

In G 2/98 (OJ EPO 2001, 413; point 9), the EBA held as follows:

“... priority of a previous application in respect of a claim in a European patent application in accordance with A 88 is to be acknowledged only if the person skilled in the art can derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole.”

Hence, this decision establishes the criterion of clear and unambiguous derivability with regard to the concept of “the same invention” referred to in A 87(1). According to G 1/03 [2.2.2; 4], the same criterion has to be applied with regard to both A 87 and A 123(2):

“It is true that the European patent system must be consistent and the concept of disclosure must be the same for the purposes of A 54, A 87 and A 123.” (point [2.2.2])

“In order to avoid any inconsistencies, the disclosure as the basis for the right to priority under A 87(1) and as the basis for amendments in an application under A 123(2) has to be interpreted in the same way.” (point [4]).

Consequently, the criterion of clear and unambiguous derivability referred to in G 2/98 has to be applied also to the requirements of A 123(2) and thus A 100(c). This is further confirmed by G 2/10, where the EBA used this criterion in the context of “disclosed disclaimers”:

“An amendment to a claim by the introduction of a disclaimer disclaiming from it subject-matter disclosed in the application as filed infringes A 123(2) if the subject-matter remaining in the claim after the introduction of the disclaimer is not, be it explicitly or implicitly, directly and unambiguously disclosed to the skilled person using common general knowledge, in the application as filed.” [order 1a].

In line with these decisions of the EBA, more recent decisions of the boards of appeal, e.g. T 868/04, T 725/08 and T 903/09 have applied the criterion of clear and unambiguous disclosure to decide on the allowability of the amendment of the term “comprises” to “consists essentially of”.

T 868/04 [2.2]:

“In order to determine whether or not an amendment [concerning the amendment of “comprising” to “consisting essentially of”] offends against A 123(2) it has to be examined whether technical information has been introduced which a skilled person would not have objectively and unambiguously derived from the application as filed...”. (Insertion in squared brackets by the present board).

T 725/08 [3.2; 3.3.1]:

“[3.2] This expression [“consisting essentially of”] is not mentioned explicitly in the application as originally filed. Thus the board has to examine on the basis of the submissions of Appellant I whether it is directly and unambiguously derivable from the content of the application as originally filed...

[3.3.1] It is, therefore, concluded that in the absence of either an explicit or an implicit disclosure of a process involving a milling mixture “consisting essentially of”, the process defined in Claim 1 of the main request extends beyond the content of the application as originally filed.” (Insertions in squared brackets by the present board).

T 903/09 [8.1-8.2]:

“[8.1] With respect to claim 1 of the main request ..., the feature “comprising” was replaced by “consisting essentially of”. This feature is not explicitly disclosed in the application as originally filed, where the feature “comprising” is always mentioned ... The question is nevertheless whether the person skilled in the art would regard the subject-matter now claimed as implicitly but unambiguously disclosed in the application as filed.

[8.2] Even it might be conceded as contended by the respondent, that the feature “consists essentially of” represents a limitation to identify more specifically the most essential elements of the invention, the question, which is different, is whether this new subject-matter meets the requirements of A 123(2) as defined above.”

[5.3] Consequently, a uniform approach has been developed by the jurisprudence of the boards of appeal, according to which an amended feature must, explicitly or implicitly, be directly and unambiguously disclosed to the skilled person using common general knowledge in the application as filed in order to be allowable under A 123(2)/100(c).

[5.4] On the basis of this uniform approach, the first referral question can be answered in the negative by the present board without the need for any referral, i.e. it is not in doubt that in order for the amendment of the term “comprising” to “consisting essentially of” to be in accordance with A 123(2), it is NOT necessary for the latter term to be found expressis verbis in the application as filed.

[5.5] Equally on the basis of this uniform approach, the second referral question can be answered in the positive by the present board without the need for any referral, i.e. it is not in doubt that it is indeed necessary in the context of A 123(2) to consider whether the term “consisting essentially of” is directly and unambiguously derivable from the content of the application as filed.

[5.6] As to the third referral question, namely whether the term “consisting essentially of” is to be considered directly and unambiguously derivable from the term “comprising” itself, in the more recent decisions which have applied the criterion of clear and unambiguous derivability (T 868/04, T 725/08 and T 903/09) the boards have considered this criterion not to be automatically fulfilled by the term “comprising” alone. This difference from the earlier decisions in T 472/88 and T 975/94 is part of the ordinary development of the jurisprudence of the Boards of Appeal and does not mean that a reference to the EBA is required for ensuring uniform application of the law: see G 3/08 [4].

More to the point, however, what the skilled person would clearly and unambiguously derive from an application as filed is a question that can only be answered by reference to the application in question. No general answer to the referred question is therefore possible and it is not a suitable subject-matter for a reference to the EBA.

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T 834/09 – Don’t Trust The Librarian

It has been a long time since we had our last library decision. Here is a fresh one. Enjoy.

The appeal was against the revocation of the patent under consideration by the Opposition Division (OD).

Claim 1 of the main request before the Board read:

1. A cathode material for a rechargeable electrochemical cell, said cell also comprising an anode and an electrolyte, the cathode comprising a compound having the formula LiMPO4 where M is at least one first-row transition-metal cation selected from the group consisting of Mn, Fe, Ni and Ti, or a combination thereof; and wherein the compound has an ordered olivine structure.

In the opposition procedure, the parties agreed that the subject-matter of above claim 1 was disclosed in its entirety in document D1, an article published in the Abstracts of the Electrochemical Society, (Spring Meeting, Los Angeles, Calif., May 5-10, 1996).

The patent proprietor contested that document D1 had been made available to the public before the priority date of the contested patent, i.e. before 23 April 1996.

In the contested decision, the OD concluded that document D1 was made available to the public before this date because it was proven it had been received by several libraries well before the above date and electronically catalogued by one of these libraries on 9 April 1996. The OD considered that “once an electronic registration took place, respective document was also retrievable for the public, even though it was not shelved”.

The patent proprietor contested the conclusions of the OD, arguing in particular that there was no evidence that D1 was catalogued or shelved, and so made available to the public, before 23 April 1996.

The Board came to the same conclusion as the OD:

[1] The main question to be decided in this appeal is whether or not document D1 – which indisputably discloses the subject-matter of claim 1 at issue – was made available to the public before the earliest priority date of the contested patent, i.e. before 23 April 1996.

[2] Regarding the public availability of a document received in a library, the jurisprudence of the boards of appeal is as follows:

In T 381/87 it was considered that the shelving before the relevant date was evidence enough for establishing the public availability of a document in a public library, regardless of whether any person looked at it or actually knew it was available.

According to other decisions (T 314/99 [5.1 to 5.6]) or T 186/01 [4]), a document did not become publicly available by its mere arrival in the archive of a library. Rather the possibility that the public could acquire knowledge or awareness of the existence of a document –  for instance by cataloguing – was seen as a precondition of its public availability in the library before the relevant date.

[3] In the case at issue, it is uncontested that document D1 was received and date stamped by the University of California Libraries San Diego on 3 April 1996. The statement of Mr Harvell […] and the date stamp “Received on: 04-03-1996” visible on the reproduction of the stamped page of the original print of the Meeting Abstracts publication - which includes the abstract D1 - corroborate the reception of document D1 in the aforementioned library well before the earliest priority date of the contested patent.

There is no evidence whatsoever that D1 was shelved before the relevant date, and the evidence from D14 that D1 was catalogued has been contested by the appellant on the basis of D19.

[4] The board observes that none of the aforementioned decisions T 381/87, T 314/99 or T 186/01 addressed the question of the public availability of a document by reception and date stamping by a staff member in a public library. This issue and in particular the quality of the staff member as belonging to the public and the possibility for the public to gain access to the information in the document will be focused on hereinafter.

[5] As to the question whether a person in charge of the reception and date stamping of a document received by mail in a public library – such as document D1 in the University of California San Diego Libraries – is a member of “the public” within the meaning of A 54(2), the board observes the following:

[5.1] According to the jurisprudence of the boards of appeal, information is said to be publicly available if only a single member of the public is in a position to gain access to it and understand it, and if there is no obligation to maintain secrecy (T 1081/01 [5] and T 1510/06 [4.2.1]).

Further, according to T 165/96 [1.1.1] which concerned the public availability of technical information drafted in Danish and disclosed in an insert in a minor small-ads newspaper (circulation: 24,000) distributed in the suburbs of Copenhagen, the “public” within the meaning of A 54(2) did not presuppose a minimum number of people or specific language skills or educational qualifications. It followed that the residents of a Copenhagen suburb were held to represent the public.

In another case (T 398/90 [6]), a marine engine installed in a ship was held to have been made available to the public because it had been known to the engine room crew.

[5.2] For the board, it follows by analogy from the above jurisprudence that the person in charge of the reception and date stamping of an incoming document at a public library is without any doubt a member of the public – just like the residents of a Copenhagen suburb or the crew working in a ship’s engine room – as this staff member is in no way bound by any obligation to maintain secrecy about the publications he/she handles and the content thereof, and after all, his/her very function as a staff member of a public library is to make information available to the public.

[6] As to the question relating to the possibility for the public to gain access to the information in said incoming document, it is observed that:

[6.1] It is part of the case law of the boards of appeal that the theoretical possibility of having access to information renders it available to the public (T 444/88 [3.1]). In the case at issue, this means that a printed document received by mail at a public library is clearly rendered available to the public, since the staff member in charge of its reception and date stamping is not bound by any obligation to maintain secrecy and is thus free to pass the document on to others, which is precisely his or her job.

[6.2] Moreover, in the case of a written disclosure it is irrelevant whether the staff member is a person skilled in the art or not, because the content of a written disclosure can be freely reproduced and distributed even without understanding it. It follows that date stamping an incoming document in a public library is the point of time at which the document is leaving the non-public domain and entering the public domain. Once placed in the public domain, there is no longer anything that restrains or obstructs access to said information, since the content of the document can be freely reproduced, distributed, transmitted, or otherwise exploited.

[6.3] It follows that the appellant’s argument that the reception and data stamping operation is not open to the “public” is no longer relevant since at least one person – the member staff in charge of the reception and stamping – had free access to the document and could, at least theoretically, have passed the information contained therein on to anybody else.

As stated in the case law cited above, this theoretical possibility of access by at least one person not bound by any explicit or implicit confidentiality agreement is sufficient. Openness to “the public” does not require access to an unlimited number of arbitrary persons (a ship’s engine room is certainly not open to the public in that sense).

[7] The board therefore concludes from the above reasoning that the action of receiving and date stamping an incoming document in a public library suffices to make a written document available to the public and that a person fulfilling this action can be described as a member of “the public” in the sense of A 54(2).

[8] In the light of the above findings, the board concludes that document D1 was made available to the public before the priority date of the patent in suit and is thus, according to A 54(2), comprised in the state of the art. It follows that claim 1 of the sole request on file, the subject-matter of which is disclosed in entirety in D1, lacks the requirements of novelty of A 54 (1) and (2). […]

The appeal is dismissed.

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R 17/11 – Speak Out

This petition for review concerns decision T 1668/09 where Board 3.2.07 had dismissed the appeal of the patent proprietor against the revocation of the opposed patent.

The petitioner raised two objections. Objection 1 was based on an alleged violation of the petitioner’s right to be heard when admitting document D16. The Board considered the objection to be unfounded.

Objection 2 was based on the treatment of (undated) brochure D5, which the Board had considered to be the closest prior art and over which the claims on file were found to lack an inventive step. The patent proprietor had pointed out during the written proceedings that D5 had not been established that this document had been made available to the public. According to the patent proprietor, the Board had taken its decision without deciding on the admissibility of D5, which amounted to a substantial procedural violation.

The Enlarged Board (EBA) considered this objection to be unfounded, too:

*** Translation of the German original ***

[13] The basic problem of the petitioner consists in that it does not assert in its request that it had asked [the Board] not to admit D5 at any time during the oral proceedings (OPs). Therefore, it lacks the required factual basis for justifying a request under A 112a(2)(d) in connection with R 104(b).

[14] In R 19/10, the EBA has noted that the EPC does not contain an explicit definition of the term “request” used in R 104(b), but that, according to the common practice in the proceedings before the EPO, requests are in general directed to executable legal consequences sought by the parties.  

This is also confirmed by the travaux préparatoires related to R 104(b), in particular CA/PL 5/02 rev. 1 Add. 1, p. 27 (referred by the President of the EPO to the “Patent Law” commission, October 7, 2002) where the following is stated:

“The assumption is that only requests submitted in writing or requests which the party had recorded in the minutes of the OPs will fall within the ambit of that provision.”

[15] In R 19/10 the EBA also established that the arguments provided by the parties in support of these legal consequences did not normally belong to its requests. When a request is not explicitly made by a party during the proceedings, the Board does not have the duty under R 104(b) to examine the submissions of the parties as to whether they might contain requests that have not been made explicitly.

[16] […] During the OPs before the EBA the petitioner insisted on the fact that in the course of a long day (the proceedings before the Technical Board (TBoA) lasted until 17:25) several arguments related to inventive step had been discussed, not only in view of D5 and D16, and that the petitioner had only found out which combination the TBoA considered to be potentially relevant for inventive step when receiving the written decision. D5 was a short document and had not played a role in the decision of the OD or in the detailed communication that the Board had sent to the parties. Moreover, there was no hint in this communication that the Board might consider D5 to play any role whatsoever in view of inventive step […]. Rather, the petitioner had assumed – rightly, in its opinion – that the TBoA would raise the question whether D5 was part of the prior art of its own motion, in order to discuss it and decide on it, if and when it considered D5 to be potentially relevant. Until then it was legitimate for [the petitioner] to assume that the contents of the communication of the TBoA still applied.

[17] At this stage of the review proceedings, where the EBA has only heard one party, it has to assume, in favour of the petitioner, that the question of the status of D5 had not been raised during the OPs. It is true that in its decision […] the TBoA only mentions that D5 is one of the two documents used by the Board as prior art, but the decision does not dwell on the objection of the petitioner that its publication before the priority date had not been established.

[18] However, the petitioner does not contend that D5 was discussed during the OPs before the TBoA within the framework of the substantive discussion of inventive step. This also follows from the impugned decision, where the arguments of the petitioner are recorded as follows […]:

“It was true that D5 concerned a packed, highly compressed filter tow bale of the kind under consideration. However, there was no hint in this document that the bale had the cuboid-shape defined in claim 1 without there being bothersome bulges (Auswölbungen) or neckings (Einschnürungen) and having the flatness of the upper and bottom sides of the bale as also defined in claim 1.”

The arguments of the [opponent] are also recorded […].

[19] The EBA does not know whether the status of D5 as prior art has not been discussed during the OPs. It may be that the TBoA has come to the conclusion, in view of the discussion on D5, which undoubtedly has taken place, that the petitioner had not maintained the objection. Anyway, this does not make any difference because the petition for review misses one fundamental point:

It is not the role of the Board of appeal to ensure of its own motion that all the points that have been raised at any stage of the appeal proceedings are discussed during the OPs. It is up to the parties to raise a point which they consider relevant and which they believe might be overlooked and to insist on it being dealt with – if necessary, by means of a formal request. If a Board then does not give a party the opportunity to state its arguments, this can justify the objection that the right to be heard pursuant to A 113(1) had been violated.

However, this is not true [in the case of] the petitioner.

[20] As the petitioner has not made any such request within the meaning of R 104(b), the petition for review is clearly unallowable in view of this objection.

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My post on related decision R 19/10 can be found here.

T 510/10 – Distinct

This appeal was filed against the revocation of the opposed patent by the Opposition Division.

One of the questions discussed by the Board was the validity of the claim to priority for Claim 1 of the main request, which read:

1. A granule comprising an enzyme core, a hydrated barrier salt coated over the enzyme core, and one or more coating layers coated over the hydrated barrier material, wherein the barrier salt is magnesium sulfate heptahydrate, zinc sulfate heptahydrate, magnesium nitrate hexahydrate or magnesium acetate tetrahydrate, the barrier salt having moderate or high water activity.

The patent proprietor argued that this subject-matter was found in claims 1, 3, and 7 of the U.S. priority document. The claims contained in this document read (my emphasis):

1. A granule comprising an enzyme core and a barrier material, wherein the barrier material comprises a stably hydrated material.

2. The granule of claim 1, wherein the stably hydrated material is a stably hydrated salt.

3. The granule of claim 1, wherein the stably hydrated salt is selected from the group consisting of magnesium sulfate heptahydrate, zinc sulfate heptahydrate, copper sulfate pentahydrate, sodium phosphate dibasic heptahydrate, magnesium nitrate hexahydrate, sodium borate decahydrate, sodium citrate dihydrate and magnesium acetate tetrahydrate.

4. The granule of claim 1, wherein the barrier material is part of the enzyme core.

5. The granule of claim 1, wherein the barrier material is coated over the enzyme core.

6. The granule of claim 1, further comprising a layer of material between the enzyme core and the barrier material.

7. The granule of claim 1, further comprising a layer of material over the barrier layer and enzyme core.

The Board did not find the priority claim to be valid:

[1.1] Claim 1 of the main request refers to a granule comprising an enzyme core, a hydrated barrier salt coated over the enzyme core and a further coating applied over the hydrated barrier material. According to the Appellant this teaching can be found in the priority document in Claims 1, 3, 7.

[1.2] The Board cannot share this view. Claim 1 of the priority document discloses a granule comprising an enzyme core and a hydrated barrier material. Claim 3, lists salts to be used as barrier material and Claim 7, which exclusively refers to Claim 1, reports on an additional “layer of material over the barrier layer and enzyme core”.

[1.3] The wording of these claims does not necessarily mean that the barrier material forms a layer on the surface of the core which is then coated with the additional layer, as the wording used in Claim 7 also covers barrier layers in the enzyme core (priority document, page 3, fourth paragraph), i.e. that in such an embodiment the hydrate barrier salt is not coated over the core.

[1.4] Although a coating of the barrier material over the enzyme core is disclosed in Claim 5, this claim exclusively refers to Claim 1, as does Claim 7. Since Claims 5 and 7 describe two distinct embodiments, the combination of features cannot be considered to be disclosed.

[1.5] When considering the description of the priority document the situation does not change. The fourth paragraph on page 3 of the priority document defines that the barrier material may be dispersed throughout the core, may be a layer in the core or be coated onto the core. The second paragraph on page 4 states that the invention can comprise one or more coating layers, i.e. that one of more coating layers are optional.

[1.6] Thus, in order to arrive at the combination of features of Claim 1 of the main request a number of selections within the description of the priority document has to be made. The specific combination of features of Claim 1 has therefore not been disclosed in the priority document.

[1.7] This reasoning applies also to the auxiliary requests 1-4. In addition the fourth auxiliary request refers to a protein core, whereas in the priority document only an enzyme core is described.

[1.8] Therefore, none of these requests validly claims the priority date.

I think that in this particular case there was little (if any) hope for the priority claim to be considered valid. Be that as it may, this case confirms what I often say to my American colleagues, i.e. that if they are aiming at patent protection in Europe, they should use multiple dependent claims in their priority documents and in their PCT applications. These multiple dependencies can easily be removed before the USPTO - and other offices that do not accept them - at a later stage, but they may prove quite useful before the EPO. I know it is not easy for American patent drafters to overcome their habits, but doing so may really improve their situation in Europe.

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T 593/09 – Sufficiently Clear

This is an appeal against the revocation of the patent under consideration by the Opposition Division (OD).

Claim 1 of the main request before the Board was identical to claim 1 as granted and read:

1. Polyethylene terephthalate resin covered metal sheet, wherein a biaxially oriented film consisting of polyethylene terephthalate having a low temperature crystallization temperature ranging from 130 to 165°C is covered at least on one side of a metal sheet by heat bonding.

The OD held that, as corroborated by A3, the low temperature crystallization (LTC) temperature depended to a substantial degree on the heating rate applied during differential scanning calorimetry (DSC). The ISO standard D8 did not give unambiguous advice on the heating rate but merely suggested a heating rate. Furthermore, no information regarding the heating rate could be found in the opposed patent or in the prior art cited therein. Also, the proprietor had not been able to convincingly show that this information was part of the common general knowledge (CGK). Finally, it was not possible to determine the required heating rate by applying DSC measurements to commercial polymers with given LTC values because, as confirmed by the proprietor, the LTC temperature also depended on the polymerisation catalyst, the molecular weight, the heat treatment and the amount of stretching of the film. As a consequence the skilled person, when having to decide whether a specific polyethylene terephthalate fell within the claimed range or not, did not have enough information to do so. The opposed patent therefore was insufficiently disclosed.

The discussion of this matter by the Board is quite interesting:

[3.1] The essence of the [opponent’s] attack on sufficiency of disclosure was that the LTC temperature range covered by claim 1 of the main request was not well-defined, since any information with regard to the heating rate to be applied during the heating step for the determination of the LTC temperature was missing. As the skilled person therefore did not know whether he was working within or outside of the scope of claim 1, sufficiency of disclosure had to be denied.

[3.2] Accordingly, it has to be analysed whether the skilled person indeed lacks information as to what heating rate to apply when determining the LTC temperature of the polyethylene terephthalate in claim 1. In this regard, (i) the information available from the opposed patent as filed and (ii) the CGK at the filing date of the opposed patent must be taken into account.

[3.3] As regards point (i), all that is contained in the opposed patent as filed with regard to the determination of the LTC temperature is the indication on page 4, lines 16-20 that an exothermic peak appears when quenched polyethylene terephthalate films are gradually heated using differential scanning calorimetry (DSC). Consequently, all that the skilled person learns from the opposed patent as filed is that the LTC temperature of the polyethylene terephthalate in claim 1 is measured by means of DSC, applying gradual heating. In particular, no information as to the heating rate to be applied during this gradual heating is contained in the opposed patent.

[3.3.1] The [patent proprietor] argued in this respect that according to page 11, lines 36-37 of the opposed patent, polyethylene terephthalate on the market had an LTC temperature of 128°C. In order to identify the heating rate applied in the opposed patent, the skilled person therefore simply had to calibrate the DSC measurement and in particular the heating rate with the help of the polyethylene terephthalate resin on the market such that an LTC temperature of 128°C resulted. The heating rate thereby determined was the heating rate applied in the opposed patent. The [patent proprietor’s] argument logically implies that at the filing date of the opposed patent either only one polyethylene terephthalate resin was available on the market or all polyethylene terephthalate resins available on the market had the same LTC temperature of 128°C. As set out by the [opponent] and as also acknowledged by the [patent proprietor], this was however not the case. Actually, “polyethylene terephthalate resin” constitutes a family of materials, each member having different properties, depending e.g. on its molecular weight, the presence and type of nucleating agents, and the intrinsic viscosity. Therefore, contrary to the [patent proprietor’s] allegation, a skilled person could not identify the heating rate to be applied in the opposed patent for the determination of the LTC temperature with the help of those polyethylene terephthalate resins which were available on the market at the filing date of the opposed patent.

[3.3.2] The [patent proprietor] additionally argued that it followed from page 3, lines 56-57 of the opposed patent that polyethylene terephthalates with an LTC temperature above 165°C could not be produced. In the [patent proprietor’s] view, the upper limit of the claim was, therefore, inherently given by the polyethylene terephthalate with the highest LTC temperature available on the market.

However, page 3, lines 56-57 in fact discloses that

“ … it is extremely difficult in the sense of economy to manufacture a Homo polymer film consisting of polyethylene terephthalate resin having a low temperature crystallisation temperature more than 165°C alone.” (emphasis added).

Consequently, what may be deduced from the opposed patent is that polyethylene terephthalates with an LTC temperature above 165°C are expensive to produce. This does however not mean that such polyethylene terephthalates were not available to the skilled person, be it on the market or otherwise. Hence, also this argument of the [patent proprietor] must fail.

[3.3.3] On the basis of the information present in the opposed patent as filed, the skilled person would thus not know what heating rate to apply for the determination of the LTC temperature.

[3.4] It remains to be examined whether this information was available to the skilled person on the basis of the CGK at the filing date of the opposed patent (point (ii) above).

[3.4.1] The [patent proprietor] argued in this respect that the skilled person would deduce from the norm D8 that, by default, a heating rate of 20°C/min had to be applied for the determination of the LTC temperature in the opposed patent.

First of all, as the date of D8 (15 March 1999) is significantly later than the filing date of the opposed patent, the information present in D8 cannot, in the absence of any further evidence, be considered to have been part of the CGK at the filing date of the opposed patent. Hence, D8 is not to be taken into account when deciding on the question what heating rate the skilled person would use in order to determine the LTC temperature in the opposed patent.

Quite apart from that, D8 does not refer to the determination of the LTC temperature and for this reason also it cannot be relevant to the question of what heating rate the skilled person would apply for the determination of the LTC temperature in the opposed patent. In particular, the procedure applied in D8 (point 9) contains only the steps of:

• performing a preliminary thermal cycle at a rate of 20°C/min, thereby heating the sample to a temperature high enough to erase the test material’s previous thermal history,
• holding the temperature for 5 minutes,
• performing a cooling cycle at a rate of 20°C/min to approximately 50°C below the extrapolated end crystallisation temperature, thereby determining the crystallisation temperature,
• holding the temperature for 5 minutes, and
• performing a second heating cycle at a rate of 20°C/min to approximately 30°C higher than the extrapolated end melting temperature, thereby determining the melting temperature.

Hence, what are determined in D8 are the melting and the crystallisation temperatures, but not the low temperature crystallisation (LTC) temperature, i.e. a temperature where crystallisation is observed in a heating cycle after a prior quenching step.

The [patent proprietor’s] argument that the skilled person would use a heating rate of 20°C/min on the basis of D8 in order to determine the LTC temperature in the opposed patent is thus not convincing.

[3.4.2] Like D8, and for the same reasons, the norm D10 (from 2007) does not reflect the CGK at the filing date of the opposed patent. Moreover, again like D8, D10 refers to the determination of a melting temperature (point 3.1 of table 2) rather than the LTC temperature. The same applies to documents D11 (from 1999) and D12 (from 2000) which are equally post-published and refer to the determination of melting points (D11, last paragraph of page 2) and “melting start points” (D12, point 2.3), rather than the determination of the LTC temperature. Hence, like D8, D10-D12 are not relevant to the question of what heating rate the skilled person would apply when determining the LTC temperature in the opposed patent.

[3.4.3] In fact, the only documents on file which were available to the skilled person at the filing date of the opposed patent and which relate to the measurement of the LTC temperature are D7 and D9.

D7 is a patent application with a publication date of 9 April 1997, which is prior to the filing date of the opposed patent (10 April 1997). This document describes on page 11, lines 14-17 the measurement of a thermal crystallisation parameter DeltaTcg. This parameter represents the difference between the peak temperature of crystallisation in DSC (Tc) and the glass transition temperature in DSC (Tg) (formula on top of page 6 of D7). The measurement comprises the steps of drying a polyester, melting it, quickly cooling it, and subsequently measuring the glass transition and crystallisation temperatures by DSC at a heating rate of 16°C/min. Due to the fact that the crystallisation temperature is determined after melting and quickly cooling the sample, this temperature is in fact the LTC temperature of the sample. So, what is determined in D7 is the LTC temperature, and to do so, a heating rate of 16°C/min is applied.

The [patent proprietor] argued in this respect that exceptionally a heating rate below 20°C/min had been used in D7 because, apart from the LTC temperature, also the glass transition temperature was determined, which was difficult to measure and which therefore required a lower heating rate. However, no evidence was provided for this allegation and, for this reason alone, the [patent proprietor’s] argument must fail.

D9 is a scientific article published in 1987, i.e. before the filing date of the opposed patent. Figure 7 of this document discloses DSC patterns of laminated polyethylene terephthalate films. These patterns show exothermic recrystallisation peaks that are obtained upon heating a rapidly quenched polyethylene terephthalate sample. The recrystallisation temperature (which is synonymous with the LTC temperature) thereby determined lies in the range of 110-130°C (first sentence of point 3 on page 641). The heating rate applied during the DSC measurement is 10°C/min (first sentence of point 2 on page 638).

[3.4.4] Consequently, the only documents on file dealing with the measurement of the LTC temperature (and being available at the filing date of the opposed patent), i.e. D7 and D9, do not teach one single but rather two different heating rates, namely 16°C/min and 10°C/min, and both heating rates are different from the one to be applied in the opposed patent according to the [patent proprietor], namely 20°C/min.

[3.5] In summary, neither from the opposed patent as filed nor on the basis of his CGK at the filing date of the opposed patent, would the skilled person know what heating rate to apply when determining the LTC temperature.

[3.6] In view of the fact that the LTC temperature strongly depends on the heating rate applied (see point 2.5 above) and in the absence of any knowledge of what heating rate to apply, the skilled person thus is not able to establish whether a given polyethylene terephthalate film has an LTC temperature as required according to the opposed patent in order to obtain the desired peel, permeation and impact resistance. Hence, because of the unclear “heating rate” parameter, the crucial LTC temperature is so ill-defined that the skilled person, when trying to carry out the invention underlying the opposed patent, is left with having to test each individual polyethylene terephthalate as to its peel, permeation and impact resistance. In view of the numerous polyethylene terephthalates with different properties on the market (see point [3.3.1] above) and the even greater number of polyethylene terephthalates which can be synthesized using e.g. different reaction conditions or catalysts, this amounts to an undue burden to solve the problem addressed in the opposed patent. Its teaching thus in effect is at most a suggestion to perform a research program in order to identify suitable materials.

[3.7] This has the consequence that the invention underlying the opposed patent is insufficiently disclosed within the meaning of A 100(b), because the requirement is not met that the invention is disclosed “in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art”. Consequently, the main request must be refused.

A 83 versus A 84

[4.1] Though arriving at the same conclusion as the OD […], the board does not share the OD’s reasoning that led to this conclusion, namely that claim 1 of the patent did not comply with A 83 because the skilled person did not have enough information when having to decide whether a specific polyethylene terephthalate “falls into the claimed range or not” […].

[4.1.1] A 100(b) or A 83 requires a European patent or a European patent application to disclose the invention in a manner sufficiently clear and complete for it to be carried out by the skilled person. (As the disclosure standard given in A 100(b) is identical to that prescribed by A 83 and the same factual and legal criteria as well as the relevant jurisprudence apply, for the sake of conciseness, henceforth reference is made to the latter provision, i.e. A 83 only).

[4.1.2] The requirement of sufficient or “enabling” disclosure in the sense of A 83 is, as such, different from and independent from the clarity requirement pursuant to A 84, namely that the claims, which define the matter for which protection is sought, “shall be clear and concise”.

This distinction e.g. underlies decision T 1062/98 [2.1.4], where the board said:

“Firstly, the question whether the skilled person is capable of determining whether a certain feature would be infringing a feature claimed is not a matter of sufficiency of disclosure as required by A 83. … Whether there is infringement is … a matter to be decided by the national courts. Secondly, the determination of the scope of the claim … relates in fact to the question whether the claims properly define the matter for which protection is sought. …. These are, however, the requirements imposed by A 84 and R 29(1), which do not form grounds of opposition … ”

[4.1.3] There is thus a distinction between the meaning of “clear” in A 83, which concerns the disclosure (the “technical teaching”) of the application or the patent on the one hand, and in A 84, where that expression relates to the claims, which “shall define the matter for which protection is sought” on the other hand. In short, there is a distinction between clarity of what has been disclosed and clarity of what is claimed. This distinction is, however, not always properly made, in particular in respect of so called “ambiguous parameters”, i.e. parameters present in the description and/or claims, whose exact definition and/or applicable measuring method remains doubtful.

For example, there exist numerous decisions of the boards of appeal according to which the, or at least one, relevant criterion for sufficiency of a disclosure containing an ill-defined parameter is whether the skilled person knows if he is working within or outside of the scope of the claim (e.g., T 256/87 [10]; T 387/01 [2.2.1-4]; T 252/02 [2.2.1-5] and T 18/08 [4.2.1-4]). It is however, not always apparent from the reasoning of these decisions whether or not this criterion was meant to be the sole or the decisive one.

On the other hand, decisions exist that consider the question of whether or not the skilled person knows if he is working within or outside of the scope of the claims not to be a matter of sufficiency of disclosure but rather a matter of A 84 (see, e.g. T 396/02 [4.8.2-3], and T 1033/02 [11.4]).

[4.1.4] It is certainly true that where the disclosure is insufficient within the meaning of A 83 due to the presence of an ill-defined parameter, claims defined by reference to this parameter - in the present case the LTC temperature - would lack clarity under A 84, since establishing the exact scope of the claim would then be impossible. But that does not allow the reverse conclusion to be drawn, namely that there is insufficient disclosure in the sense of A 83 whenever the scope of the claims is unclear, i.e. not properly defined.

The position is as follows: where a claim contains an ill-defined (“unclear”, “ambiguous”) parameter and where, as a consequence, the skilled person would not know whether he was working within or outside of the scope of the claim, this, by itself, is not a reason to deny sufficiency of disclosure as required by A 83. Nor is such a lack of clear definition necessarily a matter for objection under A 84 only. What is decisive for establishing insufficiency within the meaning of A 83 is whether the parameter, in the specific case, is so ill-defined that the skilled person is not able, on the basis of the disclosure as a whole and using his CGK, to identify (without undue burden) the technical measures (e.g. selection of suitable compounds) necessary to solve the problem underlying the patent at issue.

[4.1.5] This rationale underlies e.g. T 608/07 [2.5.2] and T 815/07 [headnote], where the following statements are contained:

“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, i.e. A 84. Since, however, A 84 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 A 84. 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, e.g. 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.” (T 608/07)

“The purpose of a parameter contained in a claim is to define an essential technical feature of the invention. Its significance is that the presence of this technical feature contributes to the solution of the technical problem underlying the invention. The method specified for determining the parameter should therefore be such as to produce consistent values, so that the skilled person will know when he carries out the invention whether what he produces will solve the problem or not.” (T 815/07).

The same rationale also underlies the decision in Kirin-Amgen Inc v. Hoechst Marion Roussel Ltd [2004] UKHL 46 of the United Kingdom House of Lords, where Lord Hoffmann said (the other members all agreeing):

“[if] … finding out which ones work will need extensive experiments, then that in my opinion is not merely lack of clarity; it is insufficiency. The lack of clarity does not merely create a fuzzy boundary between that which will work and that which will not. It makes it impossible to work the invention at all until one has found out what ingredient is needed.” (point 126).

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