T 120/08 – A Vacuous Expression

When drafting patent applications, it is crucial to well define parameters that are relevant for characterising the invention. Using parameters habitually used by the inventors but not necessarily understood without ambiguity by the skilled person may kill a patent, as can be seen from the present decision, which deals with an appeal against the decision of the Opposition Division (OD) to reject the oppositions.

The main claim under consideration was directed at a method of production of goods based on meat wherein olive oil was substituted to animal fat. The method included a step where the food mixture was encased “with simultaneous application of vacuum 1000 mbar”. It is this particular feature that triggered a discussion on whether the invention was sufficiently disclosed.

[3] Pursuant to A 83 the “European patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art”. According to the jurisprudence of the boards of appeal the standard of disclosure for this requirement is that it must be possible to reproduce the invention on the basis of the original application documents without any inventive effort and undue burden, whereby the skilled person may use his common general knowledge to supplement the information contained in the application, textbooks and general technical literature forming part of the common general knowledge (see e.g. decisions T 629/05, T 206/83, T 772/89).

[4] The subject-matter of Claim 1 as granted discloses the invention as consisting in a process for the production of goods based on meat, which process is characterised by four essential process steps (a) to (d). Process step (c) provides that the mixture produced in steps (a) and (b) “goes to filling machines where it is encased with simultaneous application of vacuum 1000 mbar …”. The equivalent wording can be found in original Claim 1.

No further information on the value of the vacuum to be applied in step (c) is found in the application as filed or in the patent specification.

Hence, in the present case it has to be examined first whether a skilled person having read the application as filed would be able, on the basis of his general knowledge and without undue burden, to reliably define “vacuum 1000 mBAR” or “vacuum 1000 mbar”, as it was granted, because keeping to that parameter during the vacuum encasing step (c) is a prerequisite for carrying out the solution to the technical problem for which protection is sought in Claim 1.

“Vacuum 1000 mbar”

[5.1] For technical purposes, a vacuum is commonly defined as being present where inside a container/apparatus the (absolute) gas pressure is lower than the gas pressure outside the container/surrounding the apparatus (see e.g. D57 […]).

[5.2] A commonly used unit for indicating the gas pressure is “bar” or “millibar” (“mbar”), the latter unit being used in the patent in suit.

[5.3] A gas pressure is normally measured as an absolute pressure relative to the absolute vacuum (pressure of zero). In contrast, where the pressure is measured relative to the given surrounding pressure (“barometric pressure”) - i.e. so-called “gauge pressure” - one speaks either of an overpressure or, if the pressure is lower than the surrounding pressure, of a reduced/lower pressure or vacuum. The latter is made clear by putting “(rel)” or “-“ before the value of the vacuum, e.g. “-50 kPA” […].

[6] It is against this background that in order to be able to carry out the claimed process the person skilled in the art must and therefore would try to establish the meaning of “vacuum 1000 mbar” in Claim 1, because the patent (and the underlying application as originally filed) is silent on the meaning of that value (as well as of “vacuum 960 mbar” mentioned in the description of step (b) of the claimed process).

[6.1] Giving “vacuum 1000 mbar” its literal meaning, i.e. that of an absolute pressure, immediately leads to difficulties, even contradictions, which would prevent the skilled person from such an understanding:

An absolute pressure of 1000 mbar would be so close to that prevailing at sea level (around 1013 mbar) that it would not constitute an reduced/lower pressure (and thus a vacuum) in the larger part of the inhabited regions of the world, with the consequence that either it would be a feature of the claimed process that it had to be carried out at or close to sea level, or the performing of the invention would be geographically restricted. There is no technical reason indicated in the application or otherwise evident to the skilled person which in the given technical context could support such an understanding. Even the proprietor did not adopt such an interpretation.

[6.2] As regards the second possible understanding of “vacuum 1000mbar”, namely as a gauge pressure, here of -1000 mbar, that is a “significant” reduction of the pressure (not to, but by 1000 mbar), as Appellant I argued and the respondent’s technical expert Dr. Genigeorgis stated before the OD (point II, above), the same difficulties arise. Again, such a gauge pressure (= a reduced/lower pressure […]), by its very definition, can only be present at places with an atmospheric/barometric pressure higher than 1000 mbar (absolute), i.e. close to sea level, and there is nothing pointing to such an understanding by the person skilled in the art.

That being so, it is immaterial whether or not [opponent I] was actually able to carry out the vacuum encasing step at a pressure of -1 bar […]. Equally, it is irrelevant whether the encasing step is indeed not feasible at an absolute pressure of 13.25 mbar since the vacuum would break down because of the low boiling temperature of the water in the mixture […], or for other technical and/or cost reasons. Therefore, these issues need not be pursued further.

[6.3] According to the proprietor’s position the true meaning of the term “vacuum 1000 mbar” as understood by the skilled person is, however, yet another one, namely the standard atmospheric pressure of 1013.25 mbar minus 1000 mbar = 13.25 mbar below the surrounding atmospheric pressure at a given place, i.e. a weak vacuum of 13,25 mbar gauge pressure.

[6.3.1] This interpretation was accepted by the OD, but without any substantiated reasoning, in fact nothing more than because “[t]his interpretation had been confirmed by the patent proprietor” […]. In respect of this crucial issue the decision under appeal thus suffers from a deficiency under R 111(2), first requirement.

[6.3.2] Documents A and B filed in response to the communication which the board had issued in preparation of the OPs and in which it gave also a preliminary view on that issue (A 100 (b)) do not support the respondent’s position […]. This is also true for document C according to which the term “Vacuum” describes the state of a fluid in a volume at a pressure below the atmospheric pressure at normal conditions, and the range between 1000 and 1 hPa (= mbar) is called “Grobvakuum” (weak vacuum). It is clear from the values indicated for the further ranges (strong, high, ultrahigh, … vacuum), that all these values are absolute values unrelated to the surrounding pressure, not gauge pressures related to the surrounding atmospheric pressure. Therefore, also from this document it cannot be derived that a “vacuum 1000 mbar” means an reduced/lower pressure (“mild vacuum” as the respondent put it) of (exactly) 13.25 mbar in relation to any surrounding pressure.

[6.3.3] Beyond this, the [patent proprietor] has not put forward any technical argumentation for his contention that the skilled person reading the specification and the claims of the patent in suit would unambiguously interpret the term “vacuum 1000 mbar” as referring to a weak vacuum of 13.25 mbar below the surrounding atmospheric pressure, a view which was not even shared by all of the respondent’s own experts […]. In particular, the respondent has not shown anything in the patent documents or in the common general knowledge from which the skilled person would conclude that the solution of the problem underlying the invention is conditional upon such a weak/”mild” vacuum.

[6.3.4] Rather, this is questionable in view of the resulting wide range of the absolute pressure at the encasing step of the claimed process, depending on the geographical location/altitude of the meat processing plant. It is furthermore questionable whether a skilled person intending to remove oxygen in order to avoid oxidation according to paragraph [0020] of the patent in suit would consider it appropriate to reduce the air pressure only marginally by 13.25 mbar.

[6.3.5] The respondent furthermore relied on the fact that [opponent I] in its own patent documents D and E used the analogous terms “vacuum 940 mbar” and “vacuum 940 to 980 mbar”. However, apart from the assertions by one of the opponents’ experts that the experiments relating to these documents had been carried out at gauge pressures in the range of 940 to 980 mbar, i.e. in a strong vacuum, an undefined term used in a patent document does not become meaningful to the person skilled in the art simply by the use in patent documents of a competitor (here opponent I), in particular where, as in the present case, it is strongly disputed that the terms in question have the same meaning in the document(s) of each side.

[6.3.6] The respondent’s eventual contention that a “vacuum 1000 mbar” at the encasing step is not essential for carrying of the claimed process is not convincing, quite the contrary. It is because of a deliberate choice by the respondent as the then applicant that the term in question appears in the application as originally filed and the specification of the patent in suit. In general, as pointed out in decision T 815/07, the purpose of a parameter contained in a claim is to define an essential 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. So, if this contention was true, the use of the critical term in the patent in suit would in addition be misleading.

[7] From the above it follows that a skilled person is at a loss when trying to perform the “application of vacuum 1000 mbar” at the encasing step of the process claimed in either of the respondent’s main and auxiliary request. Therefore, neither of these requests is allowable due to non-compliance with Article 83 EPC, a provision whose purpose is to ensure a fair and complete disclosure of the subject-matter for which protection is sought. […]

The patent is revoked.

NB: The revocation was announced at the end of the OPs. Subsequently, the patent proprietor requested an amendment of the minutes. The Board having refused this request, the proprietor “respectfully insist[ed]” on its request, which it considered decisive in view of a petition for review. This triggered another noteworthy statement by the Board:

[2] As regards the respondent’s request for amendment of the minutes, i.e. actually for a more detailed version of the minutes of the OPs, the board is bound by the decision to reject this request communicated to the parties on 19 November 2010 and can no longer change it itself. Thus, this board is no longer empowered to assess whether the minutes as they stand and/or the refusal to amend them according to the respondent's suggestions constituted a violation of any of the parties’ rights. The possibility to correct a decision under R 140 is limited to linguistic errors, errors of transcription and obvious mistakes. The respondent did not rely on any such error or mistake and the board too is not aware of any such deficiency of the decision to reject the requested amendment.

To read the whole decision, click here.

The file wrapper can be found here.

T 1635/09 – Claims Pregnant With Meaning

In the present case, the patent proprietor and three of the four opponents filed appeals against the decision of the Opposition Division (OD) to maintain the patent in amended form.

The decision is somewhat lengthy; if you are happy with a summary, here is a translation of the headnotes provided by the Board:

1. The use of a composition for oral contraception, where the claimed concentrations of the hormons contained in the composition are chosen sufficiently low to avoid or reduce the pathological secondary effects that are to be expected in oral contraception, constitutes a method for treatment by therapy that is excluded from patentability pursuant to A 53 c).


2. As the question of whether a claimed use is therapeutic or non-therapeutic is to be decided exclusively on the basis of the actions carried out during this use and/or the effects obtained, the exclusion from patentability pursuant to A 53 c) cannot be overcome by limiting [the claim] to a “non-therapeutic use” in the case of a therapeutic method wherein a non-therapeutic use (contraception) is inseparably linked with a therapeutic use (avoiding or reducing the pathological secondary effects).


3. The transformation of a claim directed to the use of a substance or composition for a certain purpose into a Swiss-type claim or a purpose-limited product claim pursuant to A 54(5) leads to an extension of the scope of protection.


4. When considering whether series of trials needed for reproducing a claim may reasonably be expected (zumutbar), the question of whether they could have been avoided is also to be taken into account. One may not reasonably expect that time consuming and ethically questionable series of trials are carried out when [the applicant] could have defined the claimed subject-matter by means of features which would have made said series of trials – in view of reproducibility by the skilled person - unnecessary, without reducing the scope of the claim.

The decision provides some insight into the exclusion from patentability under A 53 c), possible ways to circumvent this problem and the scope of protection offered by the different types of claims that are used when further medical uses are to be protected. Let tribute be paid to the patent proprietor who greatly enriched this decision by fighting like a devil and proposing a great variety of claim alternatives.

*** Translated from the German (*) ***

Main request – A 53(c)

1. Use of an oral monophasic dosage form comprising

0.015 to 0.020 mg of ethinylestradiol;

and a gestagen selected from

0.05 to 0.075 mg of gestodene,

0.075 to 0.125 mg of levonorgestrel,

0.06 to 0.15 mg of desogestrel,

0.06 to 0.15 mg of 3-ketodesogestrel,

0.2 to 0.3 mg of norgestimate, and

> 0.35 to 0.75 mg of norethisterone,

for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

[3.1] Claim 1 under consideration concerns the use of an oral monophasic dosage form comprising ethinylestradiol as well as a gestagen, selected from a list of six specific compositions, for contraception for a woman of fertile age who has not yet reached the premenopause.

When considering the question of whether the use under consideration is an activity which is excluded from patentability pursuant to A 53 c), first of all it has to be taken into account that, according to the established case law of the Boards of appeal, pregnancy is not an illness and, as a consequence, that contraception is not a therapeutic treatment, not even within the meaning of prevention (T 820/92 [5.2 et seq., confirmed by T 74/93 [2.2.3])

However, it has also to be noted that the purpose of use given in claim 1 “for contraception for a woman of fertile age who has not yet reached the premenopause” is not the sole criterion for the existence or absence of an exclusion from patentability (Patentierungsverbot) pursuant to A 53 c). Rather, it has to be examined whether the subject-matter of the claim taken as a whole comprises one or several therapeutic steps and/or therapeutic effects, because, as has been stated in decision T 820/92 cited by the patent proprietor, there is an exclusion from patentability pursuant to A 53 c) (and A 52(4) EPC 1973, respectively) even though they concern only part of the claimed subject-matter (see [5.3]).

When analysing claim 1 it has to be noted that all active substances, the ethinylestradiol as well as each of the six gestagens, are characterised by indications of concentrations, wherein the chosen domains show that the product is a low-dose contraceptive. From the description (see paragraph [0008]) it can be seen that it is hoped that the reduction of the daily hormone dose reduces the undesirable secondary effects and that epidemiologic data confirm the desired tendency towards the improvement of low-dose compositions in view of cardiovascular complications. Moreover, paragraph [0009] of the patent specification presumes a link between the estrogen dose and the incidence of cardiovascular disorders.

In this context it has to be underlined that the reduction of the concentrations of active substances does not lead to an improvement of the contraceptive efficiency but exclusively to avoiding or reducing the above mentioned secondary effects. In the above mentioned paragraph [0009] of the patent specification it is unambiguously stated that an extreme reduction of the daily estrogen dose conflicts with contraceptive efficiency and makes a satisfying cycle control difficult. Thus claim 1 under consideration indeed claims a non-therapeutic use, but at the same time the choice of the concentrations of active substances as defined in the claim results in preventing secondary effects to be expected during the non-therapeutic use. This prevention, which is anchored in claim 1 via the indication of the concentrations of active substances and which clearly is to be classified as therapeutic because of the pathologic nature of the secondary effects (e.g. cardiovascular or thrombolytic complications), is inseparably linked with obtaining the contraceptive effect, which as such is non-therapeutic. Therefore, the subject-matter of claim 1 of the main request under consideration as a whole includes a therapeutic method. According to the established case law of the Boards of appeal a claim falls under the exclusion from patentability pursuant to A 53 c) even if part of the claimed subject-matter is a method for treatment of the human or animal body by therapy (G 1/04 [6.2.1], confirmed by G 1/07 [3.2] and G 1/08 (sic) [5.6]). Therefore, claim 1 of the main request is excluded from patentability pursuant to A 53 c).

[3.2] Decisions T 144/83 and T 36/83, which have been cited by the patent proprietor are not relevant for the present case, for the following reasons:

T 144/83

[3.2.1] In decision T 144/83 the Board came to the conclusion that the wording of the main claim, which was directed at the use of naltrexone for improving the bodily appearance, wherein the naltrexone is orally administered until a cosmetically beneficial loss of body weight has occurred, clearly encompassed a cosmetic method and did not concern a therapeutic treatment of the human or animal body. The fact that a chemical substance has both a cosmetic and a therapeutic effect cannot render the cosmetic treatment unpatentable (see paragraphs [3-4]).

It is true that naltrexone belongs to the group of opioid antagonists and is a pharmacologically highly active substance, so that one cannot exclude that there are further effects parallel to the non-therapeutic effect claimed, which further effects can indeed be of a therapeutic kind. However, this is irrelevant in the context of A 53 c) if the additional, potentially therapeutic effects can be clearly separated from the non-therapeutic use and are not covered by the claimed subject-matter. The essential difference with respect to the use claimed in claim 1 under consideration consists in that in case T 144/83 the wording of the claim encompasses only non-therapeutic uses. Naltrexone is administered to persons not suffering from obesity in sufficient doses until a cosmetically beneficial loss of body weight has occurred. Incidentally, if read in a reasonable and appropriate way, such a claim cannot be considered to correspond to the prevention of obesity.

In contrast, claim 1 under consideration is worded so as to encompass a use wherein the non-therapeutic part is inseparably linked to a therapeutic part and the preventive-therapeutic part is an essential part of the claimed method (cf. T 290/86 [3.2])

T 36/83

[3.2.2] In case T 36/83 the Board came to the conclusion that the uses disclosed for thenoyl peroxide were of both therapeutic (acne) and cosmetic nature (comedolytic effect). As far as the admissibility if the claim directed to the cosmetic use was concerned, the Board considered that the question of whether the cosmetic use can be distinguished from the therapeutic use was essential. Based on the indications provided in the description, the Board came to the conclusion that those uses could be distinguished (see paragraph [6]). Although the cosmetic treatment could sometimes comprise a therapeutic treatment (see [6.1]), the cosmetic application assisted in skin cleansing, which the Board regarded as clearly belonging to the field of non-medical body hygiene (see [6.2]). Therefore, this situation is analogous to the situation of decision T 144/83: an exclusively cosmetic and thus non-therapeutic effect is possible and this is all that the wording of claim 1 of the main request claimed. Therefore, in case T 36/83 there is no inseparable link of a non-therapeutic and a therapeutic step, such as the one found in claim 1 of the main request under consideration.

[3.3] Based on this fundamental difference the decision that the subject-matter of claim 1 of the main request under consideration falls under the exclusion from patentability pursuant to A 53 c) is not contradictory with decision T 36/83. A referral to the Enlarged Board of appeal pursuant to A 112(1), as requested by the patent proprietor, is not indicated. […]

Auxiliary request 1

1. Non-therapeutic use of an oral monophasic dosage form comprising

0.015 to 0.020 mg of ethinylestradiol;

and a gestagen selected from

0.05 to 0.075 mg of gestodene,

0.075 to 0.125 mg of levonorgestrel,

0.06 to 0.15 mg of desogestrel,

0.06 to 0.15 mg of 3-ketodesogestrel,

0.2 to 0.3 mg of norgestimate, and

> 0.35 to 0.75 mg of norethisterone,

for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

[5] The wording of claim 1 of auxiliary request 1 differs from claim 1 of the main request in that the disclaimer “non-therapeutic” has been inserted. In a claim that comprises both therapeutic and non-therapeutic uses which can be separated on a factual, and therefore objective (gegenständlich) level, such a disclaimer allows to exclude the therapeutic uses, so that the remaining subject-matter is not concerned by the exclusion from patentability pursuant to A 53 c). However, such a disclaimer cannot define a use which necessarily comprises one or several therapeutic steps to be non-therapeutic, because the question of whether a claimed use is therapeutic or non-therapeutic is to be decided exclusively on the basis of the actions carried out during this use, or the effects obtained, respectively. As has been stated above under [3.2.1] the subject-matter of claim 1 concerns a use where a non-therapeutic part is inseparably linked to a therapeutic part and wherein the preventive-therapeutic part concerns essential features of the claimed use. Therefore, the exclusion from patentability pursuant to A 53 c) also applies to the subject-matter of claim 1 of auxiliary request 1, despite the introduction of the disclaimer “non-therapeutic”.

Moreover, as the disclaimer “non-therapeutic” contradicts the use that is defined in the claim and which, when considered according to its content, is of therapeutic nature, the subject-matter of claim 1 of auxiliary request 1 does not comply with the requirements of A 84. […]

Auxiliary request 2 – A 83

5. Use of a composition comprising

0.020 mg of ethinylestradiol;

and a gestagen selected from

0.25 mg drospirenone up to a dose of drospirenone equivalent to 0.075 mg of gestodene, and

0.1 mg of cyproteron acetate up to a dose of cyproteron acetate equivalent to 0.075 mg of gestodene,

for the manufacture of a medicament for an oral monophasic ovulation inhibiting dosage form for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

[7] The subject-matter of claim 5 of auxiliary request 2 concerns the use of a composition for the manufacture of a medicament for an oral monophasic ovulation inhibiting dosage form, wherein the quantities of active substances are as follows:
0.25 mg drospirenone up to a dose of drospirenone equivalent to 0.075 mg of gestodene, and

0.1 mg of cyproteron acetate up to a dose of cyproteron acetate equivalent to 0.075 mg of gestodene.

[7.1] According to the established case law of the Boards of appeal, an invention is sufficiently disclosed only if [the disclosure] allows to carry out the [the invention] over substantially the whole claimed domain. In the present case, it has become apparent during the grant proceedings that the quantities of active substances that had been disclosed for drospirenone and cyproteron acetate (i.e. 0.1 to 0.3 mg and 0.1 to 0.2 mg, respectively, see claim 1 of the application as filed) were chosen ten times too small, as the result of an error (see submission of the then applicant dated August 25, 2003, paragraph “Amendments pursuant to R 88”), from which it can be concluded that neither drospirenone nor cyproteron acetate may be expected to have an ovulation inhibiting effect below a dose of 1 mg. This means that considerable domains of the claimed use cannot be carried out because no ovulation inhibiting effect can be obtained in the whole lower domain of concentrations (0.25 mg to about 1 mg drospirenone and 0.1 mg to about 1 mg cyproteron acetate). For this reason alone the subject-matter of auxiliary request 5 under consideration does not comply with the requirements of A 83.

[7.2] Moreover it is to be noted that the skilled person is not able to determine whether a certain product has an ovulation inhibiting effect or not without carrying out time consuming trials. As a matter of fact, the skilled person not only has to face the fact that there is no ovulation inhibiting effect in the lower domain of the claimed concentrations of the active substances (see [7.1] above). He will also find that even for the determination of the upper limit trials will be required because, as will be shown hereafter, the dose of drospirenone and cyproteron acetate equivalent to 0.075 mg of gestodene, cannot be determined by simple calculation, as alleged by the patent proprietor, even if it is assumed, in favour of the patent proprietor, that the dose of both active substances mentioned above that is equivalent to 0.075 mg of gestodene can indeed be determined in proportion, based on the minimum ovulation inhibiting dose.

Minimum ovulation inhibiting dose of gestodene

[7.2.1] As explained by the patent proprietor […] the prior art gives varying values for the minimum ovulation inhibiting dose of gestodene, i.e. 40 μg per day in documents D24, D94, D107, D111, D 112, D120 and D121, and 30 μg per day in documents D1, D101 and D122. However, the Board cannot endorse the argument presented by the patent proprietor according to which the skilled person would immediately realize that, as far as the minimum ovulation inhibiting dose of gestodene is concerned, the first series of documents, which postulates 40 μg per day, were more reliable than documents D1, D101 and D122. It is indeed true that in said documents D1, D101 and D122 there is no description of how the minimum ovulation inhibiting dose was determined. However this appears not to be necessary because, as also pointed out by the patent proprietor, the method for its determination was well known to the skilled person. Moreover, the skilled person would take interest in document D1 because this document is recommended in the application as filed […] as reference for the determination of dose equivalents of several gestagene active substances. Faced with contradictory indications in documents that are equivalent as far as credibility is concerned, the skilled person would come to the conclusion that a series of trials was required in order to determine the correct minimum ovulation inhibiting dose of gestodene.

Minimum ovulation inhibiting dose of drospirenone

[7.2.2] The minimum ovulation inhibiting dose of drospirenone cannot be determined unambiguously from the prior art either and, therefore, also has to be determined experimentally by means of corresponding series of trials. In its argumentation, the patent proprietor relied in particular on document D 109 from which it can be seen that the administration of 2 mg of drospirenone over a period of 21 days did lead to an ovulation inhibiting effect, whereas this effect was not found when 1 mg were administered over the same period […]. It cannot be derived from this information that the minimum ovulation inhibiting dose of drospirenone is equal to 2 mg; it can only be derived that ovulation inhibition can certainly be obtained with a daily dose of 2 mg and that the minimum ovulation inhibiting dose for drospirenone is somewhere between 1 and 2 mg. Also, this conclusion is not rendered moot by “Study 2” presented in document D109, wherein the effects of a daily administration of 2 mg of drospirenone over a period of two monthly cycles were compared with an administered dose of 1 mg of cyproteron acetate over the same period. The patent proprietor referred to document D113 and argued that the minimum ovulation inhibiting dose of cyproteron acetate was found to be 1 mg and that a comparative study was meaningful only if equivalents were compared, from which the skilled person would unmistakably conclude that the minimum ovulation inhibiting dose of drospirenone was equal to 2 mg. The same would apply for “Study II” presented in document D21a.

The Board is of the opinion that it is not possible to unambiguously derive from “Study 2” of document D109 or from “Study II” of document D21a that the minimum ovulation inhibiting dose is 2 mg. The purpose of both studies (Study 2 and Study II) consisted in examining the effect of the administration of drospirenone as ovulation inhibitor in view of the concentrations of sodium, potassium and aldosterone-18-glucuronide in urine, the concentrations of sodium and potassium in serum as well as the plasma renin activity and the plasma aldosterone concentration. To this purpose, it was reasonable to choose a dose with ovulation inhibiting effect and to exclude the dose of 1 mg, which did not yield the desired effect. Even if the comparison was carried out with 1 mg of cyproteron acetate, i.e. the minimum ovulation inhibiting dose of cyproteron acetate, this does not mean that for reasons of equivalence the minimum ovulation inhibiting dose of drospirenone has to be 2 mg. It is equally plausible that in both studies mentioned above, as the precise minimum ovulation inhibiting dose of drospirenone was unknown, a dose had been chosen for which an ovulation inhibition effect was certain.

[7.3] It follows that for both gestodene and drospirenone the minimum ovulation inhibiting dose has to be determined experimentally. Only for cyproteron acetate the value that is uniformly defined to be 1 mg (see e.g. documents D1 […], D24 […] or D 101 […]) can be adopted.

As far as these series of trials are concerned, the patent proprietor has pointed out, both during oral proceedings and in written submissions […] that for ethical reasons the trials had to be reduced to a minimum, so that the question arises whether such trials can reasonably be expected (Frage der Zumutbarkeit).

In the context of reproducibility, it is often necessary to carry out trials when claims are formulated in terms of results to be obtained (aufgabenhaft) or defined via parameters and when it is not possible, without unduly limiting the claimed subject-matter, to define the subject-matter by means of concrete structural features.

However, claim 5 of auxiliary request 2 under consideration is fundamentally different from this situation because a concrete active substance (drospirenone) is defined with a concentration range (Mengenbereich) that is, in principle, concrete. In such a case third parties, as a rule, do not have to carry out trials as far as reproducibility is concerned.

However, in claim 5 under consideration, the upper limit of the concentration range (Mengenbereich) for drospirenone is not defined by “x mg of drospirenone” but by a “dose of drospirenone equivalent to 0.075 mg of gestodene”. By choosing this indirect definition, for which there is no necessity related to the scope of the claim, because it does not change the claimed subject-matter with respect to the direct definition via “x mg of drospirenone”, [the patent proprietor] forces third parties wishing to reproduce the claim to carry out time consuming and ethically questionable series of trials. The Board is of the opinion that when considering whether series of trials needed for reproducing a claim may be expected, the question of whether they could have been avoided is also to be taken into account. One may not expect that time consuming and ethically questionable series of trials are carried out when, as in the present case, the applicant could have defined the claimed subject-matter by means of features which would have made said series of trials – in view of reproducibility - unnecessary, without reducing the scope of the claim. For this reason also, the invention defined in claim 5 of auxiliary request 2 does not comply with the requirements of A 83. […]

Auxiliary request 23 – A 123(3)

1. Use of a composition comprising

0.015 to 0.020 mg of ethinylestradiol;

and a gestagen selected from

0.05 to 0.075 mg of gestodene,

0.075 to 0.125 mg of levonorgestrel,

0.06 to 0.15 mg of desogestrel,

0.06 to 0.15 mg of 3-ketodesogestrel,

0.2 to 0.3 mg of norgestimate, and

> 0.35 to 0.75 mg of norethisterone,

for the manufacture of a medicament for an oral monophasic dosage form for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

[14] Claim 1 of auxiliary request 23 differs from claim 1 as granted in that the granted use claim was rewritten in the so-called Swiss-claim form, i.e. as a claim directed to the use of a substance or composition for the manufacture of a medicament for a certain therapeutic application.

When examining whether this amendment has extended the scope of the claim, the established case law of the Boards of appeal requires that the whole set of claims as granted be taken into account. In the present case, the set of claims as granted comprises not only the use claims 1 to 8 but also product claims 9 to 19. However, as far as the concentration of ethinylestradiol of 0.015 mg to less than 0.020 mg is concerned, the subject-matter of claim 1 of auxiliary request 23, wherein ethinylestradiol is present with concentrations ranging from 0.015 to 0.020 mg, extends beyond the scope of product claims 9 to 19 as granted, where the part of ethinylestradiol is limited to 0.020 mg.

[14.2] Thus it has to be checked whether the reformulation of a claim directed to the “use of an oral dosage form comprising … for contraception …” towards a claim directed to the “use of a composition comprising … for the manufacture of … an oral dosage form for contraception …” is in line with the requirements of A 123(3). In this context it is of decisive importance whether the Swiss-type claim wording is to be understood as a claim directed to (a) the use of a substance or a composition for a certain purpose, or (b) to the manufacture of a medicament. An interpretation as a use claim is not reconcilable with EBA decision G 1/83. According to this decision, a claim directed to the “use of a substance or composition for the treatment of the human or animal body by therapy” is in no way different in essential content from a claim directed to “a method of treatment of the human or animal body by therapy with the substance or composition” (G 1/83 [13]).

The opinion according to which a use claim included the manufacture of a pharmaceutical product, with instructions for use in the treatment of illness (“augenfällige Herrichtung”), whereas a method claim did not, was rejected by the EBA (G 1/83 [11,17,18]). Faced with this question, the EBA found it to be justified to admit patent claims directed to a substance or composition being used for the manufacture of a medicament, even though the method of manufacture as such does not differ from a known method, wherein the same active substance is used. This is justified as follows in the third paragraph of point [21] of the reasons:

“Based on the general order to grant patents anchored in A 52(1), it seems justifiable to derive the novelty of the manufacture of a substance or composition known as such from its new therapeutic use, irrespective of whether a pharmaceutical use of the substance or composition is known or not.” (emphasis by the Board)

NB: This is my translation of G 1/83 (which was issued in German). The English equivalent (G 5/83) has a wording that is somewhat different from the wording of its German counterpart.

Consequently, in point [21] of the reasons the Swiss-type claim form is understood as a method of manufacture, wherein, however - similar to the exceptional provision for the so-called first medical use pursuant to A 54(5) EPC 1973 – the purpose of use of the manufactured product exceptionally constitutes a feature that justifies the novelty of the method of manufacture. It was this way of looking at things alone that allowed the exclusion from patentability pursuant to A 53 c) (or A 52(4) EPC 1973) to be considered to have been overcome. If the Swiss-type claim form, considered according to its content, was equivalent to a use claim within the meaning that a substance or a composition is used in order to obtain a certain technical effect, instead of being equivalent to a method of manufacture, then, according to the ratio decidendi of decision G 1/83, it would still fall under the exclusion from patentability pursuant to A 53 c) (A 52(4) EPC 1973) because it defines a method wherein the core of the invention would reside in the claimed new use, i.e. the treatment of the human or animal body by therapy, without being directed to the previous manufacture of a medicament.

Thus the amendment underlying claim 1 of auxiliary request 23 has resulted in a change of category from a claim that was limited to a certain use of a product towards a claim comprising the previous manufacture of this product.

When examining of a change of category of claims complies with the requirements of A 123(3), one has to compare the scope of protection offered by the claim category of the previous version of the claim to the scope of protection of the new claim category that has been introduced by the amendment (G 2/88 [4.1]) As far as the scope of protection of a manufacturing claim is concerned, as compared to [the scope of protection of] a use claim, the EBA has made the following statement in its decision G 2/88, considering in particular A 64(2):

“A 64(2) is not directed to a patent whose claimed subject-matter is the use of a process to achieve an effect (this being the normal subject of a use claim): it is directed to a European patent whose claimed technical subject-matter is a process of manufacture of a product; the Article provides that for such a patent, protection is conferred not only upon the claimed process of manufacture, but also upon the product resulting directly from the manufacture.

Thus, provided that a use claim in reality defines the use of a particular physical entity to achieve an “effect”, and does not define such a use to produce a “product”, the use claim is not a process claim within the meaning of A 64(2).”

It follows that the manufacturing method claimed in claim 1 of auxiliary request 23, considered according to its content extends beyond the scope of protection of the use claims as granted: Pursuant to A 64(2), when a claim is directed to a manufacturing method, the protection conferred extends to the “products” (of whatever kind they may be) of the method, whereas a use claim does not include the manufacture of the pharmaceutical product (G 1/83 [11]) and its scope of protection, therefore, does not extend to the product that is directly obtained by the method. Therefore, the requirements of A 123(3) are not fulfilled.

Auxiliary request 24

1. Monophasic dosage form comprising

0.015 to 0.020 mg of ethinylestradiol;

and a gestagen selected from

0.05 to 0.075 mg of gestodene,

0.075 to 0.125 mg of levonorgestrel,

0.06 to 0.15 mg of desogestrel,

0.06 to 0.15 mg of 3-ketodesogestrel,

0.2 to 0.3 mg of norgestimate, and

> 0.35 to 0.75 mg of norethisterone,

for contraception for a woman of fertile age who has not yet reached the premenopause, by administering the dosage form for 23 or 24 days, starting on day one of the menstrual cycle, followed by 5 or 4 pill-free or placebo pill days, for a total of 28 days in the administration cycle.

[15.1] In auxiliary request 24 the Swiss-type claim form of claim 1 of auxiliary request 23 was transformed into the corresponding purpose-limited product claim (zweckgebundener Produktanspruch), with reference to A 54(5) EPC 2000.

As far as the applicability of A 54(5) EPC 2000 to the present case is concerned, it has to be taken into account that the opposed patent was granted on November 2, 2006, i.e. before entry into force of the EPC 2000. According to the transitional provisions applicable to the EPC 2000, A 54(5) is not to be applied to European patents that had been granted before the entry into force of the EPC 2000 (see OJ EPO 2007, Special edition n° 1, table on page 217).

Apart from the fact that A 54(5) EPC 2000 is not applicable in the present case, which means that a claim wording of the “purpose-limited substance claim” (zweckgebundener Stoffanspruch) type would only be admissible for the first medical use, the transformation of the use claims 1 to 8 of the patent as granted into a purpose-limited product claim corresponds to an extension of the scope of protection that is inadmissible pursuant to A 123(3). This is because the latter is directed to the product itself, which means that the manufacture of the product is comprised in the scope of protection of this claim type, which is not the case for a use claim (see point [14.2]).

[15.2] Concerning the determination of the scope of protection of product claims 9 to 19 as granted and its comparison with claim 1 of auxiliary request 24, which is needed for examining whether there is an inadmissible extension within the meaning of A 123(3), the Board refers to point [14.1], which also applies to the subject-matter of claim 1 if auxiliary request 24.

[15.3] Thus the subject-matter of claim 1 of auxiliary request 24 does not comply with the requirements of A 123(3). […]

The patent is revoked.

To read the whole decision (in German), click here.

To have a look at the file wrapper, click here.

(*) This decision is going to be published in the OJ, so a better translation will become available.

T 822/07 – Bulb Fiction

Making a great discovery is one thing. Transforming it into a valid patent is quite another, as can be seen in the present decision, which deals with a refusal of an application by the Examining Division (ED). As we will see, the applicant fell into the insufficiency trap.

Claim 1 before the Board read as follows:

A glucocorticoid receptor antagonist (GRA) for use in treating mild cognitive impairment (MCI) in a patient suffering therefrom to prevent or slow further memory impairment, wherein the patient is 45 years or older and has normal levels of cortisol for a human population of that age, wherein the patient meets the following criteria :

(i) obtains at least one perfect score on the Folstein Mini Mental Status Exam in three administration of said Exam;

(ii) receives a rating of 0.5 on the Clinical Dementia Rating Scale, and

(iii) scores 1.5 standard deviations or more below the age- and education-adjusted normal value on a paragraph recall test;

wherein the GRA preferentially binds to the GR rather than the mineralcorticoid receptor (MR) at a rate of at least 100-fold.

The appellant submitted that claim 1 was drafted as purpose-delimited medical use claim. Thus, the claim sought protection for the use of any thinkable (i.e. known and/or unknown substances) GRA, which preferentially bound to the glucocorticoid receptor (GR) rather than to the mineralcorticoid receptor (MR) at a rate of at least 100-fold, for the treating mild cognitive impairment (MCI) in a particular group of patients. The specific subgroup of patients defined in the claim was suffering MCI, which was a disease on its own right.

Questioned by the Board, whether the treatment defined in claim 1 encompassed the treatment of MCI independently from its cause, meaning that the treatment claimed also encompassed the treatment of patients who had suffered from a stroke (without diagnostic), or suffering an untreated diabetes condition, hormonal imbalance (brain fog) etc., the appellant answered that it did.

The appellant further contended that the application concerned a “break-through invention” and that claim 1 was not a reach-through claim, since the claim was not a compound “per se” claim looking for absolute product protection. The “invention” lay on the function of the substances for a particular use. The gist of the invention was the fact that the antagonist blocks GR for its natural ligand. The present invention was like a “light-bulb invention”, it came as a conclusion of observations in a variety of places in relation to the compound mifepristone, which is representative for the GRA group. That was the proof that the principle worked …

[2.1] A 83 requires that the European patent application discloses the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

It is to be reminded that the content of the whole patent application including the description and the examples, has to be investigated by the skilled person in the light of the general common knowledge of the technical field involved. It is the claimed “invention” which has to be investigated. The general legal principle is that the claims define the matter for which protection is sought and the examples illustrate specific ways of performing the invention.

As for the amount of technical detail needed for a sufficient disclosure, this is a matter which depends on an assessment of the facts of each particular case, such as the character of the technical field, and the actual technical detail disclosed.

The presently claimed “invention” is based on an alleged new and inventive medical use of an infinite number of compounds, which encompass known and unknown substances, defined by their function as a glucocorticoid receptor antagonist (GRA) (binding preferably, by a factor of about 100-fold higher, to the glucocorticoid receptor (GR) rather than to the mineralcorticoid receptor (MR)). The medical use concerns the treatment of mild cognitive impairment (MCI) independently from its aetiology (except from the exclusion of Cushing’s syndrome) in a particular patient subgroup which is characterised by including relatively young patients (45 years or older), not suffering from dementia (delimited in the claim by the criteria (i) to (iii)) and having normal levels of cortisol (for a population of that age). The technical effect specified in the claim is “to prevent or slow further memory impairment”.

Thus, the “invention” claimed in the main request addresses the general principle that each and every GRA (binding preferentially to GR rather than to MR) is able to prevent or slow further memory impairment in the particular subgroup of patients defined in the claim, independently from the cause or origin of its cognitive impairment. Thus, there are two aspects to be investigated in relation to sufficiency of the claimed “invention” which concern the biochemical basis regarding the definition of the substance to be used as GRA (binding to GR rather than to MR) and the medical basis relating to the choice of a particular subgroup of patients to be successfully treated. These two aspects require sufficient disclosure for a credible functional link to the technical effect claimed, which is to prevent or slow further memory impairment in the particular group of patients.

An inspection of the description of the application as filed shows the following passages, which have been cited by the appellant as a basis for the complete disclosure. In the general introduction, where the background is dealt with, it is stated:

“Cortisol, which is secreted in response to ACTH (corticotropin), shows circadian rhythm variation, and further, is an important element in responsiveness to many physical and psychological stress. It has been proposed that, with age, the cortisol regulatory system becomes hyperactivated in some individuals, resulting in hypercortisolemia. It has additionally been postulated that high levels of cortisol are neurotoxic, particularly in the hippocampus, a brain structure that is thought to be central to the processing and temporary storage of complex information and memory” […].

On page 3, first paragraph, it can be read:

“There has been no evidence prior to this invention, however, that a glucocorticoid receptor antagonist can be an effective treatment for memory impairment in a mature population, especially in patients having cortisol levels that fall within a normal range”.

This statement is followed by further comments about patients in which the cortisol levels increase and about those “mature individuals who have experienced an aging-associated increase in basal cortisol levels” who “can have a level of glucocorticoid receptor activity that, with time, directly or indirectly results in impaired memory function”. However, claim 1 of the main request addresses the treatment of young patients (45 years or older) with normal levels of cortisol for their age. Therefore, the mentioned passages of the description do not disclose the intended effects and functions claimed.

Additionally, at the end of the first paragraph on page 3, the compound RU486 (mifepristone) is identified as being one GRA which does not antagonise MR functions, and thus it is mentioned to be an appropriate substance for the use according to the “invention”. However, further on page 3, lines 20-21, it is stated:

“There have been no studies, however, that have shown that RU486 can improve memory function”.

The next paragraph on page 3 […] includes the mere statement that:

“The present inventors have determined that glucocorticoid receptor antagonists such as RU486 are effective agents for specific treatment of age-associated memory impairment that is not affiliated with dementia in mature patients with normal cortisol levels”. This statement has only a declaratory nature.

As regards the detailed description of the claimed “invention”, the description does not contain any model disclosing the alleged improvements in memory function attained by the use of the GRA. Neither a model based on biochemical or pharmacological in vitro assays, nor an animal model showing any beneficial effects on memory for the GRA, can be found in the description. There is also no disclosure relating to any in vivo assays, or clinical assays, irrespective of the group of MCI patients to be treated. In particular, there is a lack of disclosure in relation to the intended technical effect for the subgroup of younger patients with normal cortisol levels defined in claim 1. The statements relating to the “selective” blockade of GR by the substance to be used, without affecting the MR in order to avoid undesirable effects, are insufficient for providing a clear and complete disclosure in relation to the claimed beneficial effects on memory function in the intended medical treatment of the particular group of patients suffering from MCI.

In fact, the whole description is devoid of any data which could have served to fill the gap of an insufficient disclosure. Although part number 4, […] is dedicated to “Treatment of MCI using the glucocorticoid receptor antagonists” it does not contain any specific information relating to the claimed “invention” but only refers to the general knowledge known in the pharmaceutical field for physically providing pharmaceutical formulations and dosage forms for medical use.

It has to be kept in mind that the claimed “invention” relates to a particular medical use linked to an intended technical effect for which sufficient support and disclosure should have been provided in the description.

The only passage cited by the appellant, when asked directly by the board during the oral proceedings, was the following:

“In one embodiment, the methods of the invention use agents that act as GR antagonists, blocking the interaction of cortisol with GR, to treat or ameliorate MCI” […].

This teaching is clearly insufficient for a clear and complete disclosure of the general principle claimed, which relates to the prevention of memory impairment, or retardation of further memory impairment, in MCI patients of 45 years (or older), independently from aetiology (apart from the exclusion of patients suffering from Cushing’s syndrome) and which have normal levels of cortisol for their age.

Even if considering in favour of the appellant that the description of the application as filed establishes the existence of a link between high levels of cortisol and cognitive impairment, including memory function, in the light of which the suitability of using a GRA devoid of MR activity would appear plausible, there is still a lack of sufficiency of disclosure of the “invention” claimed. The claimed “invention” for which sufficient disclosure is lacking concerns the treatment of younger patients with normal cortisol levels, suffering mild cognitive impairment deriving from unknown causes. Moreover, there is a further lack of disclosure for the technical effect relating to a memory function improvement and/or preservation in those patients. In this respect the description rather invites the skilled person to perform a scientific research program than contains a complete disclosure of the “invention” within the sense of A 83.

Therefore, the main request does not meet the requirements of A 83.

Since the main request fails for lack of sufficiency of disclosure (A 83) in relation to the medical treatment specified by means of the technical effect on a particular group of patients, it is not necessary to further investigate the broad functional definition given in claim 1, for identifying the compounds to be used, within the sense of A 84 (clarity and support in the description) and A 83 (in relation to the method for determining the GRA activity).

As regards the appellant’s argument that the claimed invention is based on several observations in different places, unfortunately, these are not part of the content of the description.

Additionally, the argument that after the present “invention” all the development went in the sense predicted in the application, had been already answered with the board’s communication sent on 29 June 2010. With said communication the board informed the appellant that, in view of the fact that the documents it had filed with its letter of 13 May 2010 have been published several years after the effective filing date of the application in suit (one of them more than nine years later), they could not serve as a basis for defining the knowledge of the skilled person at the time of the invention, nor could they be used to fill the gap of the specification in the application in suit in order to ensure a sufficient disclosure within the meaning of A 83.

In relation to the alleged plausibility of the existence of a preventive beneficial effect on memory preservation owing to the hindrance of the binding of the natural ligand cortisol to GRs in the brain, a straight line should be drawn between the establishment of a scientific hypothesis or theory, which encourages scientific research to prove or disprove it, and the requirements for a clear and complete disclosure under A 83 justifying a broad patent protection, and its corresponding monopoly, for a particular medical use of an infinite number of compounds.

Should you wish to read the whole decision, just click here.

The file wrapper can be found here.

T 1549/07 – What’s In Is In (*)

Thought everything had been said on late filed grounds for opposition? Well, perhaps not.

The present case deals with an opposition that had been rejected by the Opposition Division (OD). But let us have a closer look at the proceedings that led to this verdict.

When filing its notice of opposition, the opponent raised objections under A 100 (a), all based on one single document D1.

In its summons to oral proceedings (OPs) the OD referred only to grounds of opposition under A 100 (a).

In a written submission dated February 12, 2007, the opponent introduced documents D2 and D3. It explained that those documents disclosed the very same methods and, therefore, products as the opposed patent and added:

“In case this is contested, the question arises whether there is [reason to raise] a ground for opposition pursuant to A 100 (b) because the disclosure is insufficient.”

In its response dated April 27, 2007, the patent proprietor contested that the methods according to D1, D2 and D3 would necessarily lead to a product according to the opposed patent. It further stated:

“Therefore, it is not necessary to examine the ground for opposition pursuant to A 100 (b). Moreover, no such ground was formulated (aufgeführt).”

In its letter of June 28, 2007, the opponent state once more that in case the arguments of the patent proprietor in favour of novelty were accepted, then “the ground for opposition pursuant to A 100 (b) [would have] to be examined”. It also submitted results of studies (referred to as “VB1”) intended to show that the claimed effect was not reached under the conditions of example 1 of the opposed patent.

As already mentioned, the OD dismissed the opposition.

In its statements of grounds of appeal, the opponent contested the way in which the OD had dealt with the questions of insufficient disclosure, novelty and inventive step.

In its response, the patent proprietor requested the Board not to deal with the ground for opposition pursuant to A 100 (b).

In what follows the Board tackles this problem.

*** Translated from the German ***

Ground for opposition pursuant to A 100 (b)

[1] This ground for opposition was not raised within the time limit for filing an opposition and, therefore, has to be considered as belated. This also holds true for the VB1 data.

[1.1] In its opinion G 10/91, the Enlarged Board of appeal (EBA) […] has found that exceptionally, the OD may, in application of A 114(1), consider other grounds for opposition which, prima facie, in whole or in part would seem to prejudice the maintenance of the European patent. Moreover, it was decided in decision T 1002/92 that late filed evidence and corresponding arguments were to be admitted into the proceedings in exceptional cases only, if prima facie relevant reasons suggested that the late filed documents would prejudice the maintenance of the patent.

Therefore, the Board of appeal notes that in principle the OD had the right to admit or introduce, respectively, both the new ground for opposition pursuant to A 100 (b) and the late filed data VB1 into the proceedings, even during the OPs.

[1.2] However, the case law of the Boards of appeal of the EPO has established that when new grounds for opposition are introduced into the proceedings by the OD, this has to be done in such a way that it is ensured that the proprietor is informed not only of the new ground for opposition (i.e. the new legal basis for the opposition), but also of the legal and factual reasons (i.e. its substantiation) that substantiate the new ground: the patent proprietor has to be fully informed of the case which he has to meet, and have a proper opportunity to present comments and to prepare an appropriate defence against the new grounds for opposition (see Case Law, 6th edition, VII-D 3.2.3 c) i)). In particular, the stages (Phasen) of admission/introduction and assessment/substantiation should be treated. In principle, the parties should be informed on the new objections in writing, as soon as possible (T 433/93; T 1164/00; T 64/03).

[1.3] In the present case the Board notes that the late submission and the admission of the new ground for opposition into the proceedings have not been mentioned in writing or orally. The OD has not mentioned those matters in its notification of June 2, 2006, and has never informed the patent proprietor during the opposition proceedings that it intended to introduce this new ground. In particular, it can be seen from the minutes of the OPs before the OD […] that the discussions concerned exclusively the substantiation of the ground for opposition pursuant to A 100 (b). The discussions were terminated after a pause for deliberation by the OD, via the announcement of the decision that the requirements of A 83 were fulfilled. In other words, the OD simultaneously informed the patent proprietor on the – implicit – admission of the ground for opposition pursuant to A 100 (b) and its unsuccessfulness. The late submission of the ground for opposition pursuant to A 100 (b) and of the VB1 data during the opposition proceedings has never been criticized by the patent proprietor. It can be seen from both the minutes […] and the decision […] that the patent proprietor had the possibility to comment on this ground for opposition (A 113(1)), but on the other hand, neither the decision nor the minutes of the proceedings contain indications as to which criteria and reasons determined the decision of the OD when it exercised its discretion to admit the ground for opposition pursuant to A 100 (b) and the experimental data VB1, which were filed belatedly in order to substantiate this ground for opposition, into the proceedings and whether the OD has indeed weighed the pros and cons of whether it should exercise its discretion. Considering the late submission of new legal and factual elements (rechtlicher und tatsächlicher Sachverhalte), it would have been necessary to expose the considerations that appeared relevant when weighing the pros and cons […] The question of whether the first instance has exercised its discretion according to the wrong principles, or without taking into account the right principles, or in an unreasonable way can be examined by the Board of appeal (cf. Case law, 6th edition, VII-E 6.6).

[1.4] In the present case the Board has to note that the decision to introduce the new ground for opposition pursuant to A 100 (b) and to admit the VB1 data has not been justified by the OD. Therefore, the Board cannot examine which criteria were decisive for the OD’s introduction of the new ground for opposition as well as the VB1 data. Thus, the question arises whether there has been a substantial procedural violation which justifies that the decision be set aside and the case be remitted to the first instance (cf. Article 11 RPBA). As far as this question is concerned, the Board is clearly of the opinion that the insufficiently reasoned decision of the OD constitutes a procedural violation, but that it was never criticized during the OPs and has not led to a decision that adversely affects the patent proprietor. In view of this, a remittal to the first instance based on this reason only would not make any sense.

Request of the [patent proprietor] concerning A 100 (b)

[2] The [patent proprietor] has requested that “the ground for opposition pursuant to A 100 (b) not be dealt with any more”.

[2.1] The EPC does not contain any provisions, nor does [the Board] know any other regulations (in contrast to the request to exclude certain documents from file inspection, for example) allowing to grant such a request aiming at excluding from the proceedings, at the appeal stage, a ground for opposition that has been introduced into and discussed in the proceedings. This way of proceeding has no legal basis and would violate the right of the opponent to have the competent department of the EPO examine the grounds for opposition which it has raised and which have been introduced – perhaps, wrongly (zu Unrecht) – into the proceedings (A 101(1)).

[2.2] Quite to the contrary, the Board is of the opinion that this request is inadmissible, for the following reasons:

[2.2.1] According to R 100(1) the provisions relating to proceedings before the department which has taken the decision impugned – here, the OD – shall apply to appeal proceedings, unless otherwise provided. In the present case, pursuant to A 101(1), the OD had the duty to examine, in accordance with the IR, whether at least one ground for opposition under A 100 prejudices the maintenance of the European patent.

[2.2.2] Normally, the OD only examines the grounds for opposition which have been duly submitted and substantiated, pursuant to A 99(1) together with R 55 c) EPC 1973, i.e. in the present case, A 100 (a) together with A 54 and A 56.

[2.2.3] However, in the present case the OD has decided to admit the ground for opposition pursuant to A 100 (b) into the proceedings, which, as has already been explained, is possible in application of A 114(1). […]

[2.2.4] This decision of the OD has the consequence that the ground pursuant to A 100 (b) is not a “fresh ground” within the meaning of the opinion G 10/91 of the EBA. As a matter of fact, in decision G 1/95 [5.3] the EBA has declared that when opinion G 10/91 used the term “fresh ground for opposition” it intended to refer to a ground for opposition

“which was neither raised and substantiated in the notice of opposition, nor introduced into the proceedings by the OD in application of A 114(1) and in accordance with the principles set out in G 10/91 [16]”.

NB: Why do the Boards so often cite G 10/91, which is an empty shell referring to G 9/91? To find the reasons, you have to go to G 9/91.

Consequently, as there is no “fresh” ground for opposition within the meaning of opinion G 10/91 in the appeal proceedings, there is no need for the approval of the patent proprietor in view of the introduction of the ground for opposition pursuant to A 100 (b).

Thus the OD’s admission of the ground for opposition pursuant to A 100 (b) constitutes a new, additional legal basis with respect to the legal basis indicated in the notice of appeal (A 100 (a)); the opposition is now based on these grounds.

[2.2.5] Moreover, the EBA has made the following statement in its opinion G 10/91:

“The purpose of the appeal procedure inter partes is mainly to give the losing party the possibility of challenging the decision of the OD on its merits. It is not in conformity with this purpose to consider grounds for opposition on which the decision of the OD has not been based.”

It should be noted that the impugned decision has dismissed the opposition and has maintained the patent unamended. Therefore, the patent proprietor has not been a “losing” party that could contest the decision of the OD. The fact that the OD has insufficiently reasoned its decision on the admission/introduction of the late filed ground for opposition does not alter this fact. In particular the Board of appeal is not entitled (befugt) to set aside this decision for this reason, the decision of the OD not having led to a final decision by which the patent proprietor was adversely affected.

Quite to the contrary, as the OD has carried out an examination of the ground for opposition pursuant to A 100 (b), as the impugned decision has dealt with (sich auseinandersetzen) the belated ground of appeal in detail […] and as the [patent proprietor] has elaborated on this topic in its statement of grounds of appeal, the Board is clearly of the opinion that it is necessary for it to comment on this ground for opposition.

[2.3] To sum up, the ground for opposition pursuant to A 100 (b) has been admitted into the proceedings by the OD and, therefore, is part of the impugned decision. Thus the ground for opposition pursuant to A 100 (b) has to be further examined by the Board of appeal and the request of the [patent proprietor] “not to deal any more” with this ground has to be dismissed by the Board of appeal.

The Board then examined the evidence filed by the opponent (both the VB1 data and additional evidence VB2 filed during the appeal proceedings) and found that the factual situation had completely changed. It then pursued:

[4] The present case corresponds to a somewhat unusual situation: although the new ground for opposition pursuant to A 100 (b) and the trials VB1 that had been filed belatedly by the [opponent] had been admitted into the proceedings by the OD, the OD has decided that the VB1 data did not sufficiently substantiate this ground. Thus the invention of the impugned patent was considered to have been sufficiently disclosed. Consequently, the decision of the OD to admit a late filed, supposedly prima facie highly relevant, but finally unsuccessful ground for opposition, appears not to adversely affect the patent proprietor at first sight […] However, the present case shows that this decision of the OD can entail very serious, negative consequences for the patent proprietor and could even cause the revocation of the patent, in the worst case scenario for the patent proprietor.

This being said, the patent proprietor has not criticized the legitimacy (Rechtmässigkeit) of this admission during the opposition proceedings. Moreover, as the opposition was rejected, the patent proprietor had no possibility to file an appeal against this decision (A 107). However, the opponent could do so and use the appeal proceedings to further substantiate the late filed ground for opposition with new and more relevant evidence, and it has done so by filing VB2. Thus the opponent has been allowed, at a very late stage of the proceedings, well beyond the time limit for filing an opposition, to significantly extend the framework of the factual reasons for the opposition, and, consequently, its factual submissions (Sachvortrag).

Therefore, it is particularly appropriate in this situation to remit the case to the first instance pursuant to A 111(1) in order to ensure that the [patent proprietor] is not deprived of an instance for examining this late submission.

To read the whole decision (in German), click here.

To have a look at the file wrapper, click here.

(*) Austrian subtitle: Wos ligt des pickt.

T 143/06 – Clear & Close

Independent claim 1 of the main request read:

An uncoated nanocomposite dense sintered silicon carbonitride ceramic cutting tool, obtainable by cold pressing a spray-dried flowable granulate of a nanosized powder of α-Si3N4 and SiC, the mean particle size of α-Si3N4 and SiC being lower than 200 nm, containing an amount lower than 30% by weight of nanosized SiC particles, in the presence of an amount of from 3% to 6% of sintering aids Y2O3 and Al2O3 and of further additives consisting of polyethylene glycol with a molecular weight ranging of from 400 to 12000, by sintering the so obtained pressed products at a temperature of from 1800°C to 1900°C, for a time of from 0.5 to 2 hours and with an over-pressure of inert gas to a product having density close to the theoretical maximum and by machining the cutting tool from the so obtained sintered near net shape blank.

The Examining Division (ED) had found the expressions “close” and “near” to be unclear. The Board comes to a different conclusion:

Clarity of the claims (A 84)

[11] It has to be decided, whether the following features are sufficiently clear within the meaning of A 84, or not:

(i) a density “close to the theoretical maximum”;

(ii) “the sintered near net shape blank”.

[12] As to the first feature, the board notes that neither the claims nor the description contain an indication, how close the density is in respect to the theoretical maximum.

[12.1] According to the description, the sintered blanks are characterised by high densities […]. Such high densities are achieved by using the process for preparing the cutting tools set out in claims 1 and 7, respectively, particularly by cold pressing of the spray-dried flowable granulate of a nanosized powder of α-Si3N4 and SiC in the presence of Y2O3 and Al2O3 as sintering aids, followed by gaspressure assisted sintering […]. It has been found that the sintered blanks thus obtained have densities which are close to the theoretical maximum, which means that they contain little or no porosity […].

In the case of example 1, a value of 3.26 g/cm3 or “nearly 100 % of the theoretical full density” was achieved […]. Compared to the theoretical full density of 3.27 g/cm3, i.e. the theoretical density of a product having no porosity at all, this corresponds to about 99.7 % of the theoretical maximum […].

In example 2, nearly the identical result was obtained […], whereas in example 3, a density of “>98.5%”, i.e. at least 98.5 % of the theoretical maximum was found […].

[12.2] Ideally, the product of the sintering step is free of pores, so that a density of 100 % of the theoretical maximum is achieved. In practice, it will hardly be possible to reach the theoretical maximum. Minor deviations towards lower values will occur and may be tolerated, as long as the densities are “close” to the theoretical maximum. The examples 1 to 3 provide specific information on acceptable densities in terms of percents of the theoretical maximum, namely 99,7 % (examples 1 and 2) and > 98.5 % (example 3). In particular, the density of > 98.5 % in example 3 has to be regarded as representing a specific value, which is sufficiently close to the theoretical maximum of 100 %, to be qualified as acceptable.

In example 1, it is stated that after analysis and characterisation, the product was “found to be fully dense (nearly 100% of the theoretical full density) and pore free” […]. Thus, the density of the product is a functional feature of the process conditions and, as such, inextricably linked to these conditions. The density of the sintered product, which is obtained whenever the claimed process is carried out, is a property of said product, as opposed to the features of the process as such. In other words, it is a technical effect or a function of the process steps set out in claims 1 and 7, respectively.

Having regard to the specific densities obtained in examples 1 to 3, and in the absence of any evidence to the contrary, the board is of the opinion that it is justified to assume that, whenever the process features set out in claims 1 and 7 are put into practice, the resulting densities of the products will reach values of some 98.5 % or more, compared to the theoretical maximum. Such high values may be regarded without difficulty as being “close to” 100 %.

[12.3] In the board’s view it would not be appropriate to restrict the scope of the claims by defining a fixed numerical value of the minimum density, since the effect of the density on the mechanical properties of the sintered products is gradual.

In this respect, the examples 1 and 3 are informative: Whereas the product of example 1 with its density of about 99.7 % of the theoretical maximum gave rise to a hardness HV5 of 1785 ± 25 and a Palmqvist toughness of 7.0 ± 0.7 MPa m1/2, the somewhat reduced density of roughly 98.5 % of the theoretical maximum of the product of example 3 led to a hardness HV5 of 1552 ± 26 and a Palmqvist toughness of 6.5 ± 0.7 MPa m1/2 […]. Under these circumstances, the relative term “close to the theoretical maximum” can be considered as sufficiently clear in the context of the application read as a whole. Therefore no objection of lack of clarity arises under A 84.

[13] Another issue, which has to be examined, is whether the expression “the sintered near net shape blank” has a sufficiently clear meaning within the context of the present application, or not.

In this respect, the appellant referred to page 9, lines 3 to 7 of the description, where it is stated that in order to obtain a cost-effective manufacture of ceramic cutting tools, production of “near net shape items” is required.

What is meant by the term “near net shape” can be derived from the following explanation contained in the description:

“For the preparation of cutting tools meeting the dimensional specifications laid down in the standard ISO products, hard metal dies of appropriate geometry and dimensions are used such that the parts after sintering are of dimensions larger, by a controlled amount, than the required final tool dimensions in order to allow for machining to precise final dimensions” […].

[13.1] For practical reasons the amount of machining, which is required for bringing the sintered blanks into the final dimensions, is kept to a minimum in order to achieve an effective manufacture of the cutting tools, while avoiding unnecessary loss of material. Therefore the sintered blanks are only slightly oversized. This is illustrated by example 4, where special care was taken to adjust the size of the pressing die and the pressing pressure to the shrinkage characteristics of the powder during firing,

“such that slightly oversized cutting tool blanks were produced appropriate for the accurate diamond grinding of the standard tool geometry” […] (emphasis added by the board).

[13.2] Consequently, the term “near net shape” has to be construed to mean that the dimensions of the blanks are only slightly larger than the precise final dimensions of the cutting tools. Such a definition is in conformity with the recognised terminology in the technical field of ceramics.

It concurs also with relevant handbooks, for example the “Dictionary of Ceramic Science and Engineering” (H1), referred to by the appellant. There, the following definition of the term “near net shaping” is given: “Forming process designed to limit the amount of final grinding and polishing needed to meet specification” […] (emphasis added by the board).

[13.3] Having regard to the considerations set out above, it is clear that, although it is desirable to limit the amount of final machining, the degree of oversizing of the blanks may vary within wide ranges.

In the board’s view, it is acceptable to define the oversizing in relative terms such as “near net shape”, particularly because the degree of oversizing has no impact on the essential properties of the claimed cutting tools, namely the mechanical characteristics.

[13.4] For these reasons the board is satisfied that the feature “the sintered near net shape blank” is sufficiently clear within the context of the present application, so that no objection of lack of clarity arises under A 84.

[14] In the decision under appeal, the ED argued that the range of 50 to 200 nm for the particle size of the starting powder forms part of the essential features. Therefore, said range should have been included in the independent claims relating to the cutting tool and the process for its preparation. In this respect, the ED relied on a statement made by the applicant (now the appellant), according to which the present application teaches the preparation of an uncoated cutting tool material by using spray dried powder “obtained with raw materials based on silicon nitride - silicon carbide having a particle size distribution in the range of about 50-200 nm” […] (emphasis added by the board).

[14.1] The board notes that no corresponding statement is comprised in the application. In particular, nowhere in the application there is any disclosure of a lower limit of the particle size of 50 nm. According to claims 1 and 7, respectively, a “nanosized powder of α- Si3N4 and SiC, the mean particle size of α-Si3N4 and SiC being lower than 200 nm” (emphasis added by the board) is used in the spray-drying step.

[14.2] As far as the examples are concerned, it is indisputable that the treatment of the starting material in example 1 led to a nanosized powder having a mean particle size of α-Si3N4 and SiC lower than 200 nm, as required by claims 1 and 7, respectively […]. Nothing in example 1 or the remaining examples implies, however, that there was a lower limit of 50 nm of the particle size.

[14.3] It follows from the foregoing, that the statement made by the applicant in its letter […], according to which the silicon nitride and the silicon carbide have a particle size distribution in the range of “about 50-200 nm”, has to be regarded merely as an indication of a typical range of the distribution of the particle size. It cannot be derived from said statement, that the value of 50 nm represents the lower limit of the particle size of α-Si3N4 and SiC, let alone that this value is an essential feature of the claimed subject-matter.

[14.4] For these reasons the board is of the opinion that there is no need to include the feature of a range of 50 to 200 nm in the claims.

The board observes that, in any case, the specific range of 50 to 200 nm does not have a proper basis in the application as originally filed. Thus, its incorporation into the claims would contravene A 123(2).

[15] The board concludes that the set of amended claims 1 to 11 according to the main request, submitted together with the grounds of appeal, concurs with the requirements laid down in A 123(2) and A 84.

Boards also have generous days, huh?

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