Search This Blog

Labels

T 421/14 - Sufficiency for a composition with non-responders

No response for a subpopulation

How credible should evidence for a composition be? In this case, the opponent argued that the initial analysis of therapeutic efficacy lacked statistical significance. Only a post hoc analysis revealed a  significantly better response for a treatment group compared to a placebo group. Moreover, the effect only occurred in a subpopulation of responders, not for the general population. Is one allowed to claim a composition for a general group even if the majority are non-responders, or should one disclaim the non-responders?  

Another issue, was the public availability of two documents C30 and C31.  C30 was poster and C31 a slide show, both allegedly displayed at a public conference by the proprietor. Both were also included in the IDS statement for a corresponding US patent. Who should prove the public availability in this situation, and what is the appropriate standard?

A related case T 799/16 sharing some of its reasons with the present decision has also been decided. 

T 383/14 - Sufficiency of "only"


This opposition concerns a sorting table for sorting out the foreign bodies from harvested small fruit. The table has openings that will only let the small foreign objects pass through (de façon à laisser passer uniquement les petits corps étrangers). Elsewhere, there are openings that permit only berries to pass through (permettre le passage et la chute des baies de raisin à trier seulement).

The opponent questioned the sufficiency of the description with respect to  these features. The means shown in the description will at times also allow unintended objects to pass through; hence the shown means neither satisfy the 'uniquement' nor the 'seulement' requirement. Moreover, these terms are perfectly clear, so no interpretation based on the description should be allowed for them.

The board explains that the skilled person will try to reach an interpretation of the claims that makes technical sense, and that takes into account the whole of the disclosure of the invention in the patent. The sorting table allows sorting of foreign bodies that are either smaller or larger than the berries. That it is not "only" the grape berries that pass through the openings, did not convince the Board . This is not the realistic situation in which the reproducibility of the sorting needs to be shown, but rather that of an occasional failure perfectly foreseeable for a sorting machine. The claim is thus sufficiently disclosed.

That the disputed terms are clear in themselves is no objection, as they are used in claim which is to a certain point abstracted to an ideal situation. The skilled person will understand this. 

T 1811/13 - Can lack clarity imply lack of sufficiency?

Where exactly are the boundaries of the forbidden  area?

Can a lack of clarity in a claim lead to insufficiency of disclosure? The opponent tries to convert a clarity objection into a lack of sufficiency. The argument is that, the impossibility for the skilled person to know whether he is working within the forbidden area entails the impossibility of carrying out the invention.
To support the point a number of T decisions are cited which side with this argument. The board trumps it though with even more T decisions that do not agree. At the end, the board does concede though that in other situations this argument might work. 

T 2249/10 - Lack of sufficiency for combination of parameters




The  polyethylene composition in Claim 24 in this opposition appeal is defined by a combination of parameters. Claim 24 according to the main request reads (simplified and formatted)

An injection moulded pipe fitting comprising a polyethylene composition (...)
- the flow rate ratio FRR21/5 of the polyethylene composition (...)  is within the range of 15-28
- the melt flow rate MFR5/190°C of the polyethylene composition (...) is within the range of 0.5-1.1 g/10 min, 
- the composition has a shear thinning index (SHI) (...) within the range of 10-60 (...)

The proprietor had successfully argued that  the flow rate ratio and melt flow ratio ranges do not imply a shear thinning index within the claimed range. The application gives two examples 1 and 2 which do have the required parameters. Unfortunately, the board does not see how the preparation of these examples differs from that of the comparative examples.


The claim is rejected for lack of sufficiency.


Reasons for the Decision
1. The appeal is admissible.

T 943/13 - Not obvious as a food supplement



The opposition division revoked the following second medical use claim:

"1. A soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting and/or chronic muscle wasting and/or sarcopenia, the dietary fibre comprising at least 30 wt.% of oligosaccharides having a chain length of 3-10 anhydromonose units."

I understand that document D12 appears to disclose a soluble dietary fibre for use in the treatment or reduction of the incidence of muscle wasting which contains the required oligosaccharides. However, D12 does not disclose that the oligosaccharide prevents muscle wasting. On this basis the board finds the claim inventive. 

To be a bit pedantic, claim 1 does not actually say that it is the oligosaccharides that prevent the muscle wasting, but from the description this is clearly the purpose of including them. 

The board also devotes an interesting discussion to the sufficiency of this broad claim.

T 1164/11 - Use the force




This Examination appeal concerns a medical apparatus for cutaneous administration of medicaments, i.e., through the skin. The main claim in the appeal reads:
 
"A medical apparatus for cutaneous administration of medicaments comprising:
- a supporting frame (100);
- an energy emitter (9) in engagement with the frame (100) and active on the molecules of at least one medicament to cause penetration of same into a skin region to be treated (10); (...) said energy emitter (9) being an electromagnetic wave generator (11) emitting a laser light of a wavelength comprised in the range of 600 to 650 nm."

The board has its doubts whether such a electromagnetic wave generator can really  be  active on the molecules of a medicament to cause penetration into a skin region. The board  evaluates if there is a plausible explanation of the claimed effect and, in the absence thereof, the available evidence.

T 2431/11 - Meshing gear wheels


This opposition appeal deals with sufficiency of disclosure for a mechanical invention. Claim 1 of the main request in this opposition appeal read as follows:



A gear wheel with a plurality of teeth capable of meshing with the teeth of another corresponding gear wheel, characterised in that the profile of each tooth falls within a band of tolerance of ± 1 /20th of the depth of the tooth (H) with respect to a theoretical profile similar to a profile defined by a natural spline function passing through a plurality of nodal points having pre-established coordinates {X, Y}, expressed in a system of Cartesian coordinates having their origin at the centre (O) of the the pitch circle (P) of the gear wheel, corresponding to tables 1 to 6, also given below, for gear wheels with a number of teeth equal respectively to five, six, seven, eight, nine and ten:

The board is unhappy with this claim and the corresponding description for two reasons. It appears that the gear defined by a spline through these points would not produce a working gear, and that the claim puts an undue burden on the skilled person to select working gears within the band of tolerance.



Reasons for the Decision

2. Background

2.1 The patent concerns gear pumps having a driving and a driven gear wheel, specification paragraph [0001] and [0002]. In this context the gear wheels must mesh without encapsulation, that is without trapping fluid in cavities between interlocked teeth, (specification paragraphs [0004] and [0005]).

To this end claim 1 as granted proposes a gear wheel having a plurality of teeth with particular tooth profiles falling within a tolerance band about a theoretical tooth profile. The theoretical tooth profile is similar to a profile defined by a natural spline function passing through a plurality of nodal points tabulated for five, six, seven, eight, nine and ten toothed gear wheels respectively. The term "natural spline function" commonly refers to the piece-wise polynomial function resulting from spline interpolation of a set of known data points, where each of intervals defined between successive data points is interpolated by a respective polynomial function that passes through the interval's end points such that it is twice differentiable in those points. For a natural spline function the polynomials are cubic and together form a set of cubic polynomials, one for each interval between nodes where the nodes define their end points, and where adjacent polynomials have the same slope at their common node.

2.2 The gear wheel claimed is also limited by the functional feature that it must be capable of meshing with a corresponding gear wheel. Giving the terms their normal meaning, gears mesh when, viewed in profile, the flank of a driving gear's tooth profile contacts that of the driven gear, at a single point which moves as the two flanks roll over one another until they separate.

(...)

4. Sufficiency of disclosure

4.1 Article 83 EPC requires that 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.

4.2 According to established jurisprudence, an invention is sufficiently disclosed if it can be
performed by a person skilled in the art in the whole area claimed, using common general knowledge and taking into account further information given in the description of the patent or patent application, see the Case Law of the Boards of Appeal of the EPO, 7th edition, 2013 (CLBA hereinafter) II.C. introductory portion.

Furthermore, the skilled person must be able to perform the invention without undue burden. Where the skilled person can only establish by trial and error whether his choice of numerous parameters will provide a satisfactory result, this amounts to an undue burden, see CLBA II.C.5.6 and 5.7.

4.3 As explained above, a key element of claim 1 is the theoretical tooth profile (one each for 5-10 tooth gears) that is similar to the profile defined by a natural spline function passing through the tabulated data points.

The decision under appeal found that the resultant profiles using all data points were so irregular that they would not practically mesh, as required by the claim, nor prevent encapsulation. It further held that if, as argued interpolation was only through selected but not all of the tabulated points, this would put an undue burden on the skilled person.

4.4 Contrary to what was argued before the opposition division (cf. decision, page 7, second paragraph) and until recently in appeal (cf. Meneghello, page 8, 2nd paragraph, last sentence), the appellant in the oral proceedings before the Board argues that the spline function profile does pass through all the points of a given table in the claim, and that the resultant profile will mesh and prevent encapsulation. Insofar as the profile passing through all points is concerned the Board can agree with such a reading of claim 1. This reading corresponds to the skilled person's understanding of "natural spline function" (see above) in relation to "a plurality" of nodal points which contextually can only be the plurality given in the table. This point is thus no longer in dispute between the parties.

4.5 It is also undisputed that, based on the nodal points listed in claim 1, parts of the theoretical profiles claimed undulate, that is when set out in a graph these data points produce a profile that is irregular, i.e. that is not smooth but has considerable local variations. See for example figures 1 to 3 in Meneghello, or the tabulated points in the various figures of D18 Figure 1.

4.6 The only point in dispute is thus whether or not the resultant profile and band of profiles as defined in claim 1 can mesh, as required by the claim, and prevent encapsulation. The respondent has consistently argued that a profile passing through all points does not, and indeed from the appellant proprietor's initial response in opposition and appeal that not all points were meant it can be inferred that he initially agreed. In appeal the appellant now however expressly states that the main profile resulting from interpolation through all points does result in a meshing and non-encapsulating gear.

4.7 Normally, as explained in CLBA II.C.8, and in particular T 63/06, after the grant of the patent a legal presumption exists that the patent meets the requirements of the EPC. In order to establish insufficiency, the burden of proof is upon an opponent to establish on the balance of probabilities that a skilled reader of the patent, using his common general knowledge, would be unable to carry out the invention.

However, when the patent does not give any information as to how a feature of the invention can be put into practice, the presumption of sufficiency of disclosure is weak. The opponent can discharge his burden by plausibly arguing that common general knowledge would not enable the skilled person to put this feature into practice. The patent proprietor then has the burden of proof for the contrary assertion that common general knowledge would indeed enable the skilled person to carry out the invention.

4.8 In the present case the patent provides no information, by tests or otherwise, that would support the claimed meshing and non-encapsulating of the resultant gears. The patent, at specification paragraph [0011] mentions experiments that led to the identification of the tooth profiles, but the relevant data has not been included or provided subsequently in opposition or the following appeal. The respondent-opponent on the other hand has presented a plausible, substantiated case why there would not be meshing and non-encapsulating. Given further the varying positions of the proprietor-appellant in this point the Board concludes that there can be only a weak presumption of sufficiency in the present case, and that the onus now rests on the proprietor to prove sufficiency. In weighing the parties' submissions against each other he can therefore no longer enjoy the benefit of the doubt.

4.8.1 In the respondent's submission of 2 July 2012 in reply to the appeal, see page 5, reference is made to his submission in opposition dated 15 December 2010, in particular figures 1 and 1b which plot the data points of table 3 for a 7 toothed gear wheel (table 3 of the claim) having a pitch circle of approximately 11 mm and an outer diameter of approximately 19mm, that is for a gear wheel of typical dimensions. Further figures 2 to 15 of the same submission show the contact area between an enlarged section of the flank profile of the driving gear with the flank and the corresponding identical driven gear profile at various angles of rotation. It is evident that during rotation the profiles cross and overlap each other due the irregularity of the opposing flanks. He argues that since gear teeth cannot overlap, at worst they would not fit together, at best they would not mesh but touch at more than one point, thereby jamming and encapsulating fluid.

This was reiterated in D18, page 18, first paragraph, and further substantiated in D18 by calculating profiles and their so-called conjugates using natural spline functions applied to limited sets of the tabulated data points. A conjugate profile is derived from the main profile under condition of conjugation, that is that the normal to the instantaneous point of contact always intersects to centres of the two gears, D18, page 16, first paragraph. These limited set conjugates already exhibit unphysical anomalies, see D18, figures 5b, 6b, 7b, 8b/c, 9b/c and 10b/c, with interference as above also for these limited set profiles, see D18 figures 10c,d,e and 11c, and page 39, 5th and 6th paragraphs. Thus even for limited set approximations the irregularities and anomalies persist.

4.8.2 The appellant has argued that the irregularities in the profile are not significant enough to prevent meshing or cause encapsulation. The profiles would be based on measurements made on actual meshing and non-encapsulating gear wheels and fluctuations would merely result from measurement error and/or surface roughness.

The Board is unconvinced by this argument. Most importantly, it is in direct contradiction with the Meneghello report commissioned by the appellant himself, which at page 8, second paragraph, states that it is "not possible nor permissible to perform an interpolation passing through each of the digitized points [as] this .... does not allow to obtain a profile that meets the functional requirements" (in reference to the geometric-functional characteristics including meshing and conjugation mentioned on page 2). The tests or empirical data, or even the actual gear from which the measurement data is said to derive, and which might have proven his case, are lacking. Without such evidence the arguments that the irregularities would be insignificant and the profiles mesh and not encapsulate are nothing more than unproven assertions that can be of little weight.

4.8.3 Weighing the various submissions against each other - the respondent's substantiated arguments on the one hand, the appellant's varying positions and unsubstantiated assertions on the other - the Board decides that a gear with a profile defined by a natural spline function passing through all of the tabulated data points (or for that matter only through a limited set) will not mesh and will encapsulate, and thus fails to produce the desired, claimed effect of the invention. For this reason already the claimed invention is insufficiently disclosed.

4.9 In addition, the Board notes that the claim 1 does not define a single theoretical tooth profile (for each number of teeth), but also other profiles that lie in a tolerance band of +/-1/20th of tooth depth with respect to each theoretical profile. The band width corresponds to about 10% of tooth height. This figure, much larger than normal machining tolerances, represents a range of profiles as explained elsewhere in the specification and argued by the appellant: experiments on various gears reveal a "range of tooth profiles" (paragraph [0005]); and "...the actual tooth profile falls within a band of tolerance T ...", (paragraph [0011] and figure 1).

As submitted by the appellant, the profiles within this band are not different scaled versions of the basic profile defined by the data. The tolerance band is rather meant to encompass an unlimited number of tooth profiles of varying shape, as long as they give gears that mesh. Only profiles that meet this important functional limitation of the claim are to be protected.
The appellant acknowledges that there are some within the band that do not meet this requirement and should therefore be excluded from protection. Which profiles do and which do not meet this requirement would then, so the argument goes, need to be determined by trial and error.

4.9.1 The question therefore arises as to whether or not such trial and error does not constitute an undue burden on the skilled person for him or her to successfully carry out the claimed invention, see section 4.2 above.

4.9.2 The patent is silent as to how to distinguish a working profile from one that does not. One way would be to prototype, i.e. manufacture, the corresponding gears and measure meshing and encapsulation. Another alternative suggested by the appellant would be to generate the gears mathematically, or model them, using a variety of analytical techniques known to the skilled person, see e.g. the Meneghello report, page 8, last two paragraphs.

4.9.3 Given the myriad of possible profiles, and the effort involved in prototyping or modelling the corresponding gear, this is a daunting task. In particular, the Board holds that this would far exceed routine experimental work. For each possible profile the skilled person must prototype or model two gear wheels and investigate whether or not they mesh without encapsulation. This process of trial and error in the Board's view represents an undue burden for the skilled person.

4.10 In summary the Board concludes that on the balance of probabilities the main gear tooth profiles defined in claim 1, which are central to the invention, do not result in a working gear wheel. Furthermore, the skilled person would not be able to determine which of the remaining profiles within the tolerance band defined in the claim would result in working gears without undue burden. The invention according to claim 1 of the main request is thus insufficiently disclosed, Article 100(b) EPC with Article 83 EPC.

 
This decision has European Case Law Identifier: ECLI:EP:BA:2014:T243111.20140924. The whole decision can be found here. The file wrapper can be found here. Photo by Sergei Golyshev
obtained via Flickr.


T2403/11 - Bound by earlier reasoning and statements in application


This appeal decision relates to a discussion of insufficiency of disclosure in opposition proceedings. In this opposition proceedings, all requests were rejected because it was not well defined how the claimed "viscosity" could be determined. The Board also discusses this subject with reference to previous case law. Furthermore, in the appeal the patent proprietor tried to argue that viscosity was not an important feature of the claim, however, contradictory arguments were provided earlier and statements in the patent application seems to contradict the new line or arguments.



Citations from the decision:


Catchwords:
An ill-defined parameter in a claim may lead to insufficiency of disclosure if this parameter is relevant for solving the problem addressed in the patent (T 593/09 followed). If, in such a situation, the patent specification states that the ill-defined parameter is relevant and the patent proprietor initially argued along those lines, then, normally it cannot argue, later on in the proceedings, that this parameter does not matter (points 2.6.1 and 2.6.2 of the Reasons).

[...]


The opposition division's position can be summarised as follows:
None of the requests met the requirements of Article 100(b) EPC. It had not been substantiated that there was a particular method in the prior art which had to be used to determine the viscosity. The skilled person was therefore faced with a number of choices as to which procedure to use, choices which influenced the outcome of the measurement. While claim 1 specified which temperature had to be employed, further conditions such as the selection of the viscosimeter, as well as the container used and the sample pre-treatment, had to be selected and there was no unambiguous instruction on these choices. In fact, given that D10 (section 11 "Report") specified that these conditions had to be controlled, the skilled person would infer that these conditions had an appreciable effect on the measurement. It also appeared from D10 that the spindle/speed combination had a major bearing on the outcome of the measurement. This was further demonstrated by the proprietor itself in its letter of 8 August 2011, which showed large differences in the measured viscosity at different spindle speeds. It could therefore only be concluded that it had not been proven that the skilled person knew which method to use, and, within a single method, the number of selections required inevitably led to different results. Reproducing the invention thus required a significant effort which went beyond any normal trial and error. As the viscosity was an essential parameter in practising or reproducing the invention, without proper instruction on this parameter the skilled person was not able to perform the invention.

Reasons for the Decision
[...]
  
2. Sufficiency of disclosure (Article 100(b) EPC)
 2.1 Claim 1 is directed to a composition for coating foodstuffs which comprises a galactomannan, such as guar gum, and 2 to 7 wt% of alginate, and has a viscosity of 80-110 Pas at a temperature of 20°C (for the exact wording of claim 1, see point IV above).
According to the respondent, the viscosity parameter in claim 1 is ambiguous since the patent does not give the method for identifying it, and this ambiguity means that the invention underlying the patent is insufficiently disclosed.

2.2 The present case is similar to the one underlying decision T 593/09 (not published in OJ EPO), in which sufficiency of disclosure had likewise to be decided in relation to a parameter ("LTC temperature") for which the measurement method was not sufficiently defined in the patent. As set out in this decision (catchword and point 4.1.4 of the Reasons), the ambiguity of a parameter in a claim is not, by itself, a reason to deny sufficiency of disclosure. What is decisive for establishing insufficiency within the meaning of Article 83 EPC 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 common general knowledge, to identify without undue burden the technical measures necessary to solve the problem underlying the patent.
As set out in this decision, in order to find out whether this condition for insufficiency of disclosure is met, a four-step approach can be applied. Firstly, the problem to be solved by the invention in the patent is identified (point 2.1 of the Reasons), secondly the relevance of the attacked parameter for solving this problem is determined (point 2.2 of the Reasons), thirdly it is analysed whether the parameter in the claim is indeed ambiguous (points 3.1 to 3.5 of the Reasons) and fourthly, if the parameter is ambiguous, it is determined whether due to this ambiguity and the relevance of the parameter for solving the problem, sufficiency of disclosure has to be denied (points 3.6 and 3.7 of the Reasons). This four-step approach will be applied in the present case as well (points 2.3 to 2.6 below).

2.3 The opposed patent relates to compositions for coating foodstuffs (paragraph [0001]). The objective of the invention underlying the patent is the provision of a coating composition with which a sufficiently robust and stable coating can be formed using the extrusion or co-extrusion techniques that are commonly used in the food industry (paragraph [0013]).

2.4 As set out in paragraph [0004], the rheological properties, and especially the viscosity, of the coating composition play a major role in achieving the objective of the opposed patent. If the viscosity is too low, the composition deliquesces before it can be gelled, so that no cohesive coating can be formed. Too high a viscosity can lead to problems in extrusion and to undesirable ripping of the coating. To achieve this objective, the coating composition must have a viscosity of 80-110 Pas at a temperature of 20°C (claim 1 and paragraph [0029]).
The skilled person who wants to carry out the invention, i.e. to obtain coating compositions with which a sufficiently robust and stable coating can be formed, thus needs to determine the viscosity of the coating composition in order to check whether it is within the required range.

2.5 It needs to be examined, as a next step, whether the viscosity is indeed ambiguous.

2.5.1 In this respect, it was acknowledged by the appellant that the patent does not contain any information as regards the type of measurement device or measurement parameters to determine the viscosity, that there are various measurement methods available to the skilled person and that the measured viscosity values depend on the type of measurement device and, for a given device, on the measurement parameters.

2.5.2 The appellant argued however that the skilled person was nevertheless able to find out which method and parameters to use in order to determine the required viscosity. All that the skilled person needed to do was to calibrate the measurement characteristics on the basis of the examples of the opposed patent. More specifically, the skilled person had simply to prepare the compositions of these examples and then to "tune" the measurement parameters until the viscosity values reported in these examples were obtained. The appellant in this respect referred to D12 and D13, where two independent test institutes had reworked the examples of the patent (D12: examples 1 to 4, D13: examples 1 to 3 and 5) and, by tuning the measurement frequency, had been able to obtain the reported viscosity values. The measurement method thus found could be used to check whether the viscosity of any other given coating composition was as required in claim 1. By doing so, compositions suitable to provide robust and stable coatings could be obtained.
Firstly, however, it is nowhere shown in D12 or D13 that the compositions prepared therein are indeed suitable to prepare robust and stable coatings. In fact, it is explicitly stated by the authors of D12 that "[F]urther work described in the patent concerning the application of the gels to be used as a coating of sausages was not part of the investigations [of D12]".
Secondly, it was necessary in the tests reported in D12 and D13 to experiment with various measurement devices that are typical for university departments specialised in viscosity measurement and only a sophisticated multi-step analysis in the end led to viscosity values that were at least close to those in the examples. Such a calibration could thus only be done by a person specialised in the field of viscosity measurement. The patent is however not directed at an analytical scientist specialised in viscosity measurement but to food technologists (paragraph [0001]: "The invention relates to a composition for coating foodstuffs..."). Hence, the skilled person in the art relevant to the patent would not be able to use the calibration techniques applied in D12 or D13.
Thirdly, in fact a calibration of the viscosity measurement is, as a matter of principle, not possible on the basis of the examples of the patent. Such a calibration presupposes that the measurement parameters are the only variables in the examples that determine the viscosity. As will be shown in the following, this condition is not met:
All examples of the patent use guar gum without specifying the type of guar gum. As evidenced by D14, D15 and D16, different guar gums are available. As shown in D17 (table on last page), the viscosity of the compositions used in the examples depend on the type of guar gum. More specifically, in D17, the viscosities of three mixtures each containing a different guar gum are determined, namely containing (i) alginate and Guar HV (a guar gum having a viscosity of 6500 ctp) (test 1), (ii) alginate and Guar standard (3500 ctp) (test 2) and (iii) alginate and depolymerised Guar (50 ctp) (test 3). The viscosity of these mixtures was 1360 Pas for mixture (i), 497.5 Pas for mixture (ii) and 185.6 Pas for mixture (iii), and thus depends on the type of guar gum used. Consequently, the fact that the authors of D12 and D13 were able to tune the measurement method such that the viscosities reported in the corresponding examples were obtained does not mean that it is this method that is to be used according to the patent. On the contrary, it could equally be a different method, if a different guar gum was used in the examples.
For these reasons, the appellant's argument that the measurement method for the determination of the viscosity can be calibrated and thus identified on the basis of the examples of the patent must fail.

2.5.3 As regards the dependence of the viscosity on the type of guar gum shown in D17, the appellant's expert Mr Knoch argued that he had doubts about the correctness of these values, since no details were given in D17 about how the experiments had been carried out. This submission can however not be taken into account in view of the fact that it was made at the latest possible time during the appeal proceedings, while the report had already been available for two years and furthermore since the doubts raised by the expert were not substantiated. Irrespective of this, even if there were some doubt about the absolute values reported in D17, this test report shows at least qualitatively a dependence of the viscosity on the type of guar gum.

2.5.4 The appellant also argued that the skilled person would use a standard guard gum in the examples of the patent and that this standard guar gum had a viscosity between 3000 and 5000 cps, as evidenced by D14. The skilled person would thus know which type of guar gum to use and therefore would be able to calibrate the viscosity measurement method on the basis of the examples.
The board does not find this argument convincing. First of all, nowhere does the patent indicate that indeed standard guar gum is used in the examples. Secondly, even if, in the appellant's favour, it is assumed that the skilled person reading the examples of the patent would indeed use standard guar gum, it would still not be possible to use the examples to calibrate the viscosity measurement method. More specifically, as acknowledged by the appellant, standard guar gum is available within a viscosity range of 3000 to 5000 cps. Thus, the type of the guar gum would still be a variable in the examples that would affect the viscosity of the resulting coating composition.

2.5.5 Consequently, on the basis of the patent and his common general knowledge, the skilled person is unable to identify the measurement method by which the viscosity values required by claim 1 have to be determined. In view of the fact that the values depend on the type of measurement method and parameters, the skilled person cannot tell whether or not a given composition has a viscosity as required by claim 1. The viscosity in claim 1 is thus ambiguous.

2.6 In view of its ambiguity, the viscosity is not available as a selection criterion to identify suitable coating compositions that solve the problem underlying the opposed patent. The skilled person therefore has to identify suitable compositions by trial and error. Hence, the patent is nothing more than an invitation to perform a research programme.

2.6.1 While the appellant during the oral proceedings initially acknowledged that the viscosity as required by claim 1 was indeed essential to solve the problem underlying the patent, it later on presented a second line of argument starting from the assumption that the viscosity was in fact not relevant. According to this line of argument, all that was needed to carry out the invention was to select the preferred galactomannan, namely guar gum, in the amounts indicated in the description of the patent. For instance, the skilled person simply needed to repeat the examples of the opposed patent and choose a standard guar gum to obtain a suitable coating composition. Hence, in order to carry out the invention the skilled person did not need to know how to determine the viscosity. In fact the viscosity had only been included in claim 1 to determine later on whether a given composition infringed the patent or not.

2.6.2 The board does not find this argument acceptable. The proprietor is not free to choose a particular approach when drafting the patent and when arguing its case, and then to change it later on when it realises that this approach might fail. So if the proprietor (and in the present case appellant) chooses to include a statement when drafting the patent that, in order to solve the problem underlying the patent, the coating composition must have a certain viscosity, then normally it cannot argue, later on in the proceedings, that in fact the viscosity does not matter.
Furthermore, even if one accepts the appellant's argument, the patent does not teach the skilled person how to obtain a suitable coating for any composition different from those of the examples, for instance a composition containing a galactomannan different from guar gum. Since, due to its ambiguity, the viscosity is not available as a selection criterion to identify suitable components and amounts for these different compositions, the conclusion remains valid that the skilled person has to rely on trial and error such that the patent is nothing more than an invitation to perform a research programme.

[...]
 2.8 The invention underlying claim 1 is thus insufficiently disclosed.
 
Order
For these reasons it is decided that:
The appeal is dismissed.

This decision has European Case Law Identifier: ECLI:EP:BA:2014:T240311.20140430.
The whole decision can be found here.
The file wrapper can be found here.

Photo obtained from FreeDigitalPhotos.net.

 
 

T 1141/10 - Sufficient Identity





In this opposition appeal an insufficiency objection (Art. 83 EPC) was raised. Claim 9 requires a collagen like material prepared by genetic engineering having "an amino acid sequence equivalent to that occurring in nature for collagen, wherein equivalent implies amino acid identity of at least 80%".

The board takes care to distinguish sufficiency from a clarity (Art. 84 EPC).

Reasons for the Decision


(...)
Article 100(b) EPC; Article 83 EPC

5. Although Article 100(b) EPC was an original ground of opposition, there is no decision of the opposition division on this article in the decision under appeal.

5.1 In a first decision dated 12 January 2007, the opposition division decided that the main and sole request fulfilled the requirements of Article 83 EPC. In the First Appeal, the respondent/opponent submitted arguments to contest the decision of the opposition division on Article 83 EPC. There was, however, no reasoned decision of the board on this issue in the decision T 98/07 of the First Appeal.

5.2 After the board's remittal of the case for further prosecution, both the opposition division and the patentee considered that the board had decided on Article 100(b) EPC/Article 83 EPC and that it was not an issue in the further prosecution of the case. This was contested by the opponent in opposition proceedings and in the present appeal proceedings.

5.3 In the light thereof, the board considers the ground of opposition based on Article 100(b) EPC/Article 83 EPC to be part of the present appeal proceedings and the parties' arguments on this ground are to be examined by the board.

6. The respondent's objections under this article arise essentially through the presence of ambiguity in the claims, in particular concerning the features "amino acid identity of at least 80%" (claim 9) and "being free of helix structure" (claims 1 and 9) (cf. point XIX supra).

6.1 According to the case law of the Boards of Appeal, care has to be taken that an insufficiency objection is not in fact an objection under Article 84 EPC. A distinction has to be made between the clarity of what has been disclosed and the clarity of what is claimed. For Article 83 EPC, it is necessary to show that the feature is so ill-defined that the skilled person is not able, on the basis of the disclosure as a whole and using its common general knowledge to identify (without undue burden) the technical measures or suitable parameters necessary to solve the problem underlying the patent (cf. inter alia, T 593/09 of 20 December 2011, Catchword and point 4.1.4 of the Reasons, T 608/07 of 27 April 2009, point 2.5.2 of the Reasons).

7. As for the objected first feature, the following points are of relevance:

7.1 The objection against the first feature was raised with the respondent's letter of 23 November 2009 (page 18) for the first time in the proceedings. Although a similar feature was present in product claim 50 as granted, it was always discussed in the context of Article 84 EPC and its relevance for a broad interpretation of the claim under Article 54 EPC. In these submissions, reference was made to prior art disclosing several methods for determining the level of sequence identity and to sequence alignments with known sequences occurring in nature for collagen. No problems were encountered to argue against the novelty of the claimed subject-matter in these earlier stages of the proceedings. These arguments are also submitted by the respondent under Article 100(a) EPC/Article 54 EPC in the present appeal proceedings (infra).

7.2 There is obviously no information on new (non-disclosed) sequences of collagen occurring in nature and thus, the respondent's argument is based on mere assumptions, namely the existence of new collagen sequences that might be significantly different from the known collagen sequences.

8. As for the objected second feature, the following points are of relevance:

8.1 The method cited in the patent and disclosed in document D25 allows a skilled person to identify and measure the presence of (collagen, gelatin) helix structures. Although the selection of several parameters influences the presence of these structures, these parameters are identified in document D25 (temperature, pH, ionic strength, concentration, etc.) and conditions disclosed for which the presence of these structures is most probable.

9. In view thereof, the board considers the Main Request to fulfil the requirements of Article 83 EPC.

(...) 

This decision has European Case Law Identifier:  ECLI:EP:BA:2014:T114110.20140311. The whole decision can be found here. The file wrapper can be found here. Photo by Maria Teresa Ambrosi obtained via Flickr.


T 59/08 - Just pipe down

`







 The unsurpassed K's law which has been kept by O

This is an opposition appeal.

The claims according to the  main and an auxiliary request were identical to the claims as granted.  Claim 1 contains the feature "said HMW fraction having a lower molecular weight limit of 3500".  

The application gave no method for determining the lower limit of the high molecular weight (HMW). The opponents objected that the invention was not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

The board found that the claim may give the skilled person a clarity problem, when deciding if a particular composition falls under the claim. However he is sufficiently enabled to work the invention.

Reasons for the Decision
 
1. The appeal is admissible.

2. The question to be answered when assessing sufficiency of disclosure is whether the invention as defined in the claims can be performed by a person skilled in the art throughout the whole area(s) claimed without undue burden, taking into account the information given in the patent in suit and using common general knowledge.

2.1 The invention of which the sufficiency of disclosure has to be judged is the object defined in present claim 1 by the combination of the following features:

(i) a multimodal polyethylene composition suitable for pipes,
the multimodal polyethylene having
(ii) a density of 0.930-0.965 g/cm**(3),
(iii)a MFR5 of 0.2-1.2 g/10 min,
(iv) a Mn of 8000-15000, a Mw of 180?330 x 10**(3) and a Mw/Mn of 20-35,
and comprising
(v) a low molecular weight (LMW) ethylene homopolymer fraction and a high molecular weight (HMW) ethylene copolymer fraction in a weight ratio of the LMW fraction to the HMW fraction of (35-55) : (65-45)
(vi) said HMW ethylene copolymer fraction having a lower molecular weight limit of 3500.

2.2 The contested decision nor the parties on appeal addressed the question whether the present patent specification disclosed a technical concept fit for generalisation and whether it made available to the skilled person, with his common general knowledge, compositions suitable for pipes meeting the combination of parameters defined in claim 1, as well as the pipes according to claim 12. The questions addressed were rather which meaning should be attributed to the feature "lower limit of the high molecular weight (HMW) ethylene copolymer fraction" and whether, in the absence of any mention in the patent with respect to the measurement methods for determining Mn, Mw and the lower limit of the high molecular weight (HMW) ethylene copolymer fraction, the skilled person would know which measurement method was to be employed.

2.3 Following the normal rule of claim construction according to which terms used in a claim should be given their ordinary meaning in the context of the claim in which they appear, the lower molecular weight limit of the HMW ethylene copolymer fraction defined in claim 1 designates the lowest molecular weight of any of the molecules of the HMW fraction. This view is supported by the statement provided in the specification on page 3, lines 9-12 and was not disputed any longer during the oral proceedings.

2.4 In the absence in the claim of any indication of a method for determining Mn, Mw and the lower limit of the high molecular weight (HMW) ethylene copolymer fraction, the claim has to be read as allowing any method of measurement, including any setting, that can be said to be standard in the art concerned; in other words, any ordinary method within the context of the present claim. In this respect, the parties do not dispute that different methods (for example GPC), including different settings, would be available to determine values for those parameters, nor that the choice of the measurement method for determining said parameters has an influence on the values obtained.

2.5 The notions of "true value" and closeness to that "true value" in relation to Mw and Mn parameters, to which the appellant referred, are however not only vague, but also not reflected by the information provided in the patent in suit. If a patent proprietor wishes to argue that a parameter range in a claim should be read in a special way or needs to be measured in a particular manner because several possibilities are available, then for that argument to be accepted it is necessary to limit the claim to this method of measurement by way of amendment, provided that this can be done meeting the requirements of Article 123(2) EPC. It is not enough to argue that the claim should be read in a particular way when the wording of the claim does not require this. For lack of information to that effect, it is not apparent that the skilled person would try to determine the "true value" of Mw and Mn, as it is at least equally credible that he would choose any standard method meeting his needs in the context of the technical circumstances of the case, i.e. also taking into account the convenience and reproducibility of that method.

2.6 Therefore, the present claims should be read as to encompass any composition or pipe that meets the defined values of Mw, Mn and "lower limit of the high molecular weight (HMW) ethylene copolymer fraction" using any method that can be considered to be standard in the art in the technical context of the present claims as the method of measurement for those parameters.

2.7 Such a reading of the claim may on the one hand result in a larger number of compositions or pipes meeting the claimed values than when one specific method were used, and therefore in less difficulty to obtain compositions or pipes as defined by the claims, i.e. in less stringent requirements for assessing sufficiency of disclosure of the claimed combination of features. In that case it may on the other hand require stronger arguments in favour of novelty and inventive step, in particular if the claimed values were held to distinguish the claimed subject-matter from the prior art and to be considered essential for providing a technical effect vis-à-vis the prior art.

3. The Respondents' argument that the conventional methods for determining Mw and Mn led to different values out of which a lack of guidance resulted for the skilled person wishing to obtain the result defined in the patent specification (paragraph [0013]), namely to obtain a pressure pipe with a desired combination of good processability and good strength, cannot be accepted as an argument pertaining to sufficiency of disclosure of the invention, as those results or effects are not features of the present claims. This follows from the consideration that - in accordance with Rule 43(1) EPC - the invention in the European patent application is defined by the subject-matter of a claim, i.e. the specific combination of features present in the claim, as is reminded in Opinion G 2/98 of the Enlarged Board of Appeal (OJ 2001, 413; point 2 of the Reasons). Whether the result defined in the present patent specification (paragraph [0013]), is achieved or not, may, however, become relevant under the requirement of inventive step, for assessing the technical problem which can be held to be successfully solved by the combination of features claimed.

4. The uncertainty about which method the skilled person would select to determine Mn, Mw and the lower limit of the high molecular weight (HMW) ethylene copolymer fraction, which was the central issue addressed by the parties both in opposition and in appeal proceedings, is in the present case not adequate to make a case against sufficiency of disclosure. The argument that the choice of the measurement method for determining Mn, Mw and the lower limit of the high molecular weight (HMW) ethylene copolymer fraction had an influence on the values obtained and that therefore the skilled person would not know whether he had obtained something falling within the ambit of the claims - as it was argued by the respondents as well as in the decision under appeal - boils down to the argument that the boundaries of the claims are not clearly defined, which is a matter of Article 84 EPC, not sufficiency of disclosure. Such an objection under Article 84 EPC cannot be successful as it would not arise out of any amendment made in opposition or appeal proceedings. 

5. For assessing the requirement for sufficiency of disclosure the question should be answered whether the skilled person, following the teaching provided in the patent specification, in particular in paragraphs [0025] to [0029] and the Examples, and also taking into account his general knowledge, would be able to obtain without undue burden multimodal polyethylene compositions meeting all criteria defined in claim 1 of the patent in suit (see point 2.1 above) and the pipe according to claim 12.

5.1 In this respect, points raised before the opposition division (points 3.1.1 to 3.1.8 of the letter of 8 June 2005 of Opponents 1 and points 4.1 to 4.4 of the Patent Proprietors' letter of 19 January 2006), which in particular relate to the process conditions that are needed to obtain the combination of technical features defined in the claims, and which appear to be essential to assess the sufficiency of the disclosure, should also be considered.

5.2 However, none of those issues was decided by Opposition Division, nor argued by the parties before the Board.

6. Under those circumstances, as the essential issues to be addressed in respect of sufficiency of disclosure have not been dealt with in the contested decision, the Board exercises its discretion under Article 111(1) EPC to remit the case to the first instance for further prosecution.

Order
For these reasons it is decided that:
1. The decision under appeal is set aside.
2. The case is remitted to the department of first instance for further prosecution.


This decision has European Case Law Identifier:  ECLI:EP:BA:2013:T005908.20130906. The whole decision can be found here. The file wrapper can be found here.

Photo by Danndalf obtained via Flickr.