Search This Blog

Labels

T 2070/13 - When is routine work an experimental programme?

An experimental programme

Claim 1 in this opposition appeal requires a combination of  a viscoelastant material and an anti-adherent material. A large number of possibilities for the anti-adherent material is claimed, while the anti-adherent property is not very well defined. The Board found that this is too much for the skilled person. Reasons 1.11 discusses where the burden of proof lies in this case. 
"A topical viscoelastic fluid modifying composition for topical application to the skin and hair in the perianal and/or labial areas comprising at least one viscoelastant material and an anti-adherent material, wherein the composition comprises between 0.01% to 25% by weight of the viscoelastant material and between 0.01% and 25% by weight of an anti-adherent material; wherein the viscoelastant material comprises a material selected from the group consisting of enzymes, linked enzymes, alkyl polyglycosides having 8-10 carbon atoms in the alkyl chain, bovine lipid extract surfactant, dextrans and dextran derivative; and wherein the anti-adherent material comprises a material selected from the group consisting of casein, farnesol, flavones, fucans, galactolipid, kininogen, inulin, iridoid glycosides, perlecan, poloxamer 407, sulphated exopolysaccharides, and combinations thereof."

T 1818/12 - On evidence, sufficiency, and effect

This pencil cracked under the pressure

The main claim in this opposition appeal concerns an E. coli host cell sample subjected to non-lysing pressure. According to the opponent the examples in the patent are the only known cell systems that do not lyse under the conditions of the claim, or that give the effect of increased yield. As a result, the claim is neither workable nor inventive over the entire scope claimed. 
The Board has problems with the evidentiary value of the documents cited by the opponent. Furthermore, that there exists an embodiment falling under the scope of the claim that does not show the effect is in itself not enough to deny inventive step. 

R 2/14 - Is there an undue burden?

Undue burden?

This is a successful petition for review.  

Claim 1 as granted refers to an amino acid sequence "SEQ ID NO:4". Unfortunately, the sequence contains an error and does not provide the required desaturase activity. The opposition division revoked the patent as not complying to Art. 83 EPC. In the appeal, the proprietor countered that the skilled person could nevertheless prepare a protein having the desired activity. 

In the appeal decision, the board rejects this argument. The relevant part of the decision is the following:



"30. Since the skilled person relying on the patent application was not informed that the protein defined by SEQ ID NO:4 was inactive, and since the patent application neither disclosed any active sequence variants having at least 60% sequence identity nor which positions of SEQ ID NO:4 had to be modified in order to obtain a functional desaturase, it had to go back to E. gracilis and redone the desaturase in order to put the claimed invention into practice. Even though each of the steps necessary for recloning could be performed by a person skilled in the art,- it is the combination of all the necessary steps (isolation of total mRNA, PCR amplification and selection of a group of amplification products with homology to known desaturases, completion of the 5' and 3' ends by RACE amplification, cloning and expression of the full length sequence to assess its function) which creates an undue burden on the skilled person trying to perform the invention. The same applies to the two alternative approaches mentioned by the appellant.

31. Thus, contrary to the requirements of Article 83 EPC, the skilled person would not have been in a position to perform the claimed invention readily and without undue burden across essentially the entire scope of claim 1."

The proprietor raised two complaints against the decision, the second of which is that the board based its decision on facts and arguments in respect of which the parties were not heard and did not reason its conclusions about the objection under Articles 100(b) and 83 EPC.


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.


T 0718/08 - Defining 'optimal chewability'

No need for brushing your dogs teeth anymore? The present case provides a chewable product for the dental care of pets. In the claims, the chewable product is not defined directly in terms of composition, but rather in reference to a particular property, namely to the minimum force required to penetrate the product by chewing.

According to GL F-IV, 4.11, where the invention relates to a product, it may be defined in a claim exceptionally by its parameters, namely only in those cases where the invention cannot be adequately defined in any other way. A necessary condition is that those parameters can be clearly and reliably determined either by indications in the description or by objective procedures usual in the art (T 94/82). 

According to GL F-IV, 4.18, where a claim contains an ill-defined ("unclear", "ambiguous") parameter, and 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 application at issue, an objection under Art. 83 should be raised.

The present case illustrates the above, in that the Board concludes that the skilled person is unable to reliably measure penetration force and thus reproduce the claimed invention.

Reasons for the Decision
1. The appeal is admissible.

2. Sufficiency of Disclosure

2.1 The invention is concerned with a chewable product for the dental care of pets comprising continuous and discontinuous phases, with claims to the product itself, its method of manufacture and its use in a method for reducing tartar. The main idea of the invention is to take into account the biting force of the pet in the design of the product (specification paragraph [0016]). To this end the independent claims require the phases to be in a proportion such that a force of at least 100 N is required to penetrate the product's surface. This is greater than the anticipated bite force of the pet (paragraph [0019]) ensuring optimum chewability and improved cleaning action in particular of molars and premolars, (paragraphs [0009], [0054]).

2.2 The product (and its method of manufacture and use) is not defined directly in terms of composition, but is characterized rather in reference to a particular property, namely the minimum force required to penetrate the product. Where a product is so defined in terms of a parameter, the disclosure will normally also need to provide sufficient information as to how to reliably and objectively measure the value of the parameter in question (unless, for example, this is known to the skilled person from his common general knowledge). This requirement ensures not only that the claimed subject-matter is clearly and unambiguously defined, but also that the skilled person, using that information to supplement his common general knowledge, is able to reproduce the invention without undue burden. Without such information he or she would not be able to successfully carry out the invention, and the invention would be insufficiently disclosed. Cf. Case Law of the Boards of Appeal, 5th Edition, 2006 (CLBA), II.A.6.1, first paragraph, and the decisions cited therein.

2.3 Information regarding the method for measuring penetration force can be found in paragraphs [0059] and [0088]. These refer to a "specially constructed "model tooth"" (paragraph [0059], line 59) and an analysis system "designed to simulate the biting action of a dog's teeth"(paragraph [0088], lines 12 to 13). The teeth in question are the premolars and molars (paragraph [0009]). To this end the system, identified as a TA XT2I Texture analyser from Rheo Ltd, uses "a specially designed cone-shaped penetrometry probe of length 12mm" pushed into the product "at a rate of 2mm/s" (paragraph [0088], lines 13 to 14). The skilled person learns from these passages read in context that he is to use a cone-shaped probe of 12mm length as a model of a dog's tooth to simulate biting action under given conditions. The description, figures and claims however do not specify the particular cone angle of this specially designed probe. As stands to reason the penetration force depends significantly on this angle : a sharp cone (small angle) will penetrate the product with greater ease than a blunt one (large angle). This is borne out clearly by the results of the tests summarized in figures 3, 6 and 8 of D2 and the tables on page 14 of D12, which show a variation in the order of 1000 over the measurement range (10° to 140°). The fact that cone angle is critical to measurement of the penetration force is undisputed, as is the fact that the disclosure fails to expressly mention any value for the cone angle.

2.4 The Appellant argues that the missing cone angle can be inferred from the probe's stated function as model dog tooth, and the fact that the product is aimed mainly at better cleaning of molars and premolars. This would instruct the skilled person, using his background knowledge of premolar and molar dimensions as reflected in D19 and condensed in D20, to choose that tooth having the same height as the probe, and, equating its width to the diameter of the conical probe's base, to so arrive at the value of its cone angle.

2.5 This line of reasoning is unconvincing. It assumes firstly a particular correlation between conical shape of the model and actual teeth size and shape, in this case buccal (cheek-side) height and width, for which the Board is unable to find any basis in the patent. It is also decidedly not part of the skilled person's common general knowledge to simply equate height and base diameter of a conical model tooth to buccal height and width of a given tooth. Premolars and molars have complex non-conical shapes that vary from tooth to tooth, as the photographs 105 to 110 and 405 to 411 of D11 (boxer premolars/molars taken from different angles), or also figure 1 (top) or figure 3 of D19 (side views of beagle teeth) clearly illustrate. Such a variety of complex shapes does not lend itself to simple modelling. Thus, even if a simple cone model is adopted, it is neither immediately apparent nor obvious how to determine the cone shape and size from the wide variety of actual teeth shapes and sizes, let alone that its dimensions should be based on buccal width and height of a single tooth.

The Board can also not subscribe to the further underlying assumption that the information provided in D19 belongs to common general knowledge. D19 is a scientific paper, published in a specialist journal, the Journal of Veterinary Dentistry, in 2002, two years after priority, which presents the results of a study of buccal (cheek side) surface dimensions of beagle teeth in comparison to those of cats and humans. The narrow scope of this study, its select readership (veterinary dentists), not to mention the fact that it was made public after priority, can but lead to the conclusion that D19 and the information therein does not belong to the skilled person's common knowledge. That person is a pet food engineer specializing in dental care products, whose background knowledge of animal teeth will have been drawn from dictionaries and encyclopaedias, and textbooks and handbooks on the subject (cf. T 890/02 (OJ EPO 2005, 97) cited in CLBA, I.C.1.5, first paragraph).

2.6 In the Board's view the skilled person is much more likely to try and find the missing cone angle amongst actual teeth angles. If his background knowledge as defined above offers a particular value (or very limited range of values) that he would immediately consider both as suitable and representative than the invention can be regarded as sufficiently disclosed. The photographs of D11 and declaration D19, however, show that no such particular value, or even a very narrow range of values, exists. As noted, the subject teeth, premolars and molars have various highly complex shapes. The different angle views in photographs 105 to 110 and 405 to 411 of D11, for example, show the premolar/molar surfaces of a boxer to have a varying number of rounded projections with different angles depending on the point of view (front or side). Thus even for premolars/molars the angles are spread widely, between say 30° to 140°, and there is no single value that is prevalent. This observation is confirmed by expert declaration D21, see section 5.3, which also mentions angle variation between breeds (section 4.2, 4.3).

At best a range can be identified where observed angles occur more frequently. D21 in section 5.3 gives some examples. The Appellant has previously suggested 30° to 90°, or an even narrower range, 30° to 50° (see the table in D20). In these progressively narrower ranges variation is still by a factor of 3 to 4 and 1.6 to 1.8 respectively (cf. D2, figures 6,8; D12, page 14, Rancho). This is still to an extent so as to preclude reliable measurement of the penetration force.

2.7 As for reverse-engineering the cone angle from table 3 and the specific examples described in the preceding paragraphs, the Board is of the firm conviction that this would place an undue burden on the skilled person.

Firstly, various factors and parameters of the manufacturing process that influence the material properties are left open in the patent. Besides duration of the various stages, this includes the nature and quality of the raw materials, the particular extruder used as well as the specific mechanical energy (SME) applied during extrusion. Table 1 on page 8 of the Respondent's submission of 14 November 2008, for example, demonstrates the significance of SME for penetration force.

Secondly, the extent of testing required to unambiguously determine which cone angle was used to produce the table values would far exceed routine experimental work. For each composition it would require producing a multitude of samples for different process parameters and subjecting each to flexion tests and repeated measurements of penetration force with different cone angles until the table values are returned.

2.8 In the light of the above the Board concludes that the skilled person is unable to determine the missing cone angle on the basis of the patent and his common general knowledge. Failing a specific value of the cone angle he will be unable to reliably measure penetration force and thus reproduce the claimed invention. The invention according to the claims of the main request is thus insufficiently disclosed (Articles 83, 100(b) EPC).

2.9 The specific value of the penetration force is central to the invention as it attempts to give expression to the underlying qualitative idea (see above) in objectively verifiable terms. As it fails herein, the invention is inherently deficient and any attempt to formulate the invention more precisely must fail. The auxiliary requests are thus also not allowable for the above reason.


Order
For these reasons it is decided that:

The appeal is dismissed.
This decision has European Case Law Identifier: ECLI:EP:BA:2009:T071808.20090911. The whole decision can be found here. The file wrapper can be found here. Photo from www.freedigitalphotos.net