T 1170/20 - Reach through claim and functional definitions

Key points

• Claim 1 is directed to, in translation: "Medium and/or high voltage gas-insulated electrical equipment comprising .... a gas-tight sealed envelope whose interior volume is filled with an electrically insulating gas comprising at least one fluorinated compound whose global warming potential is less than 3500"
• The Board rejects the claim as a reach-through claim. 
• In translation: "The appellant [opponent] argues that the characteristic "an electrically insulating gas containing at least one fluorinated compound with a global warming potential (GWP) of less than 3500" gives the claim a so-called “reach through” character, namely that the claim relates to a chemical compound defined only in functional terms. The Board agrees with the [opponent]."
• "The claim requires an insulating gas in a medium or high voltage gas-insulated electrical apparatus. The skilled person must find among the broad class of fluorinated compounds those having both a GWP of less than 3500 and a suitability for producing an insulating gas in a medium or high voltage apparatus. The argument that any fluorinated compound would be suitable for electrical insulation of a medium or high voltage apparatus does not convince the Board. The applicant rightly argues that significant efforts are being made to replace SF6 as an insulating gas. It is in fact difficult to find other promising solutions"
• The patent mentions classes of gases. "For these classes, a few individual compounds are disclosed as examples [in the patent]. The Board is satisfied that there are fluoroketones suitable for electrical insulation of electrical apparatus as claimed (see documents A3 and A4). However, the rest of these examples are presented without any proof of their suitability. Some of these examples are clearly erroneous, such as "HFO 1336 mzzzM" or "C7F18O", as the respondent itself argues.
• The Board is of the opinion that it is not sufficient to present a few broad classes of fluorinated compounds and a few individual specific examples with a desired GWP without proof that in essence all members of the classes of compounds satisfy all the criteria for suitability as insulating gases for medium or even high voltage switchgear. "

• "the respondent argued that the invention was not aimed at finding all suitable compounds as low GWP insulating gas. On the contrary, an apparatus using such insulating gas was the background against which the invention was made. The current invention aimed at avoiding heat losses by managing the condensate, ensuring that a sufficient amount of insulating gas is in the gas phase." 

• "The Board cannot accept this argument. The requirement of sufficiency of disclosure concerns the invention in its entirety, and not only that part which the applicant or proprietor considers to be the inventive contribution. If any part of the invention defined in the claims cannot be carried out, then that invention may be the subject of an objection for insufficiency of disclosure. Otherwise, speculative patents may have to be granted because their subject-matter relates in part to construction details which can be carried out even though that subject-matter would not be possible in its entirety."

• "contrary to the respondent's claim, the technical field to which a claim relates is irrelevant when it is characterized as being of the "reach-through" type. The essential idea of ​​not allowing claims of this type is explained in the cited section of the Guidelines as follows:  [F-III,9] [Quote from the English Guidelines added, PJL] "A functional definition of a chemical compound ("reach-through" claim) covers all compounds possessing the activity or effect specified in the claim. It would be an undue burden to isolate and characterise all potential compounds (e.g. agonists/antagonists), without any effective pointer to their identity (see F‑III, 1), or to test every known compound and every conceivable future compound for this activity to see if it falls within the scope of the claim. In effect, the applicant is attempting to patent what has not yet been invented, and the fact that the applicant can test for the effect used to define the compounds does not necessarily confer sufficiency on the claim; in fact it constitutes an invitation for the skilled person to perform a research programme (see T 435/91 (Reasons 2.2.1), followed by T 1063/06 (Headnote II)). "

• "This explanation is extended to the present case. The claim covers all compounds having a GWP of less than 3500 and having the function of an insulating gas for medium and/or high voltages. The patent does not contain any clear indication as to their identity, beyond an indication that these compounds contain fluorine. The board pointed out above that the difficulty lies in finding suitable compounds. The respondent simply states and without providing any evidence that a person skilled in the art could find the suitable compounds using only his ordinary skills and given a suitable compound, the GWP could be determined. However, this is exactly the case described in the Guidelines, namely that in reality the respondent is trying to patent what has not yet been invented, and the fact that the effects used to define compounds can be tested does not mean that the claim sufficiently discloses the invention. The claim is in fact an invitation to carry out a search program."

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EPO 

The link to the decision and an extract of it can be found after the jump.

T 1311/22 - Result to be achieved (vacuum cleaner quality factor)

Key points

•  Claim 1 of the patent as granted is directed to a vacuum cleaner and specifies, in translation, "a vacuum cleaner with an average power consumption of less than 1200 W and a filter bag with a separation efficiency of the filter bag material greater than 60%, the device for vacuuming having a quality factor for an unfilled filter bag Q(w)un defined by ... which is greater than 25"
• The Board, on sufficiency, in translation: "Claim 1 defines the device by functional characteristics, namely in relation to a result to be achieved, which in turn is expressed by values ​​of the newly defined parameter "quality factor""
• " The peculiarity of the functional definition of a technical feature is that it is defined by its effect. Such a definition refers quite abstractly to an indefinite number of possible alternatives and is permissible as long as all alternatives are available to the person skilled in the art and deliver the desired result; Therefore, it must be checked whether the patent discloses a generalizable technical teaching that makes the entire spectrum of variants that fall under the functional definition accessible to the person skilled in the art."
• " Claim 1 itself only contains minimum values ​​for the two quality factors, but no information as to which structural features of the vacuum cleaner and/or filter bag must be set and adjusted so that these minimum values ​​can be achieved in contrast to the comparative examples. In other words, the scope of protection of the granted claim 1 includes all vacuum-cleaning devices with filter bags and the claimed parameters, completely regardless of the way in which a vacuum loss is reduced in such a way that correspondingly high quality factors are achieved (the only thing excluded is their achievement via a low degree of separation, see above). As explained below, the person skilled in the art cannot deduce from the description how this can basically be accomplished without unreasonable effort, possibly based on a specific exemplary embodiment."
• "These very specific exemplary embodiments also do not give the person skilled in the art any clues as to which of the numerous features and measures - whether all or only certain of them - are crucial for achieving the claimed quality factors, so that he can also determine the subject matter of the claim through a targeted selection of other suitable pairings of filter bags and vacuum cleaner devices "
• "The scope of protection of claim 1 therefore includes any device of the generic type in terms of power consumption, negative pressure in the floor nozzle and degree of separation with an at least slightly better quality factor/efficiency than devices from the prior art, including those with as yet unknown, future components such as new filter bag materials. In contrast, only very specific exemplary embodiments are disclosed, which enable a rather limited improvement in the quality factors to values ​​of up to just over 30% or 25%."
• "the patent does not disclose the invention so clearly and completely that a person skilled in the art can carry it out, Article 100(b) EPC."
• As a comment, T0595/90 permitted a claim to a steel sheet having an "iron loss of less than 0.90 W/kg" (i.e. down to 0.00 W/kg), low iron loss values being the desired feature (but not an unusual parameter as such).  Whether the cases can be distinguished from each other or whether the case law is developing remains to be seen. 

EPO 

The link to the decision is provided after the jump, as well as (an extract of) the decision text.

T 0552/22 - Functional features and G 2/21

Key points

• G 2/21, r.74 held that for second medical use claims: " a technical effect, which in the case of for example a second medical use claim is usually a therapeutic effect, is a feature of the claim, so that the issue of whether it has been shown that this effect is achieved is a question of sufficiency of disclosure under Article 83 EPC. Hence, because the subject-matter of second medical use claims is commonly limited to a known therapeutic agent for use in a new therapeutic application, it is necessary that the patent at the date of its filing renders it credible that the known therapeutic agent, i.e. the product, is suitable for the claimed therapeutic application."
• The present claim 1 is directed to a bacterial cell: " A bacterial cell to be stably cultured in a medium for the production of ...] fucosyllactose, the cell being transformed to comprise at least one nucleic acid sequence coding for a fucosyltransferase".
• The present decision seems to illustrate that the rule of G 2/21 r.74 is not limited to second medical use claims.
• In Examples 2 to 4, the protein SetA is used. The claim also covers SetB and SetC as the encoded fucosyltransferase.
• "The board therefore agrees with the appellant [opponent] that if, according to the patent, it already came as a surprise that the SET protein with the broadest substrate specificity - SetA - exports fucosyllactose (see point 11. above), it was not demonstrated to the skilled person that SetB and SetC, having a narrower substrate specificity, also export fucosyllactose. Mentioning SetB and SetC in the patent therefore does not suffice to enable the skilled person to achieve the technical effect claimed over the whole ambit of the claim."
• "The opposition division held that with SetA, the patent provided one way of working the invention; that it was not inherently implausible that fucosyllactose could be a substrate for SetB and SetC as well; and that post-published evidence D18 suggested that the invention could also be practised with SetB and SetC. The opposition division concluded that there was not sufficient doubt, supported by verifiable facts, that the person skilled in the art could work the invention over the whole scope of the claim."
• "sufficiency of disclosure must be given at the effective date of the patent (see point 7. above), and post-published evidence is manifestly unsuitable for guiding the skilled person in carrying out the claimed invention on the effective date. Lack of disclosure on the suitability of SET family members for fucosyllactose export upon overexpression could not therefore be remedied by post-published evidence such as D18"
• "To meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, the patent would have to credibly disclose either that all SET family proteins lead to an export of fucosyllactose upon overexpression or provide the skilled person at least with sufficient guidance on how to select the SET family proteins that do lead to an export of fucosyllactose upon overexpression without undue experimentation "
• As I understand it, the debate was not about whether the skilled person could m ake the cell with the genetic transformation as such, but whether the application asf filed made the functional feature credible over the whole scope of the (structural features) of the claim.
  
  
• The auxiliary requests (which were carry-over requests from the first instance procedure) are not admitted because only the basis was indicated, which was considered to be insufficient substantiation (Art. 12(3) RPBA).  
• "regarding the respondent's [proprietors] argument that the amendments made in auxiliary request 2 were self-explanatory in that they addressed the appellant's sufficiency of disclosure objection, the board notes that the appellant also raised objections as to lack of inventive step and that the respondent did not provide any explanation as to how the amendments made in auxiliary request 2 address these objections."
•  As a comment, the proprietor may have considered the opponent's inventive step attack against the main request to be flawed. I don't see why an amendment should be responsive to all objections on file. 
• The patent is revoked.

The link to the decision is provided after the jump, as well as (an extract of) the decision text.

T 0835/21 - A valid functional antibody claim

Key points

• This case seems to illustrate that there is no Amgen v. Sanofi rule at the EPO. 
• Claim 1 is directed to an antibody defined purely in functional terms, i.e. in terms of what it binds to, without any restriction on the sequence/composition of the antibody itself.
• " A monoclonal antibody or an antigen-binding fragment thereof that specifically binds to human low-density-lipoprotein receptor-related protein 6 polypeptide (LRP6) having the amino acid sequence of SEQ ID NO:1, is capable of antagonizing the Wnt signaling pathway, and inhibits Wnt3- and Wnt3a-specific signaling activity, wherein the antigen binding portion binds to an epitope of human LRP6 within amino acids 631-932 of SEQ ID NO:1 as shown in Table 1." 
• On Art.83: " The preparation of a monoclonal antibody that binds to an epitope within a defined amino acid sequence, i.e. a known target, for example by immunisation of an animal with a protein or peptide consisting of or contained within the defined amino acid sequence, or by phage display using such a peptide, is a routine task for the skilled person and does not require any inventive activity. " 
• " The scant number of exemplary Fabs disclosed in the application, the lack of disclosure of the sequences of these exemplary Fabs, the lack of a direct link between Tables II and III of the application and the missing figures are hence not in themselves sufficient to call into question the general teaching in the application that the Wnt ligands fall into two groups which are preferentially antagonised by LRP6 antibodies binding to different propeller regions of LRP6, a teaching which is incidentally supported by post-published documents D2 and D5. Therefore, this argument does not persuade the board either." 
• On inventive step: " Document D8 discloses a monoclonal antibody that binds to the propeller 2 domain of LRP6 and inhibits Wnt3a-induced signalling activity (see point 52. above). The claimed antibody differs from this in that it binds to an epitope within amino acids 631 to 932 of SEQ ID NO:1, i.e. to an epitope within the propeller 3 domain of LRP6. Moreover, document D8 is silent on whether or not the inhibition of Wnt3a-induced signalling that it discloses is Wnt3- and Wnt3a-specific, as required for the claimed antibody. " 
• " The objective technical problem can therefore be formulated as the provision of an antagonistic LRP6 antibody that preferentially inhibits Wnt3 and Wnt3a signalling activity over signalling activity induced by other Wnt ligands "
• "  Nothing in the prior art pointed the skilled person towards an antibody that bound to an epitope within the propeller 3 domain of LRP6 as a solution to this technical problem. Indeed, it was not known in the art that different Wnt ligands bound to different propeller domains of LRP6, and that therefore antibodies that preferentially inhibited the signalling activity induced by particular Wnt ligands could be prepared by targeting different LRP6 propeller domains. The link between binding to the propeller 3 domain of LRP6 and preferential inhibition of Wnt3 and Wnt3a signalling activity was therefore not suggested in the prior art and hence was not obvious to the skilled person." 
• " it was not obvious to the skilled person, solely from the fact that Dkk1 binds to the LRP6 propeller 3 domain, that an LRP6 antibody that bound to the propeller 3 domain would inhibit Wnt3- and Wnt3a-specific signalling activity. This line of argument is therefore not persuasive. No other arguments that took the preferential inhibition of the Wnt3- and Wnt3a-induced signalling activity by the claimed antibodies into account were submitted by the appellant. Hence, the claimed subject-matter involves an inventive step over the antibody disclosed in document D8."
  

The link to the decision is provided after the jump.

T 0435/20 - Anti-IL-23 antibodies binding at conformational epitope

Key points

•  Claim 1 as granted: "1. An antibody ... that binds to  human IL-23p19 [i.e. subunit p19 of human interleukin-23] at an epitope comprising residues 82-95 and residues 133-140 of SEQ ID NO: 29."
• Hence, no sequence or structure of the antibody is specified, only of the epitope, i.e. the substrate.
• The patent is roveked for insufficiency of the Amgen/Sanofi type (https://patentlyo.com/patent/2022/11/rethinking-enablement-grants.html) 
• The Board: "The claim is not for a single antibody but for a pool of antibodies each of which binds human interleukin-23 at an epitope as defined in the claim."
• "While the epitope bound by the claimed antibodies must include both stretches of amino acids, the claim does not unambiguously delimit the spatial extent of the epitope. Interpretation is therefore required to determine its extent. The board does this according to the normal rules of claim construction, in which the terms used in the claim are given their broadest technically sensible meaning in the context in which they appear and having regard to the common general knowledge and the teaching in the patent"
• "in an embodiment, although the claim is not limited to this embodiment, the claim encompasses antibodies that are functionally defined by their ability to bind to human IL-23p19 and contact several of the amino acid residues within both amino acid stretches recited in the claim, i.e. antibodies with the same specificity as the exemplified antibody 7G10 [i.e. the antibody shown in the examples of the patent, probably with the sequence specified in the sequence listing /description], but which are not structurally related to it."
• "Antibody 7G10 is therefore one way of performing the claimed invention. However, claim 1 is not limited to antibody 7G10 and structural related variants but encompasses antibodies which are solely defined by the functional feature that they have the same specificity as the exemplified antibody 7G10"
• That the skilled person can manufacture 7G10 based on the patent is not disputed.
• Turning to sufficiency, "In a first line of argument the appellant [patentee] submitted that, at the priority date of the patent, the generation and screening of antibodies that bind to the p19 subunit of hIL-23 did not amount to an undue burden of experimentation for a skilled person and that according to the case law of the Boards of Appeal, it was a matter of routine to raise and screen antibodies to a known antigen "
• "The board acknowledges that raising and screening antibodies involves only routine experimentation. However, this is the case only if the skilled person knows from the disclosure in the patent or from common general knowledge (i) which antigens are suitable for raising antibodies having the desired properties and (ii) which screening process should be used to select these antibodies without undue burden"
• " the generation and screening of antibodies that bind (anywhere) to the p19 subunit of hIL-23 would not involve an undue burden for the skilled person.  However, the patent in suit discloses neither a suitable antigen nor a screening process that would ensure the reliable generation and selection of antibodies having the required properties by applying routine methodology and a reasonable amount of experimentation. It is common ground that peptides consisting of the primary sequence of the claimed conformational epitope are unsuitable for raising the claimed antibodies or screening for them."
• "It is moreover undisputed that the patent does not disclose how antibody 7G10 was prepared, i.e. which antigen/immunogen was used for its generation or the screening process that was used to select for it. The board must therefore conclude that the patent contains no guidance regarding a suitable antigen or screening process for the generation and selection of antibodies that are structurally unrelated to antibody 7G10. "
• The Board then discusses the issue of sufficiency in more detail, discussing screening with ELISA, and the choice of the immunogen.
• "that the evidence on file does not support the appellant's assertion that suitable methods for screening a pool of anti-hIL-23 antibodies for p19-specificity were part of the skilled person's common general knowledge at the priority date. Since the patent provides no guidance in this respect either, the skilled person wanting to perform the claimed invention would have to develop a screening process for identifying antibodies that bind an epitope on the p19 subunit of hIL-23 and without risking to miss antibodies that bind the claimed conformational epitope, an undertaking that cannot be regarded as routine."
• "the functional definition of the claimed antibody amounts to an invitation to perform a research program without any guarantee of success. Such a situation is considered to amount to an undue burden for the skilled person "

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EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t200435eu1.html

Main request (patent as granted) - claim 1

The claimed invention - claim construction

16. Claim 1 is directed to antibodies (or antigen binding fragment thereof) that bind to subunit p19 of human interleukin-23 (hIL-23p19) at an epitope comprising amino acid residues 82 to 95 and amino acid residues 133 to 140 of the amino acid sequence of mature hIL-23p19 (SEQ ID NO: 29). The claim is not for a single antibody but for a pool of antibodies each of which binds human interleukin-23 at an epitope as defined in the claim.

17. The two amino acid stretches recited in the claim are not contiguous along the primary sequence of the hIL-23p19 protein chain, thus the epitope defined in the claim is a so-called discontinuous or conformational epitope.

18. While the epitope bound by the claimed antibodies must include both stretches of amino acids, the claim does not unambiguously delimit the spatial extent of the epitope. Interpretation is therefore required to determine its extent. The board does this according to the normal rules of claim construction, in which the terms used in the claim are given their broadest technically sensible meaning in the context in which they appear and having regard to the common general knowledge and the teaching in the patent (see also CLBA, II.A.6.1).

19. The broadest technically sensible construction of the epitope defined in the claim is one where the epitope includes amino acid residues outside the two recited stretches of amino acids, recited in claim 1. Firstly, this is in keeping with the claim wording "comprising". Secondly, it is supported by dependent claim 2, according to which the bound epitope comprises 16 residues located within the recited stretches and 1 additional residue, H106, that is located outside these stretches. Indeed, the claimed antibodies need not bind exactly the amino acid residues recited in the claim as long as their epitope comprises these amino acid residues.

20. The appellant's submission that binding at least one amino acid residue in each stretch would be the broadest technically sensible interpretation is not found persuasive for the following reasons. First, the appellant's interpretation is not supported by the teaching of the patent in the general part of the description (see paragraph [0019] of the patent) and second, it is also no supported by antibody 7G10, relied on in this context by the appellant. Indeed, antibody 7G10 was determined by X-ray crystallography (X-RC) to be within 4.0 Å of the antibody (i.e. to "bind") at 9 of the 14 amino acid residues in stretch 82 to 95 of SEQ ID NO: 29 and 7 of the 8 amino acid residues in stretch 133 to 140 of SEQ ID NO: 29 (see paragraph [0180] of the patent).

21. Contrary to the decision under appeal, a technically meaningful interpretation of claim 1 does not require that it be implied that X-RC must be used to determine binding of the antibody at the target epitope. First, the use of X-RC is not a necessary consequence of the express language of the claim and thus not an implicit feature. Second, construction of the claim in light of the teaching of the patent does not imply the use of X-RC either. While the patent discloses that binding may be determined by X-RC (see paragraph [0019] of the patent), it discloses further methods for determining binding of the antibody at the epitope, (see e.g. paragraphs [0110], [0111] and [0113]).

22. Accordingly, in an embodiment, although the claim is not limited to this embodiment, the claim encompasses antibodies that are functionally defined by their ability to bind to human IL-23p19 and contact several of the amino acid residues within both amino acid stretches recited in the claim, i.e. antibodies with the same specificity as the exemplified antibody 7G10, but which are not structurally related to it. Binding to the conformational epitope may be determined by X-RC, but this is not mandatory.

Disclosure of the invention (Article 100(b) EPC)

23. According to the established case law of the Boards of Appeal, a patent complies with the requirement of sufficiency of disclosure if the skilled person, on the basis of the information provided in the patent and taking into account the common general knowledge, is able to perform the invention as claimed in the whole range claimed without undue burden, i.e. with reasonable effort (see CLBA, II.C.1).

24. The patent discloses, inter alia, a mouse anti-human IL-23p19 antibody termed 7G10 (see Tables 2 and 3), and a humanised version of this antibody, hum7G10 (see Example 2 and Tables 2 and 3). As mentioned in

point 20. above, antibody 7G10 was determined by X-RC to bind 9 of the 14 amino acid residues in stretch 82 to 95 of SEQ ID NO: 29 and 7 of the 8 amino acid residues in stretch 133 to 140 of SEQ ID NO: 29 (see Example 6).

25. Antibody 7G10 is therefore one way of performing the claimed invention. However, claim 1 is not limited to antibody 7G10 and structural related variants but encompasses antibodies which are solely defined by the functional feature that they have the same specificity as the exemplified antibody 7G10 (see also point 22. above).

26. For meeting the requirement of sufficiency of disclosure it is required that the patent, when considered in combination with the common general knowledge at the priority date, provides technical guidance which is sufficiently clear and complete to allow the skilled person to reliably obtain the above mentioned, functionally defined antibodies without an undue burden.

27. In a first line of argument the appellant submitted that, at the priority date of the patent, the generation and screening of antibodies that bind to the p19 subunit of hIL-23 did not amount to an undue burden of experimentation for a skilled person and that according to the case law of the Boards of Appeal, it was a matter of routine to raise and screen antibodies to a known antigen (see decision T 431/96).

28. The board acknowledges that raising and screening antibodies involves only routine experimentation. However, this is the case only if the skilled person knows from the disclosure in the patent or from common general knowledge (i) which antigens are suitable for raising antibodies having the desired properties and (ii) which screening process should be used to select these antibodies without undue burden (see also decision T 431/96, Reasons, points 6, 7, 10, 11, 12).

29. Indeed, the generation and screening of antibodies that bind (anywhere) to the p19 subunit of hIL-23 would not involve an undue burden for the skilled person.

30. However, the patent in suit discloses neither a suitable antigen nor a screening process that would ensure the reliable generation and selection of antibodies having the required properties (see

point 22. above) by applying routine methodology and a reasonable amount of experimentation. It is common ground that peptides consisting of the primary sequence of the claimed conformational epitope are unsuitable for raising the claimed antibodies or screening for them.

31. It is moreover undisputed that the patent does not disclose how antibody 7G10 was prepared, i.e. which antigen/immunogen was used for its generation or the screening process that was used to select for it. The board must therefore conclude that the patent contains no guidance regarding a suitable antigen or screening process for the generation and selection of antibodies that are structurally unrelated to antibody 7G10. For these reasons, the conclusion reached in decision T 431/96 that generation of antibodies to known antigens is routine, does not apply.

32. In a further line of argument the appellant maintained that the process of generating antibodies to hIL-23p19 involved immunisation with hIL-23 heterodimer to raise a pool of antibodies, and then identifying those antibodies that bind specifically to the p19 subunit. Selected anti-hIL-23p19 antibodies could then be analysed by X-RC to determine their epitopes. Since suitable methods for raising and screening antibodies were part of the skilled person's common general knowledge at the priority date, the requirement of sufficiency of disclosure was met.

33. The board is not persuaded by this this line of argument for the following reasons.

Choice of immunogen

34. The patent does not teach that the complete hIL-23 heterodimer should be used for the generation of antibodies that bind to hIL-23p19 at the claimed conformational epitope (see paragraphs [0079] and [0080] of the patent).

35. The appellant asserted that the common general knowledge would have led the skilled person to understand that not any fragment or the p19 monomer but the complete hIL-23 heterodimer (composed of a p19 and a p40 subunit) was the most suitable immunogen to raise antibodies that bind to hIL-23p19 at the claimed conformational epitope. No evidence supporting the pertinent common general knowledge was provided by the appellant.

36. Since p19 is one of the two subunits of hIL-23, the board accepts, for the sake of argument, that the skilled person might consider that the complete hIL-23 heterodimer was a suitable immunogen to raise the claimed antibodies.

37. It is common ground that in using the hIL-23 heterodimer for immunisation, the skilled person would obtain a pool of antibodies recognising (linear and conformational) epitopes anywhere on the surface of the hIL-23 heterodimer and its subunits, p19 and p40.

38. Moreover, since the generation of antibodies to the claimed epitope on p19 cannot be controlled by using the hIL-23 heterodimer, it is a matter of chance whether the antibody pool comprises an antibody that has the same specificity as the exemplified antibody 7G10 (see point 22. above).

39. Therefore, if the skilled person were to choose the hIL-23 heterodimer for raising antibodies, they would obtain a pool of antibodies, which may or may not comprise antibodies having the required properties.

40. However, the board holds that starting from the above mentioned pool of antibodies, the skilled person would not be able to arrive at the claimed antibodies without an undue burden of experimentation for the following reasons.

Screening antibodies for p19 specificity

41. The appellant submitted that, having raised a pool of antibodies against the hIL-23 heterodimer, the skilled person, seeking to put the claimed invention into practice, would have screened the pool to identify those antibodies that bind an epitope on the p19 subunit using any conventional assay available in the art, e.g. an enzyme-linked immunosorbent assay (ELISA).

42. The board acknowledges that at the priority date of the patent, the skilled person was familiar with ELISAs, e.g., for screening hybridoma supernatants for antibodies that bind to a given antigen. For this, the antigen is offered in an ELISA as a binding partner allowing the selection from a pool of antibodies those candidates that bind the antigen.

43. The patent does not disclose which antigen should be used in an ELISA to screen the pool of antibodies raised by immunisation with the hIL-23 heterodimer to obtain those antibodies that bind a conformational epitope on the p19 subunit of hIL-23 (see paragraphs [0082] and [0084]). The only ELISA mentioned in the patent refers to testing of antibodies "for specificity of binding by comparing binding to IL-23 to binding to irrelevant antigen or antigen mixture under a given set of conditions" (see paragraph [0118]).

44. Document D32, relied on by the appellant as evidence that ELISAs were well known in the state of the art, merely confirms that an ELISA can be set up, provided an antigen suitable to screen for the desired property is available (see page 168, second and third paragraph). However, document D32 provides no information as regards antigens or screening steps, e.g. positive and/or negative, which would be suitable to select antibodies that bind an epitope on the p19 subunit, nor does it address the difficulties in selecting an antibody as claimed from a pool of antibodies raised against hIL-23 and without missing antibodies that bind at p19 in the conformation that this subunit adopts in the presence of p40.

45. Documents D13 and D43, relied on by the appellant to confirm that ELISA tests were commonly used in the field at the priority date, and in the "specific context of determining p19-specificity" are production information sheets for commercially available anti-IL-23p19 antibodies. These documents do not constitute what is commonly understood to represent the common general knowledge of the person skilled in the art (see CLBA I.C.2.8.1).

46. Furthermore, document D13 discloses an anti-p19 antibody that was selected for its ability to neutralise the bioactivity of human IL-23. As regards ELISA tests, document D13 discloses that the selected antibody detects the human IL-23 heterodimer and does not cross-react with rhIL-12 p35, rhIL-12 heterodimer, rmIL-23 p40, or rmIL-23 heterodimer. Document D13 does not disclose that any of these ELISA tests was used for isolating the antibody. As for document D43, it discloses another anti-p19 antibody, which was selected by passing sera from immunised goats over a human IL-23 affinity column and then passing the bound fraction over a human IL-12/23 p40 column to remove p40 specific IgG. However, neither document D13 nor document D43 discloses an ELISA that can be used to screen a pool of anti-hIL-23 antibodies to identify antibodies that bind to p19. A fortiori, these documents are unsuitable to provide evidence that the skilled person could have used a routine ELISA to identify and isolate antibodies that bind a conformational epitope on the p19 subunit of hIL-23.

47. The appellant's further argument that alternatively, or in addition, a routine ELISA could have been used to screen for antibodies that bind to the hIL-23 heterodimer but do not bind to the related hIL-12 heterodimer (which lacks the p19 subunit) or to p40 alone and a conventional bioassay to screen the antibodies for inhibition of IL-23 activity but not IL-12 activity is not found persuasive either.

48. There is no teaching or guidance in the patent that would suggest the use of any of these ELISA assays, nor has the appellant referred to any evidence that they were common general knowledge at the priority date. A fortiori, there is no guidance or information with respect to how these assays would need to be performed and whether they would at all be suitable to reliably identify antibodies that bind a conformational epitope on the p19 subunit of hIL-23.

49. Screening for antibodies inhibiting the biological activity of hIL-23, as also suggested by the appellant, cannot differentiate between antibodies binding to the p19 and the p40 subunit of hIL-23. Therefore, this method is not suitable to specifically select antibodies that bind a conformational epitope on the p19 subunit of hIL-23.

Optional additional pre-screening to narrow down the pool of anti-hIL-23p19 antibodies

50. The appellant's argument that the skilled person could narrow down an initial pool of anti-hIL-23p19 antibodies to a smaller group of candidates by a conventional cross-blocking assay to eliminate antibodies that are unlikely to bind at the claimed conformational epitope is not found persuasive either. In fact, the patent proposes to use such an assay for exactly the opposite purpose, namely "to screen for antibodies that bind to the epitope on human IL-23 (i.e. the p19 subunit) bound by an antibody of interest" (see paragraph [0110]), not to eliminate antibodies that are unlikely to bind.

51. Moreover, the appellant's reasoning for using a cross-blocking assay to eliminate antibodies that are unlikely to bind at the claimed conformational epitope is based on its knowledge of antibody 7G10's footprint on hIL-23. However, this footprint is only disclosed in post-published document D18 (see page 948). Based on the teaching in the patent, the skilled person had no reason to expect that a cross-blocking assay would significantly reduce the number of candidate antibodies in a preselected pool of anti-p19 antibodies.

52. Finally, even if the skilled person were to use a cross-blocking assay to eliminate antibodies unlikely to bind at the claimed conformational epitope, they would be aware that the remaining antibodies will not necessarily bind at the claimed epitope. Indeed the patent confirms that not all cross-blocking antibodies necessarily bind at precisely the same epitope, since cross-blocking may result from steric hindrance (see paragraphs [0110] of the patent).

53. As regards the further strategy proposed by the appellant to reduce a pool of anti-p19 antibodies, the board notes that the patent does not teach that grouping of antibodies based on CDR sequences should be included in the process for identifying antibodies that bind at the epitope defined in the claim. No evidence was presented by the appellant that such an assay represented common general knowledge or was routine for the skilled person. Furthermore, the board has seen no evidence to support the thesis that the probability of finding an antibody with the desired binding properties increases by grouping the candidate antibodies into such sub-classes (see also documents D80, points 20 and 21 and document D81, point 58).

Undue burden

54. It is apparent from the above considerations (see points 41. to 49.) that the evidence on file does not support the appellant's assertion that suitable methods for screening a pool of anti-hIL-23 antibodies for p19-specificity were part of the skilled person's common general knowledge at the priority date. Since the patent provides no guidance in this respect either, the skilled person wanting to perform the claimed invention would have to develop a screening process for identifying antibodies that bind an epitope on the p19 subunit of hIL-23 and without risking to miss antibodies that bind the claimed conformational epitope, an undertaking that cannot be regarded as routine.

55. The appellant's argument that it was a matter of routine for the skilled person to perform further screening and narrow down a pool of p19-specific antibodies to arrive at a subset of antibodies that is "most likely to bind the claimed epitope", is not supported by the evidence on file either. Indeed, none of the screening assays proposed by the appellant selects specifically for antibodies that have the same specificity as the exemplified antibody 7G10 (see points 50. to 53. above).

56. Moreover, as set out above (see points 38. and 39.), there is no guarantee that even a single antibody having the same specificity as the exemplified antibody 7G10 is generated when using hIL-23 heterodimer for immunisation. Therefore, removing antibodies that are unlikely to bind at the claimed epitope, does not guarantee that any of the remaining antibodies is more likely to have the required specificity. Indeed, there is no guarantee that even a single antibody that is taken forward to determine its epitope, by X-RC or otherwise, has the same specificity as the exemplified antibody 7G10.

57. The patent does not provide any information regarding the epitopes recognised by the antibodies raised against hIL-23 heterodimer. In particular, the patent provides no evidence that antibodies having the required properties would be generated frequently enough to be identified reliably. Whilst the appellant submitted that the pool of antibodies raised against hIL-23 heterodimer would be expected to include many p19-specific antibodies that are highly unlikely to bind to hIL-23p19 at either of the epitope regions recited in claim 1, it provided no argument let alone evidence on how likely it was that such a pool of antibodies would include ones that do have the required specificity.

58. In summary, given the lack of relevant guidance in the patent or in the common general knowledge, the skilled person attempting to carry out the claimed invention is confronted with having to develop an elaborate screening strategy, without a reasonable expectation of success. Indeed such a screening strategy relies on chance, without the skilled person having any knowledge of the likelihood of success.

59. Finally, if after such a screening process, the antibody taken forward for epitope determination does not have the required specificity, i.e. in case of failure, neither the patent nor the common general knowledge provides adequate information regarding what should be changed or how to guarantee success.

Conclusion on disclosure of the invention (Article 100(b) EPC)

60. An invention may be regarded as sufficiently disclosed even if it requires a certain amount of experimentation by the skilled person to carry it out, as long as this experimentation is not an undue burden on the skilled person. Such a situation may exist where the skilled person has sufficient information to lead them directly towards success through the evaluation of initial failures. Based on the evidence on file, the board considers that in the present case, critical information on the antigen suitable for raising antibodies with the desired properties and screening assays for reliably identifying them is lacking. Moreover, the board has seen no evidence that antibodies binding at the claimed epitope can be generated frequently enough and can be identified reliably enough to guarantee success (see points 34.

to 59. above). Therefore, the functional definition of the claimed antibody amounts to an invitation to perform a research program without any guarantee of success. Such a situation is considered to amount to an undue burden for the skilled person (see also CLBA, section II.C.6.7 and II.C.7.4).

61. Contrary to the appellant's submissions, the fact pattern of the case under consideration (see points 34. to 53. above) is comparable to the facts underlying the case considered in decision T 1466/05. Thus, also in decision T 1466/05, the claimed antibodies were defined functionally (by their binding activity) and while the application provided one exemplary antibody having this function, it failed to provide (i) the antigen required to raise further antibodies as claimed and (ii) a screening process for the specific selection of the same (see Reasons, points 9 and 25).

62. Disclosure of the specific regions within the p19 subunit of hIL-23 that are comprised in the epitope of the claimed antibodies does not distinguish the case at hand from the case underlying T 1466/05 because it does not equate with disclosure of a suitable antigen that can be used for raising and screening antibodies binding at the claimed epitope by applying routine methodology (see also point 30. above).

63. In the circumstances of the case at hand, serious doubts arise from the verifiable fact that there is no relevant guidance in the patent and in the common general knowledge with respect to (i) an antigen suitable for raising antibodies with the desired properties and (ii) screening assays for reliably identifying them. Contrary to the appellant's assertion, the respondents were therefore under no obligation to provide experimental evidence to support the insufficiency objection.

64. The claimed invention is not sufficiently disclosed in the patent and therefore the ground for opposition under Article 100(b) EPC prejudices the maintenance of the patent as granted.

Auxiliary requests 1 to 49

Disclosure of the invention (Article 83 EPC)

65. Claim 1 of these claim requests is directed to antibodies defined solely by the functional feature of binding the conformational epitope defined therein (see section VI. above). The provision of these antibodies involves an undue burden for the reasons set out in points 23. to 64. above. The invention defined in auxiliary requests 1 to 49 is thus not sufficiently disclosed within the meaning of Article 83 EPC.

Order

For these reasons it is decided that:

The appeal is dismissed.

T 1708/18 - Standard of proof for anticipation by inherent feature

Key points

• Claim 5 is directed to: "An isolated antibody that binds specifically to the isolated polypeptide of SEQ ID NO:2 or SEQ ID NO:4."
• In other words, no structure of the antibody is specified at all in the claim.
•  "The opposition division considered that the subject-matter of claim 5 was novel over the disclosure of each of the documents cited by the opponents, including document D3"
• "According to the opposition division, the opponents "did not show beyond doubt that one of the antibodies disclosed in documents D3, D5, D6, ... or D35 is able to bind the antigen of SEQ ID NOs:2 or 4". "
• The Board: "The question of whether or not a given known antibody binds to a particular polypeptide is a question of fact. It is correct that the inherent binding property of the antibody concerned must be demonstrated by the party making the allegation, i.e., in the case at hand, the burden to prove that the antibody disclosed in document D3 binds to the PCSK9b and/or PCSK9c polypeptides lay with the opponents"
• " however, the standard of proof generally applied at the EPO for deciding on an issue of fact is the balance of probabilities."
• "According to this standard, the EPO must base its decisions on statements of fact which, based on the available evidence, are more likely than not to be true"
• As a comment, see also  T 0768/20: "“the board wishes to point out that the practical relevance of the distinction between the "balance of probabilities" standard and the "beyond reasonable doubt" standard is often overestimated. Both standards are only fulfilled if the deciding body is persuaded that the alleged fact is true, which is not a matter of "just tipping the balance slightly".
• "The board is not persuaded by the arguments of the opposition division and the patent proprietor that, by way of exception, a higher standard must apply in the present case."
• "the opposition division appears to mix up two issues which are distinct and unrelated: i) the issue of which standard of disclosure applies when assessing the legal question of novelty, and ii) the issue of which standard of proof applies when assessing evidence and factual questions. The fact that the standard of disclosure required for a finding of lack of novelty (or for allowing an amendment to the application under Article 123(2) EPC) is the standard of a direct and unambiguous disclosure is immaterial to the question of which standard of proof applies when considering evidence and factual issues in the context of novelty (or inventive step)."
• The Board notes that T 464/94 held that: "In the board's view, it is not justifiable to decide whether a document is prejudicial to novelty on the basis of probability. When a patent is revoked for lack of novelty, the department concerned has to be sure, having taken all the facts and arguments put forward during the proceedings into consideration, that the revocation is justified. In case of doubts, further clarification of the factual situation must be carried out; otherwise, the patent cannot be revoked for lack of novelty".
• As a comment, see Guidelines G-VI,6, "the lack of novelty may be ... implicit in the sense that, in carrying out the teaching of the prior-art document, the skilled person would inevitably arrive at a result falling within the terms of the claim. An objection of lack of novelty of this kind is raised by the examiner only where there can be no reasonable doubt as to the practical effect of the prior teaching".
• "this board notes, however, that it is not clear whether the deciding board [in T 464/94] was referring in this statement to the assessment of legal issues in the context of novelty, such as the question of whether the skilled person would have directly and unambiguously derived a specific piece of information from a document, or to the assessment of factual questions, such as whether particular information was published on a specific date, whether a given process resulted in a particular product or whether the product concerned had a specific property. This board is therefore not persuaded that the board in decision T 464/94 indeed adopted an approach to the assessment of factual questions that was different from that which this board intends to follow.'
• "The factual question to be decided upon in the present case is whether it is more likely than not that a known PCSK9 antibody would bind specifically to the PCSK9b and/or the PCSK9c polypeptide. In assessing this question, any evidence submitted by the parties is considered by the board and such evidence does not necessarily have to be in the form of "wet lab" experiments, as argued by the patent proprietor."
• "The question must be answered in the affirmative in the board's opinion, for the reasons set out in the following."
• "The polyclonal antibody disclosed in document D3 recognises an epitope determined by the linear sequence of a peptide (see point 24. above), which is fully contained within the PCSK9b and PCSK9c polypeptides (see point 25. above). In view of this factual assessment, the board considers that it is more likely than not that this antibody, the availability of which had not been questioned, also specifically binds to the PCSK9b or PCSK9c polypeptides, at least in a so-called "Western blot"[]." 
• The patent is revoked.
• As a comment, the Board seems correct in that the current case law is not entirely consistent about the standard of proof with respect to prior art.

EPO 

The link to the decision is provided after the jump.

T 1430/15 - Perpetual motion devices and the GL

Key points

• This examination appeal is directed to an 'energy transducer' which is specified in claim 1 to be able to ‘generate useful work’. According to the Examiner (para. 1.1 of this Communication), it is a perpetual motion device. 
• “Claim 1 is directed to an energy transducer [...], which is able to generate useful work by lowering the internal energy of the material. Since the claimed transducer is limited to exhibiting this effect, the disclosure has to enable a skilled person to achieve it in order to meet the requirements of Article 83 EPC.”
• The Board then analyses the application as filed and the physics involved.
• “To summarise, the Board is not convinced that the model predictions [submitted by the applicant] are correct, there is no disclosure in the application as filed concerning the transduction of internal energy to useful work, merely a hypothesis to this effect, and there is no experimental evidence that the transduction from internal energy, as hypothesised in the application as filed, will necessarily occur when the claim prescriptions regarding the application of forces and choice of material are followed. For these reasons, the application in the version of the main request does not meet the requirements of Article 83 EPC.”
• This analysis is perhaps not very surprising. However, it's interesting to compare this case with the  - in my view rather cryptic - remark in the GL G-III.1 that “An objection could arise under Art. 57 only in so far as the claim specifies the intended function or purpose of the invention, but if, say, a perpetual motion machine is claimed merely as an article having a particular specified construction, then an objection is made under Art. 83”.
• I find this remark in the GL rather confusing. Say I have a claim directed to 'a stack of hexagonal copper plates and pentagonal gold plates' (i.e. merely as a device having this configuration) and the description says that it will generate net energy when exposed to some magnetic field. The skilled person can easily manufacture the stack of plates, still the rejection is under Art. 83 according to the cited GL passage. If on the other hand, the claim has additionally the functional feature ‘the stack is capable of generating net energy’, which is something the skilled person can not reduce to practice according to thermodynamics, the rejection is under Art.57, still according to the GL. The other way around would make much more sense to me (i.e. the impossible functional feature causes a problem under Article 83; merely specifying a structure of a device without plausible function give a problem under Art.57).
• T0541/96 explains that "An invention or an application for a patent for an alleged invention which would not comply with the generally accepted laws of physics would be incompatible with the requirements of Articles 57 and 83 because it cannot be used and therefore lacks industrial application. Also the description would be insufficient to the extent that the applicant would not be able to describe how it could be made to work." 
• GL F-III,3 state that: If the claims for such a machine are directed to its function, and not merely to its structure, an objection arises not only under Art. 83 but also under Art. 52(1) in that the invention is not "susceptible of industrial application". Implicitly, if the claims merely specify a structure, the objection is supposed to be under Art.83.
• In the auxiliary request, the functional feature was deleted. This is not accepted under Art.123(2), because “the application as filed consistently discloses that the transducer produces useful work by lowering the internal energy of a material”.

T 1430/15 -  link

Reasons for the Decision

1. The appeal is admissible.

2. Main request

2.1 The patent application does not meet the requirements of Article 83 EPC because it does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a skilled person.

2.2 Claim 1 is directed to an energy transducer containing a material with unequal cross coupling coefficients between first and second forces and corresponding energy conjugate physical properties, such as for example strain and magnetisation, which is able to generate useful work by lowering the internal energy of the material. Since the claimed transducer is limited to exhibiting this effect, the disclosure has to enable a skilled person to achieve it in order to meet the requirements of Article 83 EPC.

T 2186/14 - On the ashtray example

Key points

• In this examination appeal, the board finds claim 1 unclear. Claim 1 is directed to essentially a nasal spray device for spraying a medicine into a patients nose and has the feature that the device "is configured such that at least 30 % of the dose [of the medicine is deposited in a specific part of the nose], and thereby provides a [pain relieve] effect which is significantly greater than that predicted from a counterpart blood plasma concentration of the [medicine]".
• The appellant argues that these features meet the requirements for allowable 'result to be achieved' features according to GL F-IV.4.10.
• GL F-IV.4.10: "For example, the invention may relate to an ashtray in which a smouldering cigarette end will be automatically extinguished due to the shape and relative dimensions of the ashtray. The latter may vary considerably in a manner difficult to define whilst still providing the desired effect. So long as the claim specifies the construction and shape of the ashtray as clearly as possible, it may define the relative dimensions by reference to the result to be achieved, provided that the specification includes adequate directions to enable the skilled person to determine the required dimensions by routine test procedures "
• The present Board: "In this example [of the Guidelines about the ashtray], it is clear which structural features have to be appropriately designed to achieve the desired effect. The relative dimensions of the ashtray may vary but will always be such that a cigarette is automatically extinguished. However, in the present case, the specific structural features which have to be appropriately designed are not clear from the wording of the claim. The only structural features included in the claim are a nosepiece unit comprising a nozzle and a substance supply unit."
• I guess that the ashtray example was already in the first edition of the GL (still looking for those) and comes from some actual (older) decision of the German Patent Office (most likely) but I would like to learn more about that. Apparently, the self-extinguishing effect of the ashtray was due to both the shape and the relative dimensions and it was sufficient that the claim specified the shape of the ashtray as clearly as possible. 

EPO T 2186/14 -  link

3. Article 84 EPC

3.1 Article 84 EPC requires that the claims define the matter for which protection is sought in a clear and concise manner and that the claims be supported by the description. These requirements ensure that the public is not left in any doubt as to the subject-matter covered by a claim.

3.2 Claim 1 includes a functional feature, namely, that the delivery device is configured such that at least 30 % of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the nasal airway which is posterior of the nasal valve and above the inferior meatus.

T 2658/16 - Conjugate unclear

Key points

• In this examination appeal, claim 1 is directed to a "covalent conjugate of an alpha amino acid ester and a modulator of the activity of a target intracellular enzyme". The Board considers the 'modulator' feature unclear. The applicant's argument that the modulator feature is not an essential element of the invention, does not help. 
• " Although functional features are generally allowable, a functional feature must remain clear in the sense that the person skilled in the art with his common general knowledge in reading the claim, must be able to understand what is meant by the claim without ambiguity and without complicated, time-consuming investigations, i.e. without undue burden, and must be able to derive a clear definition of what is intended to be claimed. Said features must provide instructions which are sufficiently clear for the skilled person to reduce them to practice without undue burden. This is not the case with the functional feature "a modulator of the activity of a target intracellular enzyme or receptor".
•  " the assessment of clarity of a claim cannot be limited to some of its features, presented objectively or subjectively as the essential elements of the claimed invention. All features present in a claim must meet the requirements of Article 84 EPC." 
• " claim 1 of the main request is furthermore not restricted to the delivery system or the conjugation link and comprises further features relating inter alia to the conjugated modulator. The remaining features considered as non-essential by the appellant must also be taken in account for the assessment of the further requirements of the EPC, such as novelty or inventive step. If the core of the invention was indeed the modulator delivery system or the conjugation link, the applicant had the possibility of limiting the subject matter of the claim to that particular subject matter, with the consequence that said limited subject-matter has also to be assessed as such as regards the remaining requirements of the EPC, such as inter alia novelty and inventive step." 

EPO T 2658/16 - link

Claim 1 of the main request (corresponding to former auxiliary request 8) read thus as follows:

"1. A covalent conjugate of an alpha amino acid ester and a modulator of the activity of a target intracellular enzyme or receptor for use in a method of treatment of the human or animal body by therapy, wherein:
the ester group of the conjugate is hydrolysable by one or more intracellular carboxylesterase enzymes to the corresponding acid, wherein the corresponding acid is capable of selectively accumulating in hCE-1 expressing cells;
the nitrogen of the amino group of the amino acid ester is not linked directly to a carbonyl moiety, or left unsubstituted; and
the alpha amino acid ester is conjugated to the modulator at a position remote from the binding interface between the modulator and the target intracellular enzyme or receptor, wherein the position of conjugation is remote when the conjugate has a potency in a cellular activity assay at least as high as that of the unconjugated modulator in the same assay, which cellular activity assay is a cell proliferation inhibition assay carried out in U937 cancer cells."

Reasons for the Decision

1.1 One of the components of the claimed conjugate is thus "a modulator of the activity of a target intracellular enzyme or receptor", and is defined in the form of a functional feature.

Although functional features are generally allowable, a functional feature must remain clear in the sense that the person skilled in the art with his common general knowledge in reading the claim, must be able to understand what is meant by the claim without ambiguity and without complicated, time-consuming investigations, i.e. without undue burden, and must be able to derive a clear definition of what is intended to be claimed. Said features must provide instructions which are sufficiently clear for the skilled person to reduce them to practice without undue burden. This is not the case with the functional feature "a modulator of the activity of a target intracellular enzyme or receptor".

T 0313/13 - Functional feature thus clear

Key points

• The Board finds the expression "nearly abutting" in the claims to be clear in this examination appeal, because it is considered as a "functional feature".

EPO T 0313/13 - link


3. Article 84 EPC 1973
The appellant has introduced the expression "nearly abutting" several times in the amended independent claims. This expression was objected to for lack of clarity, because it was vague (see point 2.2 of the decision under appeal).


The board notes that the wording of a claim has to be clear in itself (see T 454/89 of 11 March 1991).


In view of the passages of the description referred to by the appellant, in particular [0052] of the application as filed, the board interprets "nearly abutting" as a functional feature.


Paragraph [0052] reads "... a distance of separation for nearly abutting key structures corresponds to a distance that is of the order of a tolerance level for assembling the housing and interconnecting components or layers (excluding the actual keypad)) [sic] to make the keyboard effective. That is to say, as close together as the manufacturing process can achieve whilst reliably providing independent movement of one key structure relative to an adjacent key structure" (emphasis added).
Taking the expression "nearly abutting" to be a functional feature, the board considers the independent claims comprising these words to fulfil the requirements of Article 84 EPC 1973.

T 2067/12 - Result to be achieved

Key points

• The Board decides on clarity of a functional feature " defin[ing] the device by a technical result to be achieved". The Board states that in accordance with established case law  such features are permissible in a claim " if (i) from an objective viewpoint they could not otherwise be defined more precisely without restricting the scope of the invention, and (ii) if they provide instructions that are sufficiently clear for a skilled person to be able to reduce them to practice without undue burden, if necessary with reasonable experiments [] In other words, the functional feature must not only be such that the skilled person can understand it, but he must also be able to implement it in accordance with the requirements of Article 84 EPC."  (As a comment, I am not sure whether this introduces an element of sufficiency of disclosure)
• The Board finds that in this case, the functional feature defines an advantage of the device in its functioning state. Thus, the functional feature amounts to a mere desideratum. " It is not apparent how such a broadly defined desideratum could provide the skilled person with instructions which are sufficiently clear to enable him to reduce them to practice" . Therefore, the requirement (ii) is not complied with. 

EPO T 2067/12 - link

Reasons for the Decision

1. Amendments

1.1 Claim 1 of the sole request differs from claim 1 as granted in that the device is further defined by indicating at the end of the claim that

"and only the needles that have been inserted into the product deliver liquid".

This feature is based on page 2, lines 5 to 6 of the application as filed (see also paragraph [0006] of the patent specification).

The amendment was made during the opposition proceedings in order to establish novelty over a public prior use involving device MBI-135-C No. 420 (D6). The opposition division had denied novelty of granted claim 1 because this known device disclosed both the features of the preamble of claim 1 and the characterising part, namely that locking means were provided for locking the needles in their position projecting relatively less far out of the holder.

1.3 The amendment amounts to the introduction of a functional feature into the claim, in the sense that it now defines the device by a technical result to be achieved, that is to say the locking means (15) of the device are to be constructed in such a way that they ensure that "only the needles that have been inserted into the product deliver liquid" (and, by implication, that those not inserted do not deliver liquid).

1.4 As the claim has been amended by introducing a feature taken from the description, it is first necessary to examine whether it fulfils the clarity requirements of Article 84 EPC.

1.4.1 In accordance with established case law of the boards of appeal, functional features defining a technical result are permissible in a claim if (i) from an objective viewpoint they could not otherwise be defined more precisely without restricting the scope of the invention, and (ii) if they provide instructions that are sufficiently clear for a skilled person to be able to reduce them to practice without undue burden, if necessary with reasonable experiments (see decision T 68/85, OJ 1987, 228, headnote). In other words, the functional feature must not only be such that the skilled person can understand it, but he must also be able to implement it in accordance with the requirements of Article 84 EPC.

Concerning the first criterion it is noted that the patent specification in paragraphs [0007] to [0009] describes technical features of a locking system that ensure that only the needles that have been inserted into the product deliver liquid and that they do this both when they are being pushed into the product and when they are being extracted from it.

1.4.3 Whether or not the introduction of these specific technical features would unduly restrict the scope of the invention can be left unanswered because the functional feature does not in any case fulfil the second criterion, namely it does not provide clear instructions of how to put it into practice. This is the case for the following reasons:

- Firstly, the functional feature defines an advantage of the device in its functioning state, as can be seen from paragraph [0006] of the patent specification. Thus, the functional feature amounts to a mere desideratum. It is not apparent how such a broadly defined desideratum could provide the skilled person with instructions which are sufficiently clear to enable him to reduce them to practice (see in this context point 8.4.3 of T 68/85). It is, for example, not clear whether and how the added functional feature is interrelated with the locking means (15), whether the control of the delivery of liquid occurs automatically or via the locking means (15), or which other means are envisaged.

Moreover, this lack of clarity is aggravated by the fact that the use of the device includes a first descending step of inserting the needles into the product and a second ascending step of extracting them. Although it is mentioned in paragraph [0006] of the patent specification that the needles deliver liquid both when they are being pushed into the product and when they are being extracted from it, this is not clear from the wording of the claim itself, which is open on this issue.

1.5 In summary, the functional definition present in claim 1 cannot be accepted and the claim does not fulfil the requirements of Article 84 EPC.

2. Consequently, the respondent's request is not allowable.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.

T 0809/12 - Result to be achieved

EPO Headnote:

If an independent claim contains a feature defined by a result to be achieved which essentially corresponds to the problem underlying the application, to comply with Article 84 EPC 1973 the remaining features of the claim must comprise all essential features necessary for achieving that result.

Comment - The hadnote requires a bit of analysis. Of course, any claim must contain "all essential features necessary for achieving that result", not only claims containing a result-to-be-achieved feature - as the Board acknowledges. In fact, the Board distinguishes over T 68/85 and subsequent case law that held that it is not necessary to include all such features, if this would unduly restrict the claim. The Board notes that in T 68/85, the claimed technical result (i.e. result to be achieved recited as feature in the claim) did not in fact correspond to the problem underlying the application.

 EPO T 809/12 - [C] - link

Reasons for the Decision

[...] 2.2 Claim 1 contains, apart from structural features such as the thickness of the first and second Ni or NiCr inclusive layers, the feature "said coated article has a DeltaE* value (glass side) no greater than 2.5 after or due to heat treatment". The question to be answered by the board is whether this feature leads to non-compliance with Article 84 EPC 1973.

2.3 The application concerns low-E coated articles and methods of making the same. According to the description, page 3, second paragraph, "there ... exists the need in the art for a low-E coating or layer system which after heat treatment substantially matches in color ... its non-heat treated counter part. In other words, there exists a need in the art for a low-E matchable coating or layering system". Further according to the description, page 13, lines 4 et seq., "The value ... DeltaE* ... [is] important in determining whether or not there is matchability, or substantial matchability, in the context of the invention". The contentious feature relating to the DeltaE* value thus amounts in essence to claiming the effect aimed at by the invention, i.e. improved matchability of the coated article. Put differently, the feature relating to the DeltaE* value is defined as a result to be achieved corresponding essentially to the problem underlying the application.