II. DEMANDE DE BREVET ET MODIFICATIONS

In T 1096/23 opponent 1 (appellant) raised among other things a clarity objection against auxiliary request 2. In this request, features of granted claim 6, which had originally been disclosed only as a dependent method claim, had been included in the independent apparatus claim 11. Opponent 1 submitted that clarity of these features had to be assessed, since G 3/14 did not apply when the category of the (dependent) claim was changed. As there was no disclosure of an apparatus which was configured to carry out these method steps, it was unclear how the method steps were implemented in the apparatus. Therefore, the subject-matter of independent apparatus claim 11 did not meet the requirements of Art. 84 EPC.

The board agreed with the patent proprietor (appellant) that according to G 3/14, when "complete dependent claims" have been added to the corresponding independent claim, the patent must not be examined for compliance with the requirements of Art. 84 EPC. But the board agreed with the reasoning of opponent 1 that this did not apply in the present case to the implementation of the method of the dependent method claim in the apparatus defined in claim 11. However, when a complete granted dependent claim is incorporated into an independent claim of another category (here: method step -> method step carried out by an apparatus), then only the amendments related to the change of category can be examined for clarity under G 3/14.

The board held that in the case of a sub-step of a method, which was (implicitly) executed in a computer program, it made no difference for the purposes of clarity whether this method step was part of a (computer-implemented) method or was implemented in computational means in an apparatus claim, so that no ambiguity could arise. Consequently, adding the features of the original dependent method claim 6 to the wording of apparatus claim 11 did not result in any ambiguity for the skilled person. Claim 11 of auxiliary request 2 met the requirements of Art. 84 EPC.

In T 48/24 claim 1 as granted defined a device comprising a "training data generation unit", a "model construction unit" and an "estimation unit". The device was for training and using machine learning for obtaining a "value representing the composition of waste" in a waste pit upon inputting "data of" a captured image of the waste.

The board observed that sufficiency of disclosure had to be assessed for each case individually. The board saw no apparent reason to treat inventions in the field of machine learning differently from other inventions in this regard. According to the board, it went without saying that the implementation of a suitable machine learning model, its training, and whether the trained model can successfully estimate the specified output based on the input parameters as claimed may be important aspects of sufficiency of disclosure of machine learning inventions. However, there were no special requirements and no general rules for assessing whether these aspects were sufficiently disclosed.

With regard to the decisions referred to by the appellant (opponent), the board considered that it was not possible to derive from T 161/18 any general criteria which might be applicable to the present case. Similarly, the board observed that T 1669/21 illustrated the glaring gap between the breadth of the claimed invention and the level of detail in the patent, but did not provide generally applicable criteria required for sufficiently disclosing a machine learning invention. Likewise, the board also pointed out that the considerations in the present case did not imply any universally applicable criteria for assessing sufficiency of disclosure of machine learning inventions.

In the case in hand, the board noted that the patent did not contain a specific example of the claimed invention. That is, it did not disclose any specific combination of certain "data of" captured images and a particular "value representing composition" of the waste in the images, nor did it provide any details on the implementation and training of an exemplary machine learning model, or any information on the achieved accuracy of estimation. In other words, the patent did not contain any concrete, reproducible example of implementation of the invention. Such a specific example was not in itself an absolute requirement for sufficient disclosure, provided that the skilled person was aware of "at least one way" of carrying out the invention in other ways, for example, through the generic disclosure in the patent or the common general knowledge (see R. 42(1)(e) EPC, "using examples where appropriate"). In the present case, however, providing such an example could have demonstrated that the invention was workable at all, at least in this specific case of the example. It could have served as a reference to better understand the claimed invention, its terms and purpose and the achievable or expected level of accuracy.

The board also explained that sufficiency of disclosure required that the invention could be carried out over the whole claimed breadth without undue burden. This requirement had been formulated in decisions across all technical fields (T 149/21). It reflected the general principle that the protection obtained with the patent had to be commensurate with the disclosed teaching. Even if "one way" of performing the invention was disclosed, this would only be sufficient if this disclosure enabled the skilled person to perform the invention over the whole claimed breadth. The patent in suit taught the general idea of using machine learning to infer properties of the waste composition that could be relevant for operating and controlling a waste incineration plant from images of the surface of the waste pit. However, the disclosure was mostly limited to stating a "result to be achieved". The patent left it to the skilled person to select and evaluate combinations of input data and machine learning models for different desired outputs. Each evaluation involved implementing, training and evaluating the selected models. Overall, this resulted in an enormous number of parameter combinations to choose from. Exploring all the possible combinations of these parameters would require a comprehensive research programme and would place an undue burden on the skilled person.

The board concluded that the maintenance of the patent as granted according to the main request was prejudiced by the ground for opposition under Art. 100(b) EPC. Auxiliary requests 1 to 7 were not allowable under Art. 83 EPC either.

In T 1555/23 the patent related to the medical use of chimeric antigen receptor-modified T cell (CAR T cell) products for cancer therapy in combination with IL-6 inhibitors for toxicity management. The appellants argued that the subject-matter of claims 1 and 5 was not entitled to the priority of the first priority document (P1)..

The board recalled that assessing the requirement of the "same invention" within the meaning of Art. 87 EPC was based on the determination whether the subject-matter claimed could be derived by the skilled person directly and unambiguously, explicitly or implicitly, using common general knowledge, from the previous application as a whole (G 2/98). For the subject-matter of further medical use claims, this entailed assessing whether the priority (or previous) application at the date of its filing rendered it credible that the known therapeutic agent was suitable for the claimed therapeutic application (see e.g. T 843/03). This was consistent with the general teaching in G 1/03 that the process of making the invention has to be completed when an application for a patent is filed.

Appellants II and III argued that the subject-matter of claim 1 was not directly and unambiguously derivable from P1. Their reasoning was essentially based on an interpretation of current claim 1 in which no causal link between the monitoring step and the second-line therapy existed. Such a method without a causal link was not disclosed in P1. Appellant II further argued that P1 did not disclose the general use of a single cytokine inhibitory therapy for managing toxicity resulting from CAR T cell infusion..

The board disagreed. Claim 1 did not refer to the general use of a (or any) single cytokine inhibitory therapy but rather to IL-6 as the cytokine to be monitored and inhibited when its level was increased. Claim 1 also included a causal link between the result of the monitoring, i.e. increased IL-6 levels, and the administration of an IL-6 inhibitor as a second-line therapy. As also pointed out by the respondents and acknowledged by the opposition division, a basis for IL-6 as the cytokine to be monitored and inhibited when its level is elevated could be found in several passages in P1. A further basis for this subject-matter could be found in claims 1 to 4 of P1. P1 further disclosed: "(CAR) in combination with toxicity management, where a profile of soluble factors from a post T cell infusion patient is generated and a therapy directed against the elevated soluble factor is carried out in order to treat the cancer" and "second-line of therapy appropriate to treat the patient as a consequence of the first-line of therapy". Thus, according to the board, the subject-matter of claim 1 was directly and unambiguously derivable from the disclosure of P1.

Claim 5 required the second-line therapy to be tocilizumab. Appellants II and III also argued that this subject-matter was not directly and unambiguously derivable from P1. The board concluded that the skilled person would have derived directly and unambiguously that the IL-6 inhibitory compound tocilizumab was a preferred embodiment of the cytokine inhibitory therapy disclosed in claims 1 to 5 of P1, i.e. the same invention as in current claim 5..

The appellants further contended that the invention as claimed was not enabled in P1 over its whole breadth, raising several objections, none of which were found convincing by the board. For example, the appellants argued that P1 did not disclose that a single agent, i.e. an IL-6 inhibitory compound, was capable of managing the toxicity arising from CAR T cell treatment and that the document only contained assertions to this effect, while the experimental evidence in Figure 9 was not conclusive. The board noted that, in this context, the relevant question was whether P1 made it credible that tocilizumab was effective in managing toxicity of CAR T cells. The board disagreed with the appellant’s contention that the document only contained assertions to that effect which, in accordance with T 609/02, might not represent sufficient evidence for a therapeutic effect. In the current case, a clinical trial had been conducted, albeit with only one or two patients, and the inventors drew conclusions from it. The board therefore considered the teaching of P1 sufficient to make it credible that the toxicity of CAR T cell therapy could be managed with a single agent..

The board concluded that the invention to which claims 1 and 5 related was disclosed in an enabling manner in P1 and, therefore, the claims enjoyed priority from P1.

In T 1052/23 the board explained that an amended claim the wording of which was not literally included in the (earlier) application as originally filed, as in the case in hand, must generally be interpreted by using a mind willing to understand and by consulting the description and the drawings, prior to assessing whether the claimed subject-matter can be directly and unambiguously derived from the (earlier) application as filed. The board agreed with the two-step approach applied in T 2048/22 and T 873/23.

The board did not agree with the patent proprietor's narrower interpretation of claim 1, according to which a "selection" or "switching" step between two types of shapes of the printing features of the same printing plate was included. The board observed that, as held by many boards following G 1/24, the consultation of the description did not mean that restrictive features that were contained in specific embodiments in the description could limit the wording of the claims, see for example T 1232/23, T 1465/23, T 1846/23, T 1069/23, T 1351/23, T 412/24, T 2034/23 and T 1402/24. The board was of the view that also the more general statement in paragraph [0008] of the patent relating to the background of the invention and merely pointing to an advantageous method and apparatus would not prompt the skilled person to a narrower interpretation of claim 1.

The board consulted the description when interpreting claim 1 and interpreted it in a broad, technically reasonable manner. According to the board’s interpretation, claim 1 did not include the aspect of controlling the top shapes of the printing features on a same printing plate by selecting the first or second illumination intensity, so that the claim was not restricted accordingly. Omitting this essential aspect, which was included in the relevant independent claims of the parent application and presented throughout its description as a core feature of the invention, led to a broadening of the claim which therefore encompassed subject-matter that was not originally disclosed in the parent application as originally filed. Consequently, the omission amounted to an unallowable amendment and to an extension beyond the content of the parent application as filed.

With respect to dependent claims 5 and 6, the board was of the view that the features of said dependent claims were not disclosed in the claims of the parent application as originally filed. They were taken from the description, but from a specific technical context. Claim 5 and 6 as granted constituted unallowable intermediate generalisations of specific examples provided in the parent application as originally filed.

Therefore, the board concluded that the subject-matter of claims 1, 5 and 6 extended beyond the content of the earlier application as filed so that the ground for opposition under Art. 100(c) EPC prejudiced the maintenance of the opposed patent as granted.

In T 439/22 of 11 December 2025 the board applied the conclusions of the Enlarged Board in G 1/24 to interpret the term "gathered sheet" in claim 1 of the referring case.

The board held that in interpreting the language used in a claim, "consulting", "referring to", "using" and "taking into account" the description and figures are synonyms for the act of deriving the necessary information from the patent as a whole to understand which meaning a person skilled in the art would attribute to the terms used in the claim.

Furthermore, the board stated that claim interpretation was the result of both reading the claims and consulting the description and drawings as a unitary process. It explained that this holistic approach followed from the Order of the Enlarged Board, according to which, if, on the one hand the claims are the starting point and the basis for assessing the patentability of an invention under Art. 52 to 57 EPC, the interpretation of the claims requires, on the other hand, that "the description and drawings shall always be consulted when assessing the patentability of an invention under Art. 52 to 57 EPC". Moreover, this was confirmed in point 17 of G 1/24, which provides that "the finding that the language of a claim is clear and unambiguous is an act of interpretation, not a preliminary stage to such an interpretative act"..

The board was of the view that a skilled person aiming to correctly determine the subject-matter for which protection was sought and reading the patent specification with a mind willing to understand would attribute considerable weight to any definition of a term used in the claims. Having cross-checked that the claim in itself and in the context of the other claims made technical sense and was in line with the information presented in other passages of the description, the person skilled in the art would have no reason to disregard such definitions and to give the defined terms a different meaning in the claim. In the case in hand the definition of "gathered" given in paragraph [0035] did not contradict but rather encompassed the commonly accepted meaning of the term "gathered sheet", namely a sheet that is folded and convoluted to occupy a three-dimensional space. The definition was simply not restricted to folded sheets but included other forms of transverse constrictions of the extension of a sheet. The board concluded that the wound tobacco sheet of D1 equated to the "gathered sheet" feature of claim 1 when this term was correctly interpreted according to paragraph [0035] of the description. Hence, the subject-matter of claim 1 of the main request lacked novelty over the content of document D1.

The sole amendment in the auxiliary request was the deletion of paragraph [0035] from the description of the contested patent, which read as follows: "As used herein, the term 'gathered' denotes that the sheet of tobacco material is convoluted, folded, or otherwise compressed or constricted substantially transversely to the cylindrical axis of the rod". The appellant submitted that said deletion altered the interpretation of the term "gathered sheet" in claim 1 and, consequently, the scope of the protection conferred. In the absence of the broader definition provided in paragraph [0035], the term "gathered sheet" no longer encompassed other limiting features, namely that the gathered tobacco sheet was "compressed or constricted substantially transversely to the cylindrical axis of the rod".

The board noted that, in line with the Enlarged Board's holistic approach to claim interpretation in G 1/24, a person skilled in the art reading the claim in the context of the description and figures would try to take a definition found in the description at face value. As long as the definition was technically reasonable and complied with the overall teaching expressed in the claims, description and figures, the skilled person would read the terms in the claim in the sense of the definition, taking into account both the broadening and limiting aspects found in that definition. It was therefore not permissible to consider only the broadening aspects contained in a definition and disregard any limiting aspects. As set out by the Enlarged Board in G 1/24, point 20 of the Reasons, Art. 84 EPC may require that limiting or broadening aspects are expressed in the claim to avoid any unclarity, but a granted claim had to be read in light of all aspects of a definition found in the description. Therefore, the board concluded that the auxiliary request did not comply with the requirement of Art. 123(3) EPC.

In T 781/23 the opposition division had held that the patent was entitled to claim priority from the priority document, a US provisional patent application filed in the name of the inventors, with the consequence that documents D12 and D13 did not belong to the state of the art according to Art. 54 EPC. The appellant (opponent) argued that the applicant for the patent in suit was not the successor in title of the applicants for the priority document.

The board recalled that, in accordance with decision G 1/22, under the autonomous law of the EPC there is a rebuttable presumption that the applicant claiming priority is entitled to claim priority. Furthermore, the presumption of priority entitlement applies to any case in which the subsequent applicant is not identical to the priority applicant but receives the support of the priority applicant required under Art. 88(1) EPC. Thus, the presumption applied in the case in hand. The board explained that the existence of a presumption of validity implied that it was the burden of the party challenging the applicant's entitlement to priority to prove that this entitlement was lacking. Thus, the appellant's argument that it was on the proprietor to demonstrate that it had the right to claim priority had to fail..

Also referring to G 1/22, the board stated that the presumption was rebuttable, for example, in cases of bad faith behaviour of the subsequent applicant or as a result of other proceedings such as litigation before national courts concerning title to the subsequent application. It further stated that the presumption of entitlement existed on the date on which the priority was claimed and the rebuttal of the presumption also had to relate to that date.

According to the board, in the case at hand, the appellant had not provided any such evidence to rebut the presumption of priority entitlement. Document D19 was an assignment by the inventors to the applicant of the patent in suit and could not rebut this presumption. The further evidence provided relied on requirements of national law, such as the distinction under French law between the right to the invention and the right to the priority claim. The board was of the view that, following the presumption of priority entitlement existing under the autonomous law of the EPC, considerations based on national law became irrelevant.

In light of the foregoing, the board came to the conclusion that the patent was entitled to the priority claimed.

In T 1489/23 the patent related to additive manufacturing process control, in particular for Selective Laser Sintering (SLS). The patent proposed "real-time statistical process control monitoring and control". It relied on monitoring the "spark plume" created during sintering.

Regarding the particular way in which sufficiency of disclosure had been challenged by the appellant (opponent), the board observed that an objection to sufficiency had to be reasoned. This burden was with the party raising the objection. According to the board, to justify an objection to sufficiency, one may contest factual allegations in the disclosure (for example, that certain things can be done in a certain way or that a technical effect is effectively achieved), or one may point out gaps in the disclosure, i.e. to information, which is missing from the disclosure but required for the skilled person to carry out the invention over the full scope of the claims. For either argument to be convincing, it must raise "serious doubts". It cannot be limited to mere allegations of insufficiency, but has to be reasoned in a way that allows the deciding body to evaluate, i.e. "verify" its merit.

The board explained that to make an objection of the "first type", it may be appropriate to submit evidence showing that an alleged fact was actually incorrect. It may be less straightforward to provide evidence to substantiate an objection of the "second type", because establishing a gap in the disclosure was similar to "proving a negative". For the same reason, it was unclear to what extent an objection of the latter type could be based on "verifiable facts".

In the case in hand the appellant had pointed to specific information missing from the disclosure and the common general knowledge. The corresponding arguments were in part verifiable and otherwise sufficiently substantiated for the board to assess them. In the board's judgement, therefore, the appellant had provided sufficient reasons to substantiate its objection of insufficient disclosure.

The board agreed with the respondent that the patent taught that the spark plume may be an indicator for in-process quality factors and also that it provided a list of characteristics that may be useful as indicators. The board was of the opinion that the skilled person would be capable of extracting specifically given image characteristics from suitably "derived" image data using common-place image processing tools. This was part of the common general knowledge. Considering the cited prior art, the board was also convinced that at least some useful information existed in the image of the spark plume. For some instances, the success of the claimed method was predictable.

Regarding the alleged gaps in the disclosure, the board considered that the patent did not (a) define the intended meaning of the term "spark plume", i.e. which incandescent matter (plasma, spatter, condensate) was to be monitored; (b) disclose which characteristics of the so-defined spark plume were (not just might be) useful as indicators, and for which quality factors; or (c) provide any evidence to that effect. Based on the evidence on file, this missing information was not part of the common general knowledge. Because the patent provided no working examples, the skilled person had to make three choices without any guidance, namely which "plume" constituents to identify in the image, which characteristics to derive from that image, and in view of which quality factors to assess abnormality of the derived characteristics.

The complexity of the task that the skilled person had to accomplish was therefore of combinatorial nature, and without any guarantee of success. It did not appear trivial to make appropriate selections for a large number of quality factors, manufacturing processes and products. It was not even clear which quality factors may be reflected at all in any of the plume characteristics. It may be possible with reasonable effort to find parameter combinations which work for some cases, but it appeared difficult to identify such cases beforehand. In the board's judgment, the successful accomplishment of this task by the skilled person required a considerable effort and went well beyond routine experimentation. It therefore amounted to an undue burden.

The board concluded that the claimed invention was insufficiently disclosed for it to be carried out, over its full breadth, by the skilled person.

In T 709/23 the board explained that claim 1 was drafted as a purpose-limited product claim under Art. 54(5) EPC. The therapeutic indication "for use in treating a pruritic or allergic condition in cats" constituted a functional technical feature of the claim. The antibody was defined solely by two functional features: its specific binding to feline IL-31 and its inhibition of IL-31-mediated pSTAT signalling. However, the board noted that defining the antibody in terms of functional features did not, in itself, establish a credible link to the claimed therapeutic indication. The application as filed had to provide clear and direct disclosure demonstrating that the functionally defined antibody was indeed suitable for achieving the claimed therapeutic effect..

The board observed that, while the extrapolation of the therapeutic effect from dogs to cats was disputed, its assessment under Art. 83 EPC was based on the objection that the claimed invention could not be carried out across the entire scope claimed. Accordingly, it was not necessary for the board to decide whether the skilled person would have credibly extrapolated the data on IL-31 in dogs to cats..

The board explained that while the patent application showed that feline IL-31 could activate pSTAT in canine DH-82 cells, it did not demonstrate that antibody 11E12 or 34D03 inhibited IL-31-mediated pSTAT signalling in feline cells or was effective in treating pruritic or allergic conditions in cats in vivo. A person skilled in the art attempting to carry out the invention in cats as claimed, would have selected one of the few antibodies disclosed, which were described as binding to an epitope conserved between canine and feline IL-31 and felinised it as disclosed for antibody 34D03 in Example 11. The skilled person would have expected that each of the disclosed antibodies, i.e. both 11E12 and 34D03, would be capable of achieving the claimed effect in cats. Whether the approach would have worked with antibody 34D03 remained speculative. However, in post-published document D51, an in vivo effect in cats was demonstrated only for antibody 15H05, which binds to a distinct epitope on IL-31. Contrary to the central teaching of the patent application that inhibition of feline IL-31- mediated pSTAT signalling correlated with therapeutic efficacy in vivo, the data generated in D51 using 11E12 antibody variants showed that an antibody targeting the conserved antigenic region on IL-31 according to the patent application, while being able to inhibit feline IL-31- mediated pSTAT signalling in cat cells, failed to achieve significant therapeutic effects in cats.

The board found that, as shown by document D51, additional research was necessary to arrive at an anti-IL-31 antibody capable of treating a pruritic or allergic condition in cats. Hence, there were serious doubts substantiated by verifiable facts whether, following the teaching of the patent application, a skilled person would arrive without undue burden at an antibody suitable for treating a pruritic or allergic condition in cats.

The board concluded that the patent application did not disclose the invention as defined in claim 1 of the main request in a manner sufficiently clear and complete for it to be carried out by the person skilled in the art (Art. 83 EPC). The reasons provided for the invention according to claim 1 of the main request applied mutatis mutandis to the invention according to claim 1 of auxiliary requests 1 to 20 which also failed to fulfil the requirements of Art. 83 EPC.

In T 1396/23 the appeal was filed by the opponent against the opposition division's decision rejecting the opposition. The appellant contested the opposition division's finding that the invention defined in claim 1 of the opposed patent was sufficiently disclosed. While the appellant did not dispute that claim 1 related to a medical use and was drafted as per Art. 54(5) EPC, it argued that the effect induced by whey protein micelle complexes (WPM complexes) described in the opposed patent was not therapeutic. According to the appellant, the claimed complexes provided nutrition but were unsuitable to prevent the claimed conditions, even less so to treat them.

The board was not persuaded by the arguments of the appellant. The board referred to the opposed patent, which explained that, prior to the filing date, whey protein isolates were considered not only to be essential nutrients but also to be beneficial in reducing the risk of, and treating, metabolic diseases associated with high-fat diets and/or elevated postprandial insulin levels, such as diabetes. On this basis alone, the board found it reasonable to assume that the claimed WPM complexes, which contained whey proteins, could likewise induce these effects..

The board observed that the opposed patent taught that using the claimed WPM complexes rather than conventional whey proteins was beneficial for subjects who were at risk of or suffered from the diseases indicated in claim 1. The board explained that it was immaterial what the underlying mechanism of action was, and also whether the complexes acted on a specific target and whether a comparator such as whey protein isolate or uncomplexed WPM was explicitly mentioned in claim 1. The skilled person would appreciate that the claimed WPM complexes were intended to be incorporated into a nutritional composition in place of whey proteins in order to achieve the stated therapeutic effect. The board concluded that, in the context of the invention, the claimed compositions comprising WPM complexes could thus be regarded as "a substance or composition" within the meaning of Art. 54(5) EPC that was used to carry out the claimed therapeutic method.

In T 866/24, during the oral proceedings before the board, the opponent (respondent) submitted that the unclear features underlying the amendments made to claim 1, which were based on the patent description, were building up on corresponding unclear formulations taken from dependent claim 6 as granted. Raising an objection under Art. 84 EPC against unclear features stemming from granted dependent claims should, in the opponent’s view, be admissible under such circumstances.

The board agreed, in principle, with the opponent's concerns. According to the board’s perception, there was a recent tendency to examine dependent claims less and less with respect to clarity in examination proceedings despite the fact that their full examination under Art. 84 EPC was not considered "unrealistic" in G 3/14, point 32 of the Reasons. Such a full examination was even expressly encouraged by the Enlarged Board in G 1/24, point 20 of the Reasons (i.e. highlighting "the importance of the examining division carrying out a high quality examination of whether a claim fulfils the clarity requirements of Article 84 EPC"). The board noted that the justification for such leniency may be found in the assumption that the protection conferred by a granted patent is defined only by the independent claims. Where dependent claims are subsequently added to an independent claim in the course of opposition proceedings, opponents are ultimately faced with unclear claim features which, as in the present case, were deemed to have been examined for clarity, although de facto they had not been. Nonetheless, they could not be objected to under Art. 84 EPC due to the conclusions of G 3/14.

The board observed that this result was unsatisfactory, as an independent claim with unclear features leaves much to the readers' imagination. It added that unclear features tend to elude a sensible comparison with the prior art. Furthermore, since opponents may not anticipate with certainty which claim construction will be adopted by the board or a court in infringement proceedings, they may feel obliged to put forward different lines of argumentation for all of the different potential interpretations. In the board’s view, categorically barring opponents in such cases from raising clarity objections under Art. 84 EPC causes undue complexities in the discussion on novelty and inventive step, to the detriment not only of opponents but also of the opposition divisions and the boards of appeal.

In T 878/23 claim 1 of the main request concerned a product claim. The claimed composition comprised an amino acid combination selected from seven combinations containing two or three amino acids selected from cysteine, alanine, lysine and arginine. Claim 1 further specified that the composition contained specified concentrations (amounts) of each of lysine, alanine and arginine (from "8 to 20 wt.%") and cysteine (from "2 to 10 wt.%") based on the composition's total dry weight. Claim 1 thus defined minimum and maximum amounts for each of the four indicated amino acids in the claimed composition. Dependent claim 4 further specified that the composition of claim 1 contained a "total amino acid concentration ... in the range from 3.5 to 36.5 wt%, based on the total dry weight of the composition". Claim 4 added thus a further limit to the composition as defined in claim 1 concerning the used total minimum and maximum concentration (amount) of amino acids.

The board observed that the minimum concentration of amino acids that had to be present in the claimed composition differed between the ranges indicated in claims 1 and 4. The board explained that since a dependent claim (here claim 4) contained more technical features than an independent claim (here claim 1) on which it depended, the subject-matter of a dependent claim was generally more limited than that of the independent one. However, in the case in hand, the compositions specified in claim 4 were broader than those of claim 1, since claim 4 allowed the presence of lower amino acid concentrations in the claimed composition than claim 1. Since the concentration ranges defined in claims 1 and 4 were mutually exclusive, i.e. incompatible, over a substantial part of their ranges, the skilled person could not technically prepare the composition as defined in claim 4 across substantially the whole breadth claimed, even if taking common general knowledge into account. The subject-matter of claim 4 was therefore insufficiently disclosed.

While appellant I (the patent proprietor) admitted that there was an inconsistency between the concentration ranges indicated in claims 1 and 4, it argued that this inconsistency exclusively resulted in a clarity issue (Art. 84 EPC). The board disagreed. The board explained that the decisive issue did not concern an ambiguity of the scope of protection of the claimed invention, as would be the case, for example, if a specific compound would be defined by an unclear parameter. In the case in hand, standard amino acids were used for preparing the claimed composition. These were specified by standard concentration ranges. The methods for determining these concentrations were standard too. Nevertheless, despite these clear instructions in claims 1 and 4, the skilled person could not prepare the claimed composition over substantially the whole breadth of claim 4 due to the at least in part incompatible or mutually exclusive concentration requirements indicated in claims 1 and 4. Claim 4 thus contained no "forbidden area", but an area which could not be prepared for technical reasons.

The board concluded that Art. 100(b) EPC prejudiced the maintenance of the patent as granted. Since the objections under insufficiency indicated above for claim 4 as granted applied likewise to auxiliary requests 1 to 18, the board held that auxiliary requests 1 to 18 did not comply with the requirements of Art. 83 EPC.

In T 883/23 the board had to decide whether claim 1 of the main request was entitled to claim priority from the earliest priority application (P1). P1 disclosed a method for treating pancreatic cancer in a human subject who has not previously received chemotherapy involving the administration of MM-398 liposomal irinotecan, wherein the liposomal irinotecan was administered in combination with oxaliplatin, leucovorin and 5-fluorouracil (claim 3). P1 defined doses of 60 or 80 mg/m2 liposomal irinotecan (claim 5) and 60, 75 or 85 mg/m2 oxaliplatin (claim 8)..

Example 4 of the patent presented the results of a dose escalation/de-escalation study demonstrating the tolerability of the selected dose combination of claim 1 of the main request, as opposed to the intolerable and thus unsuitable alternative dose combinations defined in claims 5 and 8 of P1. The board observed that information concerning the tolerability of the selected dose combination of claim 1 of the main request was not revealed in P1. In particular, this information was not provided by the mere outline for the dose escalation/de-escalation study in P1, which the patent proprietor relied on as a pointer to the subject-matter of claim 1 of the main request with reference to T 1261/21. The board noted that in T 1261/21 the competent board had explained that a "pointer" in an original disclosure was an implicit or explicit indication or hint towards a combination of features, which demonstrated that this combination of features did not represent an arbitrary combination of features only conceptually comprised, but was actually envisaged in the original disclosure. However, the competent board had emphasised that what information a skilled person would directly and unambiguously derive from the original disclosure remained to be assessed on a case-by-case basis.

According to the board, in the present case, P1 provided with the outline for the dose escalation/de-escalation study only a conditional proposal for the use of a combination of 60 mg/m2 liposomal irinotecan and 60 mg/m2 oxaliplatin as part of a study still to be carried out. This proposal could not be considered to provide any pointer to the combination of 60 mg/m2 liposomal irinotecan and 60 mg/m2 oxaliplatin uniquely tolerable in first-line treatment of patients with metastatic pancreatic cancer as defined in claim 1 of the main request.

The board rejected the patent proprietor's argument that P1 described the same subject-matter as defined in claim 1 of the main request, which should in accordance with G 2/98 therefore benefit from the priority of P1, regardless of any additional technical effects, such as the results of the dose escalation/de-escalation study, which may have been described only in the subsequent application from which the patent was derived. The board observed that, according to the established jurisprudence of the Boards of Appeal, attaining the claimed therapeutic effect was regarded as a functional technical feature of claims in the format of Art. 54(5) EPC. Notably, the tolerability of the defined treatment was a prerequisite for the therapeutic efficacy (T 2506/12). The tolerability of the dose combination as defined in claim 1 of the main request, as opposed to the intolerability of the alternative combinations with higher doses of claims 5 and 8 and the dose escalation/de-escalation scheme in P1, was thus a functional technical feature of the subject-matter defined in claim 1 of the main request. This feature concerned information which was not directly and unambiguously derivable from P1.

The board further observed that the Enlarged Board determined in G 2/98 that it is a condition for the compliance with the requirement of "the same invention" that the claimed subject-matter is directly and unambiguously derivable from the earlier application. However, the Enlarged Board did not conclude that the requirement of "the same invention" is necessarily satisfied if this condition is fulfilled, irrespective of any technical information associated with the claimed subject-matter, which is only described in the subsequent patent application. Notably, the established jurisprudence confirmed the need for sufficient disclosure of the claimed invention in the priority document.

In T 2565/22 the patent concerned a system for replacing a deficient native heart valve. The proprietor submitted in the written procedure that for each feature of claim 1 a basis could be found in the priority application D34. In its communication the board expressed the preliminary view that only a partial priority was validly claimed. At the oral proceedings, the proprietor did not provide any further argument but merely referred to its written submission in this respect.

The board explained that, compared with D34, granted claim 1 had been broadened by deleting the feature "adapted to be deployed by exerting substantially radial forces from within by means of a deployment device". Claim 1 could be regarded as a generic OR-claim in the sense of G 1/15. The two alternatives comprised by the claim were:.

(a) a device comprising a support frame "adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state", such as a balloon-expandable stent; and.

(b) a device comprising a support frame which is not adapted in this way, i.e. non-balloon-expandable or self-expandable.

Contrary to the proprietor's submission, D34 did not disclose the mechanism by which the frame expands in a generic way. Even though the expansion mechanism was not specified each time the frame was mentioned, D34 was directed to devices adapted to be deployed by exerting substantially radial forces from within by means of a deployment device. Unlike D35, D34 did not disclose any self-expandable frames or deployment methods that did not involve deployment means such as a balloon catheter. The fact that nitinol was disclosed as a material for the frame in D34 did not imply that its shape memory properties were used to provide a self-expandable frame, i.e. a stent made of nitinol was not necessarily self-expanding even though this material had been used for this purpose in several prior art documents. Therefore, D34 did not disclose the combination of features of granted claim 1 without the feature omitted by granted claim 1. The board was thus of the opinion that only part (a) above enjoyed priority. Accordingly, D1 was prior art under Art. 54(2) EPC for part (b) and could be considered in deciding whether there had been an inventive step.

In T 1065/23, claim 10 of the first auxiliary request, which became the main request, defined a pea protein extract obtainable by the method of claims 1 to 9..

The board noted that the method of claim 1 was characterised by a step in which a precipitated pea protein contained in a slurry having a pH of 4.0 to 5.8 was subjected to a specific heat treatment. As shown in Examples 2 and 3 of the opposed patent, pea protein extracts subjected to this step had a significantly lower nitrogen solubility index, gel strength and viscosity than those which were heated at a different pH or were kept at the claimed pH but were not subjected to the claimed heating step. Moreover, Examples 4 and 5 showed that protein extracts obtained by the claimed method, which had these physicochemical properties, had better wine-fining and baking properties. For example, they allowed a reduction of the water content in the dough used to prepare biscuits, while preserving or even improving sensory properties.

Opponent 2 argued among other things that claim 10 had to be rejected because its product-by-process format was, as such, not allowable. The claimed product could be described by specific features defining e.g. its properties. Citing decision T 150/82 and section F-IV, 4.12 of the Guidelines, opponent 2 submitted that the product-by-process format could only be used if it was impossible to claim/define the product other than in terms of a process of manufacture. It argued that, assuming that the product obtainable by the method of claim 1 had low solubility, gel strength and viscosity, these parameters could and should have been used to define that product. Hence, the criteria for drafting a product-by-process claim were not fulfilled, and claim 10 should not be allowed.

The board did not agree with these conclusions. It held that the mere fact that claim 10 was drafted as a product-by-process, despite the fact that the claimed product could be satisfactorily defined by reference to its composition, structure or other testable parameter, is not a ground for opposition set out in Art. 100 EPC. The issue could be, at most, one of a lack of clarity. Section F-IV, 4.12 of the Guidelines mentioned by opponent 2 indeed related to the requirement of clarity. Furthermore, decision T 150/82 related to an appeal against the refusal of a patent application and not to an appeal concerning an opposition filed against a granted patent. Consequently, this decision was not applicable.

For these reasons, the board held that considering that claim 10 was a granted claim, its format could not be objected to on the ground that it was drafted in the product-by-process format or that it lacked clarity (G 3/14).

In T 0867/23 the board decided on the basis of the patent as granted (main request). Claim 1 was worded as a purpose-limited product claim in accordance with Art. 54(5) EPC. The treatment of "primary negative symptoms of schizophrenia" was a functional feature of claim 1.

The parties were in dispute regarding whether the application as filed made the claimed therapeutic effect plausible, and whether post-published evidence could be taken into account. The question was whether, on the basis of the evidence contained in the application as filed, cariprazine was demonstrated to have the claimed therapeutic effect on primary negative symptoms of schizophrenia.

In support of its reasoning, the board cited G 2/21 (point 77 of the Reasons), in which the Enlarged Board had explained that, in order to meet the requirement of sufficiency of disclosure, "[…] the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post-published evidence..

In the board's view, this statement of the Enlarged Board did not set a new standard for reliance on post-published evidence in the context of sufficiency of disclosure, i.e. a standard which would depart from the previously cited case law summarised in G 2/21 (as noted in T 979/23). Following G 2/21, a reliance on post-published evidence was not ruled out generally in the context of sufficiency of disclosure for second medical use claims. The reliance on post-published evidence could also not be limited to situations in which it served no useful purpose, i.e. cases in which the effect was already convincingly proven in the application to such an extent that the use of post-published evidence, as a superfluous confirmation of the already proven effect, would be of no relevance. The board explained that, in other words, the scope of reliance on post-published evidence was not zero.

In the case in hand, the board considered that the application as filed contained experimental data reflecting an effect on primary negative symptoms of schizophrenia, and thus disclosed the suitability of cariprazine for the claimed therapeutic indication (see T 609/02). Under these circumstances, the board established that post-published evidence D13 could be taken into account to back up the findings in the application as filed.

The board found that D13 confirmed the findings of the patent, and showed improvements in negative symptoms while excluding indirect effects related to positive, depressive, or EPS (extrapyramidal) symptoms as causal factor. Accordingly, D13 supported the conclusion that cariprazine was effective on primary negative symptoms and refuted the appellants' objection that the improvement could relate to secondary negative symptoms. Therefore, the criteria of sufficiency of disclosure were satisfied.

In T 195/23 was an appeal against the interlocutory decision of the opposition division concerning the maintenance of the patent in amended form. The opponents disputed the decision's finding that the priority claim was valid. In particular, they challenged the validity of the priority claim for the alternative "wherein the smoke modifying additive is disposed only in said axial region of the filter material of the first filter section" in the feature directed to the location of the smoke modifying article in claim 1 of auxiliary request 3.

The board concurred with the proprietor that the drawings in the priority document were specifically intended to show the location of the smoke modifying additive. In fact, figures 1-5 of the priority document depicted various types of additive located in the central region of a filter section. For example, in figures 1 and 4, a capsule was located in an axial region of a first filter section. In figures 2 and 5, the absorbent material had an additive carrying thread disposed therein in an axial region. In figure 3, the absorbent material 47 had a plurality of microcapsules disposed therein in an axial region thereof. However, none of these passages contained a statement to the effect that the depicted smoke modifying additive was the only additive in the filter. In the board's view, these drawings therefore could only serve as a basis for a positive feature directed to the presence of such additive in a central region of the filter. Such a positive feature did not rule out the presence of some further, non-depicted additive in another region of the filter.

In contrast, the board construed the feature "only in the axial region" as a negative feature which was directed to the absence of any smoke modifying additive from other regions of the filter, e.g. its peripheral region. The board referred to established jurisprudence (see CLB, II.E.1.13.3, 10th edition) according to which, a negative feature, i.e. the absence of not depicted elements, usually cannot be derived from drawings. This was aggravated in the present case by the disclosure in the priority document, which explicitly stated that there could be additive – though at a lower concentration – in non-axial regions of the filter. In light of this explicit disclosure in the priority document, which did not contradict the drawings and the corresponding explanations to the drawings in the description, the board was not convinced by the respondent's argument that the skilled person would interpret the drawings as such, rather than entertaining the notion that they did not illustrate some smoke modifying additive. As a consequence, the board did not consider the feature directed to the smoke modifying additive being disposed only in the axial region of the first filter section to be an implicit feature of the priority document.

The board concluded that the application underlying the patent in suit was not filed in respect of the same invention for the alternative "wherein the smoke modifying additive is disposed only in said axial region of the filter material of the first filter section" of claim 1 of auxiliary request 3, and thus, the patent proprietor should not enjoy a right of priority for this alternative..

The above conclusions also applied to independent claim 1 of auxiliary requests 5 to 18, which also contained the alternative "wherein the smoke modifying additive is disposed only in said axial region of the filter material of the first filter section".

In T 98/23 the patent related to a CRISPR-Cas 9 composition for therapeutic use. It was based on a European patent application resulting from an international PCT application claiming priority from 13 earlier US applications including P1, P2, P3, P5 and P13. In its decision revoking the patent, the opposition division had found that formal entitlement to priority from P1, P2, P5 and P13 had not been validly claimed because not all applicants of these priority applications were named in the subsequent application leading to the patent. Thus, novelty and inventive step were examined based only on documents published before P3, in particular D10. The subject-matter of claim 1 of the patent as granted was found to lack novelty over the disclosure of D10.

References to G 1/22 in this abstract should be understood as referring to both G 1/22 and G 2/22.

The board explained that, as in T 844/18, T 2360/19, T 2516/19 and T 2689/19, the issue was whether Mr Marraffini as one of the claimed inventors or The Rockefeller University as his successor in title, had given their consent to the subsequent filing of the patent application in question. A further issue was whether The President and Fellows of Harvard College had given their consent to the subsequent filing of the patent application. The presumption, following G 1/22, is that they did. This presumption may be rebutted.

The board recalled that according to G 1/22, the presumption of priority entitlement, by way of an implicit (implied/informal or tacit) agreement on the transfer of the right to claim priority "under almost any circumstances" applied to any case where the subsequent applicant was not identical with the priority applicant. Also ex-post (retroactive, nunc pro tunc, ex tunc) transfers concluded after the filing of the subsequent application were valid. The presumption of an implied agreement was rebuttable. To question the implied agreement, evidence was thus needed that such agreement had not been reached or was fundamentally flawed.

In the board's opinion, there was no evidence that rebutted the presumption in this case, rather there was evidence on file that supported the presumption. The inventorship dispute between Mr Marraffini/The Rockefeller University and Mr Zhang/The Broad Institute Inc/Massachusetts Institute of Technology had been settled in 2018 by decision of an arbitrator. Applying G 1/22, the settlement by arbitration contained (and confirmed that there was), at least, an implicit agreement nunc pro tunc. Thus, the presumption of entitlement to priority was on the earliest date on which priority was claimed, 12 December 2012. G 1/22 explicitly also stated that "the presumption of entitlement exists on the date on which the priority is claimed and the rebuttal of the presumption must also relate to this date", and that "later developments cannot affect the rebuttable presumption". As being retroactive, the at least implicit transfer agreement by way of the settlement of the inventorship dispute related to this date, and confirmed the presumption of entitlement to exist on this date.

As to whether The President and Fellows of Harvard College had given their consent, no evidence had been filed by the opponents either establishing that the real priority right holder did not allow the subsequent applicants to rely on the priority (see also T 1975/19).

The board concluded that entitlement to priority had been validly claimed in view of G 1/22. The case was remitted to the opposition division for a fresh assessment of the patentability requirements of the main request (the patent as granted), based on a valid priority entitlement to P1.

In case T 816/22, the patent contained data from a randomised, double-blind, placebo-controlled pilot study to evaluate the safety and efficacy of Cinryze (C1 esterase inhibitor [human]) for the treatment of acute antibody-mediated rejection (AMR) in recipients of donor-sensitised kidney transplants.

The patent proprietor had alleged inter alia that for medical use claims, the patent had to disclose the suitability of the product to be manufactured for the claimed therapeutic application. Clinical trials were not required to establish such suitability.

According to the opponent, D54 (clinical trial results) represented the best available evidence concerning the efficacy of the claimed treatment and it demonstrated a complete failure to provide any therapeutic effect. The opponent alleged also that it could not be expected that an opponent had to conduct even more comprehensive clinical studies than a phase III trial in order to discharge its burden of proof of insufficiency. The disclosure of a patent was insufficient if the invention could not be reproduced across the whole breadth of the claims. Even a plausible disclosure of a therapeutic effect (which was missing in the present case) still had to be subject to refutation by evidence that the therapeutic effect was not in fact attained (which was provided by documents D15, D16 and D54), the standard of proof being "serious doubts, substantiated by verifiable facts".

In view of the small number of patients (clinical trial), the opponent considered that a treatment effect had not been demonstrated. The board, however, did not deem it necessary to establish this and instead started from the assumption that the opposition division was correct in finding that the experimental data provided in the patent, together with the mechanistic explanation provided, made it plausible (or credible) to the skilled person at the time of filing that a therapeutic effect on AMR could be achieved; however, this in itself was not enough to demonstrate that the invention was sufficiently disclosed if the opponent provided evidence which raised serious doubts that the therapeutic effect could indeed be achieved.

Post-published documents D15, D16 and D54 related to the phase III clinical trial. Due to the termination of the trial after 36 months, data was not collected, analysed and reported for any of the secondary endpoints related to efficacy (see D54). The patent proprietor argued that the termination of the trial was a commercial decision which did not mean that there was no therapeutic effect of any kind.

To the board, what was crucial was whether the skilled person, with the teaching of the patent in hand and applying common general knowledge, was able to reproduce the invention, i.e. to achieve a therapeutic effect on kidney transplant AMR when administering C1-INH intravenously using the dosage regimen indicated in the claim and identified in the presently discussed embodiment. The board agreed with the patent proprietor that therapy was not limited to completely curing a disease or condition, but also included alleviating, removing or lessening the symptoms of any disorder or malfunction of the human or animal body.

D54 showed the complete absence of any therapeutic effect with the claimed dosage regimen. For the very parameter that was considered "a clinical marker of AMR in a transplant patient" in the patent, D54 found no effect for a larger patient cohort. The board considered this sufficient to raise serious doubts based on verifiable facts that the claimed treatment achieved a therapeutic effect. In view of this evidence, it was not sufficient for the patent proprietor to refer to potential beneficial effects that might arise when following up with patients for a longer period of time.

In conclusion, a phase III clinical trial with the same setup as the examples in the patent and using the dosage regimen which was an embodiment of the claim could not reproduce the claimed subject-matter as exemplified in the embodiment under discussion as it did not exhibit any efficacy after 36 months. The patent proprietor had not dispelled the serious doubts regarding the presence of a treatment effect in view of these data. Therefore, the invention as claimed was not reproducible.

In T 493/23 the invention related to a threaded pipe connection. The patent had been granted on the basis of an application (the "PCT application") filed on 15 September 2017 published under the PCT and claiming priority from application JP 2016-181176 (the "priority application"). The appellant (opponent) argued that neither claim 1 of the twelfth auxiliary request nor claim 1 of the thirteenth auxiliary request validly claimed priority from the priority application.

(1) Twelfth auxiliary request

Compared to the priority application, claim 1 of the twelfth auxiliary request had been amended by adding, inter alia, feature 1.3. This requirement limited the female thread in that it should include a varying-thread-width portion having a thread-ridge width gradually increasing and a thread-groove width gradually decreasing toward a centre of the box. The parties agreed that this additional feature was taken verbatim from the description of the priority application and, in this respect, mentioned paragraph [0049] of D10 (a marked-up version of the English translation of the PCT-application showing the changes made in relation to the priority application). The appellant's objection was directed against the fact that the additional constraint of paragraph [0049] of D10 that the thread-groove width of the female thread corresponds to the thread-ridge width of the male thread in the respective varying-thread-width portions was not incorporated in claim 1 of the twelfth auxiliary request. The appellant argued that the verb "to correspond" implied that the widths were equal. Contrary to the view of the opposition division, the additional text in claim 1, did not require this.

According to the board, the expression "correspond to" in paragraph [0049] of D10 was not to be understood in a broad sense as encompassing variations that result in gaps between the thread flanks. The opposition division seemed to have inferred the additional constraint of paragraph [0049] from features 1.4 to 1.6 of claim 1 of the then auxiliary request 9. However, the board was unable to derive from the general wording of these features whether or not the widths of the individual female ridges and grooves corresponded to those of the male grooves and ridges, respectively, in the varying-thread-width portions. Also the additional features 1.7a and 1.8a of claim 1 of the twelfth auxiliary request did not imply the constraint set by the last sentence of paragraph [0049] of D10. The board concluded that there was no direct and unambiguous disclosure in the priority application of a threaded connection having feature 1.3 of claim 1 without the additional constraint.

In a further line of argument and referring to G 1/15, the respondents (patent proprietors) submitted that claim 1 enjoyed partial priority for those threaded connections where the widths were the same in the varying-thread-width portions. The board was not persuaded. In the present case, claim 1 did not contain any generic expression that could be understood to encompass alternative subject-matter. Claim 1 was not a generic "OR"-claim in the sense of G 1/15. The board concluded that claim 1 of the twelfth auxiliary did not validly claim priority. As a result, D5 was novelty destroying.

(2) Thirteenth auxiliary request

All three lines of argument raised by the appellant were rejected by the board. On the first, the board concluded that, compared to the priority application, the meaning of the expression "toward a centre of the box" in feature 1.3 of claim 1 did not change by adding it to a claim which did not specify the type of threaded connection. Also for embodiments of the integral-type connection there was basis in the priority application for the claimed changes of the female thread width towards the centre of the box. On the second line of argument (which built further on the objection raised in the context of the twelfth auxiliary request), the board concluded that the various restrictions of claim 1 were such that also the feature disclosed in the last-but-one sentence of paragraph [0049] of D10 was implicit. The third line of argument was directed against the omission from claim 1 of the physical location of the constant-thread-width portions and the varying-thread-width portions, despite it being disclosed in paragraphs [0054] and [0055] of D10 on which the amendments of features 1.5 and 1.6 were based. The board considered these positions to be implicit in claim 1. The board concluded that claim 1 of the thirteenth auxiliary request validly claimed the priority from the priority application. The effective date was thus 16 September 2016. As a consequence, D5 was not comprised in the state of the art under Art. 54(2) or (3) EPC.

In T 518/22 the board established that the "A3" mutant disclosed in D2 anticipated the subject-matter of claim 1 of auxiliary request 1 at least under Art. 54(3) EPC.

Claims 1 and 9 of auxiliary request 2 differed from the respective claims in auxiliary request 1 in that an undisclosed disclaimer had been introduced to exclude the A3 mutant disclosed in D2 from the subject-matter claimed.

The board explained that, according to G 1/03, an amendment to a claim by the introduction of a disclaimer may not be refused under Art. 123(2) EPC for the sole reason that neither the disclaimer nor the subject-matter excluded by it from the scope of the claim have a basis in the application as filed. G 1/03 defines the criteria when such an undisclosed disclaimer is allowable, stipulating that it can be introduced into a claim inter alia to restore novelty by delimiting a claim against the state of the art under Art. 54(3) EPC but not under Art. 54(2) EPC (except for a so-called accidental disclosure).

In order to determine whether D2 was prior art under Art. 54(2) or (3) EPC for the claimed subject-matter, the board assessed whether the subject-matter of claim 1 as a whole was entitled to claim priority from P and whether D2 was entitled to claim priority from P1.

The board found that D2's priority based on P1 was valid. Appellant I had objected to D2's formal entitlement to priority because the applicants of P1 and those of the international patent application D2 were not the same. The board explained that G 1/22 and G 2/22 established that a presumption exists that a claim to priority is valid by way of an implicit agreement on the transfer of the right to claim priority in the absence of evidence that such an agreement (implicit or explicit) did not exist. This presumption applies to any case where the subsequent applicant is not identical with the priority applicant. On account of this general teaching, the board understood that the presumption applied also to patent applications cited as prior art, as in the present case (see also T 521/18).

This presumption could be rebutted to take into account "rare exceptional cases" where the subsequent applicant could not justifiably rely on the priority (G 1/22). This, however, involved the reversal of the burden of proof, i.e. the party challenging the subsequent applicant’s priority entitlement (here appellant I) had to prove that this entitlement was missing. Merely raising speculative doubts was not sufficient. Instead, evidence was required that specific facts supported serious doubts about the subsequent applicant's entitlement to priority (G 1/22). In the absence of evidence suitable to establish that the alleged real priority right holder did not allow the subsequent applicant to rely on the priority (see also T 1975/19), appellant I's objection against D2's formal entitlement to priority from P1 was not sufficient to rebut the presumption of validity, which always existed on the date on which priority was claimed (G 1/22). Hence, D2 validly claimed priority from P1.

As regards the validity of the patent's priority claim based on P, the board established that the relevant date for the subject-matter of claim 1 in several embodiments concerning SEQ ID NOs: 5 to 8 was the filing date of the patent application, whereas several embodiments of claim 1 in relation to SEQ ID NO: 4 were entitled to claim partial priority from P (G 1/15).

Therefore, D2 was prior art under Art. 54(2) EPC for the subject-matter of claim 1 not enjoying priority, i.e. in relation to several embodiments concerning SEQ ID NOs: 5 to 8, and prior art under Art. 54(3) EPC for the subject-matter of claim 1 enjoying priority, i.e. in relation to several embodiments concerning SEQ ID NO: 4.

Since the undisclosed disclaimer added to claim 1 in auxiliary request 2 removed embodiments of D2 which belonged to the state of the art pursuant to Art. 54(2) EPC and were not an accidental disclosure, such amendment was not allowable under Art. 123(2) EPC. Auxiliary request 2 comprised added subject-matter (G 1/03 and G 1/16) and did not fulfil the requirements of Art. 123(2) EPC.

In case T 1977/22, the opposition division revoked the patent arguing that the definition of certain parameters in terms of an open-ended range rendered the invention insufficiently disclosed, as these parameters could not be reproduced over the whole scope of the open-ended side.

The board addressed this question by first reviewing the landmark decisions which gave rise to the principle of "reproducibility over the whole claimed scope" (T 435/91, T 292/85, T 226/85, T 409/91, and G 1/03), then reviewing the case law specifically dealing with open-ended range desiderata and sufficiency of disclosure, before addressing the question of how to apply the general requirement of "reproducibility over the whole scope“ to the specific case of inventions defined in terms of an open-ended range desideratum, and finally by applying the proposed criteria.

More specifically, the board stated that the main idea behind the principle of reproducibility over the whole scope is that where an invention is defined as a combination of process and/or structural features (A+B) to achieve a certain result or desideratum (X), the skilled person should be enabled to achieve the result (X) over the whole scope of the claim, which is intended to ensure that the breadth of the claimed invention is commensurate with the teachings of the patent, i.e. that the scope of protection is restricted to the actual technical contribution of the patent. According to the landmark decisions, the assessment should be based on balanced criteria, avoiding unrealistic requirements, such as excluding all non-working embodiments or providing instructions to identify every possible working embodiment, while still ensuring that the claim includes all features essential to achieving the defined desideratum and that the breadth covered by the functional definition is commensurate with the teachings of the patent.

The board then turned to review in detail the case law dealing with "open-ended ranges desideratum and sufficiency of disclosure" (point 3 of the Reasons). Following this, the board dealt with the key question of the reproducibility over the whole scope of open-ended ranges (point 4 of the Reasons). It stated that where the desideratum was, as in the present case, defined in terms of an open-ended range for a physical parameter of a product, the problem of reproducibility over the whole scope was analogous to that addressed in the landmark decisions, with the key distinction being that the inclusion of non-working embodiments may also stem from the desideratum itself, as the open definition broadens the claimed scope in such a way as to implicitly encompass non-working embodiments, i.e. irreproducible parametric values (unrealistically high) and/or yet-to-be-discovered alternatives (values only achieved with inventive skill). That the claim covered non-working embodiments was not in itself sufficient to conclude that the invention would not be reproducible over the whole scope. The key issue was the burden to be applied for assessing whether the teachings in the patent would enable the skilled person to reproduce the open-ended range over the whole scope of the open-ended side. In this respect, the open-ended definition should not be interpreted literally as requiring teachings enabling the skilled person to achieve any parametric value in the upward direction; interpreting the concept literally would impose a technically unsurmountable burden and would be in contradiction with the landmark decisions that it was not required that all non-working embodiments be excluded or that every working embodiment be enabled. Instead the board concluded that open-ended ranges should be interpreted as equivalent to a directional requirement to adjust and increase the parameter to obtain values as high as achievable (beyond the lower end value) with the structural and/or process features defined in the claim (see details point 4.6.7of the Reasons; also Catchword and conclusions point 4.13). By making routine adjustments within the scope of these features, it was possible to achieve parametric values exceeding the lower-end limits.

The differing outcomes in the case law (open-ended ranges) did not stem from any fundamental divergences.