C. Novelty

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 1898/23 claim 1 related to a cold atmospheric plasma (CAP) for use in the treatment of therapy-refractory actinic keratosis. It was undisputed that both CAP itself and its use in the treatment of actinic keratosis were comprised in the state of the art.

The first question addressed by the board was whether claim 1 concerned a substance or composition within the meaning of Art. 54(4) and (5) EPC. Regarding the interpretation of Art. 54(4) and (5) EPC, the board pointed out that the ordinary meaning of the wording "substance or composition" was broader than that of "medicament" or "pharmaceutical product". This understanding was confirmed by the Travaux Préparatoires EPC 1973, in which the drafters of the predecessor provision to Art. 54(4) EPC deliberately chose a wording which was less restrictive than the term "medicament" (see Travaux Préparatoires on Art. 52E EPC 1973, page 101).

The board saw no reason to deviate from the argument of the respondent that a substance or composition within the meaning of Art. 54(4) and (5) EPC had to be understood as a product which qualified as a chemical entity or a composition of chemical entities (T 2003/08 of 31 October 2012, referring to G 5/83). The board explained that while this subgroup of the larger group of "products" (see T 2003/08 of 31 October 2012) excluded medical devices (see T 1252/20), it did not seem justified to say that any product which did not qualify as a medical device because of, for example, a lack of shape automatically qualified as a substance or composition within the meaning of Art. 54(4) and (5) EPC (contrary to what seemed to be indicated in T 1252/20). If that were so, any shapeless physical entity (for example, electromagnetic radiation or ultrasound waves) could qualify as a substance or composition, regardless of whether it is a chemical entity. Having said this, the current board agreed that whether something qualified as a substance or composition within the meaning of Art. 54(4) and (5) EPC should be decided, in the first place, on the basis of what was claimed as such and not on the basis of its mode of action (see T 1252/20; compare also T 264/17).

It was undisputed that the claimed plasma contained a variety of components. The board observed that, according to paragraph [0021] of the description, these components included reactive oxygen and nitrogen species, OH radicals, ions, electrons, photons and UV light. While some of these qualified as chemical entities and hence as a substance or composition (for example, reactive oxygen and nitrogen species, OH radicals and ions), others did not (for example, electrons, photons and UV light). On whether the alleged therapeutic effect could be ascribed to the chemical entities in the plasma or (only) to the other entities, the board referred to paragraph [0002] of the patent, which included both photons and UV light in the list of active species of the claimed CAP. In the absence of any further information, the biological mode of action remained "unclear". It could not be ruled out that it was the photons and/or the UV light, i.e. subject-matter other than a substance or composition, which were (exclusively) responsible for the alleged therapeutic effect. For the sake of argument, the board assumed that the alleged therapeutic effect was caused by the parts of the claimed plasma that qualified as a substance or composition under Art. 54(5) EPC.

As to whether the claimed use qualified as a specific use in a method referred to in Art. 53(c) EPC which was not comprised in the state of the art, the board agreed that a patient group fulfilling the three criteria in T 1491/14 would render the claimed subject-matter novel. The three criteria were that: (i) the patient group was not disclosed in the relevant prior art; (ii) the patients belonging to the group could be distinguished from those of the prior art by their physiological and pathological status; and (iii) there was a functional relationship between the characterising physiological or pathological status and the therapeutic treatment, and thus the selection of the patients was not arbitrary. With regard to criterion (i), the board agreed that the prior art (D22) did not disclose the treatment of patients diagnosed with therapy-refractory actinic keratosis. On criterion (ii), the board agreed that the actinic keratosis patients who were not successfully treated could be distinguished from patients who were successfully treated. As regards criterion (iii), the board explained that it could be assumed that the technical effect resulting from the treatment of therapy-refractory actinic keratosis with CAP was the successful amelioration of the symptoms in patients whose previous treatment by standard therapies had not resulted in satisfactory clearance. Hence, there was a functional relationship between the physiological or pathological status of the patient group and the CAP treatment. Furthermore, the board observed that it was not required that the technical effect be surprising for criterion (iii) to be fulfilled.

In T 2192/22, the claims related to improved processes for purifying polypeptides of interest, by increasing the amount of a polypeptide of interest bound to a cation-exchange matrix relative to the amount of one or more impurities bound to the ion-exchange matrix..

The patent proprietor was of the view that the claim was such that its subject-matter should be recognised as novel under G 2/88 since it related to the use of a known compound for a new purpose not made available in the prior art – i.e. "the reduction of host cell proteins (HCPs) in the purification of a polypeptide of interest by cation-exchange chromatography".

The board however, concurred with the findings in T 892/94, that applying the concept of novelty developed in G 2/88 to claims for processes of producing a product, even when drafted as use for achieving a technical effect that results in an improved product could potentially result in a permanent monopoly of the use of a known substance for a known purpose. Such a permanent monopoly would arise from the repeated drafting of claims for a process of production including a new, possibly only subtly different, technical effect associated with this known process (T 1179/07).

In the present case, drafting the claim as a "use" of a chemical compound could not mask the fact that the claim defined a production/purification process and the new technical effect could only take place in the context of this process. The mere formatting of the claim to give the appearance that its subject-matter falls under the principles established by G 2/88 could not circumvent the fact that on analysis, the claim was directed to a use or process for the production of a product, here one having the "improved" property of having "reduction of host cell proteins".

Moreover, the alleged new technical effect of reduction of host cell proteins pertained to the product (the polypeptide) and could not be considered a technical limiting feature of the "use" according to G 2/88. Indeed, where an invention relates to a new technical effect of a physical entity that can only occur as part of a process for the production or manufacture of a product, such that this effect is inextricably linked to and cannot occur in isolation from the production process, a claim directed to that "use" of the physical entity to achieve that effect must be regarded as directed to the production process per se (T 1913/21).

The assessment of novelty in the present case was therefore done by answering the question of whether or not there was a disclosure forming part of the state of the art of a process having the same physical steps as the claimed process, i.e. purifying a polypeptide of interest by CEX chromatography, wherein at least one of the equilibration, loading and/or washing fluids contained a chemical structure with amino groups and/or cationic amino acid polymers, in a concentration of at least 7 mM. No other features were explicitly or implicitly implied by the wording of the claim. The board found that the prior art anticipated the claimed subject-matter and denied novelty.

In T 1816/22 the appellant's objection of lack of novelty of claim 1 as granted was based on the disclosure provided in D1 and a sentence which referred to D2 by stating: "Perfumes are generally described in U.S. Patent No. 7,186,680 at column 10, line 56, to column 25, line 22". In the opinion of the appellant, this sentence disclosed all the perfumes mentioned in the portions of this document that were specifically identified above, thus also "ethyl vanillin", listed for example at the top of the table in column 13 of D2, which was also present in both of the only two fully formulated examples "Enduring Perfume A" and "Enduring Perfume B" disclosed in D2. Accordingly, a single selection — if any — among the perfumes implicitly disclosed in D1 (through its reference to D2) would be sufficient to arrive at the laundry product of claim 1 of the opposed patent.

For the board, the reference to D2 was so vague that it could not be equated to a (albeit implicit, but nevertheless) direct and unambiguous disclosure that the "perfume" components of the prior art fabric treatment composition described in D1 could be any one of the specific perfumes disclosed in the cited portion of D2.

According to the board, already upon reading the wording "generally described" in the reference to D2 per se, a skilled person might expect that such a reference pertains exclusively to the general definitions of groups/ classes of perfumes (e.g., in terms of their chemical classes, origin, type of scent, or other properties) possibly provided in D2.

This at least seemingly possible — if not more probable — interpretation of the reference to D2 made in D1 appeared also consistent with the actual disclosure in the specific portions of D2 identified in D1.

Even when considering the entire portion of D2 identified in D1, the board found the reference to D2 too vague, as it remained at least possible that the intention was to refer only to the groups or classes of perfumes described in general.

Since the reference to D2 did not render part of the direct and unambiguous disclosure of the prior art in D1 the possible use of any specific perfumes disclosed in D2 (including the "ethyl vanillin" cited by the appellant), the subject-matter of claim 1 was not anticipated in D1.

In T 295/22 claim 1 of "Main request A" was formulated in the "compound for use" format of Art. 54(4) and (5) EPC, wherein the utility as a medicament was further specified as the use as a medicament which is administered orally. The Guidelines G-VI, 6.1.2 – March 2024 version (see example 2: "Composition comprising X for use in therapy by topical administration") suggest with reference to T 51/93 that in a claim which only defines the mode of delivery but no specific therapeutic effect, the definition of the mode of delivery is merely illustrative and not a restrictive technical feature capable of establishing novelty. However, the board in this case held that the requirement underlying the specificity of the use within the meaning of Art. 54(5) of the EPC 2000 was according to the explicit conclusion in G 2/08 (see point 5.10.3 of the Reasons) to be construed merely by contrast to the generic broad protection conferred by the first claimed medical application of a substance or composition, and was in principle not confined to a particular medical indication.

Contrary to the suggestion in the Guidelines, the board stated that the decision in T 51/93 actually recognized without reference to any requirement regarding the definition of a specific medical condition that the definition of the mode of administration of a medicament represented a characterizing feature of a claim formulated in the so-called "Swiss-type" format as approved according to G 5/83 for defining inventions relating to new medical uses of known pharmaceuticals under the provisions of the EPC 1973 (see T 51/93, point 3.1.2 of the Reasons).

According to the board, the decision in T 51/93 further confirmed that in a claim formulated as a "Process for making X for use Y comprising the steps of..." the definition of a specific medical purpose under Y illustrated what X could be used for, but did not further characterize the claimed subject-matter under the provisions of the EPC 1973 (see T 51/93, point 2.2.2 of the Reasons). However, the format of the claim discussed in this part of T 51/93 neither corresponded to the "Swiss-type" format as approved according to G 5/83 for defining inventions relating to new medical uses nor to the format outlined in Art. 54(5) EPC 2000.

In line with the considerations in G 2/08 (see point 5.10.3 of the Reasons) the board therefore considered that the oral administration as defined in claim 1 of "Main request A" represented, in accordance with Art.54(5) EPC, a characterizing feature of the claimed subject-matter.

In T 2463/22 the opposition division had held that the prior uses had not been proven beyond reasonable doubt (up to the hilt), in particular with regard to whether the products of the prior uses had actually been delivered. The parties before the board focused on which standard of proof had to be applied in view of G 2/21 and T 1138/20 and whether the applicable standard had been met. In the respondent-proprietor’s view, T 1138/20 was an isolated decision, not compatible with G 2/21.

On the required standard of proof, the present board observed that G 2/21 recognised that different concepts as to the standard of proof had been developed in the case law. According to T 1138/20 only one standard should be applied, namely "the deciding body must be convinced, taking into account the circumstances of the case and the relevant evidence before it, that the alleged fact occurred".

In the present board's view, under the principle of free evaluation of evidence, it was always decisive in the evaluation of evidence that the members of the deciding body were personally "convinced". Moreover, they had to always be convinced of whether, as stated in T 1138/20, "the alleged fact has occurred". The board stated this was true regardless of which standard of proof was applied. The standard of proof refers to the nature or degree of conviction that the members of the deciding body must have to be satisfied that an alleged fact occurred (see T 832/22).

According to the board, and with reference to a UK House of Lords decision, two important aspects had to be stressed. Firstly, that the standard of proof is related to the required degree of conviction of the members of the deciding body. Secondly, that it is not related to what is evaluated by the deciding body. Hence, also when a lower standard of proof such as the balance of probabilities is applied, the deciding body must assess whether or not the alleged fact indeed occurred. In other words, also when such a standard of proof is applied, the question is not whether the alleged fact might have occurred with some probability. The board considered G 2/21 (points 31 and 45 of the Reasons) consistent with this understanding.

The more specific question as to whether there was only a single standard of proof or more than one could be left unanswered according to the board. The board held that if the deciding body was convinced beyond reasonable doubt that an alleged fact had occurred, there was no need to decide how many standards of proof there were and which one was applicable (see T 832/22).

The board then gave some consideration to the assessment of factual allegations using the beyond reasonable doubt standard of proof. The European Patent Organisation being an independent international organisation, the board stated the standard had an autonomous meaning within this autonomous legal order. Secondly the board agreed with T 832/22 that it seemed expedient to focus on the term "reasonable".

The board then considered the prior uses, focusing especially on prior use relating to the sale of product 5 (sample of a powder mix from a specific lot number), the content of the sample and whether it was available to the public. In view of all the information (including invoices, affidavit, emails, test report, excerpt from database), which also involved evidence provided by a third party (the buyer), the board was convinced beyond reasonable doubt that product 5, with a specific lot number, was sold prior to the effective date of the patent. Since it had also been shown that product 5 disclosed all features of claim 1, lack of novelty prejudiced the maintenance of the patent as granted. Concerning the third auxiliary request, product 5 was suitable for use as closest prior art. The board referred to the reluctance sometimes in the case law to treat an object of a prior use as the closest prior art. Often, there was neither information on what the object did and what properties it had in the technical environment in which it was applied nor on how the process for its manufacture could be modified. These considerations indeed spoke against regarding a prior use as a suitable starting point for assessing inventive step. In the case in hand however, the skilled person was faced with a different situation. The board concluded that the third auxiliary request did not involve an inventive step. The decision of the opposition division was set aside and the patent revoked.

In T 1612/21 hatte die Einspruchsabteilung auf Grundlage der ihr zur Verfügung stehenden Beweismittel zutreffend festgestellt, dass es deutliche Hinweise auf das Bestehen einer Geheimhaltungsverpflichtung gab – insbesondere durch die Aussage des Zeugens der Beschwerdeführerin, Herrn Trick, wonach die Beschwerdeführerin grundsätzlich eine Geheimhaltung mit ihren Kunden vereinbart.

Der von der Beschwerdeführerin selbst angebotene Zeuge, Herr Trick, hatte vor der Einspruchsabteilung zudem ausdrücklich erklärt, dass die Generation 2 der CBC-200 für den Auftrag der Daimler AG entwickelt worden war. Dazu war die Maschine verändert worden. Dies möge vorrangig die Prozessentwicklung betroffen haben, wie es die Beschwerdeführerin vortrug, dies führte jedoch laut der Aussage des Zeugens auch zu Veränderungen an der Maschine. Es handelte sich bei der an die Daimler AG gelieferten Anlage CBC-200 also nicht von Anfang an um eine Standardmaschine der Beschwerdeführerin, sondern diese war das Ergebnis der Kooperation mit der Daimler AG.

Vor diesem Hintergrund ließ die Aussage des Zeugens, dass grundsätzlich eine Geheimhaltung mit den Kunden bestand, ob schriftlich oder üblicherweise in mündlicher Form zu den Verfahrensparametern, wie es die Beschwerdeführerin angab, ausreichend Zweifel an der Behauptung der Beschwerdeführerin entstehen, dass die Lieferung der Anlage CBC-200 nicht einer Geheimhaltungsvereinbarung unterlag, so dass sich die Beweislast zur Existenz der Geheimhaltungsverpflichtung auf die Beschwerdeführerin verlagerte.

Vor diesem Hintergrund waren die von der Beschwerdeführerin angeführten Entscheidungen T 2210/12 und T 2273/11 für den gegebenen Fall nicht einschlägig, da diese jeweils Sachverhalte betrafen, in dem sich keinerlei Anhalt für eine Geheimhaltungsverpflichtung bot, bzw. eine solche explizit verneint wurde. Die Beschwerdeführerin war hingegen an der geltend gemachten Vorbenutzung als Verkäuferin beteiligt. Folglich lagen praktisch alle Beweismittel zu der Offenkundigkeit in ihrer Verfügungsmacht und ihrem Wissen. Es oblag auch deshalb im gegebenen Fall der Beschwerdeführerin, die durch ihren eigenen Zeugen aufgebrachten Zweifel an der Offenkundigkeit der Vorbenutzung in überzeugender Weise auszuräumen.

Da aber auch die weiteren im Verfahren befindlichen Beweismittel nicht geeignet waren, diese Zweifel auszuräumen, sondern im Gegenteil zu der Geschäftspraxis schwiegen und insbesondere der von der Beschwerdeführerin selbst angebotene Zeugenbeweis die Existenz einer Geheimhaltungsverpflichtung als geschäftsüblich nahelegte, schließ sich die Kammer der Feststellung der Einspruchsabteilung an, dass die geltend gemachte Vorbenutzung CDC-200 nicht offenkundig war und somit nicht dem Stand der Technik zugerechnet werden konnte.

In T 733/23 the opposition division had concluded that there had been insufficient evidence to prove that the data sheets D2, D4, and D7 to D9 had been made available to the public before the filing date. Rather than concluding that, as a result of the data sheets not being considered state of the art under Art. 54 EPC, the subject-matter of the claims was novel, the opposition division decided not to admit them into the opposition proceedings. The board concluded that not admitting these data sheets, filed in due time, constituted a substantial procedural violation (see details as from point 4 of the Reasons including discussion on D19, an affidavit).

The board, in support of its decision, presented some key considerations on public availability of advertising brochures and data sheets, as well as the standard of proof to be applied. The board stated that when a document was clearly intended to be publicly distributed, as was the case with advertising or commercial brochures, the absence of a specific publication or distribution date, a situation quite common in this type of document, was not in itself sufficient to conclude that the document did not constitute prior art. As with any other type of evidence, the key question was not whether the exact date of publication could be determined, but whether it could be established that the relevant subject-matter was made available to the public before the priority or filing date.

Data sheets often represent an intermediate case between internal documents and advertising brochures. Where no publication date is present, the board held it should first be assessed whether the document was intended for public distribution. If so, additional sources must be examined to establish whether the relevant subject-matter was publicly accessible before the patent’s filing or priority date. Here, the opposition division had failed to provide a reasoned decision on public availability, giving no weight to the dates printed on their front pages.

As to the standard of proof, the present board concurred with the position in T 1138/20 that there is only one standard of proof: the deciding body must be convinced, based on the underlying circumstances.

According to the present board, this did not imply that all cases were to be treated identically, as in practice the degree of proof required to establish credibility (i.e. to persuade the board) might vary depending on the specific circumstances. In other words, it was not the standard of proof that adjusted with the circumstances, but rather the credibility of the arguments made by the different parties. For example, when the evidence was exclusively controlled by one party, any gaps in the relevant information might significantly undermine that party's credibility. Conversely, when the information was equally accessible to both parties but only one party submitted evidence, merely raising doubts might not be sufficient to challenge the credibility.

In the present case, the conclusions of the opposition division suggested that the standard of proof "up-to-the-hilt" was applied to determine the public availability of the data sheets. Even if the board agreed that different standards should be applied, this would not be justified in the case in hand, as the relevant information to prove the public availability of the data sheets was not within the exclusive sphere of the appellant (opponent). In this instance, the relevant information would more likely be within the sphere of the patentee. Therefore, there was no basis for applying the strict standard of "up-to-the-hilt" or for questioning the credibility of the appellant (opponent) solely on the grounds that some information was missing.

The patentee argued that, when in doubt, the patent should be upheld. The board disagreed. Fact-finding boiled down to a binary exercise: either something had been proven, or it had not. In addition, there was no presumption of patent validity in proceedings meant to re-assess the validity of this very patent.

In T 1249/22 the application related to the development – including the training – of an analytical model (e.g. a machine learning model) and the deployment of the trained analytical model on a "compute engine" so as to process live incoming data. The examining division found that the independent claims of the main request lacked an inventive step in view of common general knowledge evidenced by D5.

D5 was a book comprising a collection of individual papers on grid computing, all from different groups of authors, referred to as "chapters" by the editors of the book. The appellant argued that D5 was not evidence of common general knowledge and that each of the chapters of D5 represented a separate piece of prior art; the examining division combined several distinct elements from these chapters without providing any reasoning. The board agreed with the appellant that each of the "chapters" represented a separate piece of prior art, as they appeared to be self-contained papers which did not build on each other, unlike chapters of a textbook. Definitions given in one of these papers did not necessarily apply to the others. D5 rather resembled a conference proceedings volume including a collection of separate papers on a common topic. The mere fact that the papers were published in the same book with a single ISBN did not imply that the whole content of the book formed a single piece of prior art.

As to whether D5, or its individual chapters, were generally suitable as evidence for common general knowledge, the board noted that an allegation that a teaching was common general knowledge might be supported by specific evidence. The deciding body evaluates such evidence by applying the principle of free evaluation of evidence on a case-by-case basis (G 2/21). The board explained that while it might be relevant that the cited evidence was a "book" or a "textbook", this could not, on its own, be decisive, as no firm rules dictate which types of evidence are convincing.

The board further observed that information often appears in a textbook because it was common general knowledge when the book was drafted. However, this did not mean that all textbook content necessarily was common general knowledge or became so upon publication. In the decision under appeal, the examining division referred to Part G, Chapter VII, 3.1 of the Guidelines, in which it was stated that "[i]nformation does not become common general knowledge because it has been published in a particular textbook, reference work, etc.; on the contrary, it appears in books of this kind because it is already common general knowledge (see T 766/91). This means that the information in such a publication must have already become part of common general knowledge some time before the date of publication". The board noted however, that the cited decision T 766/91 only described what is "normally" accepted and what is "usually" the case. In a statement according to Art. 20(2) RPBA, the board explained that the Guidelines had lost this nuance when saying "must" in the passage cited above.

Regarding the examining division's reliance on chapters of D5 as evidence of alleged common general knowledge, the board considered the examining division's reasoning to be insufficient regarding what alleged common general knowledge it was relying on (R. 111(2) EPC). For instance, the examining division referred merely to the "known paradigm of message-based grid computing" without indicating which features of this paradigm were considered to be common general knowledge, despite appearing to rely on more than the knowledge of the existence of that paradigm when considering that all the features relating to the processing pipeline "form part of the common general knowledge of the skilled person".

Thus, the board concluded that the first-instance decision was not sufficiently reasoned within the meaning of R. 111(2) EPC. The case was remitted to the examining division for further prosecution under Art. 111(1), second sentence, EPC and Art. 11 RPBA and the appeal fee was reimbursed under R. 103(1)(a) EPC.