T 0749/23 - Any embodiment as starting point (Mite composition)

Key points

• Claim 1 of AR-3 at issue  “is for a composition comprising (i) a population of individuals from a Phytoseiid mite species, (ii) a food source for the mite individuals selected from rearing prey from the suborder Astigmata and (iii) stacked carrier elements selected from millet husks, where the carrier elements comprise shelters for mite individuals”
• Documents D3/D9 describe five mite compositions comprising, as equal alternatives, the carrier elements wheat bran, buckwheat husks, rice husks, saw dust and corn cob grits”
• “The patent proprietor contended that the composition comprising rice husks of documents D3/D9 was not a suitable starting point for the assessment of inventive step for various reasons. First, they argued that buckwheat husks, rather than rice husks, should be taken as the starting point since buckwheat husks were used in the examples of documents D3/D9 and were therefore highlighted.”
• The Board: “The starting point for assessing inventive step is normally a set of features disclosed in combination in a document, typically in the form of an embodiment or example.”
• “the board considers that each of these embodiments [of the five compositions] can be used as the starting point for assessing inventive step. All embodiments are presented as suitable, and there is nothing in documents D3/D9 that would disqualify any of them. Since each embodiment can be used, the board also agrees with the opponents that the assessment of inventive step can be based on a mite composition containing rice husks as carrier elements as the starting point.”
• “the board does not concur with the patent proprietor's view [that the rice husk embodiment of D3 is not a starting point].  First, Article 56 EPC requires that an invention, having regard to the state of the art, not be obvious to a person skilled in the art. The state of the art for the purpose of considering inventive step is the entire state of the art as defined in Article 54(2) EPC, without any ranking or distinction (T 2140/22, Reasons 1.9.1).”
• “if inventive step is to be acknowledged, the claimed subject-matter must be inventive starting from any starting point in the prior art. Conversely, if the invention is obvious to the skilled person from at least one starting point, an inventive step is lacking (Case Law, I.D.3.3). Neither the EPC nor the case law of the boards stipulate that the starting point for assessing inventive step must be the entire disclosure, an example, or a preferred embodiment in the prior art. Rather, the starting point may be any disclosure in the prior art.”
• Still, it may not be obvious to a skilled person to develop a non-preferred embodiment.
• “There is also no requirement that an embodiment must be exemplified for it to be considered in the assessment of inventive step. There is, likewise, no requirement that the prior art contain any pointer, suggestion or incentive to select a particular embodiment for further development for this embodiment to qualify as the starting point in the problem solution approach”.
• “as a matter of principle and in agreement with T 2001/23 (Reasons 3), that if the subject-matter of a claim is found to lack an inventive step starting from a particular disclosure, as is the case here (see below), it is not possible to establish inventive step by proposing that the assessment be started from a different starting point.”
• The Board then distinguishes T 1126/19 on the facts.
• “Third, G 1/23 does not support the patent proprietor's argument that the skilled person is the relevant point of reference in selecting the starting point for the inventive step analysis. Points 93 to 95 of decision G 1/23 are concerned with the impact on novelty and inventive step of accessible but not fully reproducible products which the Enlarged Board of Appeal accepted as being part of the prior art. According to these considerations, the relevance of such a product for assessing inventive step, namely its suitability as a starting point or secondary source of information, depends on the available information associated with the product, i.e. it depends on what is disclosed to the skilled person.”
• “ The Enlarged Board of Appeal [in G 1/23] did not make any finding that the choice of starting point in the problem-solution approach requires motivation by the skilled person. In the case in hand, all carrier elements disclosed in documents D3/D9 are available, and all can be used. Indeed, the patent proprietor never argued that rice husks would be obviously defective or not enabled.”
• In view of T 2759/17: “In the case in hand, as correctly noted by opponent 2, the starting point for assessment of inventive step, namely a composition comprising rice husks, is disclosed for the same purpose as the compositions comprising other carrier materials disclosed in documents D3/D9, namely the rearing of predatory mites, which is also the purpose to which the patent is directed. The board concludes that in the case in hand, a composition comprising rice husks would also be a realistic starting point under the approach set out in T 2759/17.”
• “The patent proprietor's assertion that documents D3/D9 did not disclose a list of equal alternatives to the skilled person is based on the results in Example II of the [opposed] patent, in which millet husks performed better than bran. Since the closest prior art must be assessed from the skilled person's point of view on the day before the filing or priority date valid for the claimed invention, the assertion must be rejected for this reason alone.”
• One would expect that, starting from the embodiment of D3 with rice husk as the carrier element, the distinguishing feature would lie in the other components of the composition. However, the difference is that the patent claims the use of millet husk as the stacked carrier elements. The Board does not acknowledge any technical effect of that difference. “the patent describes that millet husks have a sheltering effect in comparison with the non-sheltering carriers wheat bran and vermicullite (paragraphs [0005] and [0006], experiments I and II). The patent does not indicate any advantageous effect of millet husks over rice husks.” A post-published document was not admitted, as filed late (namely, in appeal).
• The patent is revoked.
• “The objective technical problem is the provision of alternative carrier elements for a mite composition comprising a population of a phytoseiid predatory mite species and a factitious host population which comprises at least one species selected from the family of the Carpoglyphidae.”
• I think a key question could have been whether the OTP was indeed simply providing an alternative, given that the advantages of risk husk were unrecognised in the prior art document D3.
  
  
• Partiality of the OD?
• “opponent 2 submitted that the chairman of the opposition division stated during oral proceedings that in coming to the conclusion that auxiliary request 3 was inventive over document D9 as the closest prior art, it was also taken into account that the claims were restricted to particular mites and that, from the perspective of a work-around, there were sufficient possibilities.”
• The Board dismisses the objection on the ground that the reasoning about the workaround is not part of the OD’s written decision. Furthermore, “an objection on the ground of suspected partiality before the department of first instance can be disregarded if it is not raised immediately after the party concerned becomes aware of the reason for the objection (G 5/91, Reasons 4 [...]”

EPO 

The link to the decision is provided after the jump.

T 1396/23 - 2nd medical use claim for foodstuff

Key points

• Claim 1: “Composition comprising polysaccharides and whey protein micelles [provided as a complex, a so-called WPM complex] for use in the treatment or prevention of ... diabetes ...  in a subject;  .."
• “The appellant [opponent] did not contest that claim 1 defined a therapeutic method of treatment pursuant to Article 54(5) EPC. It argued, however, that the effect induced by WPM complexes described in the opposed patent was not therapeutic. The claimed complexes provided nutrition but were unsuitable to prevent the claimed conditions, even less so to treat them."
• The Board: “The patent explains 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 (see paragraphs [0005] and [0006] and the references cited in those paragraphs). On this basis alone, it is reasonable to assume that the claimed WPM complexes, which contain whey proteins, could likewise induce these effects.”
• • Here, the Board finds that it was known that whey protein isolates were ‘beneficial’ in “treating ... diabetes”, and that on this basis, it is credible that the claimed composition that comprises whey proteins meets the requirement of Art. 83 for the recited second medical use of treating (or preventing) diabetes.
  • It is unclear to me what the Board means by the statement that whey protein isolatesare ‘essential nutrients’. I assume humans can live without a regular intake of whey protein isolates, or even without a regular intake of whey proteins, for that matter. Whey proteins may contain amino acids, including essential amino acids, but that is not the same.
• The Board notes that additionally, “the patent teaches that using the claimed WPM complexes rather than conventional whey proteins is beneficial for subjects who are at risk of or suffer from the diseases indicated in claim 1. ... The tests in example 3 of the patent show that meal D - [with the WPM complex] - induces a substantially lower insulin response compared with isocaloric and isonitrogenous control meals A and B, which comprise uncomplexed WPM or whey protein isolates ... This indicates that less insulin is required to clear glucose from blood after ingestion of meals comprising the WPM complexes” - than with whey protein isolate, I understand.
• The Board: “It is immaterial what the underlying mechanism of action is ... - the skilled person would appreciate that the claimed WPM complexes are intended to be incorporated into a nutritional composition in place of whey proteins in order to achieve the stated therapeutic effect. In the context of the invention, the claimed compositions comprising WPM complexes can thus be regarded as "a substance or composition" within the meaning of Article 54(5) EPC that is used to carry out the claimed therapeutic method.”
• This leads the Board to the following headnote: “A substance or composition that induces a therapeutic effect when used to replace a known essential nutrient in a nutritional composition may be considered a "substance or composition" within the meaning of Article 54(5) EPC”
• “It is undisputed that optimising the insulin response by improving the body's sensitivity to insulin is a cornerstone of diabetes therapy. A reduction in insulin demand following a meal is beneficial in patients affected by or at risk of developing insulin resistance, type 2 diabetes and other associated metabolic diseases. Accordingly, the results of the tests described in the patent make it credible that the claimed composition is suitable for treating and preventing the diseases indicated in claim 1.
• • The headnote seems to pertain only to the second argument of the Board, not to the argument based on the known therapeutic effect of the (prior art) whey protein isolates.
  • Possibly, the view of the Board is that WPM complex is a substitute for the known whey protein (isolate), that the known whey protein is a nutrient with a lower insulin response, i.e. with a beneficial effect for diabetes patients (quite comparable to replacing sucrose/glucose with artificial sweeteners, it seems to me) and that beneficial effect on the health of diabetes patients of the known whey protein is sufficient to support a second medical use claim of the substitute WPM complex.
  • See also e.g. T 2036/21 about "omega-3 fatty acids selected from DHA, DPA and EPA, uridine, choline, and vitamin B12 and folate for preventing dementia".

The link to the decision is provided after the jump.

T 1601/22 - More than a year for the written decision

Key points

• This decision (by Board 3.3.04) was taken during oral proceedings on 10.10.2024. The written decision was issued on 23.12.2025. Two communications under Art. 15(9) RPBA were issued, in January and July 2025, indicating ‘the current workload’ as the reason for the delay in the issue of the written decision.
• • Hence, Article 15(9) RPBA was complied with, so we can’t complain about that. Whether taking more than a year to write the decision is sound caseload management is not something for me to speculate about. But it is remarkable that the Board chose to delay this decision for so long.
• “According to claim 1, IL-2, which may be either human IL-2 or aldesleukin, is the active agent responsible for the therapeutic effect of treating systemic lupus erythematosus in a human subject.” Claim 1 also specifies  “to be administered at a dose of between 1 MIU/day and 3 MIU/day”.
• "D5 [a patent application] discloses two case studies reporting a therapeutic effect of IL-2 administered intravenously at a dose of "500 U" for 14 days in the treatment of SLE"
• " In view of the early filing date in 1987 [of D5], it cannot be confirmed that the doses disclosed in D5 were established according to the WHO standard for IU."
• " The subject-matter of claim 1 differs from the disclosure in document D5 in the dosage of between 1 and 3 MIU/day of IL-2, which is not derivable from D5."
•   The claimed dosage range of between 1 and 3 MIU/day provides dosages below 3 MIU/day. This range is not selected arbitrarily, because the administration of higher IL-2 doses (not excluded by the teaching of D5) also stimulates Teffs, which is an undesirable effect"
•  "While D5 provides isolated case studies of the treatment of two patients having SLE with IL-2, these do not prove statistical significance, and furthermore, the dosage used is not apparent from the information provided in D5.
• Moreover, D5 does not provide any rationale that might guide the person skilled in the art in selecting a suitable dosage. The general range of 35 to 2000 units proposed in D5 (column 6, lines 40 to 56) is very broad. The use of un-standardised "units" and the vague description of the dosage regimen applied in the reported clinical cases does not permit any conclusions with regard to the dosage levels proposed, or the actual dosages used in the clinical cases."
• The Board considers the claim to be allowable.
• See also T1108/22 - 3.3.04 - 18.11.2024 - 22.12.2025 (no Art. 15(9) communication visible) - 9 opponents, case remitted to OD for further prosecution (so the delay in the written decision actually matters for the actual decision on the allowability of the claims!).
• See also T 1048/21, 10.10.2024 - 22.12.2025 - 3.3.04.

EPO 

The link to the decision is provided after the jump.

T 1902/23 - Twelve documents as the CPA

Key points

• “The [proprietor/respondent] argued that D11 should be considered as the closest prior art for assessing inventive step, contrary to the [opponent’s/appellant’s] position that all documents D2-D12 and D16 were suitable alternatives to be taken as the closest prior art [...]. Using twelve documents as [the] closest prior art constituted an impermissible "shotgun" approach. Reference was made to the Guidelines for Examination (G. VII. 5.1) and decision T 320/15 (point 1.1.2 of the reasons), which established that multiple starting points were only permitted when documents were equally valid springboards, and that opposition proceedings should not become a forum for unlimited inventive step attacks.”
• “ the Board concurs with the appellant for the following reasons: (a) Firstly, on the question of whether only one piece of prior art should be selected for the purpose of assessing inventive step, it is settled case law that there are often several reasonable starting points, each offering a different route that might lead to the invention without the need of hindsight”
• “In practice, the number of suitable prior art documents may also depend on the breadth of a claim, so that a broad claim may lead to a situation where several documents are equally valid starting points. The same is true in a highly competitive technical field where many closely related prior art documents have been published. However, as mentioned above, the fact that several documents are proposed as the closest prior art is per se not incompatible with the problem-solution approach.”
• “In any event, although the [opponent] started from 12 different documents for their objections of lack of inventive step, it is clear from their arguments that these objections actually boil down to two main lines of attack: ...”
• Claim 1 is found to be obvious over D2. None of the auxiliary requests is admissible and allowable over D2.

EPO 

The link to the decision is provided after the jump.

T 1909/23 - 2nd medical use claim for individualized RNA cancer vaccine

Key points

III. Claim 1 of the patent reads as follows:

"1. An individualized cancer vaccine for use in a method of treating a cancer patient, said method comprising the steps:

(A) providing the individualized cancer vaccine by a method comprising the steps:

(a) identifying cancer specific somatic mutations in a tumor specimen of the cancer patient to provide a cancer mutation signature of the cancer patient, comprising

(aa) ...  and

(b) providing an RNA vaccine featuring the cancer mutation signature obtained in step (a), wherein the RNA vaccine comprises RNA encoding a recombinant polyepitopic polypeptide comprising mutation based neo-epitopes; and

(B) administering the individualized cancer vaccine to the cancer patient."

• Claim 1 of the present patent [is very similar to] claim 1 of EP 2 714 071, dealt with in decision T 2168/21, [and differs from it] in the addition of steps (aa), (bb) and (cc) and in the absence of the further characterisation of the RNA vaccine as "featuring the mutation signature of the patient".
• T 2168/21 was published in June 2024. I missed it back then.

No cross-case res judicata effect

• "The decision in case T 2168/21 is formally not binding on the present board due to the independency of the proceedings between parent and divisional application(s). Neither has it an effect of res iudicata for the present proceedings due to the lack of identity of facts and claimed subject-matter (cf. e.g. T 1270/20, Reasons 3.8.2; T 2084/11, Reasons 1.3; see also Benkard, EPÜ (4th edition), Art. 76, Rn 10). However, in view of the very similar wording of claim 1 of both patents, the conclusions drawn in the present case and the reasoning of this decision are similar to those of T 2168/21."

Medicine preparation steps limiting

• “The claim relates to a purpose-limited product in the sense of Article 54(5) EPC. Both method steps (A) and (B), including the sub-steps (a) and (b), constitute characterising and limiting features of the claimed subject-matter because they form an integral part of the method of treating a patient, which is a method referred to in Article 53(c) EPC. Without these steps, the claimed "individualized cancer vaccine" cannot be implemented and would not be defined.”
• “The patient to which an individualised cancer vaccine is administered is therefore the same patient from which a tumour specimen for the identification of cancer-specific mutations originated giving rise to a cancer mutation signature of this very patient. Since these steps are mandatory to obtain the individualised cancer vaccine under consideration, the legal fiction of a purpose-limited product in accordance with Article 54(5) EPC applies at least to step (A), including the sub-steps (a) and (b), and step (B) of the method, which are thus limiting on the claim.”
  
  
  
• I wonder how infringement of this kind of claim will be evaluated. It seems to me there will not be any generic supplier of the vaccine? 

EPO 

The link to the decision is provided after the jump.

T 1571/23 - No harmless error rule?

Key points

• The OD revoked the patent. The proprietor appeals and requests that the impugned decision be set aside because of an alleged substantial procedural violation.
• The Board, in translation: "In the Board's view, it is immediately apparent from the grounds of appeal that the patent proprietor wishes to have the contested decision set aside due to procedural defects, in particular a violation of the right to be heard, and to have the matter remanded to the Opposition Division. In view of the alleged procedural defects, it is irrelevant whether the appeal can also be considered sufficiently substantiated with regard to the key grounds of the decision, namely the inadmissible extension and the lack of clarity concerning the requests admitted by the Opposition Division (see Case Law of the Boards of Appeal of the European Patent Office, 11th edition, 2025, V.A2.6.7.c; T 1020/13, Reasons 1)."
• • As a comment, there could also be a rule that the procedural error must not be harmless, i.e., that it could have influenced the outcome of the case.
  • CLBA V.A.2.6.7.c cites only one decision, namely T 1020/13.
  • I think a distinction should be made between procedural errors that vitiate the entire decision (i.e., wrong composition of the OD, lacking signature to the decision) and a violation of the right to be heard. In the latter case, there should be at least a prima facie argument made why the substantive reasoning was wrong on the point affected by procedural error, and how the outcome of the case could have been different with correct reasoning (to deal with the case that there are two alternative grounds for refusal, only one of them being affected by the alleged violation of the right to be heard). 
  • The decision is in line with T 0898/24.
• The Board finds no procedural error concerning the main request.
• AR 1 to 91 were not substantiated in the appeal and were not admitted.
• The proprietor's appeal against the decision revoking the patent is dismissed.

EPO 

The link to the decision is provided after the jump.

T 1113/24 - OD should have heard witnesses

Key points

• The opposition is based on an alleged public prior use. The OD rejected the opposition. The opponent appeals. The OD had refused to hear two witnesses (as requested by the opponent) in connection with the public prior use. The opponent had substantiated the public prior use with documents, including technical drawings and diagrams.
• The OD had reasoned as follows: "The witnesses had been offered to confirm that the filling and cleaning installation according to the prior use "Adelholzener" anticipates all the features of claim 1 of the contested patent. However the documentary evidence supporting the alleged prior use D21 to D39 was of such a low quality that a skilled person would not be able to read any technical information from the diagrams of documents D23, D24, ..., and thus would not be able to identify whether some of the claimed features ... were disclosed in these documents or not."
• The Board: "The appellant [opponent] convincingly demonstrated that a substantial procedural violation took place in the opposition proceedings for the following reasons."
• "the [opponent] offered witnesses specifically to corroborate and explain the technical details of the circulation paths that were visible in the diagrams (but required expert interpretation). This means that the witnesses have not been offered to introduce new facts into the proceedings, but merely to confirm the facts alleged in the notice of opposition."
• "According to the established jurisprudence (CLBA, III.G.3.1.1), if the evidence offered as proof of contested facts essential to the settlement of the dispute is decisive, the body hearing the case must, as a rule, order that it be taken."
• "The opposition division also incorrectly based its decision on the prior use on an assumption about what the witnesses would say, thereby pre-empting the evidence's evaluation."
• "Additional clarifications provided by a witness to close a potential gap in the documentary evidence on file cannot be considered per se, even before hearing the witness, as new facts; hearing a witness would otherwise be futile (CLB, point III.G.2.4.1)."
• " The absence of written declarations by the offered witnesses is also not a reason to suspect that their testimony would exclusively introduce new facts, and also does not justify the decision of not hearing them."
• "This is because, according to the established jurisprudence it is a party's choice to present whatever means of evidence it considers to be suitable, and it is an opposition division's duty to take its decision on the basis of all the relevant evidence available rather than to expect the presentation of more preferred pieces of documentary evidence, and to speculate on the reasons for and draw conclusions from their absence "
• "While it is correct that oral evidence of a witness should only be taken when required to clarify matters decisive for the decision, the opposition division should have heard the witnesses before deciding what the alleged prior use was, and was not, disclosing, as the witnesses were offered to corroborate decisive facts already alleged in the notice of opposition."
• "By refusing to hear the proposed witnesses before deciding on the allegation of prior use, the opposition division has in fact proceeded to assesDat is evidence that had not yet been completely established thereby incurring a substantial procedural violation ..."
• The impugned decision is set aside, and the case is remitted to the OD. The Board does not decide on any other points.

EPO 

The link to the decision is provided after the jump.