T 0123/23 - Food for thought - deleting alternatives

Key points

• I'm not sure what to think of this decision.
• The OD revoked the patent, for insufficient disclosure (Art. 83) of one feature.
• " Oral proceedings before the board were held on 17 December 2024. The final requests of the parties were: - The proprietor (appellant) requested that the patent be maintained on the basis of one of eighteen claim requests: main request (labelled as "auxiliary request 5"), auxiliary request 1 (labelled as "amended auxiliary request 5"), auxiliary requests 11, 23, 29, 34, 40, 45, 51, 56, 62, 67, 73, 78, 84, 89, 95 and 96. The decision under appeal is based on all those claim requests except for auxiliary request 1, which was filed during the oral proceedings before the board."
• Claim 1 as granted specifies two alternatives for one feature 1-E.l This feature is unrelated to the feature causing the Art. 83 issues before the OD. The Board finds one of the two alternatives to lack basis in the application as filed. In AR-1, filed during the oral proceedings, that alternative is deleted.
• The preliminary opinion of the Board was that there was no Art. 83 issue, i.e. that all claim requests complied with Art. 83.
• "the board does not dispute the fact that the deletion of the phrase "or other printed indicia" in claim 1 of the main request amounts to the removal of an alternative from this claim which prima facie overcomes the added-matter objection discussed with the board for the first time during the oral proceedings before it. However, this fact alone likewise does not amount to "exceptional circumstances" which necessarily justify admitting the claim request into the appeal proceedings. Instead, the whole situation of the appeal must be taken into account."
• The proprietor: "The added-matter objection to feature 1-E had not been discussed in the board's preliminary opinion. The board might have noted there (see point 7.2 of the board's communication under Article 15(1) RPBA) that further objections in relation to added subject-matter had been raised during the opposition proceedings. However, since the opposition division had not decided on any of these issues, the board's initial intention had been to remit the case on the basis of the claims of e.g. one of auxiliary requests 5, 11, 23 and 29 without conducting any further examination "
• The Board: "In any case, a patent proprietor should prepare the relevant "fallback positions" for that eventuality as early as possible, in line with the general obligation that its complete appeal case is provided as early as possible (see Article 12(3), first sentence, RPBA; see also e.g. T 614/21, Reasons 3.2). This is particularly true in the present case, as the opponents had raised the relevant objection at an early stage of the appeal proceedings, which the proprietor then attempted to overcome only at the latest possible stage, i.e. during the oral proceedings before the board. Moreover, it cannot be the purpose of a hearing held in appeal proceedings to allow an applicant or proprietor, after having discussed, in writing or orally, multiple (higher-ranking) claim requests, to present yet another amended set of claims in a trial-and-error fashion for finally defining its actual "invention" (see e.g. T 1924/20, Reasons 5.1; T 3258/19, Reasons 1.1.4(b))."
• "If the board were to admit the new claim request, it could settle the appeal immediately by remitting the case to the opposition division for further examination of novelty and inventive step - as initially intended - or it could continue with the examination of those issues in appeal, most likely in writing then due to the parties' need to present or amend their respective cases before the board. Both options would however be contrary to overall procedural economy."
• I'm not entirely sure what the Board here means with 'procedural economy' because it did not intend to consider novelty and inventive step at any rate, i.e. also if the Board would have agreed with the proprietor that the feature had basis in the application as filed. 
• "The proprietor could have filed this claim request already during the opposition proceedings, as it constitutes undeniably the safest defence against any possible objection to the presence of "indicia" in the former claims. A remittal would therefore give the proprietor a second opportunity to argue its case before the opposition division, including the possibility of filing even more claim requests if necessary."
• The request is not admitted. The patent is revoked.

• EPO 

The link to the decision can be found after the jump.

T 1418/22 - Using your failed experiments to your advantage

Key points

• Claim 1 is directed to a polymorph. "It is common ground that compound (1) as prepared in example 6 of D3 is in amorphous form (see also example 5 of the patent, reproducing example 6 of D3). Therefore, the feature distinguishing the subject-matter of claim 1 as granted from example 6 of D3 is that compound (1) is in the crystalline form I."
• "The board [...] considers that the objective technical problem should at least be seen as the provision of a more stable and non-hygroscopic form of compound (1). "
• "as pointed out by the respondent [proprietor], example 1 of the patent (page 19) shows the crystallisation procedure used to achieve form I of compound (1). Among a high number of single solvents and solvent combinations used (75 in total, see table 1 on pages 20 to 25), only four mixtures of solvents (samples 23, 24, 39 and 58) led to form I. In the other cases, when solids were obtained, these represented the amorphous form or, in two instances (samples 53 and 69), a different polymorphic form of compound (1) named form II. Anti-solvent experiments did not lead to form I of compound (1) either "
• "Additionally, while it can be accepted that it would have been expected by the skilled person that crystalline forms are more stable than amorphous forms, the results of the patent (see summary provided by the respondent on page 13 of the reply to the statement of grounds of appeal) show that two further polymorphic forms (form II and form III) of compound (1) were found to be more hygroscopic than form I."
• Including the non-working non-claimed examples and alternative polymorphs in the patent application seems a smart move in this case.
• See also: Dai Rees, Inventive Step: The Stories We Tell - link
• "as set out above, form I has a lower hygroscopicity than forms II and III. Thus, in contrast to the condition referred to under point 5.2 of the reasons of decision T 777/08 for denying inventive step, form I, in terms of its hygroscopicity, is not an arbitrary selection of a specific polymorph from a group of equally suitable candidates."
• The Board did not A14, an experimental report drawn up in 2022, i.e. seven years after the priority date, which was filed by the appellants with the statement of grounds.
• According to the opponent/appellant: "A14 demonstrated that if the skilled person had tried standard crystallisation solvents as disclosed e.g. in D7 [prior art, c.g.k.], they would necessarily have arrived at form I of compound (1) as defined in granted claim 1. A14 also showed that no other solid form was crystallised."
• The Board: "the filing of A14 raises complex issues. In fact, admitting A14 would require, for example, considering whether a characterisation by X-ray powder diffraction of the starting sample used in A14 unambiguously allows concluding that the starting material was in amorphous state and that no crystalline material was present. This was contested by the respondent. It would also require assessing whether the crystallisation procedure followed in A14 was such to unambiguously exclude the presence of unintentional seeding. The discussion and consideration of these complex issues would have been detrimental to procedural economy and contrary to the primary object of the appeal proceedings to review the appealed decision in a judicial manner (Article 12(2) RPBA)."
• After the Disappearing Spoon (a book, link) and the Disappearing Polymorph (Derk Lowe's post, the original article is older), now the Disappearing Technical Problem.

EPO 

The link to the decision can be found after the jump.

The placeholder line at the top is to be removed! 

T 0773/21 - An obligation to submit futile objections before the OD (?)

Key points

• The OD considered D22 to be not novelty destroying for AR-2 (the OD's extensive reasoning is on pages 17 - 20 of the decision).  The claim request was held to be not novel over D6. Request AR-3B, with an additional feature, was filed during the oral proceedings, was admitted, and was held to be novel over D6.
• "Claim 1 of the third auxiliary request is the combination of respective claim 1 of the first and second auxiliary requests, i.e. claim 1 of the first auxiliary request with the additional feature (M1.10) [that is specified in AR-2]."
• In other words, claim 1 of  AR-3 adds a feature to claim 1 of AR-2. Unless I overlook something, this means that the OD, having found AR-2 to be novel over D22, would have found AR-3 to be novel over D22 as well.
• The Board agrees that AR-2 is not novel over D6 and does not consider novelty over D22 of that request. 
• The opponent had attacked AR-3 as not novel over D22 in the statement of grounds. The Board does not admit the attack.
• The Board: "It is undisputed that this request was submitted for the first time during the oral proceedings and an objection of lack of novelty of claim 1 in view of document D22 has not been raised expressis verbis by the opponent during the oral proceedings before the opposition division."
• "The board finds that an objection raised with regard to other requests previously dealt with or still pending cannot be tacitly transferred to a newly submitted request. As long as an objection is not explicitly stated or submitted, it cannot be considered to have been raised or filed. "
• "The opponent could and should have formally raised this objection during the oral proceedings before the opposition division which it did not. In particular, this formal objection would not have compromised the efficiency of the procedure, as it could have been dealt with in a very brief discussion. "
• So, an obligation to make a futile attack: "Dear Chair of the OD, I know you have already decided that the claim is novel over D22, but I formally make the same attack for AR-3".
• What purpose does this obligation serve? It would not have added any substantive reasoning to the decision of the OD, the OD could just have said in their decision that claim 1 of AR-3 is novel over D22 for exactly the same reasons as for AR-2 (which reasons, three pages of them, are in the decision already and were thus available to the Board to review).
• " the opponent has not been able to convincingly demonstrate that it had admissibly raised the objection of lack of novelty in respect of document D22 for this request, let alone that it had maintained it until the decision of the opposition division, as indicated in Article 12(4), first sentence, RPBA."
• "It is not known why the opponent did not raise this objection during the oral proceedings before the opposition division. It might have forgotten to do so or it could have been that at that time, the opponent was convinced that this objection no longer served its purpose."
• ? - Perhaps because the OD had already decided that the higher ranking AR-2 is novel over D22, so that the amendment of adding a feature in AR-3B does not change that finding?
• "Since it is precisely to be avoided that a party changes its mind about objections at will in the course of the proceedings, it would have been important to clearly raise the objection of lack of novelty of claim 1 in view of document D22 at the oral proceedings before the opposition division at least formally."
• "Moreover, not having raised this objection during the oral proceedings before the opposition division leads now to the situation that the opinion of the opposition division with regard to the subject-matter defined in claim 1 is not known and cannot be reviewed by the board."
• "Even though the opposition division's opinion on the second auxiliary request is known [i.e. the three pages of extensive reasoning of the OD why that claim 1 is novel over D22, PJL], it cannot be simply transposed to the third auxiliary request - variant B, since the subject-matter of the respective claim 1 is different."
• Well, if the amendment is adding a feature, the view on novelty of the OD of the claim with that additional feature seems certain? 
• "The prima facie relevance of document D22 is however a necessary condition for admitting this objection at this advanced stage into the proceedings. "
• Cf: Article 12(4): "the suitability of the amendment to address the issues which led to the decision under appeal" (not: overcome the issues, that is in Art. 13(1)). 
• "The opponent could also not convince the board in the written proceedings that document D22 directly and unambiguously discloses all features defined in claim 1, since according to the board's preliminary opinion stated in its communication under Article 15(1) RPBA, document D22 did not disclose the width relationship of D and d of claim 1 (see point 14.5.3 of the communication). Therefore, a prima facie relevance of document D22 is not given because otherwise it should have been recognised by the opposition division and/or by the board having reviewed the extensive previous written discussions. Moreover, the discussion on this topic might well turn out to be extensive which would be contrary to procedural economy."
• So, the Board has formed a preliminary opinion on the matter,  i.e. has studied the claim and the novelty thereof over D22, but denies the opponent the opportunity to discuss this issue during the oral proceedings. 

EPO 

The link to the decision can be found after the jump.

T 1286/22 - No French style devolutive effect of appeal

Key points

• The opponent appeals. The patent is granted in French to a French proprietor, with a professional representative located in France.
• The Board finds the claims of the main request to be not novel.
• "During the oral proceedings before the Board, the respondent, after hearing the Board's findings on the main request, requested that auxiliary requests 3 to 5 as filed with the Opposition Division by letter dated 1 December 2021 be admitted into the appeal proceedings. It also requested that the case be remitted to the Opposition Division to consider these auxiliary requests."
• "The respondent referred to the minutes of the oral proceedings before the opposition division, stating in point 7.1 on page 10 that the said auxiliary requests 3 to 5 had been maintained. It argued that there had never been any question of abandoning these auxiliary requests. Since the contested decision concerned only the main request, the respondent was convinced that if the board had found the main request unfounded, the proceedings should automatically have continued on the basis of the auxiliary requests filed before the opposition division."' 
• As I understand it, this is (or traditionally was) indeed the case in French civil litigation under the 'devolutive effect' of the appeal (comments are welcome). But not at the EPO (anymore).
• The Board: "while Article 12(1)(a) RPBA provides that the appeal proceedings are to be based, inter alia, on the minutes of any oral proceedings before the Opposition Division, this provision does not mean that everything mentioned by the respondent according to the minutes of the oral proceedings before the Opposition Division, in particular the maintenance of auxiliary requests 3 to 5, automatically forms part of the grounds relied on by the respondent in the appeal."
• "None of the written submissions made by the respondent during the appeal proceedings referred to auxiliary requests 3 to 5. The raising of these auxiliary requests during the oral proceedings therefore constitutes an amendment of the respondent's grounds under Article 13(2) RPBA. The Board was unable to recognise any exceptional circumstances justifying the admission of this amendment of the respondent's grounds at such a late stage in the appeal proceedings. Indeed, compliance with the Rules of Procedure of the Boards of Appeal, in particular the provisions of Article 12(3) RPBA, is the responsibility of the parties."
• The requests are not admitted.
• The patent is revoked. 

EPO 

The link to the decision can be found after the jump.

T 2463/22 - On evidence, the standard of proof, Re B (Children) (and Francis Bacon)

Key points

• Some reflections on the standard of proof from Board 3.3.09 in this appeal about an alleged public prior uses.
• "The case law of the Boards of Appeal has tried to reconcile the following two aspects.
• - On the other hand, there is an imbalance in that one of the parties to the proceedings has access to the evidence and the other does not. The party that contests the prior use usually has little or no access to evidence that could support its case. All it can do is, essentially, point out inconsistencies or gaps in the chain of evidence provided by the other party.
• - On the one hand, under the principle of free evaluation of evidence, the deciding body must not observe any formal rules when assessing evidence, such as giving one means of evidence, as such, more weight than another. Accordingly, a lower probative value must not be systematically attributed to e.g. witness statements on a prior use from real life than to written evidence such as patent specifications."
• " In the current board's view, under the principle of free evaluation of evidence, it is always decisive in the evaluation of evidence that the members of the deciding body are personally "convinced". Moreover, they must always be convinced of whether, as stated in T 1138/20, "the alleged fact has occurred". Both is true regardless of which standard of proof is applied. "
• "The current board considers the following extracts from House of Lords, Re B (Children) [2008] UKHL 35, Reasons 2 to be an accurate and illustrative description of the issue at hand: "If a legal rule requires a fact to be proved (a 'fact in issue'), a judge or jury must decide whether or not it happened. There is no room for a finding that it might have happened. The law operates a binary system in which the only values are 0 and 1. The fact either happened or it did not. [...] [T]he standard of proof [...] is [...] the degree of persuasion which the tribunal must feel before it decides that the fact in issue did happen." (emphasis by the board)."
• As a comment, I thought "non liquet" is an essential element of the law on evidence, but legal traditions apparently differ. Even in the meaning of the phrase, it turns out. Compare the English and German Wikipedia pages for non liquet
• https://en.wikipedia.org/wiki/Non_liquet - "In law, a non liquet (commonly known as "lacuna in the law") is any situation for which there is no applicable law."
• https://de.wikipedia.org/wiki/Non_liquet - "Auch heute wird im Verfahrensrecht bei Beweisproblemen mit non liquet eine Situation bezeichnet, in der weder der Tatsachenvortrag der einen noch der anderen Seite bewiesen werden kann." ... "Im Zivilprozess hängt die Entscheidung bei einem non liquet von der (materiellen) Beweislast ab. Derjenige, der nach den Regeln der Beweislast die streitige Tatsache zu beweisen hat, verliert den Rechtsstreit, weil er beweisfällig bleibt (zumeist der Anspruchsteller)."
• I'm more familiar with the German use of the term non liquet (the term is used in the same way in Dutch law). The question for me was: what do judges do if the evidence is ambiguous in common law procedures / in the UK?
• To cite Francis Bacon in Reading on the Statute of uses (published in 1642):
• 
  
  https://books.google.nl/books?id=fusOD6ELKZ4C&newbks=1&newbks_redir=0&dq=The%20learned%20reading%20of%20Sir%20Francis%20Bacon%2C%20one%20of%20Her%20Majesty's%20learned%20counsel%20at%20law%2C%20upon%20the%20statute%20of%20uses&pg=PA305#v=onepage&q=non%20liquet&f=false 
• It seems that the view of the House of Lords in 2008 is still very much in line with the common law approach, or perhaps the remark of the House of Lords - self-evident as it is to the Lords, it is foreign to me - can be explained by the historical English approach to evidence.
• As a further remark, since under German law, the "Beweislast" rules determine the outcome of the case in the event of a (German-style) non liquet of the evidence, a concept alien to English law, it seems, it may have to be considered what 'burden of proof' precisely means in English law.
• See also T 1076/21: "If a material fact is not or cannot be proven, a decision is taken on the basis of who bears the relevant burden of proof. The fact that the real position cannot be established is to the detriment of the party which bears the burden of proof for this fact, among other things because the other party is given the benefit of the doubt. In principle, each party bears the burden of proof for the facts it alleges (T 63/06, Reasons 3.1 and 3.2)."

EPO 

The link to the decision can be found after the jump.

Pending R 16/23 - The right to oral proceedings

Key points

• Petition for review R 16/23 was forwarded to the Enlarged Board in a five-member composition. The petition for review concerns decision J 6/22 where the Legal Board did not hold oral proceedings although these were requested and decided to reject the request for re-establishment for the late filing of the Statement of grounds of appeal. 
• The petition for review is in the public part of the file here. A well-known patent attorney firm is handling the case. 
• In the end, the request for re-establishment is based (at least at the root) on a burn-out of a European patent attorney who is referred to in the petition for review as Ms. K. This  elegantly allows the petition for review to be visible in the public part of the online file.
• Oral proceedings are scheduled for 21 November 2025 by video conference and will be public - see the summons here.
• The Legal Board furthermore issued no preliminary opinion in advance. That is argued to be a separate procedural violation (Art. 113(1) EPC). So, perhaps that will be the focus of the debate.

T 0774/22 - When room temparature is no CGK

Key points

• "The board has come to the conclusion that the invention as defined in granted claim 2 is not sufficiently disclosed because, as evidenced by the opponent, essential information necessary to obtain the claimed PCC material comprising nanofibers and/or nanochain-like agglomerates is not provided in the patent. "
•  "The experimental results submitted by the opponent [] show that such a material can only be obtained if step c) is carried out at a temperature of around 20 C. In contrast, when the carbonation is carried out at 11 C or 50 C, no PCC having nanochain-like agglomerates or nanofibers can be obtained. It follows that, although the carbonation temperature is essential for carrying out the invention, this information is missing from the patent."
• Paragraph [0080] of the patent, Example 1, is silent on the temperature: 
• "CaO is reacted with water such that dry Ca(OH)2 is obtained. The reaction is controlled such that 1 molar equivalent of water is reacted per one molar equivalent of CaO and the water content of the dry Ca(OH)2 is less than 2 %. The dry Ca(OH)2 is contacted with water to provide a milk of lime. CO2 is bubbled into a milk of lime presenting a solid concentration of 15 wt. % in the presence of a crystallization controller consisting of a mixture of polyacrylic acid and sodium polyacrylate. The resulting PCC slurry presents a concentration of 19 wt. % and is then filtered, dried and milled to obtain a dry PCC (Formulation 2). The PCC contains nanochain like agglomerates, combined to form microshell like aggregates." 
• "The proprietor further pointed out that the experiments at least demonstrated that the invention could be carried out if the carbonation temperature is set at a value of around 20 C. This is not disputed by the Board, however for an invention to be sufficiently disclosed, it is not sufficient that it can be shown at a later stage how it can be carried out. Rather, this teaching must be provided in the patent itself."
• "It could of course be argued that in the absence of any indication concerning the temperature in step c), it would be obvious for the skilled person to carry out the carbonation at room temperature. The board recognises that this is one possibility, but it is not the only one. "
• "For instance, since step (b), preceding step (c), is carried out at a temperature of preferably 10-60 C (par. 0050 - note, this is the general part of the description) and since the slurry produced in step (b) can be used directly for the carbonation step (c), without any teaching in the patent to cool down the slurry, or heat it up prior to its treatment with CO2, any temperature in the range 10-60 C could be chosen for carrying out the subsequent step (c). It follows that, when repeating example 1 of the patent, a product according to claim 2 could only be obtained by chance provided that the skilled person selected the correct temperature - i.e. 20 C - for carrying out step (c)." Example 1 is silent on the temperature used.
• The steps are: "a) a step of providing CaO, which is reacted with water to form dry Ca(OH)2;
  b) a step wherein the dry Ca(OH)2 of step a) is contacted with water to form a slurry; and
  c) a step wherein the slurry of Ca(OH)2 from step b) is carbonated with CO2.""
•  Too be clear, I trust the Board had good reasons for the decision, though perhaps the decision could have benefitted from additional reasoning. Is room temperature an obvious choice in the particular field, when Example 1 is silent on the temperature? Or perhaps the proprietor did not present the argument that in the absence of express instructions on the temperature in Example 1, the skilled person would use room temperature?
• Or, possibly , the broadening of the range to 10 - 60 C in para [0050] of the description is seen as misleading in this particular case by including non-working embodiments? Would the patent have been fine if no temperature range had been mentioned? 
• 
  

EPO 

The link to the decision can be found after the jump.

T 0816/22 - Even more than plausibility is required

Key points

• With all the attention for G 2/21 r.74 (which requires the application as filed to make the claimed therapeutic use credible), it is easy to overlook that even more is required for second medical use claims. 
• The opponent had filed post-published evidence of failure of clinical trials with the (example) compound of the invention: "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"."
• Why would the opponent oppose if the compound ("Cinryze") failed in the clinical trials? Perhaps because claim 1 is not limited to a specific compound and reads: " Claim 1 of the main request reads as follows: "1. A C1 esterase inhibitor (C1-INH) for use in a method of treating antibody-mediated rejection (AMR) of an organ allograft in a patient in need thereof, wherein the method comprises intravenous administration of the C1-INH at a dose of 5,000 units to 20,000 units given in divided doses over 10 to 20 days, and wherein the organ is kidney.""
• The Board: "The board therefore concludes that the only relevant data in the patent are finding CG [a type of rejection of the organ allograft]  in 1 out of 7 patients in the Cinryze arm [treatment arm] compared with 3 out of 7 patients in the placebo arm"
• "In view of the small number of patients, the opponent considered that a treatment effect had not been demonstrated. The board, however, does not deem it necessary to establish this and instead starts from the assumption that the opposition division was correct in finding that the experimental data provided in the patent (see above), together with the mechanistic explanation provided in paragraphs [0032] to [0039] and Figure 1, 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 is not enough to demonstrate that the invention is sufficiently disclosed if the opponent provides evidence which raises serious doubts that the therapeutic effect can indeed be achieved (see below)."
• "Post-published documents D15, D16 and D54 relate to the phase III clinical trial NCT02547220 (SHP616-302), which was carried out using the same dosage regimen as in the examples of the patent and falling under the terms of the claim"
• " Document D54 shows the complete absence of any therapeutic effect with the claimed dosage regimen. "
• " In conclusion, a phase III clinical trial with the same setup as the examples in the patent and using the dosage regimen which is 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 has not dispelled the serious doubts regarding the presence of a treatment effect in view of these data. Therefore, the invention as claimed is not reproducible."
• "The board therefore considers that the patent does not disclose the claimed invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83 EPC)."
• Question: can the proprietor file post-published evidence that the invention works? E.g. for another C1 esterase inhibitor than Cinryze?

EPO 

The link to the decision can be found after the jump.

T 1908/22 - On T 1914/12 and whether arguments can be held inadmissible

Key points

• "The respondent argued that these objections [Art. 123(2)]  were raised for the first time during the oral proceedings before the board and requested not to admit these into the appeal proceedings for being late-filed."
•   The appellant was of the view that the board had no discretion not to admit "arguments" into the appeal proceedings and referred to decisions T 1914/12 and T 1875/15. "
• T 1914/12 (of 13.06.2018) observed that Article 114 EPC gives the Boards the power to hold facts and evidence, not arguments. Since that time, the Boards have declared a lot of things to be factual assertions, such as asserted claim interpretations.
• The premise of T 1914/12 is that " The RPBA can help in clarifying and interpreting the EPC but they cannot confer on the boards any powers that the EPC does not give them (T 1914/12, citing Art. 23 RPBA in this context)." (CLBA VII.1.4)
• It could be argued, perhaps, that Articles 106 - 111 EPC on appeal give the Boards the power to hold arguments inadmissible independent of Art. 114, but that is not argued in this case.
• "The board is not convinced that the findings of T 1914/12 and T 1875/15 can be applied to the present case, since the case at hand underlies the RPBA 2020 and not the RPBA 2007. "
• I don't readily see how the RPBA 2020 could confer on the boards any powers that the EPC does not give them where the RPBA 2007 does not, so is it a distinction without a difference?
• " The board notes that Article 12(2) RPBA 2020 specifies that a party's appeal case shall be directed to the requests, facts, objections, arguments and evidence on which the decision under appeal was based."
• The text of the RPBA of course does not address that premise of T 1914/12.
• "These provisions of the RPBA 2020 are not at odds with Article 114(2) EPC, which focuses on the discretionary power to disregard late-filed facts and evidence, whereas the RPBA focuses rather on the discretionary power of a board of appeal to not admit an amendment which may, for example, consist of new arguments or objections as in the present case."
• This reasoning suggests that this Board considers the  RPBA as creating powers for the Boards to hold submissions inadmissible beyond the scope of Article 114 EPC (and Article 123(2) EPC).
• 
  

EPO 

The link to the decision can be found after the jump, as well as an extract of the decision.

T 2250/21 - Is the witness a deepfake?

Key points

•  The OD revoked the patent. The proprietor appeals.
• The Board, in translation: "The appellant had essentially complained that the hearing of witnesses was not suitable to prove the alleged facts, since the chosen format of the hearing, namely by video conference, opened up a wide range of possibilities for influence or manipulation. "
• The The OD heard witnesses by video conference (in 2021). However, the Board considers the public prior use to be proven by the evidence alone, see below.
• "Therefore, questions should be submitted to the Enlarged Board of Appeal regarding the obligations of the opposition division, in particular whether the opposition division "must insure
• - whether the witness is not a deepfake,
• - whether the witness is a real human person,
• - whether the witness examined fully and not only partially confirms the identity given,
• - whether the ID is genuine and/or physically existent and/or is not a deepfake,
• - whether the witness is uninfluenced, for example by a 360° camera pan to view the entire room,
• or whether the mere testimony of the witness must be accepted physically without verification (e.g. with the risk that the witness is a deepfake acted by another person)""
• The Board, in the original German: "Wie oben unter Punkt 1. dargelegt, und im Laufe der mündlichen Verhandlung von der Vorsitzenden erläutert, ist die beanstandete Zeugenvernehmung jedoch für den Beweis der geltend gemachten offenkundigen Vorbenutzung "Space Jet 3 Almbahn", und damit die vorliegende Entscheidung, nicht relevant (Artikel 112 (1) a) EPÜ). Demgemäß erklärte die Vorsitzende während der mündlichen Verhandlung, dass eine Vorlage diesbezüglicher Fragen an die Große Beschwerdekammer nicht in Betracht komme. Die Patentinhaberin widersprach dieser Feststellung nicht und erklärte, dass die Vorlage angesichts der Auffassung der Kammer keinen Sinn mehr ergeben würde."

• In point 1 of the decision, the Board finds the public prior use proven by the documentary evidence alone.

• The documentary evidence did not include  affidavits, only documents such as a manual, technical drawing, and delivery receipt. 

• For sure, there are already some inventions addressing the authenticity of videos? 

EPO 

The link to the decision can be found after the jump.

T 0326/22 - Functional antibody claims

Key points

• The reports of the death of functional antibody claims are greatly exaggerated (see epi Information 2024/4), as this case shows.
Claim 1 reads: ""1. An isolated monoclonal antibody or immunologically active fragment thereof that binds to human CD47, wherein the antibody or immunologically active fragment thereof binds to a discontinuous epitope on CD47, wherein the discontinuous epitope comprises amino acids residues Y37, K39, K41, K43, G44, R45, D46, D51, H90, N93, E97, T99, E104, and E106 of CD47 when numbered in accordance with SEQ ID NO: 147,
and wherein the antibody or immunologically active fragment thereof prevents CD47 from interacting with signal-regulatory-protein a (SIRPalpha)
and does not cause a significant level of agglutination of cells after administration.""
• Hence, the definition of the claim is purely functional. The SEQ ID refers to the structure of the epitope (target), not the structure of the antibody itself.
• For sufficiency:  In these circumstances the issue to be assessed is whether the skilled person based on the patent application's teaching taking common general knowledge into account can reliably and without inventive skill find those antibodies in the pool of generated CD47 antibodies that show the functional properties indicated in claim 1."" 
• "as long as the generation of these further CD47 antibodies requires nothing but routine work that may be tedious and time consuming, the method of generating these antibodies cannot be regarded per se as being based on undue burden (T 431/96, Reasons 6)."
•  "the patent application provides the skilled person with the sequence information of the six CDRs of the 2A1 antibody and of various derivatives thereof including their full variable light and heavy chain sequences (Table 1 on pages 32 and 33, paragraphs [00111] and [00112]). Antibodies with these sequences fulfil the functional properties indicated in claim 1. It is also uncontested that varying these sequences and obtaining further antibodies are routine and hence impose no undue burden on the person skilled in the art. Thus, in agreement with the appealed decision (point 14.1 of the Reasons), the board considers that the skilled person in following this route routinely arrives at further antibodies with the functional properties of claim 1."
• "Example 11 of the patent application mentions that X-ray crystallography ("XRC") was used for determining the epitope structure on CD47 bound by the chimeric antibody 2A1-xi and discloses the epitope's structural information (see also Figure 11C). "
• It is unclear to me if the patent provides for an assay for the feature of the binding to the specified epitope and if the skilled person can easily screen for antibodies having that property, other than obtained by varying the example antibody 2A1.
• After a detailed technical analysis: "In view of the considerations above, it is credible that the skilled person by applying the teaching of the patent application and taking common general knowledge into account would arrive without undue burden at further antibodies falling within the scope of claim 1. "
• On inventive step: "Compared to the full-length B6H12 and 5F9 antibodies of document D1, the objective technical problem to be solved resides thus in the provision of an improved CD47 antibody."
• "Document D1 provides no pointers for the skilled person to select the epitope on CD47 as defined in claim 1 for solving the technical problem formulated above. Thus the claimed antibodies are based on an inventive step over the disclosure of the full-length monospecific and bispecific B6H12 and 5F9 antibodies of document D1."
• The claim request is held to comply with the EPC.

EPO 

The link to the decision can be found after the jump.

G 2/13 - On subject-matter and extent of protection

Key points

• "The referring Boards raised the question whether it was of relevance that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants excluded as such under Article 53(b) EPC [].
• The Enlarged Board: "the relevant point of law referred to the Enlarged Board is whether or not the "subject-matter" of a product claim or a product-by-process claim directed to a plant or plant material other than a plant variety is excluded from being patented under Article 53(b) EPC by virtue of the essentially biological nature of the process for making said plant or plant material. Thus, the aspect of the scope of protection conferred by such a claim has no direct impact on the point of law referred."
• "A distinction needs to be made between, on the one hand, the aspects of patentability and, on the other hand, the (protective) effects of European patents or patent applications. The EPC clearly provides for such a clear division, as the requirements for patentability are governed by Articles 52 to 57, 76, 83, 84 and 123 EPC whereas the extent of protection and the rights conferred by European patents or patent applications are specified in Articles 64(2) and 69 EPC in particular."
• "In this respect, reference is made to G 1/98 (supra, Order, point 3, and Reasons, point 4) where the Enlarged Board decided that Article 64(2) EPC is not to be taken into consideration in examining a claim to a process for the production of a plant variety (see also G 2/88, OJ EPO 1990, 93, Reasons, point 2.5)."
• See also points 4 and 5.1 of G2/88, of course. 
• See also Guidelines H-V, 7.1, in connection with Article 123(3): "If a patent is so amended that a claim to a product (a physical entity) is replaced by a claim to the use of this product, the degree of protection is not extended, provided that the use claim in reality defines the use of a particular physical entity to achieve an effect and does not define such a use to produce a product" (because in the latter case, the amended claim could cause the downstream product to fall under the infringing acts of the patent by the effect of Art. 64(2) EPC, see G 2/88 point 5.1 of the reasons). 
• "This conclusion applies mutatis mutandis to the examination of product and product-by-process claims directed to plants or plant products other than plant varieties."
• "As a consequence, whether a product claim [...]  is patentable is to be examined irrespective of the extent of protection that is conferred by it after grant. Its allowability depends upon the fulfilment of the formal and substantive requirements of the Convention for these kinds of claim categories."
• Not sure whether it is helpful, but I visualize it as shown below:

EPO 

The link to the decision can be found after the jump.

T 1199/22 - When must a witness be heard?

Key points

• When must an offered witness be heard by the OD? 
• "Opponent 3 criticised that the opposition division took this decision - that the alleged prior use did not form part of the state of the art - without hearing the witnesses Mr Weist and Mr Schubert, because the witnesses had not only been offered to confirm that the meeting to which D24 relates took place, but also to testify as to the participants and the contents of the meeting (opponent 3's notice of opposition, page 10, as reproduced in opponent 3's statement of grounds of appeal, page 7). This included the delivery. Opponent 3 also criticised the fact that the witness Mr Hasenclever was heard on the contents of D24 instead of the witnesses that had been offered in relation to it. In their opinion, not hearing the witnesses Mr Weist and Mr Schubert affected the outcome of the decision."
• "The opposition division found that the presentation D24 and the general statements by the witness Mr Hasenclever did not prove beyond reasonable doubt the actual delivery of the foils to Hueck, and that considerable doubts remained as to the public nature of the delivery, if any (point 2.4.2 of the impugned decision). The opposition division was of the opinion that the alleged deliveries in the presentation D24, page 11, could be considered to be more likely than unlikely, but it concluded on the basis of D24 and Mr Hasenclever's testimonial (who, however, did not participate in the relevant meeting) that "absent any indications to the contrary" there were doubts as to the public nature of the alleged sales in view of the applicable standard of proof, beyond reasonable doubt (ibid.)."
• The Board: "the witnesses Mr Weist and Mr Schubert had been offered to testify as to the content of the meeting, which included the delivery of the foil because this meeting (in the form of the internal presentation D2
• 4) was provided as the (only) evidence of the delivery (opponent 3's notice of opposition, page 10, second and fifth paragraphs). In the light of the above, it is not possible to exclude the possibility that the opposition division might have come to a different conclusion if it had heard the witnesses Mr Weist and Mr Schubert on the content of this meeting."
• " Furthermore, the alleged prior use with order number 709.437-01 seems to be highly relevant because it allegedly relates to a foil having a relevant chemical composition (D27), ... "
• "In particular, it may be more relevant than the other prior art under consideration, and - if proven - may thus be decisive for the outcome of the case. For these reasons, it appears equitable that the witnesses Mr Weist and Mr Schubert should be heard before deciding on the public availability of the prior use "Hydro/Hueck"."
• The case is remitted.

EPO 

The link to the decision can be found after the jump.

Good luck to all EQE candidates

Key points

• If you enjoy this blog, you are surely well prepared! 

T 1799/21 - Too late is too late

Key points

• The opposition is rejected. The opponent appeals. The Board agrees with the opponent, that claim 1 defines the invention in a too broad manner. 
• "claim 1 is directed to any recombinant [bacteria] strain of the order of Actinomycetales having at least one non-functional gene encoding an enzyme having vanillin reductase (vr) activity" (having a certain sequence)
• A non-functional vanillin reductase enzyme is useful when producing vanillin. 
• " The order of Actinomycetales describes a large group of bacterial strains which inter alia encompass the genus Amycolatopsis and Streptomyces. The recombinant strain of claim 1 is not further characterised besides its origin and the presence of at least one non-functional vr1 to vr5 gene. Claim 1 is in particular silent on the strain's suitability to produce a certain product, for example, vanillin."
• " A matter of particular importance in the present case is the issue of whether or not substantially all recombinant strains defined in claim 1 are capable of producing vanillin, at least to a low extent."
• After reviewing the technology: "In view of the considerations above, it has to be concluded that claim 1 encompasses as an embodiment recombinant non-vanillin producing strains of the order Actinomycetales. This embodiment will be dealt with in the following under inventive step."
• "the provision of an alternative recombinant strain with at least one non-functional vr1 to vr5 gene does not amount to more than an arbitrary choice from a number of different equal solutions, i.e. the provision of further recombinant Actinomycetales strains comprising at least one non-functional gene, each of which would be obvious to the skilled person."
• Claim 1 is considered to be obvious.
• In Auxiliary Request 13, the strain is limited to one particular strain (producing vanillin).
• "New auxiliary requests 12 and 13 were filed for the first time at the oral proceedings before the board. The respondent argued in support of their admittance that the amendments were a reaction to the board's communication and that the amended claims 1 of both claim sets were derived from the other claims as granted, in particular, from claim 12 as granted for auxiliary request 12 and from claim 3 as granted for auxiliary request 13. "
• " However, the submission of auxiliary requests 12 and 13 only at the oral proceedings as a reaction to objections that were on file since the first instance proceedings cannot represent exceptional circumstances that could justify this late reaction. These objections were also maintained by the appellant in their statement of grounds of appeal. Since therefore the objections were not brought up by the board, the submission of these new auxiliary requests cannot be justified as a reaction to the board's preliminary opinion either. In addition, procedural economy could also not provide any reason for the respondent not to file auxiliary requests 12 and 13 at an earlier stage. The issue of whether or not the appellant was taken by surprise does also not relate to the question whether exceptional circumstances have prevented the respondent from filing auxiliary requests 12 and 13 earlier, and is thus irrelevant as well."

EPO 

The link to the decision can be found after the jump.

T 2662/22 - When to present the auxiliary inventive step attack?

Key points

• If you present a novelty attack in a Notice of opposition, should you add an inventive step attack for the same document?
• "In the present case, it is not disputed that the opponent did not argue lack of inventive step starting from D3 in its opposition notice, it was only used to argue lack of novelty (cf. opposition notice, pages 4, 5 and 6). The inventive step objection was late filed in opposition. The opposition division (see its impugned decision, section 4.4) exercised its discretion under Article 114(2) EPC not to admit this objection into the proceedings."
• "Whether the objection was first made at the oral proceedings (cf. minutes point 17) or with the opponent's letter of 29 April 2022, since the latter date is well after the 9 month opposition period, in both cases the objection would be late filed."
• "In considering admittance of the late filed inventive step objection based on D3, the opposition division considered its prima facie relevance (see impugned decision, section 4.4 and minutes point 21), which is the correct principle to apply (see Guidelines for examination at the EPO, E-VI-2). That the appellant-opponent may not agree with the opposition division's conclusion does not render the principle applied by the opposition division wrong. Moreover, the matter was discussed with the parties at the oral proceedings, so they were heard. Therefore, in exercising its discretion, the opposition division appears to have applied the right principles and to have done so in a reasonable way. Therefore, the Board does not intend to overrule how the opposition division exercised its discretion."
•  The paragraph is a quote from the preliminary opinion of the Board, which was included as a ground in the Board's decision.
• " Neither in written proceedings nor at the oral proceedings did the parties comment on this part of the communication. Nor did the Board see any reason to revise its preliminary opinion. Therefore, the Board decided not to admit the objection"
• As a comment, we should perhaps not make too much out of a decision where the appellant does not contest the preliminary opinion of the Board. But to me, I think it makes sense to first await which distinguishing features the proprietor identifies for a novelty attack in their reply under Rule 79 EPC before the opponent is required to present an auxiliary inventive step attack. 
• The OD's decision is, of course, there, and it would be good to know what the current practice is of the ODs. However, the Board does not discuss the decision of the OD in great detail. 
• 
  

EPO 

The link to the decision can be found after the jump. 

T 0832/22 - On evidence and when something is proven

Key points

• When is a statement proven? What is the role of the standard of proof?
• The Board: "The Enlarged Board's reference in G 2/21 to a judge's personal conviction makes clear that it is the state of mind of the members of the fact finding body which is decisive in the evaluation of evidence. This is always the case, regardless of which standard of proof is to be applied. In other words, referring to the deciding body's conviction that an alleged fact occurred (see T 1138/20, Reasons 1.2.1, last paragraph, and T 1311/21, Reasons 3.2.1(d)(vi)), does, strictly speaking, not yet say anything about which standard of proof should be applied by the deciding body to arrive at this conviction."
• "As to "the required standard of proof" referred to by the Enlarged Board in G 2/21, different concepts have been developed in the case law of the Boards of Appeal. The EPO standard of proof is generally the balance of probabilities. By way of exception, the standard of proof is that of beyond reasonable doubt, mainly in opposition proceedings where only the opponent has access to evidence concerning, usually, an alleged public prior use "
• As a comment, I'm not sure that 51% likelihood is generally sufficient, see also below.
• "[S]tandards of proof relate, in legal systems based on the principle of free evaluation of evidence, necessarily to a mental state, namely to the nature or degree of conviction of the members of the fact finding body. Accordingly, it is difficult to quantify the difference in the required degree of conviction between "the balance of probabilities" standard and the "beyond reasonable doubt" standard. In fact, attempting to describe this difference in the form of numerical thresholds, for example as a certain percentage of likelihood that an alleged fact occurred, can even be misleading. In regard to the "beyond reasonable doubt" standard, it thus seems more expedient to focus on the term "reasonable". In the present Board's view, this expresses that the "beyond reasonable doubt" standard does not require absolute certainty, and that it is sufficient if the (majority of the) members of the deciding body have no reasonable doubt that[t] an alleged fact occurred. In other words, even if there is some remaining doubt, the "beyond reasonable doubt" standard of proof can be met as long as the remaining doubt is not reasonable, which can be understood as overall insubstantial in view of the entirety of the available evidence."
• "if the higher one of two disputed standards of proof is met, it can be left open which of these standards must be applied when assessing the evidence in question. Hence, if the deciding body is convinced beyond reasonable doubt that an alleged fact occurred, there is no need to decide which standard of proof is applicable (see, for example, T 2466/13, Reasons, 2.1.1). For the reasons given below, this is the situation in the present case."
  
  
• The opponent had filed evidence of the publication date of a document. "D39 is a digital forensic report by the company BIT4LAW SRL created "in the interest of" the opponent (see D39, page 1, and chapter 2, page 4: "Introduction". D39 establishes, inter alia, the upload dates of certain documents [including D9] from the opponent's computer system to a public web server (see chapter 5 starting on page 13)."
• "the Board considers that D39 - a document only cursorily mentioned in the appealed decision and not considered in substance - establishes that D9 was publicly available on the internet at least on 19 November 2014, i.e. well before the priority date of the patent (29 March 2017)."
• "The data on page 21 of D39 also contain the information that version 1.0 of the document in question was last updated by Daniela Volpin on 19 November 2014. Ms Volpin confirmed in her affidavit (D38) that on 19 November 2014 she "personally uploaded on the Carel website the release 1.0 dated 30/10/2014 of the Technical Manual of the Heos device". The information in D38 is thus consistent with that in the report D39."
• There was further supporting evidence in the form of affidavits.
• An interesting point is the level of evidence required in this case to show the publication date of the document. "Up to the hilt" is not limited to prior use. 

EPO 

The link to the decision can be found after the jump.

T 1224/24 - When the EPO forgets the drawings and the proprietor notices in time

Key points

• The appeal lies from the decision of the examining division to grant a European patent on the basis of the application documents indicated in the communication under Rule 71(3) EPC dated 13 December 2023.
• The appeal was filed on 03.07.2024. The DTG was dated 03.05.2024. The mention of the grant was 29.05.2024.
• The Board: "The appeal is admissible since the appellant is adversely affected by the omission of 48 out of 52 drawings in the decision to grant. The granted version of the patent corresponds neither to the text submitted by the applicant, nor to a text agreed upon or deemed approved by the applicant." 
• "A review of the file history reveals that while several versions of the description and claims were submitted by the applicant on 16 September 2021, 2 August 2022, 10 August 2022, and 13 September 2023, the figures or drawing sheets were never amended or partially withdrawn. This indicates that the drawings forming part of the applicant's request for grant were those filed with the request for entry into the European phase-namely, the original drawing sheets 1/52, 2/52, 4/52 to 27/52, 29/52 to 36/52, 38/52, 39/52, and 41/52 to 52/52, along with the amended drawing sheets 3/52, 28/52, 37/52, and 40/52, which were submitted on 27 September 2020 upon entry into the European phase. All these drawings were correctly published in the A1 application."
• "The communication under Rule 71(3) EPC dated 13 December 2023 proposed amendments to the description and to claim 1 but did not indicate that the text intended for grant differed from the applicant's request regarding the drawings. Furthermore, no prior communication from the examining division proposed amendments to the drawings filed by the applicant, or contained any comments on them. All communications stated that, for the figures, the examination was carried out on the amended drawing sheets 1/4-4/4 as filed upon entry into the regional phase before the EPO. However, the file contains no explicit approval from the applicant for the removal of the remaining 48 originally filed drawings. It appears that neither the members of the examining division nor the appellant realized that the original drawing sheets 1/52, 2/52, 4/52 to 27/52, 29/52 to 36/52, 38/52, 39/52 and 41/52 to 52/52 were omitted and only the amended drawing sheets 3/52, 28/52, 37/52 - renumbered 1/4- 4/4 - were considered by the examining division."
• " In accordance with T 1003/19 (catchword and point 2.4 of the reasons), T 1823/23 (point 1.9 of the reasons), T 2081/16 (point 1.4 of the reasons), the Board considers that the legal consequence set out in Rule 71(5) EPC can only apply if the communication under Rule 71(3) EPC reflects the examining division's intention regarding the application documents on which the patent is to be granted."
• "Under normal circumstances, it can be assumed that the text referred to in a communication under Rule 71(3) EPC reflects the examining division's intention regarding the text on which the patent is to be granted. However, this is not the case when objective elements in the communication and/or in the text annexed to the it, such as significant discrepancies between the communication and the "Druckexemplar", or within the "Druckexemplar" itself, clearly indicate that the text does not correspond to the examining division's intention (see T 1003/19, points 2.4.3 and 2.4.4)."
• "  the Board concludes in the present case that neither the documents referred to in Form 2004C nor the "Druckexemplar" reflected the text in which the examining division intended to grant the patent. Hence the text communicated to the applicant with the communication of 13 December 2023 did not correspond to the text intended for grant under Rule 71(3) EPC."
• " If the applicant is not communicated the text intended for grant under Rule 71(3) EPC, the legal consequence outlined in Rule 71(5) EPC does not apply. Therefore, the applicant's subsequent filing of translations and payment of fees for grant and publishing do not imply approval of the communicated text."
• " A decision to grant under Article 97(1) EPC, based on a text that was neither submitted nor agreed upon by the applicant, as is this case (see points 1.1- 1.11 above), does not comply with Article 113(2) EPC. Therefore, the decision under appeal is to be set aside."
• " the board considers that the present decision does not deviate from G 1/10, which determined that Rule 140 EPC cannot be used to correct the text of a patent, but did not concern the interpretation of Rule 71 (5) EPC. Therefore, Article 21 RPBA does not apply. The Board fully agrees with and refers to the reasoning in T 2081/16 (point 3) and T 1003/19 (point 4)."

EPO 

The link to the decision can be found after the jump.

T 0423/21 - When the EPO forgets the drawings

 Key points

• This applicant reaps the bitter fruits of  G 1/10 (in other words, the present case illustrates the harsh consequences of the Boards' current interpretation of G 1/10. 
• The PCT application was filed with drawings (18 pages) and had the drawings in the WO publication in 2013. 
• The PCT Pamphlet  (WO publication WO2013184830) is not included in the EPO's online file wrapper. 
• Why is unclear to me. The WO publication is usually included in the EPO online file, see e.g. this case. 
• Hence, we cannot see what the EPO received (or obtained) from the IB / WIPO as the PCT application in 2014. Does any of the readers know more about this? 
• Amended claims and an amended description are filed in the prosecution.
• The Rule 71(3) Communication does not include the drawings: they are not part of the Druckexemplar (the "Text intended for grant (version for approval")  in the online file, nor are they listed in Form 2004, i.e. the form that is the basic part of the Rule 71(3) communication). Nothing is said about the drawings in Form 2004: some amendments by the EPO are listed, but nothing about the drawings. 
• The patent is granted on 8 May 2019 (the date of the publication of the mention of the grant). The decision to grant is dated 11.04.2019.
• The applicant files a request for a correction on 23.07.2019. 
• The Board does not grant any remedy. The B1 publication corresponded to the Druckexemplar. The request for a correction under Rule 140 is refused, referring to G 1/10.
• "As it is the applicant's duty to properly check all the documents making up the communication under Rule 71(3) EPC (i.e. Form 2004 and the Druckexemplar), the responsibility for any errors remaining after grant are his alone, whether the error was made (or introduced) by him or by the examining division."
• The request under Rule 139 is also refused.
• Perhaps an appeal against the decision to grant in combination with a request for re-establishment could have been tried, but that procedure was ruled out by the recent decision T 0178/23. 
• Of course, decisions of the Enlarged Board are not carved in stone (see G3/19 point xx), so a referral could have been requested. G1/10 was about a change of a typographic error in the claims. It is not about the EPO losing parts of the application, in other words, ummarked amendments by the EPO of the application.
• Finally, possibly the error by the EPO can be treated as a correctable formatting error: H-VI,4: "Formatting/editing errors are alterations in the patent documents which occur during the preparation of the Druckexemplar and which are indicated neither by standard marks nor in Form 2004." (also in the 2019 edition). The decision of the Examining Division does not refer to this specific paragraph of the Guidelines. 
• The example in the Guidelines of a "formatting/editing error" refers to "the two top lines" in a page that "have just disappeared" from the Druckexamplar without editing marks in the Druckexmplar and without an indication on Form 2004). This can be corrected, according to the GL.
• Given that the letters in the Druckexamplar don't have little legs, the example in the GL  actually refers to the EPO's software deleting or omitting the two sentences during the preparation by the Druckexmplare (in fact, the example mentions that there are other, marked, edits by the Examining Divisio on the same page). 
• I don't see a size limit in the GL's definition of "Formatting/editing errors are alterations in the patent documents which occur during the preparation of the Druckexemplar and which are indicated neither by standard marks nor in Form 2004", i.e. no limit to alterations of less than three lines, and no exclusion of alterations in the drawings. 
• There could be possible reasons why the remedy of H-VI,4 is not applicable, but as the present  decision is not concerned with that remedy, there is no need to speculate on any possible obstacles. 
• The Board does not comment on the procedure of GL H-VI,4, so nothing in the present decision is a problem for that remedy. 

T 0294/20 - Sufficiency (plausibility) for second medical use claim

 Key points

• "Claim 1 is drafted in the form of a purpose-limited product claim, pursuant to Article 54(5) EPC, and is directed to a compound that reduces the activity or expression of a Programmed Cell Death-1 (PD-1) polypeptide (in the following "PD-1 inhibitor") for use in the treatment of nodular lymphocyte predominant Hodgkin lymphoma (NLPHL)"
• Sufficiency of disclosure in the sense of G 2/21 is at issue (i.e., former plausibility).
• "According to decision G 2/21 (OJ EPO 2023, A85, point 77 of the Reasons), "[i]n order to meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, the 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." 
• This intermediate conclusion of the Enlarged Board of Appeal can be understood as confirming the established case law that post-published evidence cannot be used to remedy a lack of sufficient disclosure in respect of a medical use (cf. T 609/02, headnote).
• By this statement, the Enlarged Board of Appeal can also [i.e., additionally] be seen to have endorsed the jurisprudence of the boards of appeal that attaining a claimed therapeutic effect is a limiting functional technical feature of a claim directed to the use of a substance or composition in a method of treatment (see also G 2/21, point 74 of the Reasons). 
• [...]  in decision G 2/21 the Enlarged Board of Appeal focussed on the issue of whether or not post-published evidence can be used by an applicant or patent proprietor in the assessment of Articles 83 and 56 EPC, but did not address the question of the level of proof in an application as filed required to substantiate a therapeutic effect as a prerequisite for using post-published evidence for assessing the requirements of Article 83 EPC."
• "The board therefore does not understand G 2/21 to have quashed the principles established by leading decision T 609/02 despite having qualified the term "plausibility" merely as a generic catchword. Indeed, as decision T 609/02 clearly sets out, a balance should be struck between enabling early patent protection for therapeutic uses and avoiding that the claimed invention is only completed at a later point in time. As a consequence, in order to fulfil the requirements of Article 83 EPC, the suitability of the product for the claimed therapeutic application must be derivable from the application, unless this is already known to the skilled person at the priority date (see T 609/02, point 9 of the Reasons and T 895/13, points 3 to 5 of the Reasons)."
• "The board cannot accept the appellants' [proprietors'] line of argument, that "plausible" in this context means that the "technical concept" and hence the suitability of the claimed compounds for the claimed therapeutic application is "plausible" as long as it is not shown to be "implausible". That would be in direct contradiction with the principles set out in decision T 609/02. 
• The current Board then adds some reasoning: "The burden to show the suitability is on the applicant (see G 1/03, OJ EPO 2004, 413, point 2.5.3 of the Reasons: "When an application for a patent is filed, the process of making the invention has to be completed. The requirement of sufficiency of disclosure ensures that a patent is only granted if there is a corresponding contribution to the state of the art. Such a contribution is not present as long as the person skilled in the art is not able to carry out the invention. Therefore, the decisive date for fulfilling the requirement has to be the date of filing or priority, as the case may be. Deficiencies in this respect cannot be remedied during the proceedings before the EPO."). This burden cannot be discharged or shifted to the EPO or the public by merely alleging that a claimed therapeutic effect has to be regarded as having been demonstrated as long as it has not been disproven."
• Cited point 2.5.3 of G 1/03 (about non-disclosed disclaimers) may not directly address the issue of the burden of proof. The current Board uses "see", probably in the strict legal sense of that term  ("See [] is used when the cited authority clearly supports a proposition but there is an inferential step between the proposition as stated and the cited authority." - link) 
• It would have been useful if the Board had spelt out the 'inferential step' since the case at hand is an opposition appeal, and the general case law is that attacks under Article 100(b)  EPC require serious doubts substantiated by verifiable facts. 
• "The board therefore assesses below what can be inferred from the information provided in the patent as to a direct effect of a PD-1 inhibitor on a metabolic mechanism specifically involved in NLPHL."
• The Board, after reviewing the technical details, "the appellants [proprietors] on the one hand argued that tumours are characterised by T cell exhaustion and on the other hand that PD-1 expression is concomitant with T cell exhaustion. This explanation would lead to the conclusion that all cancers may be treated by PD-1 blockade, which manifestly is not the case. This is acknowledged in the declaration D55 submitted by the appellants: "All cancers are distinct and it is not possible to predict that a specific pathway, such as the PD-1 pathway, is present in any given type of cancer".
• The Board concludes that the application as filed does not provide support for the second medical indication in the sense of G 2/21, r.77. 
• The argument that post-published evidence shows that the compound works (allegedly), therefore, "must fail".

EPO

The link can be found after the jump.