T 0258/21 - Applying G 2/21

Key points

• This is an appeal against a refusal decision.
• "In the Board's view, the effect of an improved activity and reduced side-effects using clevidipine compared to other antihypertensive agents, in particular nicardipine in patients with specifically ischemic strokes, is not to be taken into account nor convincingly demonstrated, for the following reasons."
• I'm not entirely sure if "in particular" here means "preferably". 
• "G 2/21 prescribes that "a patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention" (see Order 2.). Here, the Board notes that this effect was neither contemplated nor even suggested in the original application. Indeed the original application did not mention any comparison to other anti-hypertensive agents and it encompassed the treatment of both hemorrhagic and ischemic stroke (see e.g. original page 3, 2**(nd) paragraph). It follows that this technical effect relied upon by the applicant cannot be taken into account for the assessment of inventive step in accordance with G 2/21."
• Note, the asserted technical effect is for patients with ischemic strokes. The application as filed mentioned both hemorrhagic and ischemic stroke; the Board considers this to be insufficient to meet the requirement of "as being encompassed by the technical teaching".
• D1 is the closest prior art, "D1 concentrates on clevidipine and refers in particular to a study on clevidipine for the management of hypertension in patients with a hemorrhagic stroke"
• The Board also considers the evidence to be insufficient. The remark about G 2/21 hence seems obiter.
• It is also unclear to me if the objection is due to a lack of technical support for the effect in the application as filed. The Board states that the objection is that "the Board notes that this effect was neither contemplated nor even suggested in the original application".  On the other hand, "the Board observes that the original application does not provide any experimental data. No technical effect directly linked to the identified distinguishing feature, namely the reduction of ischemic stroke damage, has thus been demonstrated in the application documents. In this context, the Board underlines that the choice of clevidipine over nicardipine does not constitute the distinguishing feature over D1."
• The Board does not state that the application can only be refused if the recited medical effect was (a priori) incredible at the priority date (or filing date).
• Finally, the claim is a second medical use claim, and it is unclear to me why the Board examines the matter under inventive step instead of sufficiency. 
• The Board: "Moreover, even if said technical effect would have been derivable from the original application, the Board observes that Annex 3 and Annex 4 [i.e. post-published evidence, in particular, scientific publications] are merely abstracts reporting results of "ongoing" studies. These documents do not provide any detailed results nor any details on the protocols used. Merely average values for some properties of clevidipine and/or further anti-hypertensive drugs are provided. The meaningfulness of the appellant's exploitation of the data provided in these abstracts is therefore prima facie questionable. ... Furthermore, the study of Annex 4 appears to be a retrospective case study which was not designed as a clinical trial.
• Compare T 2036/21: " In proceedings before the EPO it is not a prerequisite to perform a statistical analysis of the results .... as it is most often required in biomedical research and by health authorities granting marketing authorisations for medicinal products."
• The Board: "As to the balance of efficacy, precision (titrability) and safety, it is not necessary to examine whether this effect can be taken into account or is suitably demonstrated by annexes 3 and 4, because in any case this effect does not modify the conclusion of the Board set out below. As a result, starting from D1, the objective technical problem may thus be formulated, as suggested by the appellant, as the provision of a medicament that can be used in a method of reducing ischemic stroke damage in a subject with an ischemic stroke (see statement of grounds page 8, 7**(th) paragraph) which provides good balance of efficacy, precision (titrability) and safety (see page 2, 4**(th) paragraph under the heading "5.1. Main request", of the letter dated 14 July 2023)."
• The Board finds the claim to be obvious.
• Note, G 2/21 hence must not be understood to limit the Board's discretion to assume a technical effect if an inventive step is denied in the end.
• 
  

EPO 

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

Some remarks about the speed of appeal cases

Key points

• Justice delayed is justice denied, especially in the context of time-limited IP rights such as patents. Moreover, patents are forward-looking rights in that they seek to protect technologies that are finalized (often) and commercialized after the application's filing date, perhaps even more than copyrights or trademarks.  
• First, the Annual Report 2022; "in 2022 the Boards of Appeal settled a record number of 3 576 cases and reduced the number of pending cases to 6 216. The number of pending cases that are older than 30 months declined by 26.1% compared to 2021."
• https://link.epo.org/web/Annual%20Report%20BoA%202022_EN_final_rev_230609.pdf 
• Productivity increased from 19 cases per technical member per year to a stable 24 cases in 2021 and 2022.
• 90% of the cases were settled in 56 months (note that this may be a figure that looks backwards, i.e. the prediction could be that 90% of the cases filed in 2022 will be decided in fewer than 56 months.
• 30% of the stock is older than 30 months.
• The oldest case decided in 2023 was T 2158/14. Appeal against the refusal of an application from 2009. The first oral proceedings were scheduled in April 2020 and were (obviously) cancelled. The oral proceedings were newly scheduled for October 2021. The applicant then withdrew the request for oral proceedings and filed amended claims in March 2021. I'm not sure what happened, but the written decision was issued in February 2023, dismissing the appeal. To be clear, my view is that the silence of the Board from 2014 to 2019 was undesirable and should not happen anymore (assuming that no interruption or stay was in place). Systems should be in place (now) to monitor. 
• One other case, T 2175/15: three partiality objections.
• Six cases from 2016, 25 cases from 2017. This seems like the regular "end of the tail" stuff. Hopefully, the BoA President can make the tail a bit shorter. 
• From 2018: 102 cases, 2019: 366 cases, 2020: 480 cases, 2021: 561 cases, 2022: 164 cases.
• On the other side, 3 cases were filed in 2023 and decided in 2023 by the Technical Boards with a decision on patentability. The fastest seems to be T 0383/23 in an opposition appeal case. Statement of Grounds 27.04.2023, no reply filed by the patentee, patent revoked by the Board by a decision issued on 11.10.2023. 
• Other good news: Since the beginning of 2024, many boards have clearly been working hard to meet the three-month time limit for putting the decision in writing, with a lot of decisions being issued (just) in time. 
• In that sense, a remainder from the past were the 7 decisions that were taken in 2021 but with the written decision issued only in 2023.  
• See e.g. decision T 0229/18, taken on 07.10.2021 and issued in writing on 06.12.2023 (also: application filed in 2008, and summons for the OD after remittal to be held in March 2024 because the parties are arguing about the adaption fo the description (perhaps the Boards should not normally remit the case to the OD for the adaption of the description, incidentally). 
• See e.g also T 0862/17 taken on 05.05.2021 and issued in August 2023, with no Art. 15(9)RPBA  communication informing the parties about the delay visible in the file.  
• Finally, a rather "unhappy" list is the list of pending petitions for review. R 8/19 is still pending at the time of writing, with oral proceedings scheduled for 08.04.2024. To cite MR/2/00, Art. 112a, note 14: "The possibility of filing a petition for review must not cause long-lasting legal uncertainty for third parties" (arguably, the next sentence is about the revival of a patent or application, so perhaps there is less urgency for petitions for review filed by an opponent, as R 4/19 indeed is; but in pending case R 1/20 the petition is filed by the proprietor and no action is visible in the online file ever since May 2020). The Annual Report of the Boards seems to contain no data about the pendency of petitions for review.

T 0307/22 - Partial priority and intermediate prior art

Key points

• EQE D-like fun with partial priority and a German utility model.
• The opponent contests the validity of the priority after the deadline for written submissions, simultaneously filing D7 which is a DE utility model published in the priority year. The OD found the priority to be valid and did not admit D7.
• The decision on priority is open to review by the Board.
• The Board considers the claims as granted to be broader than the disclosure of the priority document, such that the priority is only partially valid. The Board then is of the view that it has to decide on the admissibility of D7 in appeal.
• The Board, in machine translation:  "With regard to the remaining part of claim 1 [i.e. lacking priority] - dishwashers with a "non-parallel" arrangement of the first leg and door leaf [i.e. panel]- there is no novelty-damaging disclosure in D7, analogous to D8 [=the priority document]."
• D7 has the same contents as the priority application D8.
• The opponent submitted during the oral proceedings before the board, that D7 is full prior art for the parts of the claims not entitled to priority, that it can be cited for both novelty and inventive step against those parts, and would be detrimental to inventive step.
• The Board considers the inventive step argumentation to be not prima facie highly relevant and does not admit it (actually, does not admit D7). The Board considers the part of the claim to be a a non-obvious alternative, or at least that the opponent had not clearly shown that the part of the claim is obvious over D7.
• This part of the decision seems fact-specific. 
• 
  

EPO 

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

T 0364/20 - The admissibly-raised exception

Key points

•  The Board arrives at auxiliary requests 1  to 16, which are carry-over requests. 
• "To examine whether auxiliary requests 1 to 16 were admissibly raised before the opposition division, it is necessary to consider the file history."
• The requests were filed by the Rule 116 EPC date.
• The opponent: " It submitted that claim 1 as granted had been amended in at least seven different diverging directions in auxiliary requests 1 to 16 and referred to the table bridging pages 5 and 6 of its letter dated 3 November 2020. Moreover, claim 1 of several auxiliary requests contained various combinations of the granted dependent claims which were not disclosed as such in the claims as granted. Features from the description had also been included. "
• The Board considers that auxiliary requests filed with the reply under Rule 79(1) EPC can be held inadmissible in exceptional cases only. "The board bases this view on decision R 6/19 of the Enlarged Board of Appeal, according to which (catchword) the basis for an opposition division's discretion to admit or not claim requests is Article 123(1) EPC. The Enlarged Board held (reasons, points 7 to 9) that under Article 123(1) EPC, a patent proprietor does not always have the right to amend its patent and that "amendments and their admission into the proceedings shall be in accordance with the provisions of the implementing regulations". The Enlarged Board referred to Rule 81(3) EPC, which gives the opposition division the discretion not to admit claim requests. The Enlarged Board derived this discretion especially from the rule's provision that an opportunity to amend the patent must be given only "where necessary". The current board observes that in a similar way, Rule 79(1) EPC stipulates that a patent proprietor must be given the opportunity to amend its patent in reply to the notice of opposition only "where appropriate"."
• "The existence of a truly exceptional situation leading to the consideration of claim requests filed within the time limit set under Rule 79(1) EPC to not have been admissibly raised should be decided on a case-by-case basis. Such a situation might occur where an abuse of the proceedings occurred, e.g. when an unreasonably high number of diverging auxiliary requests were filed without proper justification. The number of grounds for opposition or different objections raised by an opponent as well as the number of opponents may represent, inter alia, criteria to be considered."
• The relation of this holding to Rule 80 EPC could be considered.
• "Decision T 221/20 (points 2.1 to 2.4) considered auxiliary requests filed after the expiry of the time limit set under Rule 79(1) EPC and before the expiry of the time limit under Rule 116(1) EPC set by the opposition division in its summons to attend oral proceedings to have been admissibly raised. In fact, the current version of the Guidelines for Examination in the EPO (March 2023 Edition), in Section E-VI.2.2.2, states that "[a]mendments submitted before the date set under Rule 116(1) cannot, as a rule, be considered as being late-filed".
•  "However, in the board's view, it cannot be held that any claim request submitted after the expiry of the time limit set under Rule 79(1) EPC and before the expiry of the time limit set under Rule 116(1) EPC is automatically filed in due time and thus was admissibly raised."
• This could be an important point for the practice of the OD if the first instance departments were to follow the present decision and/or other Boards were to follow the present decision.
• The point also raises the interesting question of how free the Boards are to depart from the GL under the "admissibly raised" exception. And, if the Boards apply different rules for the "unless clause" that the OD's, how would such a double set of rules work in practice.
• "The board holds that whether or not a claim request filed after the expiry of the time limit set under Rule 79(1) EPC and before the expiry of the time limit set under Rule 116(1) EPC is to be considered to have been filed in due time depends on whether it was submitted as a direct and timely response to a change of the subject of the proceedings introduced by the opponent or the opposition division."
• The requests are admitted, are each considered on the merits, and the patent is revoked. 

EPO 

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

T 0416/21 - Reply to the preliminary opinion

Key points

• The proprietor files an auxiliary request in reply to a new objection in the preliminary opinion of the Board.
• The Board: "If the submission of auxiliary request 0 was actually a response to the Board's communication, this application should have been submitted promptly after delivery of the communication (of August 23, 2023) and not only with the letter of November 3, 2023, and a few days before the oral hearing (November 10, 2023)."
• At any rate, the Board considers the objection to be not a new one.
• The request is not admitted.
  
  
• The appeal of opponent II is deemed to not have been filed. The opponent paid the appeal fee at the reduced rate but was not an SME.
• The Board, in translation:" Opponent II admitted that it was not an SME and that the payment of the reduced appeal fee was made in error. During the oral proceedings before the board, she withdrew an original request for correction of the form for payment of the fee in accordance with Rule 139 EPC."
• " The correct appeal fee (in full) was only paid shortly before the oral hearing. Opponent II did not pay the appeal fee in the correct amount within the time limit set out in Article 108, first sentence, EPC. According to Article 108, second sentence, EPC, the appeal is deemed not to have been filed."
• "During the oral hearing, opponent II invoked the principle of the protection of legitimate expectations. [Arguing that] she paid the reduced fee well before the deadline, so there would have been enough time [for the EPO] to point out this obvious deficiency." (G 2/97, headnote). 
• "opponent II could not expect to be informed by the EPO that the incorrect appeal fee had been paid. There is nothing in the Notice of appeal, the fee payment form or other submission that obviously requires clarification or reminder. On the contrary, the submissions were clear: the notice of appeal stated that the official appeal fee of EUR1,955.00 (fees no. 011) would be paid from the current account. This amount corresponds to the reduced fee. The accompanying letter for subsequently submitted documents (Form 1038) contains the information that the reduced appeal fee (in the amount of EUR 1,955.00) must be debited from the current account. A defect claimed by opponent II that was “obvious” to the board was therefore not present."
• The appeal of opponent I is admissible and the patent is revoked. 

EPO 

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

T 3224/19 - Technical effect

Key points

• This is a rather routine decision, but it serves as a reminder that a technical effect needs to meet more requirements than those of G 2/21 to support an inventive step.
• In particular, the post-published evidence can still be late-filed and therefore inadmissible.
• In addition, the evidence (post-published or in the application itself) can be insufficient or insufficient to support the full scope of the claims.
• Finally, the technical effect as such can be invoked late, e.g. if a proprietor first argues one technical effect and only in appeal argues a second technical effect (even if only using the examples in the application as filed as evidence). This third possibility is not illustrated by the present decision. 
• "Document D13 [experimental report filed before the OD] presents a comparison of four compositions I to IV.  ... However, composition I is also not a composition according to the closest prior art, example 2 of D2, which comprises 2-chloro-6-ethylamino-4-nitrophenol. Therefore, the results shown in document D13 can not demonstrate a technical effect caused by the differing technical feature."
• "The appellant [proprietor] submitted document D15 [further experimental report] with its statement setting out the grounds of appeal and requested to admit the document into the proceedings. The appellant argued that filing of the document at this stage of the proceedings was justified, because of a completely new line of argumentation brought forward during the oral proceedings before the opposition division. ... The board comes to the conclusion that that document D15 should have been submitted during the opposition proceedings. ... The board does therefore not admit document D15 into the proceedings". 
• "In conclusion, no technical effect has been shown related to the feature which distinguishes the claimed compositions from the closest prior art. The objective technical problem can thus, in line with the impugned decision, only be seen in the provision of alternative colouring compositions for keratin fibers."
• The appeal is dismissed.

EPO 

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

G 1/22 - Entitlement to priority (comments)

Key points

• The Enlarged Board decided that assignments of priority rights that are claimed for the benefit of European patent applications, are regulated exclusively by the EPC as autonomous law, and that accordingly implied agreements suffice for such assignments. Moreover, a rebuttable presumption exists that the applicant of the subsequent application is entitled to the priority right if the priority declaration and priority document are timely filed under Article 88 EPC and the Implementing Regulation. The key parts of the decision (paras 129-131 and paras. 99 and 100) are shown below.  
• Below the "read more", I provide a paragraph-by-paragraph analysis of G 1/22.
• The German BGH decided to follow G 1/22 in a recent decision (X ZR 83/21 para. 119;  link)
• 
  

129. The subsequent applicant wishing to file a European patent application should not only hold the title to that European application (i.e. the right to the European patent [i.e. the right of Art. 60(1) EPC) but also the priority right [Art. 87(1) EPC] if such right [i.e. priority] is claimed for the European application.
In the context of the EPC and the proceedings before the EPO, a strict distinction should be made between the two rights. The title to the subsequent application, on the one hand, is [...] assessed by national courts in view of Article 60(3) EPC (above points 79 ff). The right to claim the priority date for the subsequent European application, on the other hand, has been shown to be a right created under the autonomous law of the EPC and the Paris Convention, the transfer of which should also be assessed under the autonomous law of the EPC (above points 83 ff).

130. The exclusive application of the autonomous law of the EPC to the transfer of priority rights removes the need for conflict of laws rules and the application of national laws, thereby eliminating two main reasons invoked against the EPO's competence to assess whether a party is entitled to claim priority under Article 87(1) EPC. After evaluating various arguments supporting and denying this competence of the EPO (above points 83 ff, 93 ff), the Enlarged Board concludes that the EPO is competent to assess priority entitlement.

99. [...] The EPO should [...]  accept informal or tacit transfers of priority rights under almost any circumstances.  [...]

100. For example, the autonomous law of the EPC should not require that the assignment of priority rights has to be in writing and/or has to be signed by or on behalf of the parties to the transaction (see above point 69 for the diverging case law on this issue) since this would establish a high threshold in view of the national laws. [...]

131. In view of the interests of the parties involved, the lack of formal requirements for the transfer of priority rights [see point 99 above] and the necessary cooperation between the priority applicant and the subsequent applicant in the context of the procedural requirements under Article 88(1) EPC [i.e. the filing of the priority document], the Enlarged Board concludes that the entitlement to priority should be presumed to exist. This presumption should be rebuttable to take into account rare exceptional cases in which the claiming of the priority by the subsequent applicant appears to be unjustified (above points 101 ff).

T 1118/22 - The opponent's reply

Key points

• An important lesson today for any opponent as a respondent: don't forget to broaden the appeal in your appeal reply brief by raising all possible objections and completely substantiating these objections by writing them out in full in the reply itself.
• The OD found the claims to be not novel over D9. The proprietor appeals, arguing that the claims are novel (and inventive, presumably) over D9. The opponent files a reply.
• The Board considers the claims to be novel and inventive over D9.
• In translation: " In its response to the appeal, opponent 1 referred to a lack of novelty of the subject matter of claim 1 compared to the respective teaching of documents E18, E19, E12, E15, E4, E5, E7, E10 and E16 and a lack of inventive step based on the teaching of documents E12, E19, E8, E11, E13 and E17 as set out in the written submissions of both opponents in the opposition proceedings. It justified the mere reference to the arguments in the opposition proceedings by saying that the contested decision of the opposition division did not contain any findings on these objections raised in the opposition proceedings and that the patent proprietor itself addressed these objections in the statement of grounds of appeal and in doing so merely repeated its arguments from the opposition proceedings and consequently bring forward nothing substantially new. Furthermore, opponent 1 reserved the right to supplement its submissions as necessary and/or requested."
• The full attacks were submitted with a letter of 29.07.2023, i.e. after the summons. The attacks are not admitted under Art. 12(3) RPBA 2020.
• The Board in translation "mere reference to the objection submissions cannot therefore replace appropriate reasons in the appeal proceedings. Rather, the completeness of the appeal submissions, which is still required by Article 12(3), sentence 1 and sentence 2, second half, RPBA, is necessary because it cannot be the board's task to investigate which of the arguments from the opposition proceedings remain relevant."

EPO 

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

T 2036/21 - Preventing dementia and credible effects

Key points

• The patent was granted in 2011. Decision OD in 2016, appeal decision in 2019 to remit, next decision in 2021 to maintain the patent in amended form. The appeal of the opponent is dismissed, so after 12 years, the opposition procedure now comes to an end.
• The Board, after an extensive analysis, considers the following objective technical problem to be solved by the second medical use claim at issue: "how to provide a personalized treatment and prevent or delay the onset of dementia in the prodromal dementia group who benefit the most from intervention"
• "prodromal (dementia) patients" are subjects who, although not yet suffering from clinical dementia, are on the way towards developing it."
• "The appellant [opponent] argued that D31 and D47, filed after that remittal, provided evidence that the claimed composition neither prevented nor delayed the onset of dementia at the prodromal stage. No therapeutic effect was achieved in prodromal patients. In its opinion, this was relevant to formulating the technical problem underlying the invention and for assessing inventive step."
• "Article 111(2) EPC, does not preclude the opposition division from taking into account facts which were not at the disposal of the board remitting a case for further prosecution."'
• "D31 and D47 relate to the clinical trial "LipiDiDiet". The trial investigated the effects of Fortasyn Connect (Souvenaid), a composition according to claim 1, on patients affected by prodromal Alzheimer's disease expressing the biomarkers of claim 1."
• The Board concludes that: "D31 and D47 do not convey to the skilled person the message that "the tested composition is unsuitable for preventing or delaying the onset of dementia in a prodromal patient", but rather that "this effect was not detected, possibly because the clinical trial was not designed and adequately powered to do so".'
• "The results presented in D47 and the conclusions drawn by its authors leave no doubt that Fortasyn Connect, a composition according to the invention, induces a beneficial and unprecedented effect in prodromal Alzheimer's disease patients."
• D47: " significant benefits were observed on cognition, function, and brain atrophy, with clinically relevant effect sizes demonstrated."
• "Alzheimer's disease, the most common form of dementia, is induced by progressive degeneration of the brain cells causing a gradual decrease in cognitive functions. Therefore, it is credible that, as argued by the respondent, by slowing down this progressive degeneration, the onset of dementia will be delayed or even prevented in prodromal dementia patients as defined in claim 1."
• Let's hope it is not only credible but also true. 
• As a comment, it's not clear to me why the objective technical problem was not formulated in terms of providing "significant benefits ... on cognition, function, and brain atrophy, with clinically relevant effect sizes demonstrated", as that is what the evidence seems to demonstrate. 
• The Board: "In proceedings before the EPO it is not a prerequisite to perform a statistical analysis of the results and to determine a specific confidence interval, as is most often required in biomedical research and by health authorities granting marketing authorisations for medicinal products. As held in G 3/97, Reasons 5 "the principle of free evaluation would be contradicted by laying down firm rules of evidence defining the extent to which certain types of evidence were, or were not, convincing" (see also decision T 2717/17, Reasons 4.3.5)."

EPO 

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

T 1186/20 - Steam ovens and laundry machines

Key points

• A decision with a certain Paper C vibe.
• Claim 1 is directed to an oven for baking food products with a feeding unit for feeding steam into the baking chamber, wherein the feeding unit comprises an air trap and wherein a tank is used with two shells that are permanently joined to each other.
• The opposition was based on lack of inventive step, including obviousness over D3. The opponent in appeal argues that D3 is novelty-destroying.
• "Following G 7/95, headnote, second sentence, the Board thus decided to consider the allegation that the claims lacked novelty over D3 in the context of deciding upon the ground of lack of inventive step [over D3]." (This could be a question for EQE Paper D).
• D3 does not disclose the air trap and does not disclose the feature of two shells that are permanently joined.
• "the distinguishing features have to be grouped and relate to the following different (partial) technical problems"
• "The Board agrees with the conclusion in the appealed decision that the skilled person starting from a steam oven in D3 would - in view of technical problems 1 and 2 - consider the teaching of D5, despite the steam feeding unit disclosed herein stemming from a different household appliance than the patent (laundry machine). The fact that D5 concerns a different household appliance does not, in the present case, prevent the skilled person from considering this teaching. Water tanks for steam generators for the appliances of D3 (oven) and D5 (laundry machine) are comparable in terms of their design constraints. In addition, the manufacturing method of the tank does not seem to be related to the type of household appliance requiring steam."
• "The patent proprietor argued that the skilled person would not consider the teaching of D5 [about an air trap] since a solution to the problem was already provided in D3. The oven disclosed in D3 already had means suitable for preventing steam from leaving the oven. "
• "... the skilled person would not consider the valve and the pump in D3 as a means of solving the objective technical problem but would consult further prior art such as D5."
• "To conclude, [the air trap feature] is obvious in view of the disclosure of D5."
• Turning to the second feature: "D3 does not disclose any method for manufacturing the integral tank. Therefore, in looking for a suitable method, the skilled person would consider this teaching of D5 as being part of the common general knowledge of the skilled person and would apply it even without a particular pointer to do so."
• "To conclude, the solution to partial problems 1 and 2 according to claim 1 of the main request is obvious in light of the disclosure of D5 and common general knowledge."
• Auxiliary request 8 is allowable, however. 

EPO 

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

T 0438/22 - Adapting the description to the claims, and wishful thinking

Key points

• An applicant appealed on the issue of adaption of the description. "The examining division decided that the main request was not allowable because pages 30 to 38 of the description comprised claim-like clauses and therefore infringed what was stipulated in the Guidelines F-IV, 4.4 (in the version of March 2021) and lead "to unclarity as to the actual scope of protection (Article 84 EPC)".

Claim-like clauses

• Pages 30 to 38 of the description consist of claim-like clauses.
• Guidelines F-IV, 4.4 provides that such claim-like clauses are not permitted.
• " The board is of the view that examples 1 to 63 described on pages 30 to 38 cannot be mistaken for claims (either by patent professionals, such as patent attorneys, patent examiners or patent judges, or the public) since it is evident that they are a part of the description and because they are not denoted as "claims"." 
• "the examples described on description pages 29 to 38 are to be treated in the same way as any other part of the description. There is no justification for deleting them just because they were drafted as claim-like clauses"
• The Board also includes this as a general headnote 1 and explicitly states that the current Guidelines are not consistent with this case law (and that the Guidelines of March 2023, section F-IV, 4.4 "are contradictory" in always requiring that such clauses are deleted while also stated that such claim-like structures may give rise to a lack of clarity. "It appears, thus, that the Guidelines acknowledge that claim-like clauses do not necessarily and inevitably give rise to a lack of clarity. However, the Guidelines require deleting such clauses or amending them to "avoid claim-like language"."

Adapting the description to the allowed claims

• "The idea that the description is entirely unnecessary for claim interpretation is unrealistic and simply "wishful thinking", just like the case law expecting claims to be clear in themselves."
• The Board confirms established practice, in an extensive reasoning leading to the following headnote 2: It is a general and overarching objective, and as such also a "requirement" of the Convention, that authorities, courts and the public interpreting the claims at a later stage should, as far as possible, arrive at the same understanding of the claimed subject-matter as the EPO bodies deciding on the patentability of the same subject-matter. The only tool for achieving this objective is the patent specification as the expression of a unitary legal title. The description, as an integral part of the patent specification, should therefore also serve this overriding objective, i.e. it should provide a common understanding and interpretation of the claims. If the description contains subject-matter which manifestly impedes a common understanding, it is legitimate to insist on its removal under Articles 84 and 94(3) EPC and Rules 42, 48 and 71(1) EPC.
• "The board approves the practice where instead of a direct removal, i.e. the deletion of the subject-matter not covered by the claims, a "removal" by way of an appropriate statement is made, leaving the technical disclosure unaffected."
• This serves the needs of applicants who need technical information from non-claimed embodiments for the purposes of Art.83.
• "An established way might be to use expressions like "not encompassed by the wording of the claims","
• "The board is also not convinced that the effort required to remove the inconsistencies would be disproportionate. It is the appellant's choice how much matter is included in the claims and how much additional matter is left in the description. Furthermore, it does not seem plausible that the examination would seek to meticulously identify even the smallest inconsistency. Rather, it is to be expected that the applicant will be invited to remove only obvious inconsistencies which have become apparent during the substantive examination of the claims for novelty and inventive step, at a stage when both the examiner and the applicant are likely to be familiar with the application."
• I recommend reading the entire decision, which can be found after the jump (with a few comments added).

EPO 

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

T 1356/21 - Limits on the bonus effect rule

Key points

• The bonus effect rule can be used to hold a claim obvious despite the claimed subject matter providing a surprising technical effect. 
• "in the Board's view, the case law on bonus effects cannot be applied to all situations where a given differentiating feature [...] two separable technical effects [...], one of which may be expected. For an additional, unexpected effect to be disqualified as a mere bonus effect, it must be shown either that the situation is characterised by a lack of alternatives as regards the means for achieving the first, expected improvement (i.e. a "one-way-street" situation as explained in T 192/82), or that, considering the relative technical and practical importance of the effects in the circumstances of the case, the additional unexpected effect is merely accidental (following T 227/89 and T 1147/16) [effect was no bonus effect]. In situations which do not qualify as a "one-way street", the Board does not consider it appropriate that a /crucial and unexpected technical advantage be disregarded in the assessment of inventive step as soon as any additional obvious effect is mentioned in the patent."
• T227/89: "In determining which effect is crucial and which is merely accidental (so-called "bonus effect"), a realistic approach has to be taken, considering the relative technical and practical importance of those effects in the circumstances of a given case. In the present case, tensile strength, elongation at break and thermal stability are at least as important as the blooming properties for the overall value of the compositions in question, and any improvements thereof cannot therefore be disqualified as being merely accidental."
• "The Board is aware of the view expressed in T 1317/13 (see point 24 of the reasons) that a "one-way-street" situation is not a mandatory prerequisite for the application of the principle established in T 21/81 (see above). However, neither T 1317/13 nor T 21/81 offer a basis for an unqualified application of the bonus effect case law to any situation of plurality of technical effects without regard to their respective technical and practical importance. The Board's view in this regard is in agreement with the statement in decision T 192/82 (see point 16 of the reasons) that the use of means leading to some expected improvements might well be patentable if relying on an additional effect, provided this involves a choice from a multiplicity of possibilities."
• Note that the cited decisions are either old or relatively new.
• In the case at hand, the two effects are reduced discomfort/injection volume (unsurprising); and flatter PK/PD profile/longer duration of action (surprising) as a result of a concentration increase of an injected medicament.
• "The present case does not qualify as a "one-way-street" situation. As argued by the respondent, the skilled person could have addressed the issue of discomfort caused by the injection of larger volumes of the formulation by other means than an increased concentration, such as dividing the injection into several smaller volumes, adding further substances that facilitates diffusion at the injection site avoiding the formation of a large depot, heating the injection site to increase diffusion, including an analgesic, ..."
• "the effects of flatter PK/PD profiles and longer duration of action cannot be regarded as merely accidental, but instead represent crucial advantages in the context of basal insulins. "
• "this PK/PD effect was discovered only after arriving at the higher concentration formulation [to reduce injection volume], and would thus be nothing but an additional bonus effect [according to the opponent]. However, in the Board's opinion, it would also not be appropriate to disqualify the effect of flatter PK/PD profiles and longer duration of action as accidental, i.e. as being of lesser technical and practical importance, on account that these effects may be the result of a serendipitous discovery. What matters when deciding if the pK/PD profile effect is to be taken into account is not in what circumstances the inventors realised the invention, but what the invention achieves."
• "Similarly, the Board is not convinced that the effect of reduced discomfort and injection volume should be regarded as a bonus effect either. For the reasons given above (see 3.4.3), the fact that two technical effects arise from the same distinguishing feature does not mean that one of the two effects must necessarily be regarded as a bonus effect. However, considering that the effect on PK/PD profile and duration of action must be taken into account and already leads to the acknowledgement of an inventive step (see below), the question whether the reduced discomfort and injection volume should be additionally considered may be left unanswered."
• " the subject-matter of the main request involves an inventive step."

EPO 

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

T 1231/20 - Obvious as a solution for another problem

Key points

• The invention is about clock control units for microcontrollers. D5 is the closest prior art. It contains an oscillator, but D5 does not specify that the oscillator is a numerically controlled oscillator. 
• The filing date is in 2013. 
• " before the priority date of the present application, NCO's had evolved as a possible alternative to analog oscillators. They have since [1993] become cheaper and have become easier to integrate. It was also well known already before the priority date of the application that NCO's provide numerous advantages compared to analog oscillators: they are more agile, accurate, stable and reliable (see e.g. D6, second paragraph, first sentence). In addition, a general trend exists to use digital instead of analog components.'
• "For this reason, the skilled person, who has a natural tendency to consider alternative designs which can provide an advantage in specific circumstances, would have an incentive to consider the use of an NCO as an oscillator in a microprocessor comprising a central processing core."
• "A skilled person would thus arrive at the subject-matter of claim 1 without demonstrating any inventive activity."
• The application focuses, however, on a different advantage, namely to "fill in the gap between the binary-multiple frequency increases which can be achieved with analog oscillators". The applicant argues that the feature is not an obvious solution to this problem.
• The Board: "This argument could not sway the board's opinion. Once a convincing argument is made why the claimed invention would have been obvious to the skilled person having regard to the state of the art (Article 56 EPC), the claimed invention will no longer be considered as involving an inventive step. More specifically, if the claimed invention is found to be an obvious solution to an objective technical problem which can be assumed to have arisen - as is the case here, namely to make available the advantages of a replacement component in a piece of prior art - the identification of an alternative technical problem as a solution to which the claimed invention might not appear to be obvious does not suffice to invalidate the finding of obviousness. Especially the fact that the alternative technical problem is the one addressed in the application, i.e. the "subjective" technical problem, is insufficient to establish an inventive step."
• As a comment, the Board does not discuss the case law about bonus effects nor about one-way-street situations. 

EPO 

T 0770/21 - Opponent should present multiple inventive step attacks

Key points

• The claim differs from D2, D4, D6, D7 and D8 by the claim preamble. The claim is directed to "a bicycle derailleur motor gear unit". The documents disclose motor gear units, but not that they are for a bicycle derailleur (and/or the motor gear units are for different vehicles). 
•  Feature 1.0 [=the preamble] requires that the claimed motor gear unit has to be suitable for a bicycle derailleur. As argued by the respondent (patent proprietor) and also found by the opposition division (decision, point 10.1.1.2), feature 1.0 implies certain limitations to the motor gear unit, e.g. in size, weight or transfer ratio. Thus, the planetary gear units disclosed in document D2, D4, D6, D7 or D8 have to be suitable for the claimed application. "
• Turning to admissibility of the inventive step attacks: "The Board exercised its discretion under Article 12(4),(6) RPBA 2020 to not admit the inventive step attacks starting from one of the documents D2, D4, D6, D7 or D8 as they could and should have been presented in the first instance proceedings."
• " the opposition division indicated already in the summons to oral proceedings that in their opinion it was not only the size that qualified a planetary gear to be suitable for a bicycle derailleur. However, in their letter dated 10 December 2020 (points 2.1 and 6), the opponent countered this view and argued - under the auxiliary assumption that feature 1.0 was not disclosed in any of the documents D2, D4, D6, D7 or D8 - that then the closest prior art could be seen in P1 or P3."
• "Already at this stage, the opponent could and should have put forward the attacks on inventive step starting from one of the documents D2, D4, D6, D7 or D8. The impugned decision does not comprise any new issues with regard to the findings to feature 1.0 (point 10.1.1.2) which would justify the admittance of the attacks submitted for the first time with the opponent's statement of grounds of appeal."
• The Board considers the claims to be non-obvious over P1 and P3.

EPO 

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

T 0681/21 - Synergy and G 2/21

Key points

• "The respondents [proprietors] argued that the distinguishing feature of claim 1 at issue would provide an unexpected advantage in terms of improved softness and in particular a synergy due to the combination of the silicone with a CPP."
• "The board notes that this formulation of the technical effect differs from that identified in the patent, and thus it is important to verify whether such a formulation is in accordance with the conclusion of the Enlarged Board of Appeal in G 0002/21 (reasons 94) that "A patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would consider said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention".

• "In the present case it is not in dispute that the application as filed does not relate to a synergistic effect arising from the combination of a silicone with CPP or any other component. Also the fact that the application as filed (page 2, lines 7-8) indicates the CPP to be a preferred cationic polymer without explaining the reason for this preference cannot foreshadow that the claimed combination would provide any type of synergism. The respondents did also not file any evidence that it was common general knowledge that silicone and cationic polymers may provide a synergism in terms of improved softness."

• Note: If the application as filed mentioned improved softness as an advantage of the invention, requiring a specific mention of a synergy seems rather strict. 

• "Therefore, it follows from the above reasons that the alleged synergistic effect would not have been considered by the skilled person as being encompassed by the technical teaching of the application as filed and has to be disregarded."

• Turning to the evidence (obiter), it seems: " these data are not apt to show any possible improvement due to the choice of CPP as an additional softener and, in the absence of any other comparison against the closest prior art, it can only be concluded that improved softening has not been convincingly proven across the entire scope of claim 1."

•  In the board's view, it was thus obvious for the skilled person faced with the technical problem posed to try as an alternative to the composition of example E4, one comprising any combination of the softening agents suggested by the description such as one comprising the silicone of example E4 with any cationic polymer disclosed in the description [of E4], for example a CPP."" 

EPO 

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

T 2024/21 - The right to oral proceedings

Key points

• The ED refused the application. "The examining division noted as follows: "With respect to the so far missing summons to oral proceedings, as commented by the Applicant: Please note that it is the duty of the Applicant (not of three members of the European Patent Office) to fulfill the requirements of the EPC, to adapt the description appropriately and to provide an admissible and agreeable claim text which is adequate to provide remedy (with promise of success) and with which consensus can be achieved (Rule 137(3) EPC); a consensus (or at least an adequate approach) which is worth to spend the time and costs in oral proceedings. Please further note that oral proceedings increase the workload for three members of the Examining Division and not "reduce" it as supposed by the Applicant. Please further note that a proper amendment should be present as a first step for the Examining Division to do the next step, be it oral proceedings or to give consent. In such a case the Examining Division might be in the position to adequately and positively support the interests of the Applicant. Please further note that from the beginning, id est since the first amendments of the Applicant were submitted, the basic requirements of Article 123(2) were not met. Formulating an allowable claim text, also, is not the duty of an Examining Division." 
• The applicant then withdrew the request for oral proceedings.
• The Board 3.2.06: "According to established case law the right to an oral hearing is an extremely important procedural right which the EPO should take all reasonable steps to safeguard (T 668/89, T 808/94, T 556/95, T 996/09, T 740/15). If a request for oral proceedings has been made, such proceedings have to be appointed. This provision is mandatory and leaves no room for discretion (T 283/88, T 795/91, T 556/95, T 1048/00, T 740/15), i.e. parties have an absolute right to oral proceedings. Considerations such as the speedy conduct of the proceedings, equity or procedural economy cannot take precedence over this right (cf. Case Law of the Boards of Appeal, 10th edition, III.C.2.1)."
• Obviously, the Legal Board may disagree, in view of the remarkable (and concerning) decision J 6/22, and it will be for the Enlarged Board in the pending petition for review R 16/23 against J6/22 to settle the matter. 
• The present Board, politely it seems: "It should be noted in passing that a discussion of the recent decision J 6/22 does not appear necessary in the context of the present case, as this decision endorses, according to the understanding of the present Board, a restrictive interpretation of the right to oral proceedings for very specific procedural circumstances. However, a dynamic interpretation restricting explicitly regulated procedural rights of the parties does not seem to be considered in J 6/22 for the central area of the European grant procedure." 
• " The reasoning contained in the contested decision (by reference to the communication of 25 January 2021, see point IX. above) is thus based on a manifestly incorrect understanding of the right to oral proceedings as enshrined in the EPC. The fact that oral proceedings cause costs is anyway no reason not to comply with the appellant's repeatedly expressed wish to hold oral proceedings. The reminder in the contested decision of the applicant's duty to submit an EPC-compliant version of the application documents is also no reason not to comply with a request for oral proceedings."
• " Nor is the repeated indication in the examining division's communications that amendments would not be admitted to the proceedings or had not been admitted under Article 137(3) EPC, so that no version of the application documents approved by the applicant would exist in the proceedings, a sound reason for not holding oral proceedings. Even if the examining division considered the possibility of not admitting amended application documents into the proceedings, oral proceedings would still have had to be held in the present case in order to discuss (at least) the question of (non-)admittance of the amendments with the applicant, which would have also comprised the issue of whether the objections raised by the examining division had been overcome by the amendments (see below point 1.4)."
• "The Board thus considers that withdrawal of the request for oral proceedings under these particular circumstances did not therefore absolve the examining division from its duty to hold the originally requested oral proceedings. In this context, it must also be taken into account that the examination procedure had already lasted several years and it is immediately recognisable that the appellant was given no other way out in order to obtain an appealable decision. "
• "In view of the overall course of the examination proceedings it is to be noted that although the appellant ultimately withdrew its request for oral proceedings and requested a decision on the state of the file, it was deprived of its right to be heard in oral proceedings as enshrined in Articles 113(1) and 116(1) EPC. Due to this substantial procedural violation, the contested decision had to be set aside."
• The case is remitted. 

EPO 

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

T 0183/21 - Inventive training method for machine learning

Key points

• The application relates to a system for recommending content in a video-on-demand platform. The system is trained and retrained.
• The application states that "providing data from a huge number of users to retrain a recommender system presents challenges in that it takes up system resources." Moreover, "training activities have a high computational cost for the recommender system. Thus, the need to retrain must be balanced against the quality of recommendations being provided."
• The claim specifies, essentially, measuring the performance, comparing it to a desired performance level, and using the comparison result to set the amount of training data provided to the recommender system. Moreover, the recommender system is trained for each user separately.
• "[t]he recommender input controller 16 seeks to adapt the type and amount of usage data provided as training data to the recommender system 18 for each individual client device 22 to provide the minimum amount of data to drive the recommender system 18 towards the predetermined level of recommendation performance yref for each client device 22"
• " there is a positive correlation between the amount of training data specified by the control parameter and the measured performance metric received in the subsequent iteration"
•  "In the subsequent iteration, training data are derived from "usage data" from the client device associated with a user to which the recommendations are provided. The amount of training data derived from the usage data is based on the generated value or values of the control parameter"
• " The technical effect of the distinguishing features listed under point 8.1 is that the use of network bandwidth required to provide the training data to the recommender system is minimised, as is the amount of storage necessary for storing said training data in the communications system including the client device and the recommender system"
• "The board has come to the conclusion that this technical effect is achieved, on average, over substantially the whole scope of the claim (see, for example, G 0001/19, point 82)."
• " Since achieving a maximum performance metric of the recommender system is of paramount importance in the method of document D1, the skilled person would not use a "reference performance metric" which might be different from [i.e. lower than] a "maximum achievable performance metric", and would have no motivation to consider using a closed-loop control algorithm as claimed."
•   Starting from the disclosure of document D1, if the reference performance metric is exceeded, the skilled person would stop changing the amount of training data but would not decrease it, so that the measured performance metric oscillates towards the reference performance metric" [i.e. the possibility of decreasing the amount of training data results in oscillation of the performance].
• The board therefore considers the subject-matter of claim 10 and that of the corresponding claims 1 and 14 of the main request to be inventive (Article 56 EPC). It follows that the decision of the examining division is to be set aside.

EPO 

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

T 0367/20 - Using the description to interpret the claims under Art. 123(2)

Key points

• Claim 1 as granted is unclear. Under one interpretation, the claim involves added subject-matter, under another interpretation, not.
• "A claim feature must, however, not be interpreted in isolation but in the context of the whole document it forms part of. The context to be considered for the interpretation of a feature in a claim does therefore not only include the other features in that claim and other claims but also the description and the drawings. The general principle that the claims of a patent, being a part of a document as a whole, need to be construed in their context was recognised early in the case law and has also been understood to underlie Article 69 EPC (see T 556/02, Reasons 5.3, fourth paragraph and, more recently, T 3097/19, Reasons 29.2)."
•  " Moreover, the principle that patent claims must be interpreted through the eyes of the person skilled in the art, who should try with synthetical propensity to arrive at an interpretation of the claim which is technically sensible and takes into account the whole disclosure of the patent (established case law; see Case Law of the Boards of Appeal, 10th edition 2022, II.A.6.1, first paragraph) was formulated for the first time with reference to Article 69 EPC (see T 190/99, Reasons 2; see also T 396/99, Reasons 3.5, in which the same board examined the patentability of the claimed subject-matter with reference to Article 69 EPC)."
• " It was set out in T 1473/19 (Reasons 3.11.3 and 3.11.4) that the first step in determining the extent of protection in accordance with Article 69 EPC consists in determining the claimed subject-matter under the "general principles" of claim interpretation under Article 1 of the Protocol on the Interpretation of Article 69 EPC (without taking account of equivalents under Article 2 of the Protocol on the Interpretation of Article 69 EPC at this stage; if required at all, this is only done in infringement proceedings as a second step following claim interpretation).
• Note, I understand T 1473/19 to depart from the (then) established case law. 
• "It was further set out in T 1473/19 (Reasons 3.12, 3.12.1 and 3.19) that the interpretation and determination of the subject-matter of the same claim in the same opposition (appeal) proceedings before the EPO should be uniform and consistent, including for the purpose of Article 123(2) and (3) EPC (the application of Article 69 EPC being mandatory for the determination of the "technical subject-matter of the claims" under Article 123(3) EPC, in accordance with G 2/88, Reasons 4 and 4.1)."
• Note that Article 123(3) refers explicitly to the scope of protection, Art. 123(2) does not.
• "Moreover, it was stated in T 1473/19 (in Reasons 3.14 and 3.11.3, last sentence) that the EPO in opposition (appeal) proceedings and the national courts and the UPC in revocation proceedings have concurrent jurisdiction on (post-grant) patent validity and that national courts apply the rules for the interpretation of claims in Article 69 EPC also in revocation proceedings"
• The present Board then cites decisions from several contracting states (UK, DE, FR, NL, CH, ES, AT) that would show that the national courts apply Article 69 EPC also in the context of the validity of the patent.
• "For the above reasons, the present Board considers that the principles of claim interpretation as set out in Article 69 EPC and Article 1 of the Protocol on its interpretation should be applied when establishing the meaning of the claimed features and determining the claimed subject-matter in the present proceedings. Accordingly, the description and the drawings must be considered when interpreting the claims, taking due account of the primacy of the claims."
• "The claims to be interpreted for assessing compliance with Article 123(2) EPC are the claims as granted. These must be interpreted in the context of the whole document they form part of, i.e. the whole disclosure of the patent as granted. Accordingly, it is the description and the drawings of the patent as granted which must be used for the interpretation of the claims as granted (see T 450/20, Reasons 2.16"
• " if - as in the present case - an amended description was submitted for the set of claims which was then granted, only the description of the patent is part of the text of the "European patent" which may be examined pursuant to Article 113(2) EPC).
• Note that Article 113(2) EPC seems to imply that the Board should use any amended description filed during the opposition when determining the validity of the patent.
• "To assess whether an amended patent claim contains added subject matter under Article 123(2) EPC, the claimed subject-matter must first be determined by interpreting the claim (i.e. establishing the meaning of the claimed features) from the perspective of the person skilled in the art. In a second step, it must be assessed whether that subject-matter is disclosed in the application as filed. In other words, the claim interpretation adopted by the deciding body defines the subject-matter which must be disclosed in the application as filed."
• I fully agree with this part of the decision (see here).  
  
  
• "In the case at hand, interpretation a) and interpretation b) of claim 1 as granted result in different claimed subject-matter and are mutually exclusive"
• "In this situation, the deciding body must not adopt two mutually exclusive claim interpretations simultaneously and must - if decisive for the outcome of the case - not leave the interpretation in that regard open either. Rather, the deciding body must consider which of the two claim interpretations is correct. As stated above, this interpretation defines the claimed subject-matter which must be disclosed in the application as filed."
• The Board finds the claim to have basis in the application as filed, noting that: "The description of the patent as granted, which must be taken into account for interpreting feature M5.1 of claim 1 as granted (see points 1.3.2 to 1.3.7 above), consistently discloses that the first switching pipe is "connected to the third heat exchanger in parallel"."
• The case is remitted.
• 
  
•  

EPO 

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

T 0728/21 - Obscure prior art for sufficiency ?

Key points

• Claim 1 of the patent is directed to a tablet comprising a specific concentration of ivacaftor as the active compound and with certain excipients "for use in combination with one or more other desired therapeutics in treatment of cystic fibrosis in a patient with a DeltaF508 mutation on both alleles".
• It is not entirely clear to me if the tablet composition as such is novel.
• The proprietor filed experimental results in the appeal procedure demonstrating that the specific combination of excipients provided for better dissolution properties.
• "According to G 2/21, a technical effect may be relied upon for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention. The application as originally filed (WO 2011/019413) explicitly addressed the dissolution of tablets comprising a solid dispersion as an aspect of the disclosed invention (see paragraph [0031]) and specifically described the claimed tablet composition as an embodiment of the disclosed invention. The effect of the optimization of the dissolution associated with the specific tablet composition defined in claim 1 of the main request may therefore in accordance with the principles established in G 2/21 be taken into account for the assessment of inventive step. "
• The Board considers claim 1 to be inventive based on the improved dissolution properties.
• The claim, however, also specifies the use of ivacaftor, in combination with a further therapeutic compound, "in treatment of cystic fibrosis in a patient with a DeltaF508 mutation on both alleles". As I understand it, the patent application contained no experimental/clinical results showing this.
• The Board recalls the requirement of G 2/21 r.74 for sufficiency of second medical use claims.
• The Board: "The patent specifically explains that the DeltaF508 mutation leads in patients with cystic fibrosis to impaired trafficking to the membrane and defective channel gating of the mutant CFTR (see paragraphs [0007]-[0008]). The patent also points out that ivacaftor is a potent and selective CFTR potentiator of wild-type and mutant forms of human CFTR, including DeltaF508 (see paragraph [0012]). The patent further teaches that ivacaftor can be effectively combined with other CFTR modulators and lists examples of such agents (see paragraph [0248]). The patent does thereby not describe the activity of ivacaftor as a CFTR potentiator in the form of a simple verbal statement, which might in line with the considerations in T 609/02(see section 9) be considered not to be sufficient, but rather as specific and verifiable technical information supporting the defined therapeutic indication. This information in the patent provides according to the Board a rational basis for the claimed invention, which rendered the utility of the claimed composition in the treatment of homozygous DeltaF508 patients credible at the date of its filing."
• The Board also refers to a prior art document D16A, that provides experimental results of the compound regarding the "activity in cultures of DeltaF508/DeltaF508 human bronchial epithelia". D16A is, however, a poster session abstract. Such documents are usually not evidence of common general knowledge.
• The Board: "In accordance with the jurisprudence exemplified by T 609/02 (see section 9), the suitability of the claimed composition for the defined use needs to be disclosed in the patent, "unless this is already known". This jurisprudence confirms in the Boards view that the disclosed utility of the claimed composition may also derive its credibility from the prior art, even if this prior art does not represent common general knowledge."
• To quote T 609/02 in relevant part: "Where a therapeutic application is claimed [...] in [a second medical use claim], attaining the claimed therapeutic effect is a functional technical feature of the claim []. As a consequence, under Article 83 EPC, unless this is already known to the skilled person at the priority date, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application. It is a well-known fact that proving the suitability of a given compound as an active ingredient in a pharmaceutical composition might require years and very high developmental costs which will only be borne by the industry if it has some form of protective rights. Nonetheless, variously formulated claims to pharmaceutical products have been granted under the EPC, all through the years. The patent system takes account of the intrinsic difficulties for a compound to be officially certified as a drug by not requiring absolute proof that the compound is approved as a drug before it may be claimed as such."
• As a comment, in the case of T 609/02, the alleged effect was clearly not "known" to the skilled person in any sense on the priority date, so I don't think that T 609/02 intentionally departed from the general principle that sufficiency of disclosure must be based on the application as filed and common general knowledge of the skilled person only. 
• See e.g. G 2/21 r.76 : "T 1599/06, points 6, 7.1, 7.2 and 8 of the Reasons [...]:"[...] if a therapeutic application is to be accepted as sufficiently disclosed, the application or the patent, respectively, and/or the common general knowledge has to provide some information rendering it technically plausible for the skilled person that the claimed compounds can be applied for the claimed therapeutic use (T 219/01 of 15 December 2004; T 609/02 of 27 October 2004)[...]" (emphasis added)
• As a further comment, does the rule proposed in the present decision apply equally to the 'enablement requirement' for prior art to be novelty-destroying? I.e., would the text of the present application have been novelty-destroying for the second medical claim if published a day before?
• As a further comment, G 2/21 does not indicate that the enablement requirement for the medical indication of a second medical use claim can be lower if novelty and inventive step can be based on other features of the claim. 
• 
  

T609/02

Where a therapeutic application is claimed in the form allowed by the Enlarged Board of Appeal in its decision G 5/83 (OJ EPO 1985, 64), ie in the form of the use of a substance or composition for the manufacture of a medicament for a defined therapeutic application, attaining the claimed therapeutic effect is a functional technical feature of the claim (see G 2/88 and G 6/88, OJ EPO 1993, 93 and 114, Headnote III. and point 9 of the reasons, for non-medical applications, see also T 158/96 of 28 October 1998, point 3.1 of the reasons). As a consequence, under Article 83 EPC, unless this is already known to the skilled person at the priority date, the application must disclose the suitability of the product to be manufactured for the claimed therapeutic application. It is a well-known fact that proving the suitability of a given compound as an active ingredient in a pharmaceutical composition might require years and very high developmental costs which will only be borne by the industry if it has some form of protective rights. Nonetheless, variously formulated claims to pharmaceutical products have been granted under the EPC, all through the years. The patent system takes account of the intrinsic difficulties for a compound to be officially certified as a drug by not requiring an absolute proof that the compound is approved as a drug before it may be claimed as such. The boards of appeal have accepted that for a sufficient disclosure of a therapeutic application, it is not always necessary that results of applying the claimed composition in clinical trials, or at least to animals are reported. Yet, this does not mean that a simple verbal statement in a patent specification that compound X may be used to treat disease Y is enough to ensure sufficiency of disclosure in relation to a claim to a pharmaceutical. It is required that the patent provides some information in the form of, for example, experimental tests, to the avail that the claimed compound has a direct effect on a metabolic mechanism specifically involved in the disease, this mechanism being either known from the prior art or demonstrated in the patent per se. Showing a pharmaceutical effect in vitro may be sufficient if for the skilled person this observed effect directly and unambiguously reflects such a therapeutic application (T 241/95, OJ EPO 2001, 103, point 4.1.2 of the reasons, see also T 158/96 of 28 October 1998, point 3.5.2 of the reasons) or, as decision T 158/96 also put it, if there is a "clear and accepted established relationship" between the shown physiological activities and the disease (loc. cit.). Once this evidence is available from the patent application, then post-published (so-called) expert evidence (if any) may be taken into account, but only to back-up the findings in the patent application in relation to the use of the ingredient as a pharmaceutical, and not to establish sufficiency of disclosure on their own.

EPO 

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

T 3277/19 - Video oral proceedings

Key points

• The Board held the oral proceedings on premises despite the request for vico oral proceeding in this opposition appeal.
•  "The Board found that the subject-matter of the proceedings involved complex explanations of the duct's geometry in relation to the visualisation of several virtual planes and intersections, which made in-person proceedings the appropriate format to be used in the present case. This was already explained in item 9 of the Board's communication pursuant to Article 15(1) RPBA 2020 and the parties did not further comment on this at the oral proceedings."
• " Notably, in the oral proceedings itself flipchart drawings (see the minutes) using various colours and simultaneous explanations while developing the drawings on several occasions were made by the appellant, which the Board considers merely confirms why in-person oral proceedings was the appropriate format for these proceedings, despite both parties requesting oral proceedings by videoconference. Whilst drawings or sketches supporting or helping to illustrate oral submissions could also be made at oral proceedings held by videoconference in a different way, e.g. by sharing the screen or by using the whiteboard, the Board considered in-person oral proceedings the more appropriate and efficient format in the circumstances of the present case, not least since it expected lengthy discussions on issues for which such visual aids might be referred to often and extensively."
• As a comment, the Board clearly articulates case-specific reasons for holding oral proceedings in person against the wishes of the parties. 

EPO 

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

T 1090/21 - Breadth of claim and closest prior art

Key points

•  "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 (see Case Law, I.D.3.1). In that case, the rationale of the problem and solution approach requires that the invention be assessed relative to all these possible routes, before an inventive step can be acknowledged, even if in some cases the number of routes might be substantial."

• "For example, the number of suitable prior art documents may 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 not incompatible with the problem-solution approach."

•  "For these reasons, the Board considers that D19, and in particular its example 4, is a reasonable starting point for assessing inventive step."

• The claimed subject matter of the request is found to be obvious. Turning to an auxiliary request, the Board notes the following: "the Board cannot follow the respondent's argument that, given the large number of possible starting points, it could not be required to provide evidence of effect in each case. As noted previously (see point 1.1.5), the number of suitable prior art documents may, for example, 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 applies in a highly competitive technical field where many closely related prior art documents have been published. In such a situation, the Board considers that it would be an unjustified advantage to exempt an applicant or proprietor from providing evidence of a technical effect merely because the claims are broad and/or the number of possible starting points is relatively high."

• Turning to a further auxiliary request: "According to established case law, the objective technical problem must be derived from effects directly and causally related to the distinguishing features of the claimed invention. In particular the comparison with the closest prior art has to show convincingly that the effect is attributable to the feature distinguishing the invention. The aim of such a comparison is to demonstrate that the technical effect has its exclusive origin in the feature characterising the invention in the claims" 

• "the question to be answered is whether a technical effect can be inferred from the available experimental evidence that is related to distinguishing feature (iii), i.e. the presence of a fast-reacting crosslinker and a slow-reacting as defined in claim 1 (instead of the fast-reacting crosslinker as disclosed in D19)."

• "In order to provide evidence of an effect over the closest prior art, the parties do not necessarily have to reproduce embodiments of the closest prior art. It is true that, according to the boards' established case law, tests comparing the invention with the prior art have to be conducted in such a way that any effect can be attributed to the distinguishing feature. However, it is also permitted - and might even be necessary - to modify prior-art embodiments in line with the invention to such a degree that the only remaining difference was the feature distinguishing the claim"

• This claim request is held to be inventive.

EPO 

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