T 0439/22 - G 1/24 referral - Interpreting the claims using the description

Key points

• The description of the patent includes a broadening definition of a term used in the claim. Under the usual meaning of the term, the claim is novel. Under the broad definition given in the description, the claim is not novel. 
• The Board referred questions to the Enlarged Board of Appeal.
• After an extensive review of the case law on the role of the description (and drawings) when interpreting the claims for patentability, the Board also proposes an answer.
• " when the term in the claim is in a first step regarded in the context of all the information given in the other features, the other claims, the description and the drawings [...] the fact that [patent proprietor] apparently willingly refrained from including information from the description and drawings that give the term an alternative meaning compared to the one ordinarily linked to it may be taken into account for the following reason. In that case, there is still the risk that the skilled person reading the patent and giving considerable weight to the claims as the place where the invention is defined and the extent of protection conferred by the patent is determined might understand the term in its ordinary meaning."
• "This may be a good reason to construe the patent when in doubt in a way that the term used in the claim is understood in a broad sense, such as to include both potential meanings. Thus, where the information giving the terms in the claims the meaning as intended in the patent is not included in the claims even though it could have been by amendment of the claims, the share of prior art examined that is potentially novelty-destroying or could render an invention obvious is increased during examination and opposition proceedings. "
• "Definitions or similar information narrowing the meaning of a term will, when only contained in the description, often not suffice to totally override the ordinary meaning of the term used in the claim. On the other hand, broadening definitions and the like in the description may be a clear signal that the term used in the claim may not only be understood in the conventional way but also in the broader sense set out in the description."
• "In both cases, it would be up to the patent proprietor to correlate the wording of the claims and the content of the description to make it clear what invention is actually claimed. Where [the proprietor does not do so], another fundamental principle of claim interpretation [...] can be applied [, namely] that any understanding of the claim wording which is technically reasonable should not normally be excluded by the claim [viz. the adopted claim interpretation? ] [...]. Where a patent specification contains a definition or the like of a term used in the claim, this may be seen as a clear indication that even the patent proprietor considered the meaning according to that definition to be (at least also) encompassed by the meaning of this term."
• Given this quite clear conclusion of the Board - and assuming it is not the minority view of one member of the Board - I wonder if the Board could perhaps have decided on the case without a referral. The proposed approach to claim interpretation seems consistent enough with the case law on claim interpretation as reviewed by the Board (indeed, as the Board observes, " It seems desirable to come to a common understanding on these questions neither by developing totally new standards nor by looking at national law alone but rather also by building on the case law of the boards developed over the last 40 years."
  
  
• The Board, elsewhere in the decision: "it is the subject-matter of these claims defining the invention that is examined for sufficiency of disclosure, novelty and inventive step under Articles 83, 52, 54 and 56 EPC."
• Note that Article 53  is not included in the list. See T 0944/15. 

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1006/21 vs. T1774/21 - Late late-filed objections?

Key points

•  T 1006/21 ,  online on 12.04.2024:  Any request for remittal made by a party is not subject to the provisions of Art. 12 and 13 (r.24). Procedural requests are not amendments within the meaning of Art. 12 and 13 (r.26). Procedural requests on questions that have to be taken up ex officio may relate to remittal, as in this case, or to [a requested] referral to the Enlarged Board of Appeal (Article 112(1)(a) EPC), [or] the admissibility of the appeal (Article 110 EPC), [or to the] (non-)admission and consideration of claim requests, allegations of facts or evidence (Article 114, Rule 116(1) EPC), [or to the ] interruption of proceedings (Rule 142 EPC), exclusion of board members (Article 24(1) and (2) EPC), or the appointment of oral proceedings if expedient (Article 116(1) EPC). (r.27)

  The same applies to other procedural requests on questions that do not have to be taken up ex officio but only upon request, such as for a change of date of oral proceedings (Art.15(2)), acceleration of proceedings (Art.10(3)), objections against board members (Article 24(3) EPC) or according to Rule 106 EPC, or requests for a stay of proceedings (Rule 14 EPC) (r.28)
  None of these procedural requests are subject to the provisions of Art. 12 and 13. They can, therefore, be made at any time during the appeal proceedings and must be considered by the board, regardless of when they are made (r.29)

https://www.epo.org/en/boards-of-appeal/decisions/t211006eu1

T1774/21  online on 10.07.2024

 In the context of the RPBA 2020 the term ‘requests’ includes requests for non-admission of, for example, an objection (contrary to what is suggested in T 1006/21 […]). In particular, the term ‘requests’ is not limited to texts of patent applications or patents. If this were the case, the text of the provisions (in particular, Art.12(2), (3) and (6)) would have specified this and would not have used the general term ‘requests’.

https://www.epo.org/en/boards-of-appeal/decisions/t211774eu1

• As a comment, would a referral to the EBA be possible, or is this a priori excluded if the interpretation of the RPBA is at issue?

EPO Two-day Course on Taking of Evidence

Key points

• The EPO runs the online course on evidence again. The main topics are evidence of public prior use and witness hearings in general (e.g., also about lectures and brochures as prior art). 
• The online lectures are on: 
• 17 October 2024, 10.00 - 12.00 hrs (CEST)
• 24 October 2024, 10.00 - 13.00 hrs (CEST)
•  https://www.epo.org/en/learning/events/pu20-2024
• Registration deadline: 01.10.2024
• I signed up for the course two years ago and enjoyed it. Evidence is a topic that is highly important in practice, that is usually not tested on the EQE (and therefore not part of the training courses). Most handbooks are perhaps a bit short on it (though I revised the (still brief) chapter in Visser's Annotated EPC on Art. 117 last year in view of G2/21 (blogpost here) and other recent decisions). I think we, as a profession, perhaps do not fully use the possibilities of evidence in EPO proceedings. 
• At any rate, we now have a useful tutorial on the procural aspects of evidence in G2/21 (which was mostly about inventive step), and recent decision T0778/21.
• Recent posts about the topic can be found here:
• https://justpatentlaw.blogspot.com/search/label/A117
• https://justpatentlaw.blogspot.com/search/label/witnesses  

T 2702/19 - Open-ended range

Key points

• "Claim 1 of the granted patent defines a medical device comprising a visualisation probe comprised of illumination means, an objective lens assembly and a CMOS sensor.
• "The respondent [opponent] argued that the patent did not disclose how to carry out the invention as defined in claim 1 over the whole scope thereof. In particular, it was not disclosed how to carry out the invention for very small values of the maximum outer diameter of the medical device, i.e. for values below 1 mm or even below 0.5 mm, which fell under the terms of claim 1. Furthermore, no reasonable lower limit for the maximum outer diameter of the medical device was known or derivable from the patent."
• "The board is not convinced by the patent proprietor's argument that the person skilled in the art would understand from the example given in the patent of a 0.5 x 0.5 mm CMOS sensor that this is the smallest implementable size of a CMOS sensor and that lower values would be nonsensical."
• The Board: "In conclusion, the person skilled in the art would not be able to derive from the patent, using their common general knowledge, a limit for the values of the maximum outer diameter of the medical device below which they would immediately exclude variants as being clearly outside the scope of practical application of the claimed subject-matter and thus could not justify an objection of insufficiency of disclosure. As argued by the respondent, the patent does not disclose how to carry out the invention over the whole effective claimed range of the maximum outer diameter of the medical device, i.e. also for values of this maximum outer diameter below 1 mm or even below 0.5 mm. Therefore, the ground for opposition under Article 100(b) EPC prejudices the maintenance of the patent as granted." 
• "Claims may be considered insufficiently disclosed if they cover, through open-ended ranges, embodiments that could not be obtained with the process disclosed in the patent, but which might be obtainable with different methods still to be invented in the future (see decision T 1697/12, points 5.5.3 and 5.5.4 of the Reasons; see also Case Law, II.C.5.5.2)."
• Are the Boards getting stricter on open-ended ranges? 
• Note that in T 595/95, allowed claim 1 specified: "A grain oriented silicon steel sheet having an iron loss at W17/50 of less than 0.90 W/kg,"

EPO 

The link to the decision and an extract of it can be found after the jump.

D 0002/24 - An effective appeal

Key points

• I do not normally discuss EQE appeals on this blog, but this decision is an example of an appeal going smoothly. It concerns the Pre-Exam 2024. The decision was taken on 9 August 2024 and published online on 13 August. 
• The Board allowed the appeal and awarded the grade "PASS"
• I assume the candidate can, therefore, sit the Main Exam 2025.
• Overall, this should be the purpose of appeals about the pre-exam, of course, i.e. that a well-founded appeal affords an effective remedy and allows the candidate to sit the Main Exam without delay.
• " The appellant's argument essentially boils down to the understanding of the term "to provide" in the given context, and whether the electronic cigarette in D1 "pro­vides" only vapour, which is the appellant's understanding, or (also) a liquid solution (to avoid the health risks caused by high nicotine concen­tra­tions), which is the understanding of the Examiners' Re­port."
• The device of D1 contains a liquid solution but supplies only vapour to the user, as I understand it.
• The Board: "It follows from the setup of the pre-examination with its multiple-choice questions that they must be for­mulated clearly and unambiguously, and that remaining doubts which cannot be sorted out at the time of taking the examination, but only by way of the appeal, cannot be to the detriment of the candidate "
• This holding will be true for any multiple-choice questions (and the like) in the new EQE as well, I suppose. 
• Incidentally, it is a bit curious to see vaping picked as the topic of an exam question, even though there is plenty of patenting going on in that field. 

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1757/20 - Discretion under Rule 137(3)

Key points

• Oral proceedings before the Examining Division were held on 15.01.2020.
•  "The second and third auxiliary requests, both filed on 13 December 2019 as tenth and eleventh auxiliary requests, and then renumbered, were not ad­mitted by the examining division in the proceedings under Rule 137(3) EPC, because they defined the subject-matter in terms of the result to be achieved, see item 21.1 of the impugned decision. The examining division referred to its communication dated 21 November 2019, section 1.1.3, but did not cite any legal provisions which were not met, such as Article 84 EPC."
• "The requests were filed on 13 December 2019 within the time limit set out on the cover page of the summons to oral proceedings issued on 2 December 2019 and were therefore filed on time. These oral procee­dings were a postponement of previous oral proceedings which had set another time limit. The examining division apparently wanted to maintain the original deadline by writing in the summons the phrase "As the change of date is not substantial, the applicant and/or their representative should realise that the date set for submissions prior to the oral proceedings remains the same". However, the message communicated to the appellant was contradictory and unclear."
• "3.5 In a telephone conversation, see protocol of 15 January 2020, item 2, the examining division expressed the view that these requests were late-filed, not converging and prima facie did not overcome the objections raised in regard of defining the subject-matter in terms of the result to be achieved, with reference to a previous communication dated 21 November 2018, section 1.1.3.

  3.6 During oral proceedings, according to the minutes, the examining division maintained its previous position in regard to the late filing of these requests without a proper explanation why it considered the arguments of the then applicant not convincing.

•  In the decision, section 21.1, the examining division seems to have completely changed its mind. There is no reference to prima facie non-compliance, because of a alleged late-filing. It would seem that the examining division became aware that it was mistaken to consider these requests as late-filed. Such a mistake could have been easily avoided if the arguments of the then applicant would have been properly assessed and discussed during oral proceedings. As a consequence the examining division applied the wrong legal principle."

• "3.9 During oral proceedings, according to the protocol, the examining division considered these requests still not converging and prima facie not allowable under Article 56 EPC. The examining division seems to have abandoned its previous position that they were late filed.

•  In the decision, section 21.1, the examining division seems to have again changed its mind. The reasons for not allowing the two requests was not Article 56 EPC, as discussed during oral proceedings, but that the subject-matter of these requests is defined in terms of a result to be achieved."

• "It is not apparent from the contested decision that the examining division took all relevant factors of the examination procedure into account when exercising its discretion under Rule 137(3) EPC not to admit the requests into the proceedings. The appellant was rather confronted with alternating objections, without proper reasoning. The discretionary decision of the examining division is not fully reasoned and justified. "

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1994/22 - The application is silent on photostability

Key points

• Claim 1 of the patent as granted reads as follows: "1. A Form-II crystal of [selexipag] [with certain XRD peaks].
• "D32 is a post-published document filed by the respondent [opponent] before the opposition division. [] From this light stability test, it is concluded in D32 that Form II (according to claim 1 of the main request) is more photostable than Form III (comparative)."
• "The appellant submitted that the application as filed made no mention of the photostability of Form II, let alone contained any evidence of it."
• "According to G 2/21 (headnote 2), "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."
• I note that G 2/21 was, first of all, about effects that are mentioned in the application as filed but without any support for them.
• Separately, already since T 0184/82, there is case law about technical effects that are not mentioned the application. They can be relied on provided that "the skilled man could recognise the [asserted technical effect] as implied or related to the problem initially suggested [in the application as filed]".
• To me it seem useful to keep the requirements separate. However, the present decision illustrates how G 2/21 can also be applied to the first issue (effects not mentioned at all in the application as filed).
• "Considering order no. 2 of G 2/21, the question to be answered in the present case is thus whether the effect relied on by the respondent and demonstrated in the post-published experimental data (D32), namely that of improved photostability of Form II, can be derived by the skilled person, having the common general knowledge in mind, and based on the application as filed, as being encompassed by the technical teaching (requirement (i)) and embodied by the same originally disclosed invention (requirement (ii))."
• "All that is disclosed in paragraph [0005] of the application as filed (paragraph [0006] of the application as published), as relied on by the respondent, is a "thing of a high quality for which constant effect can be always shown and of a form which is handled easily industrially". "
• From Espacenet: "It is hoped that medicament bulk is a thing of a high quality for which constant effect can be always shown and of a form which is handled easily industrially. The present inventors have earnestly studied. As a result, the present inventors have found a novel crystal of compound A, and have completed the present invention."
• " If such a sweeping statement was sufficient, a reference to high quality would be sufficient to invoke whatever technical effect as being encompassed by an application as filed in the sense of G 2/21. This would essentially render the first criterion of order no. 2 of G 2/21 meaningless. In the present case, in more concrete terms, the application as filed is in fact directed to particle size (table 1), residual solvent content (table 2) and amount of impurities (table 3). These properties are entirely unrelated to photostability."
  
• "Therefore, based on these properties [from the tables], having the common general knowledge in mind, the skilled person would by no means have recognised that (improved) photostability is relevant to the claimed subject-matter. Going from these specific properties to the effect of photostability would also clearly change the nature of the invention, contrary to what is required by T 116/18 (point 11.13.3 of the Reasons). Hence, the effect of photostability is not encompassed by the teaching of the application as filed."
• "even if it were wrongly concluded in the respondent's [proprietor's] favour that the technical teaching of the application as filed were to encompass photostability in the sense of T 116/18, it would not do so "together with the claimed subject-matter", as required by this decision (point 11.10). More specifically, points (1) to (3) of paragraph [0006] of the application as filed (paragraph [0007] of the application as published), claims 1 and 2, and points [1] to [3] on page 37 of the application as filed, as relied on by the respondent, refer to Form I, Form II and Form III in equal terms. These passages do not teach that Form II, i.e. the form claimed in claim 1 of the main request, is the preferred polymorphic form of selexipag, let alone that it should exhibit a photostability that is improved compared with Form I and Form III. Hence, the effect of improved photostability together with Form II is not encompassed by the teaching of the application as filed."
• Turning to inventive step: "the selection of Form II is an arbitrary selection from the host of alternatives covered by the closest prior art. Such an arbitrary selection without any unexpected balance of properties being produced cannot contribute to inventive step. The subject-matter of claim 1 of the main request therefore does not involve an inventive step in view of D10 as the closest prior art."

•  

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1529/20 - Learning about the opposition after your patent is revoked

Key points

• The OD revoked the patent without having received any reply from the proprietor. The proprietor alleges that it had not received the communication under Rule 79 informing it about the filing of an opposition.
• "For the purposes of Rule 126(2) EPC, the present board therefore initiated a postal investigation concerning the delivery of the decision dated 6 April 2020 (parcel number: RD432322983NL), within one year from the date in which the decision was posted. The outcome of the investigation carried out by the responsible service provider was negative, as the postal provider could not track any delivery of the parcel to the addressee, and the parcel had thus to be declared lost. "
• "Since the EPO could not prove whether the registered letter reached the appellant, as required by Rule 126(2) EPC, it must be accepted that the legal fiction of deemed notification did not apply and the appellant became aware of the appealed decision for the first time with the email [*] on 26 June 2020. This date is therefore the date of notification of the decision. "
• * - "The appellant submitted that they had never received the opposition division's decision and that they had become aware of it and more generally of the opposition proceedings only by an email of an employee of the EPO, PA admemp patent FO Team Central Formalities MU, Dir 1.2.5.1 dated 26 June 2020, 6 pm."
• Email is not a valid means of communication. However, irregular notification (e.g. by email) is sufficient, under Rule 125(4), if the EPO can proof the date of receipt of the document.
• The appeal is admissible. The Board finds the course of events to be a violation of the right to be heard and sets aside the OD's decision.
• "The board does not disregard that Rule 126(2) EPC refers to a dispute ("im Zweifel", "en cas de contestation") for the EPO's burden of proof [i.e. only in case of "a dispute"has the EPO the burden of proof of delivery of the document], nor that the mere absence of the advice of delivery or the receipt from the file is not in itself sufficient to give rise to a dispute (see T 247/98, Reasons 2.1 and 2.6). However in this case the appellant when filing the appeal has immediately disputed having received inter alia the communication of the notice of opposition and the communication under Rule 79(1) EPC."
• "even in view of the above mentioned Notice of the European Patent Office dated 16 June 2019 concerning implementation of amended Rule 126(1) EPC (OJ EPO 2019, A57) [abolishing the advice of delivery], the requirements of Article 113 EPC must be complied with, so that before a negative decision revoking a patent is issued, it has to be established that the patent proprietor has been duly informed about the initiation of opposition proceedings."
• The term "advice of delivery" has a rather specific legal meaning, as discussed in G 1/14. 
• "In order to ensure a legally sound notification of the relevant documents, they could have even opted for a notification by public notice [i.e. in the Bulletin] according to Rule 125(2)(d) EPC in conjunction with Rule 129 EPC. The board is aware that under the applicable legal framework it was no longer required to enclose advices of delivery, or that a public notification would not have been required in the present case, because the letter was not returned (Rule 129(1) EPC). However, even if not required by law, nothing prevents the taking of additional measures to ensure legal certainty when there are serious doubts as to whether a procedurally relevant notification, such as the one concerning the notice of opposition, has actually reached the addressee."
• Note, the setup of Rule 129(1) EPC is that notification through the Bulletin requires two notification attempts by registered letter ("has proved to be impossible even after a second attempt") to protect the parties concerned.
• The OD should have noticed that no reply was received from the proprietor and should have checked if the first delivery attempt was succesful.
• A complication is that the proprietor is located in the USA and the representative withdrew during the opposition period before the opposition was filed. However, notification to unrepresented parties outside the EPC contracting states is routine under Rule 160(2) EPC (non-entry into the European phase). 

EPO 

The link to the decision and an extract of it can be found after the jump.

T 1928/22 - How many auxiliary requests

Key points

• The Board admits Auxiliary Request 88 filed with the reply of the proprietor to the appeal of the opponent.
• 107 auxiliary requests were filed with that reply. The requests involve various combinations of 10 amendments. 
• Auxiliary request 88 was discussed first during the oral proceedings and was made the main request after the Board announced a positive conclusion on its admissibility and allowability.
• " In the present case, even though the specific combination of the individual amendments was not submitted before, numerous objections of added subject-matter were raised by the opponents in opposition proceedings, and for each of these objections individual amendments, representing individual fall back positions, were submitted by the patent proprietor. Under these circumstances the Board considered that the patent proprietor was justified in not filing auxiliary requests for all possible combinations of individual amendments already in opposition proceedings, and in filing the main request including a specific combination of individual amendments with the reply to the opponent 1's statement of grounds of appeal. "
• Would a more streamlined approach to filing auxiliary requests be possible in cases where a few independent amendments are offered to address independent attacks?

EPO 

The link to the decision and an extract of it can be found after the jump.

T 0209/22 - Post-published data for sufficiency of second medical use claims

Key points

• "Appellant-opponent 2 contended that the clinical study described in document D21, which took place before the priority date of the patent in suit, constituted public prior use that anticipated the combination therapy according to claim 1 as granted. In a second approach, the appellant also argued that D21 itself (a written disclosure of the study protocol) anticipated the claimed subject-matter."
• The Board: "These objections must fail already because the study of D21 was a phase I study performed on healthy volunteers (i.e., not on patients suffering from COPD or asthma). The claim feature that requires attaining the claimed therapeutic effect in the treatment of COPD or asthma [] could not have been anticipated in such a context, simply because the study subjects did not suffer from COPD or asthma. Accordingly, neither D21 itself nor the alleged prior use based on D21 provide a basis for denying novelty. "
• Note that the Board's above remark seems to apply more broadly than the disclosure of study protocols at hand: even the results of the phase I study can not anticipate the therapeutic effect because they are results on healthy subjects in a phase I study. I will come back to this at the end of the post. 
• Turning from novelty to sufficiency: "For the requirement of sufficiency to be met, the claimed efficacy has to be credible at the effective date of the patent, i.e. on the basis of the information provided in the patent application together with the common general knowledge then available to the skilled person."
• The claim is a second medical use claim directed to the combination of two compounds, umeclidinium and vilanterol, for the treatment of COPD and/or asthma. 
• " A further study, in which a combination of umeclidinium bromide and vilanterol triacetate was administered to healthy volunteers, resulted in the finding that the combination was well tolerated and effective in providing bronchodilation, and in particular that it showed the largest difference relative to placebo (see the application as filed, pages 25 to 26). While no quantitative data or assessment of statistical significance in relation to the observed improvement ("largest difference") is reported, it may be concluded from this comparative statement that the combination was at least as efficacious as the monotherapies in providing bronchodilation, in a four-way crossover study with sixteen subjects."
• " Based on the information provided in the application as filed, there is thus a strong presumption that dual therapy with umeclidinium/vilanterol would be effective in the treatment of asthma or COPD, and that a dosage regimen of once-daily administration would be feasible. Both aspects would have been regarded as credible at the effective date."
• "The functional effect of bronchodilation is required in the treatment of both COPD and asthma. The claimed efficacy against asthma is, therefore, credible. The appellants have not established serious doubt in relation to the dual therapy's efficacy in relieving asthma."
• "The experimental set-up of the combination study on healthy volunteers described in the application as filed corresponds to the study set-up described in D21 [...]. The appellants [opponents]  submitted that, if D21 and the corresponding study, in the board's opinion, did not take away the novelty of the claimed subject-matter, then it followed that the combination study as described in the application as filed could not be regarded as enabling in support of the claimed therapeutic use."
• Note that D21 does not contain the results of the study; the application does, but only with healthy subjects.
• The Board: "different standards indeed apply. To be novelty-destroying, a prior-art disclosure must meet the standard of direct and unambiguous disclosure of the claimed subject-matter. This criterion was not met by D21 and the corresponding clinical study with regard to attaining the claimed therapeutic effect, because the study was performed with healthy subjects (see section 4 above). The study with healthy subjects as described on pages 25 to 26 of the application as filed likewise does not disclose attaining a therapeutic effect in the treatment of COPD or asthma patients."
• As a comment, it may be useful to distinguish in the context of novelty between "direct and unambiguous disclosure" (which is always met by a verbatim disclosure) and the additional requirement that the disclosure in the prior art must be enabling. This could also help to maintain a clear difference between Art.83 and Art. 123(2). In the alternative approach of the present decision, the phrase "direct and ambiguous disclosure" involves an aspect of enablement. 
• If we distinguish between disclosure and enablement, the proposed difference in standards is in the enablement factor. However, T 206/83, r.2, already emphasized that there should be a uniform concept of enablement in the EPC (I discussed this in my amicus brief in pending referral G 1/23). (Note a further component of novelty is the ''falling within the scope of the claim" rule; see my article in epi Information 4/2020).
• Because there is a difference between D21 and the application (only the application contains the results of the clinical trial, I understand), the Board seems to provide the remark about different standards as an obiter remark.
• "In the case in hand, the information presented in the application as filed is regarded as adequate for establishing sufficiency of disclosure, for the reasons given above. This conclusion is not exclusively based on the results observed in the study performed on healthy volunteers but on a combination of this with further data discussed in the application as filed [including document D3 that is discussed in the application, D3 is about monotherapy with one of the compounds, namely vilanterol] It is furthermore corroborated by post-published data"
• "Further corroboration is provided by post-published document D8, which shows that a combination product conforming to claim 1 ("ANORO") was indeed authorised in May 2014 for the treatment of COPD by once-daily administration (see D8: page 2, points 2 to 4.2 and page 15, point 9). D8 (see pages 9 to 11) also reports the supporting results of phase III clinical studies"
• Note G2/21 r.77: "In 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."
• "Starting from the disclosure of document D3, the objective technical problem may thus be formulated as providing a combination product comprising vilanterol and a specific anticholinergic agent for use in the treatment of COPD or asthma and which also facilitates patient compliance."
• The Board considers the solution to be not obvious: "At the relevant date, both vilanterol and umeclidinium were still in early stages of their pharmaceutical development. While the basis for proceeding with the pharmaceutical development of a compound is favourable preclinical data, this does not necessarily give rise to a well-founded expectation of success, even less in the case of a combination product when neither combination partner has, as yet, progressed to the clinical stage of development."
• "D3 does not disclose the practical implementation of monotherapy [with vilanterol] or combination therapy with vilanterol [and a further substance], which also means that efficacy and safety of the compound in actual patients had not yet been confirmed. On pages 99 to 100, preclinical results are summarised. "
• "While the authors in D3 assert that the proposed compounds are long-acting and "may be suitable for once-daily administration", there is no data in D3 to back up this claim, apart from the in vitro data discussed above. Thus, it cannot be verified that this assessment is more than speculation."
• As a comment, it seems that the Board would have found a second medical use claim directed to vilanterol monotherapy to be non-obvious over D3 (assuming that the claim also complies with Art. 83).
• As a comment, I understand there were no clinical results on the efficacy of vilanterol before the filing date. Yet, the second medical use claim is held to be sufficiently disclosed in this case, i.e., the therapeutic effect is credible, relying inter alia on the discussion of D3 in the application. D3 is the same document that the Board criticizes under inventive step (not verifiably more than speculation). It seems to me that the only results of Phase III clinical trials (i.e., with patients) for vilanterol were in the post-published document D8. 
• However, the present application added the results of the Phase I study in healthy subjects over the cited documents (D21 is only the protocol, and D3 contains only in vitro results). Yet, the Board also appears to indicate that even these results can not "anticipate" the second medical use claim (assuming, for the moment,  not even in combination with a verbatim disclosure of the claim).
• Hence, there appear to be two options to interpret the decision: (i) the results of the phase I study in the application as filed on healthy subjects were the critical difference of the technical teaching of the application and the prior art, or (ii), the term "credible" used in G2/21, r.74 and r.77 in connection with second medical use claims is not the same standard as "well-founded expectation of success" applied by this Board for obviousness of such a claim. Whether option (ii) is fine or problematic under the EPC is beyond the scope of this blog post. 
• 
  

EPO 

The link to the decision and an extract of it can be found after the jump.

T 2138/21 - Requests that would not have been discussed

Key points

• The Board comes to the admissibility of requests that were filed by the proprietor/respondent with the reply to the appeal. The Board: "Nor is it of any relevance for the present appeal proceedings whether the patent proprietor had filed auxiliary request 1b (or 1b') in the proceedings before the opposition division. Since the opposition division found that higher ranking auxiliary request 1a fulfilled all requirements of the EPC, lower ranking auxiliary request 1b (or 1b') would not have been discussed, even if it had been filed already at the point in time [during the first instance proceedings] suggested by the opponent. In any case the Board would be confronted with a request which the opposition division had not considered."
• " It is clear that the objection that claim 1 of auxiliary request 1 contravenes Article 123(2) EPC, due to only a part of granted claim 5 having been incorporated, is rendered moot by the inclusion of all features of claim 5. The opponent argued however that procedural economy was impeded by the need to discuss auxiliary request 1b, if it was admitted into the appeal proceedings.
• This is not convincing as the need to discuss it would be the same if auxiliary request 1b had already been submitted in the proceedings before the opposition division. Filing the request only with the reply to the opponent's statement of grounds of appeal does thus not make any difference for the procedural economy of the present proceedings. The Board can thus see no reason why auxiliary request 1b would not have been admitted into the proceedings."
• The request is admitted (with minor further amendments) and is also held to be allowable.
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• I note that the request was clearly responsive to an objection against a higher-ranking request and substantiated (to the extent necessary) when filed in appeal. In such a case, following the present Board, it should not matter if the request was filed in the first instance proceedings or (as the Board held) should have been filed in the first instance proceedings. The latter point is quite a departure from Art. 12(6), second sentence, RPBA; though this depends on the interpretation of the term "should" in that sentence.
• The Board's reasoning makes sense.
• However, assuming that the request was newly filed with the reply to the appeal, the opponent/appellant would have to reply to it for the first time with the rejoinder. The RPBA then give the appellant only one month to file a rejoinder, with the possibility of requesting an extension.
• Indeed, in this case, the opponent presented a new inventive step attack during the oral proceedings before the Board, which attack was not admitted. However, it is unclear to me if that development was related to the amendments made in Auxiliary Request 1b. 
• T1220/21 : "In this respect, the Board notes that the first auxiliary request was not addressed at the oral proceedings before the opposition division, because the opposition division rejected the opposition. Thus, even if the objection had been raised in the first instance, the Board would not have before it a decision that could be reviewed. Under these circumstances, arguments based on Article 12(2) RPBA 2020 and the primary purpose of the appeal (review of the first instance proceedings), are not suitable for justifying not admitting the objection. Furthermore, D3 is prima facie relevant and not entirely new, as it was cited at least in combination with D2 during the opposition proceedings. The Board therefore exercises its discretion under Article 12(4) RPBA 2020 to admit the inventive step objection based on D3 as the closest prior art filed with the grounds of appeal, at least for the discussion of auxiliary request 1. "

EPO 

The link to the decision and an extract of it can be found after the jump.