T 0898/21 - Harmless error rule

Key points

• "Harmless error is an error by a trial judge in the conduct of a trial that an appellate court finds was not damaging enough to the appealing party's right to a fair trial to justify reversing the judgment, or to warrant a new trial. Harmless errors include: technical errors that have no bearing on the outcome of the trial, ..." (https://www.law.cornell.edu/wex/harmless_error)
• The Board, in machine translation: "The board shares the appellant's [proprietor's] view that her right to be heard in accordance with Article 113(1) EPC was violated in the opposition proceedings. The opposition division stated in point 11 of the contested decision that the subject matter of claim 1 of [...]was not inventive, namely based  document  (Z1), in combination with the teaching of E4 []. The person skilled in the art would arrive at the subject matter of claim 1 without any inventive intervention."
• "The board agrees with the appellant that there is no record of the opposition division or the respondent having previously raised this objection in writing or orally. In their previous communications and in the discussion during the oral proceedings before the opposition division, only document E11 [] is mentioned as a starting point, while the question of inventive step is based on the technical knowledge or document Z1 in combination with the teaching of document E4 was not discussed according to the minutes."
• "The respondent [opponent] submitted that the outcome of the opposition division's deliberations would have been the same even if the appellant had had the opportunity to comment on this objection. [...] It is not immediately clear from the [proprietor's] arguments why the outcome of the decision would be different in the event of a remittance.  The board is not convinced by the respondent's arguments."
• "What is important is not whether the opposition division would have come to the same conclusion after hearing the parties involved on this objection, but whether the parties were given the opportunity to comment on this objection (Z1 as the closest prior art in combination with the teaching of E4). Such an opportunity was obviously not given, which was not disputed by the respondent. It should also be noted that an objection that took common general knowledge as a starting point was also not discussed in the opposition proceedings."
• The case is remitted, without a decision on the allowability of the claims. 
• Any reimbursement of the appeal fee is not discussed. 
• As a comment, I think the Board could have dealt with the allowability of the claims if the outcome had been clear. A remittal is discretionary, even in case of a substantial procedural violation.
• Whether or not indications of a different outcome are relevant for the question of reimbursement of the appeal fee in case of a remittal remains to be seen. If the Board had come to the conclusion that the claims were not allowable, the appeal would have been dismissed, and no reimbursement of the appeal fee would have been given.
• 
  

EPO 

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

T1435/20 - Art.83 and secret antibody

Key points

• The patent application is directed to a second medical use. 
• "Claim 1 is formulated in a further-medical-use format in which the binding of the recited antibody to C5 is the mechanistic explanation for the therapeutic effect, i.e. the suitability thereof in the medical use. In its decision G 2/21, the Enlarged Board of Appeal recently held that the proof of a claimed therapeutic effect has to be provided in the application as filed" (note, the decision was taken on 21.09.2023 and issued in writing on 20.02.2024).
• "The parts of the application as filed which purportedly provide experimental data in support of the further-medical-use format of the claim, the so-called "TRIUMPH trial" on pages 27 to 40, were conducted with an antibody designated "eculizumab". Throughout the appeal, the appellant has maintained that this "eculizumab" antibody used in the TRIUMPH trial was not the antibody as it is now defined in the claim,"
• Note, this has to do with an alleged clerical error in SEQ ID NO:4 of the patent application. However, it seems to me that the intention was to specify eculizumab in the claim.
• "The sole indication in the application as filed of the origin and identity of "eculizumab" used in the TRIUMPH trial is on page 28, lines 7 to 9 of the application as filed, where it is disclosed that "Patients were randomly assigned on a one-on-one basis to receive either placebo or eculizumab (Soliris**(TM), Alexion Pharmaceuticals, Inc.) within 10 days of the qualifying transfusion."
• " substantial part of the appellant's case in appeal (e.g. inventive step) has been based on arguments to the effect that the structure of the antibody designated "eculizumab" was not derivable from any of the disclosures in the state of the art and that all scientists working with eculizumab prior to the filing date were in fact bound by confidentiality with regard to the structure of eculizumab. However, and without having to go into any detail on these arguments, which were based on various items of documentary evidence and declarations, by the same token accepting the appellant's argument means that without the identification of the structure of eculizumab in the form of Soliris**(TM) obtainable from Alexion Pharmaceuticals, Inc. in the application as filed, the structural particularities of the antibody designated eculizumab used in the TRIUMPH trial and reported on in the application were equally not available to the skilled person at the filing date. In fact, this conclusion of non-availability based on confidentiality seems, indeed, to find corroboration in the appellant's press release, one day after the filing date of the application, announcing that the company had received marketing approval from the U.S. Food and Drug Administration (FDA) for Soliris**(TM) (eculizumab), the first therapy approved for PNH"
• "52. As a consequence of these considerations based on the appellant's arguments, it must be concluded that the structure of the antibody used in the TRIUMPH trial was not known to the skilled person (at all) when the application was filed. It however follows from this fact that the disclosed results of this TRIUMPH trial cannot be verified to apply equally to the C5-binding antibody now referred to in the claim which comprises a heavy chain consisting of SEQ ID NO: 2 and a light chain consisting of SEQ ID NO: 4. The TRIUMPH trial can therefore not serve as evidence for the C5-binding activity of this antibody and the resulting therapeutic effect as required by the claim.

  53. Accordingly, and in the absence of any indications that the unusual antibody defined in the claim has the required therapeutic effect, the patent application fails to sufficiently disclose the claimed invention of auxiliary request 4 (Article 83 EPC)." 
  
  

• As a comment, the antibody was hence not actually commercially available at the priority date and, of course, the actual statement  'eculizumab (Soliris**(TM), Alexion Pharmaceuticals, Inc.) ' does not say "commercially available from Alexion Pharmaceuticals, Inc.".

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

T 0196/22 - Goldschmidt and Habermas

Key points

• "The question is then whether the Board should give a party time to formulate questions for a potential referral in regard of points that have already been discussed and decided. The Board takes the view that it should not, for the following reason: 
• Oral proceedings, and court proceedings, for that matter, are not a domination-free discourse in the sense of Habermas where issues are discussed in whatever order until a solution agreeable to everyone has been reached. Rather, proceedings are meant to put the deciding body, in this case the Board, in a position to decide about the issues in dispute. In order to do so, procedure is structured by different stages, and once a certain stage has been concluded, a party may no longer be able or allowed to undertake certain procedural acts: Once the time limit for filing an appeal has passed, an appeal can no longer be filed; once a party has presented its complete case with the grounds of appeal or the reply thereto, any amendments may, but do not have to be allowed, Art. 13(1) Rules of Procedure of the Boards of Appeal. This is good law and has a recognised doctrinal basis in academic writings, e.g. James Goldschmidt, Der Prozeß als Rechtslage, Berlin 1925.
• I don't know the book, but it is described as "a classic monograph on German procedural law".  See also T 0360/13.
• I'm not up to speed with Habermas and would appreciate suggestions from readers for a good explanation of "a domination-free discourse in the sense of Habermas".
• The legal member in T0360/13 and in the present case is Mr. Heath. 
• Where in oral proceedings an issue has been discussed, the Board closes the debate on this issue, deliberates thereupon and announces its conclusions. The Board may of course reopen the discussion on this issue. During the oral hearing on this case, the issue of synergy was addressed. While the Board was under the impression that a discussion on synergy was all the respondent had to say on inventive step, it transpired that the respondent had been under the impression that they should address issues other than synergy at a later stage. Due to this misunderstanding, the Board then reopened the discussion on inventive step which was then continued to hear the respondent's further submissions. Reopening the discussion was thus a necessity for guaranteeing the respondent's right to be heard. A Board can also reopen the discussion of its own motion if during its deliberation further issues of relevance come to light. However, the Board is unlikely to reopen the discussion once the parties have been properly heard and the Board feels in a position to form an opinion. It may do so, but it does not have to.  
• In the case at issue, the respondent's request for time in order to formulate questions to the Enlarged Board could have had no other purpose but to reopen a debate that already been concluded. Its only aim could have been for the Board to review its conclusions of its own motion, or to request guidance from the Enlarged Board and review its conclusions in light of such guidance. As the Board had already reached its conclusions, a reopening of the discussion was at the discretion of the Board, and the Board decided that no such reopening was opportune or necessary."
• 
  
• The application was filed as a PCT application in 2007. EP Entry in 2009, examination started in 2015 (!) Grant in 2019. 

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

Visser 2024 edition now shipping

Key points

• This year's new edition of Visser's Annotated EPC  is now shipping.
• You can order the book here:
• https://law-store.wolterskluwer.com/s/product/vissers-annotated-european-patent-convention-2024-edition/01t4R00000PHPtmQAH 
• The new edition is also available online at Kluwer IP Law: https://www.kluweriplaw.com/document/TOC_Visser_AEPC

T 0808/19 - 12 years of opposition and appeal(s)

Key points

• The patent was granted in 2011. The first decision of the OD was in 2013. The decision in the first appeal was in 2018: a remittal. The second decision of the OD was in 2019. New decision Board was issued in writing in  February 2024. PCT filing date in November 2006.
• The decision itself seems run of the mill.
• 
  
• EPO 

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

T 2548/19 - The opportunity of cutting down the claims

Key points

• "3. According to the established case law, the skilled person should try, in a constructive way, to arrive at an interpretation of the claim which is technically sensible and takes into account the whole disclosure of the patent (Case Law of the Boards of Appeal, 10th edition, 2022, II.A.6.1)."
• "6. It has to be noted, however, that whereas in the embodiment the control units are embodied as control "cards", there is no such limitation in claim 1. Also, whereas in the embodiment there is a control card for each pair of independent capstans 14, there is no such limitation in claim 1. According to established case law, for the purposes of judging novelty and inventive step, Article 69 EPC and its Protocol cannot be relied on to read into a claim an implicit restrictive feature that is not suggested by the explicit wording of the claim. In proceedings before the EPO, where the patentee has the opportunity of cutting down the claims to accord with stricter limits given in the description, the scope of a claim should not be cut down by implying into it features which appear only in the description, as this would deprive claims of their intended function (Case Law, II.A.6.3.4)."
• 
  

• EPO 

The link to the decision is provided after the jump.

T 1220/21 - A tutorial on Art. 12(3) RPBA

Key points

• A carry-over auxiliary request [*] was re-submitted with the reply of the proprietor/respondent. The basis for the amendments was indicated in a marked-up copy of the claims. The Board, in the end, considers this insufficient because references were made to paragraph numbers.  "In fact, the description as originally filed does not even include numbered paragraphs, so the reference to "[SP [0056]]" (probably also the reference to claim 5) is either wrong or refers to the patent as granted rather to the application as filed".
• * =  i.e. an auxiliary request that is lower ranking that the claim request that was held to be allowable by the OD./
• The Board first confirms established case law that requests that benefit from the unless clause of Art. 12(4)(s.1) RPBA must be substantiated in appeal under Art.12(3), and adds that this involves indicating the basis for the amendments by analogous application of Art. 12(4)(s.4).
• "According to Article 12(3) and (5) RPBA 2020, a lack of or an insufficient substantiation of an amended request may lead to the non-admittance of this request. This does however not imply that the request has not been validly filed" (note that Art. 12(5) indeed mentions this discretion).
• "The admittance of an amended request which is not expressly substantiated pursuant to Article 12(3) RPBA 2020 is at the discretion of the Board under Article 12(5) RPBA, even if the amendments are self-explanatory". The reason is that "an implicit argument does not meet the requirement that the party should specify expressly the arguments relied on (T 2598/12, reasons 1.10)" Art.12(3) requires a substantiation and requires parties to specify expressly the arguments relied on, which is not complied with by an implicit argument. The Board adds that the self-explanatory nature of the amendments will be a factor to consider when deciding on whether to admit the claim request.
• I'm unsure about this reasoning. Any appeal case relies on a large number of technical/scientific arguments/facts which are implicit but evident to the skilled person as common general knowledge. Article 12(3) can not be interpreted to require that self-evident arguments/facts are spelled out in the appeal submissions. 
• "The substantiation of an amended request under Article 12(3) RPBA 2020 includes the primary duty of the proprietor to indicate the basis for the amendments in the application as originally filed, even if no objection under Article 123(2) EPC has been previously raised" (the possibility of previously raised objections applies to carry over requests).
• The Board is not in favour of annexes. "Information that can only be found in attached documents, without an explicit reference and explanation by the party, cannot be regarded as sufficient substantiation pursuant to Article 12(3) RPBA 2020".
• Turning to substantiation of amended claims in general: "(b) If a claim request is intended to overcome novelty or inventive step objections, the proprietor should at least identify the relevant documents and the features which distinguish the claimed subject-matter therefrom (see T 1659/20, reasons 2.1). According to some Boards, where a claim request is filed to overcome an objection under Article 56 EPC, the proprietor should even substantiate it on the basis of a more detailed chain of logic (see for example T 420/14, reasons 9.5).

• (c) However, the specific extent and detail of the explanations required to substantiate a claim request cannot be determined in an absolute or precise manner. This may depend on the level of detail and accuracy of the objections to be overcome in the impugned decision or as raised by the opponent (see T 1659/20, reasons 2.1). Moreover, the required degree of substantiation is not static, but might depend on how the corresponding objections evolve.'

• "The purpose of Article 12(3) RPBA 2020 is to ensure that the relevant submissions are present in the proceedings as early as possible to enable the Board and the other party(ies) to start working on the case on the basis of the parties' complete submissions (Case Law of the Boards of Appeal, 10th edition, V.A.4.3.5 a)) without being forced to speculate on the intentions of the other parties. The extent to which a lack of or an incomplete substantiation runs counter to this objective is a factor that may be taken into account when exercising the discretion under Article 12(5) RPBA 2020 (T 1659/20, reasons 2.1). This includes addressing the question of whether the amendments and the chain of logic underlying the claim requests are self-explanatory."

• I recommend reading the entire decision.

• The headnote seems to add a few points that can not be found (literally) in the reasoning itself.

EPO 

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

T 0983/20 - Admissibility and admissibility

Key points

• This post is kind of at the EQE level, but still illustrative.
• The OD rejected the opposition. The opponent appeals.
• "In the contested decision, the opposition division considered the solution proposed by claim 1 as granted to involve an inventive step. In section 2.2 of the reasons for the decision the opposition division addressed the opponent's objection of obviousness based on a combination of D1 and  D2. The opposition division summarised the opponent's arguments and set out two reasons why they were not found convincing".
• " In the statement of grounds of appeal the appellant (opponent) requested that the decision under appeal be set aside and that the patent be revoked in its entirety. They submitted that the subject-matter of all of the claims 1 to 7 of the patent lacked an inventive step over a combination of D1 and D2."
• "With further submissions filed after the statement of grounds of appeal, the appellant presented further arguments regarding the objection of lack of inventive step over documents D1 and D2. The appellant also presented a new objection of lack of novelty under Article 54(3) EPC over [D3, ] a European patent application which had not previously been cited."
• The Board considers the appeal to be inadmissible under R.99(2). 
•  "the Board concurs with the respondents that the statement of grounds of appeal does not address the reasons given in the contested decision as to why the subject-matter of claim 1 is not rendered obvious by the combination of document D1 and document D2."
• "The statement of grounds of appeal to a large extent merely repeats the submissions that were made in the letter of 10 October 2019 prior to the oral proceedings before the opposition division. The statement of grounds of appeal does not address or deal with the reasons set out in the penultimate paragraph of section 2.2 of the reasons for the decision and does not enable the board to understand immediately why they should be incorrect."
• The appeal is rejected as inadmissible.
• The Board does not arrive at the new attacks based on D3. 
• The decision illustrates that admissibility under Rule 99(2) is not a discretionary decision and is "all or nothing". Admissibility under Rule 99(2) and under Art. 12, RPBA should not be conflated. 
• 
  

EPO 

The link to the decision is provided after the jump. 

T 1252/20 - A solution for forming a blockage in a blood vessel

Key points

• Claim 1 is directed to " A composition for use in reducing ... cancerous cells in a subject by forming at least a partial blockage, ... in a blood vessel to deprive a tumor in the subject of blood supply, ...  the composition comprising: a solution comprising an amphiphilic peptide in an effective amount and in an effective concentration to form a hydrogel under physiological conditions to allow at least a partial blockage of the biological vessel to effect embolization or cell necrosis therein, ..."
• The question is whether this is a valid second medical use claim. 
• " In its decision the Examining Division came to the conclusion that the peptide solutions defined in claim 1 of the applicant's main request did not qualify as "substance or composition" in the sense of Article 54(5) EPC, their mode of action being purely mechanical. The Examining Division referred in particular to decision T 1758/15 to support this view. " 
• " The Board, however, is convinced that the peptide solutions defined in the claim do qualify as "substance or composition" in the sense of Article 54(5) EPC, and that thus the claimed subject-matter is novel over D1 and D2 due to the specific use defined therein. This will be reasoned in the following." 
• "  The question of what can be considered a "substance or composition" in the sense of Articles 54(4) and (5) EPC regularly emerges in cases before the Boards of Appeal. From the analysis of Articles 53(c) and 54(4) and (5) EPC as explained above it follows that not every object can be read on this definition, although of course every object, also a medical device, is in the end made up of substances and/or compositions. The decision G 5/83 which established the patentability of second medical indications and in fact served as the basis for Article 54(5) EPC (see T 1758/15, Reasons 5.2.5) also emphasised that the application of the special approach to novelty through the intended use is strictly limited to claims that are directed at substances or compositions intended for use in methods stipulated by Article 52(4) EPC 1973, corresponding to Article 53(c) EPC (G 5/83, Reasons 21, last sentence)." 
• " [Established] case law imposes restrictions to what may fall under the definition of "substance or composition" in the sense of Article 54(5) EPC based on its mode of action. Whereas the materials underlying these cases, collagen fillers, alginates or bone glue, would, in everyday language, be seen as substances or compositions, they were not considered "substances or compositions" in the sense of Article 54(5) EPC since once inside the body they acted as a device." 
• " [The Board] is convinced that the peptide solutions defined in the claim must be considered a "substance or composition" in the sense of Article 54(5) EPC already for more fundamental reasons. In the following, for reasons of brevity, also where only "substance" is mentioned, it is understood that a "substance or composition" within the meaning of Article 54(5) EPC is meant."
• I recommend reading the entire decision.  
• " the exceptional approach to novelty of Article 54(5) EPC (and equally of Article 54(4) EPC) is not only applicable in case of therapeutic treatments, but also for treatments by surgery and for diagnostic methods. Decision G 5/83 addresses exclusively a therapy where a medicament is administered and its active agent achieves some therapeutic effect, such as treating an illness. The claim category endorsed by G 5/83 was also explicitly directed at the "use for manufacture of a medicament". However, with the adoption of the EPC 2000 it became clear that the novelty exception now generally encompassed all uses of a substance falling under Article 53(c) EPC, e. g. also surgical treatments and diagnostic methods, meaning that the the scope of Article 54(5) EPC is broader (G 2/08, Reasons 6.5). This already speaks against a too narrow interpretation of "substance or composition", possibly limiting it to such uses where the mode of action is exclusively or at least predominantly chemical. In particular, the use of a substance in a surgical or diagnostic method may possibly involve various mechanisms of action which may not immediately appear comparable to a classical "chemical" reaction triggered by a medicament." 
• " There is no legal basis for the mode of action as a criterion for qualifying a material or object as a substance or composition under Article 54(5) EPC. " 
• " In addition to the lack of a legal basis, the use of the mode of action as the decisive criterion seems problematic for several other reasons. First of all, the material acting inside the body may not be the same than the material the claim is directed to. The material defined in the claim and the material acting inside the body may differ in composition or in some other relevant property. This is clearly so in the present case. The claim requires the presence of a peptide solution. Already for this reason the claim is not directed to any particulate or spheric form of a hydrogel formed from the peptide solution inside the body. The question to be asked is whether the peptide solution defined in the claim is a "substance or composition". This question is to be decided irrespective of whether any solidified macrostructure formed from the substance, upon application in a specific way, can also be considered a substance or composition, or should rather be seen as a device. In other cases even the chemical structure of the substance may not remain the same during the therapeutic use. The Board notes that there are classical drugs which are administered as inactive prodrugs, the active species only being formed in the body by metabolic processes. However, second medical use claims under Article 54(4) and (5) EPC are generally directed to the administered substance. Since it is this substance which is used in a method excluded under Article 53(c) EPC, such a claim drafting is entirely in line with Articles 54(4) and (5) EPC."
• "The Board does not overlook the fact that distinguishing devices from substances for the purposes of Article 54(5) EPC is indeed required, and this article should not be used to circumvent the usual assessment of novelty of devices. A pacemaker or a surgical scalpel made of a particular stainless steel alloy do not qualify as a "substance or composition", even if they are claimed for use in an arguably novel therapeutic or surgical method. However, there is no apparent reason to disqualify a solution of a peptide, i. e. a shapeless liquid defined without any device-like features, from the scope of Article 54(5) EPC."

EPO 

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

T 0956/21 - Is one way of preparing a product enough?

Key points

• Claim 1 is directed to a "Coated cutting tool comprising a substrate coated with a coating". The coating has some properties, in particular a specific texture.
• "the skilled person has to know how to choose the appropriate deposition conditions to obtain a cutting tool insert comprising an alpha-Al2O3 layer and a MTCVD TiCN layer as required by claim 1."
• "The examples of the patent describe a very detailed manufacturing method. However, this exemplified method encompasses a lot of process steps and settings (such as a "CO ramp") relating to the production of non-claimed details (such as a bonding layer), these process steps being non-essential in regard to the manufacture of a cutting tool insert according to claim 1 but still having have an influence on the texture as argued by the appellant"
•  "The experimental data presented in Table 2 of D7 raised serious doubts as to whether the skilled person could rework the invention over the whole scope of protection based on the general disclosure of the patent specification while taking into account the examples of the patent."
•  "The appellant [proprietor] accordingly argues that the skilled person could obtain coated tool inserts according to claim 1 by following the specific examples of the patent, since the examples would appear to describe a detailed manufacturing process."
• "In the present case, the appellant's arguments with regard to the experiments in D7 and D50 confirm that any minor deviation from the very detailed and very specific method described in the examples of the patent may be expected to result in failure to obtain the required texture of the alpha-Al2O3 layer even if these specific method steps relate to the manufacture of a non-essential bonding layer which is not required according to claim 1."
• "the patent does not provide any teaching which might guide the skilled person to obtain coated cutting tool inserts according to claim 1 in the event of deviation from the very specific exemplary manufacturing method described in the example."
• As a comment, according to T 595/95, "A product which can be envisaged as such with all the characteristics determining its identity including its properties in use, i.e. an otherwise obvious entity, may become non-obvious and claimable as such, if there is no known way or applicable (analogy) method in the art to make it and the claimed methods for its preparation are the first to achieve this and do so in an inventive manner". Under T 595/95, providing one way of preparing the desirable product is (as far as I know) regularly considered to be sufficient to support a product claim. 

EPO 

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

T 0614/21 - Could have presented in first instance proceedings (?)

Key points

• The OD maintained the patent as granted.
• The Board finds the claims as granted to be not new.
• The auxiliary requests were filed with the Statement of grounds and were substantiated.
• The Board does not admit them.
• "The board notes that the novelty analysis of claim 1 of the main request already required  a discussion during the oral proceedings before the board on how to interpret - the verb "to accept" in accordance with feature (d) and - the expressions "on behalf of" and "whilst identifying as" according to features (e) and (g). The amendments underlying claim 1 of auxiliary requests 1 to 7 would further necessitate an interpretation of several new expressions for the first time. The board refers in particular to - the expressions like "intercept", "masquerade" and "terminates" as per features (i), (k) and (l), or, similarly, "intercepting", "masquerading" and "terminating" as per features (j) and (m) and to - the term "believes" in accordance with features (l) and (m)."
• As a comment, it seems to me that any added feature may involve new expressions and hence claim interpretation. I do not see how a need for claim interpretation could be a reason for holding the amended claims inadmissible, in particular if there are no clarity objections.
• I am also not sure if the Board here is perhaps holding the fact that the proprietor made use of its right under Article 116 EPC to defend the main request in oral proceedings against the proprietor.
• "It is also worth noting that the appellant [opponent] indicated already in its statement setting out the grounds of appeal that the term "masquerading" did not have "a well recognised meaning in the field". It raised an objection as to insufficiency of disclosure under Article 100(b) in combination with Article 83 EPC in this respect. The board therefore considers that admitting auxiliary requests 1 to 7 into the proceedings would be detrimental to procedural economy."
• The Board does not indicate if the opponent's objections made sense prima facie. The mere fact that the opponent had objections is stated as ground.
• The patent is revoked.
• The Board does not explicitly consider the two other factors of Art. 12(4) besides procedural economy. 
• The issues about new allegations under Art. 83 seem to pertain to Art. 13(1)(s.4) (and, for completeness' sake,  the phrase "does not give rise to new objections" in Art. 13(1) logically means (in my opinion) (prima facie) valid objections, not the mere fact that an opponent comes up with some allegations.

• The Board, "The respondent [proprietor] explained that there was no need to file any auxiliary requests during the opposition proceedings because the opposition division rejected the opposition. The board, however, considers that a party prevailing in opposition proceedings is not relieved from its duty to timely prepare its case for the event of subsequent appeal proceedings. Indeed, each party should take into account that either the opposition division or the board of appeal may depart from the preliminary view expressed by the opposition division and adopt an opposing view. The patent proprietor should prepare the relevant "fallback positions" for that eventuality. There is however no right to present on appeal "fallback positions" that could have been presented already in the first-instance proceedings. Anything else would be contrary to the primary purpose of the appeal proceedings as laid down in Article 12(2) RPBA 2020, i.e. the judicial review of the decision under appeal."
• As a comment, the Board does not invoke Article 12(6) RPBA. The status of the remark is, therefore, unclear to me.  Moreover, the Board uses "could" have been presented already in the first-instance proceedings" but Article 12(6) uses "should". 
• As a further comment, the filing of the auxiliary requests already before the OD would not have assisted the Board with the judicial review because the OD would not have decided on them.

 

EPO 

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

T 0762/20 - Is email a valid means of communication?

Key points

•  "point 9 of the contested decision states the following:

  "An email was sent to the applicant on 08-10-2019, in which the first examiner communicated the feature mapping of the inventive step objection under Article 56 EPC. The Article 56 EPC objection was based on document D5 (XP010914819, 'Towards Protecting Sensitive Files in a Compromised System') a further document found by the examining division which appeared to be a closer prior art document than D4."

• "However, the electronic file, which is the sole official file relating to the European patent application (Rule 147(1) EPC) and the record of the first-instance proceedings available for file inspection and used by the board in its judicial review, does not contain the email sent to the appellant on 8 October 2019."

•  "it seems that the email apparently sent on 8 October 2019 was the only occasion on which the examining division may have commented on document D5 and could have given a clear indication that this document would be relevant for the assessment of inventive step before issuing the written decision. The board thus agrees with the appellant's objections (see point IV. above) to the extent that the appellant was not officially informed of an inventive-step objection based on document D5 by the EPO before the notification of the contested decision. Moreover, in the circumstances of the current case, the missing email is the essential piece of evidence for reviewing whether the appellant's right to be heard under Article 113(1) EPC was respected. Since this email is not available to the board, the board cannot review the contested decision in a judicial manner (Article 12(2) RPBA 2020). "

• I wonder whether, had the email been available in the electronic file, it would have counted as a valid means of communication to safeguard the applicant's right to be heard.  Possible the present decision should not be interpreted in this way because the Board was addressing only the case at hand where it was not available in the file.

EPO 

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

T 0602/21- Admitting a request cancelling independent claims

Key points

• "It is further noted that in the present case, the main request allowed by the opposition division contained several independent claims, namely claims 1, 2, 3, 4, 5, 6, 9 and 10. Under these circumstances, it would have been the duty of the appellant [opponent] to duly substantiate already in their statement of grounds of appeal why they considered that the decision of the opposition division was wrong that each of these independent claims met the requirements of the EPC. In that regard, admitting the appellant's objections of lack of inventive step raised against claims 1, 2 and 4 of auxiliary request 3 (which correspond to claims 1, 2 and 6 of the main request) would go against the stipulations of Article 12(3) RPBA that the appellant should present their complete case in the statement of grounds of appeal."
• The Board admits the auxiliary request limiting to three of the independent claims that was filed after the notification of the summons, i.e. under Art. 13(2) and does not admit the inventive step attacks presented in reply to it during the oral proceedings.
• The Board finds the auxiliary request to be allowable. 

EPO 

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

T 1324/21 - Spontaneously forming polymorphs

Key points

• From Derk Lowe's weblog: "The classic story is ritonavir, the anti-HIV medication (now used as a CYP metabolism inhibitor in Paxlovid and other formulations). Eighteen months after FDA approval and the arrival of the drug on the market, a more stable and less soluble polymorph began to take over the world, first noticed as a higher dissolution-test failure rate on the manufacturing line. This extremely unwelcome development precipitated a crisis (couldn’t resist the wording) which was only solved by a great deal of experimentation under severe time pressure, and the whole affair greatly impacted severely ill patients while costing Abbott hundreds of millions of dollars." (https://www.science.org/content/blog-post/stalking-polymorphs) 
• See here for a further review, also discussing patent litigation on polymorphs: https://onlinelibrary.wiley.com/doi/full/10.1002/anie.201410356
• Turning to the present case, claim 1 is directed to a pharmaceutical composition comprising rifaximin in polymorphic form alpha and in polymorphic form delta, and comprising 10 wt% to 45 wt% filler.
• The OD found the claim to be novel, as follows: " Xifaxan tablets of batch 13012, which according to document D9 were purchased before the priority date, had been shown in document D7 to comprise the polymorph forms alpha and delta of rifaximin in the ratio and total amount as defined in claim 1 of the main request. However, it had not been demonstrated that these Xifaxan tablets could be analysed to comprise a relevant amount of filler." 
•  The proprietor argued as follows for inventive step: " The Xifaxan tablets of batch 13012 comprised in addition to rifaximin form alpha also rifaximin form delta. The presence of rifaximin form delta was contrary to the official documentation on the Xifaxan tablets, in particular document D15, according to which only rifaximin form alpha was used for the preparation of the tablets, which would not convert to other forms during manufacture or storage. Document D15 actually recommended to ensure that the commercial preparation of rifaximin is the poorly absorbed polymorphic form alpha in view of the greater oral bioavailability of other polymorphic forms. The Xifaxan tablets of batch 13012 were therefore defective and unsuitable as starting point for the assessment of inventive step." 
• The Board, on novelty: " The declaration in document D44 reports that Xifaxan 550 mg tablets as available on the market before the priority date of the patent had been prepared using the filler MCC with a water content of 3.2% in an amount which corresponded to 29.9 wt% of filler in the tablets [] Document D44 therefore indicates that the Xifaxan tablets of batch 13012 did indeed comprise an amount of filler as defined in claim 1 of the main request." 
• " The experimental report in document A55 demonstrates that the amount of filler in Xifaxan tablets of batch 13012 could be analysed using methods as described in documents A56 and A57, which were available at the relevant time. Document A55 confirms that using these methods the Xifaxan tablets of batch 13012 were found to comprise a MCC content of 28.2-29.0% on the basis of dry MCC " 
• " Accordingly, the Board concludes that the subject-matter of claim 1 of the main request lacks novelty." 
• Auxiliary Request 1 is limited to a method of preparing a tablet comprising " providing (A) rifaximin in polymorphic form alpha and (D) rifaximin in polymorphic form delta"  and compressing.
• The question is whether the public prior use is a suitable starting point for inventive step. " Whilst the originally contained rifaximin form alpha in the Xifaxan tablets of batch 13012 had thus according to document D7 apparently partially [and spontaneously, during storage] converted to form delta by 17 December 2015, these tablets had at that time not yet expired. "
  
• " Contrary to the finding in the decision under appeal the Board considers that this approved market product, which had not expired, cannot be disqualified as a realistic starting point for the assessment of inventive step with respect to the method for preparing tablets comprising corresponding amounts of rifaximin form alpha and delta as defined in claim 1 of auxiliary request 1." 
• " the Board concludes that the subject-matter of claim 1 of the auxiliary request lacks an inventive step." 
• 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 2046/19 - Combining in vivo and in vitro diagnostics

Key points

• Claim 1 reads as follows: ""1. A method for the prognosis .... of patients with COPD the method comprising the steps of:

  i) providing a sample of a bodily fluid from said patient, ii) determining in said sample the level of at least one biomarker, selected from the group consisting of proadrenomedullin (proADM), pro-natriuretic peptide, pro-Vasopressin (proAVP) and Procalcitonin (PCT) or fragments thereof of at least 12 amino acids in length, [and]

  iii) determining the BODE-index parameters according to one of the following steps:

  iii-a) determining the BODE-index parameters body-mass index (BMI, parameter B), degree of airflow obstruction (FEV1, parameter O), and dyspnea (parameter D), omitting the BODE-index parameter exercise capacity (parameter E);

  iii-b) determining the BODE-index parameters body-mass index (BMI, parameter B) and dyspnea (parameter D), omitting the BODE-index parameters exercise capacity (parameter E) and degree of airflow obstruction (FEV1, parameter O);

  iv) correlating said level of said at least one biomarker determined in step ii), in combination with said BODE-index parameters determined in step iii-a) or in step iii-b) to the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD."'

• The patent was opposed. The Board considers the claim to be insufficiently disclosed.
• However, my question initially was, how is a claim reciting 'determining dyspnea' (shortness of breath) not a diagnostic method under G 1/04? 
• The answer is probably r.9 of G1/04: "The grant of a European patent in respect of a diagnostic method which includes preceding method steps of a technical nature carried out by a device (cf. point 6.4.3 above) does not contravene [Article 53(c) EPC 2000] because the performance of the respective method steps does not satisfy the criterion "practised on the human or animal body". However, in the event of patent protection, it will normally be sufficient to purchase the device in question in order to be entitled to carry out such a method [*]. In cases where the same diagnostic conclusions can be attained by a method not including the use of the device, those carrying it out will not be inhibited by the patent. Therefore, the medical or veterinary practitioners cannot be considered to be hampered by the existence of such a patent."
• [*] - the Enlarged Board refers to the national case law and rules about exhaustion and implied licenses. 
• Hence, according to this decision, it seems that a method of in vitro diagnosis is still patentable even if combined with an in vivo diagnostic test.
• "the so-called "BODE index" was known as a tool for the prognosis of mortality and hospitalisation for COPD in patients with COPD."
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EPO 

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

T 0686/22 - Does the Board play games?

Key points

• The applicant is Nintendo.
• "The [claimed] apparatus [i.e, the gaming device] ]is provided with a restriction process means which restricts the number of players permitted to play a multi-player game when the apparatus display means is used rather than an external TV"
• "In its [preliminary opinion] the Board discussed for the first time the Nintendo Wii U system with its Wii U game console and Wii U GamePad operator device as prior art, in particular with reference to Nintendo customer support documentation for a Minecraft game, available on-line at the time of writing the communication. The Board will refer to this collectively as D4."
• The Board refers to "https://en-americas-support.nintendo.com/app/answers/ detail/a_id/15831/~/how-to-start-a-multiplayer-game-%28minecraft%3A-wii-edition%29#:~:text=How%20to%20Start,mode%20will%20begin" (a page that no longer exists).
• From the preliminary opinion:  "the appellant-applicant will undoubtably be aware of the Wii U game console (released 2012) with its Wii U gamepad. The Wii U gamepad has its own screen which can be used to display game play. It can also be connected to an external screen by HDMI cable. Therefore, it has an output destination control means. Like D1, the Wii U console also supports multiplayer games. According to the Nintendo customer support, Minecraft on the Wii U (released December 2015, thus at least a month before the relevant date of the present application) has a multiplayer split screen mode which is only supported for a [larger] HDMI external screen connected by a HDMI cable. Whist [sic] the Board realises that the above customer support information is not prior art, the Board has no reason to doubt that the Wii U playing a minecraft game would have been the same at the relevant date. " (square brackets added in the decision).
• "The subject-matter of claim 1 differs from D4 in that, when the restriction is in place, that is when the game is played on the display means rather than the TV, multiplayer play is not performed by players exceeding a predetermined number of players. Because this claim feature is concerned with multiplayer play, it is implicit that the predetermined number of players is more than one (cf. D4's restriction to a single Minecraft player). For example, according to the invention it could be two players in accordance with the number of [two] operation devices (cf. published application, paragraph [0026])."
• Hence, compared to D4, no longer only single player mode is available on the Wii U game pad, but also a limited multiplayer mode.
• The Board considers the feature to be not inventive.
• "the idea of restricting the number of players permitted to play a certain game according to the screen used (display or TV) determines how gameplay is permitted to develop and thus lies firmly in the domain of the game designer who conceives the game. The game designer will make this choice based, amongst other things on the screen area and screen resolution needed for a player to comfortably view the content of a particular game. Moreover, the players will be well aware of the game designer's choice in this respect: They would know that using a certain screen determines how many players can play the game. Thus the Board considers that a game rule underpins this feature."
• "the Board adopts the approach as set out in T 1543/06 (Gameaccount) which is based foremost on T 0641/00 (Comvik, OJ EPO 2003, 352). Thus, only those features that contribute to technical character are to be taken into account when assessing inventive step. That requirement cannot rely on excluded (non-technical) subject-matter alone, however original it may be. The mere technical implementation of something excluded [under Art. 52(2), i.e. a game rule] cannot therefore form the basis for inventive step. Rather, it is necessary to consider in detail how that matter has been technically implemented."
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EPO 

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