29 December 2023

T 1438/21 - Two meanings of the term invention

Key points

  • "The heart of the invention defined in claim 1 consists in the finding that the generation of wrinkles remains acceptable as long as the liner thickness is equal to or greater than the "minimum liner thickness" t that can be computed from the outer pipe diameter DH and wall thickness tH, the reel radius R, and the [radial insertion gap] RIG g, using formula II (see point VIII. above)."
  • According to the opponent, the RIG is an unclear parameter, and the claim is, therefore, insufficiently disclosed.
  • "The considerations that led the opposition division to conclude that the claimed method is insufficiently disclosed for it to be carried out by a person skilled in the art are based on the definition of the RIG, which is needed for computing the minimum liner thickness using formula II. It is therefore necessary to examine whether this alleged deficiency hinders the skilled person from carrying out the claimed method."
  • "It is important to understand that, in accordance with the established case law of the boards of appeal, the "invention" mentioned in Article 100(b) EPC is defined by the subject-matter of the claims of the patent. Although an invention is commonly understood to be a technical solution to a problem, the problem allegedly solved by the subject-matter of the claim is not part of the "invention" within the meaning of Article 100(b) EPC if it does not find any expression in the claim."
    • I understand the phrase "a technical solution to a problem" to mean that an invention is provided by the combination of subject matter and the teaching that this subject matter solves a technical problem. 
    • Cf. G 2/21, which requires that the technical effect is: "... embodied by the same originally disclosed invention" (r.94). I'm not entirely sure in which sense the Enlarged Board used the term 'invention' here.
    • As an exercise for the reader: what does " invention " mean in Art. 54 and in Art. 56? 
  • The Board refers to G2/03, r.2.5.2, about non-working embodiments.
  • The Board considers the "invention" to be sufficiently disclosed. 
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the decision text.

27 December 2023

T 0641/20 - Decisions to admit of the OD

Key points

  • The proprietor appeals against the decision of the OD to revoke the patent.
  • The proprietor complains about the decision of the OD to admit late-filed document E6 into the procedure and requests the reimbursement of the appeal fee on the ground that it is a substantial procedural violation.
    • My comment is that a decision to hold a submission of a party inadmissible can violate that party's right to be heard under Article 113(1) EPC and that if the document is admitted, the right to be heard of the other party can be violated by giving that other party insufficient time to reply, i.e. by taking the decision on the merits too quickly, but not by the decision to admit a document. 
    • The appeal decision does not indicate that the proprietor complains specifically about the OD giving him (them?) insufficient time to react to E6 in the first instance proceedings.
  • The Board, in machine translation: "The question of whether a discretion was exercised correctly, for example taking the correct criteria into account, is a substantive question of a substantive legal nature and not a procedural law one. Therefore, a substantively incorrect discretionary decision, which was made with the correct application of the procedural rules of the EPC, does not constitute a procedural defect within the meaning of Rule 103(1)(a) EPC."
  • "the [proprietor] argued that the E6 does not meet the criterion of prima facie relevance because it does not obviously anticipate all the features of claim 1 of auxiliary request 3 in a way that is detrimental to novelty. The approval was therefore an error of judgment on the part of the opposition division and consequently a substantial procedural violation.
  • The Board, hence, sees no substantial procedural violation in how the OD handled document E6.
  • Under Art. 12(1) RPBA, E6 is also part of the appeal proceedings. 

  • The OD introduced document E4 into the procedure of own motion.
  • "The E4 was introduced into the opposition proceedings ex officio by the opposition division in its decision of June 28, 2018 with reference to the principle of official investigation pursuant to Article 114(1) EPC."
  • "[Ex officio] new submissions [by the OD] are possible if prima facie there are compelling reasons to suggest that they are relevant and would completely or partially conflict with the maintenance of the patent (see also T 1002/92, point 3.2 of the reasons)."
  • The OD found E4 to be novelty-destroying.
  • "The introduction of a new document by the opposition division cannot, in principle, constitute a procedural defect. This applies at least if the criterion of “prima facie relevance” is the basis for this introduction, as was also the case by the opposition division for the introduction of the E4 into the proceedings"
  • The Board also examines whether the proprietor had sufficient time to react and finds that this was the case.


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

22 December 2023

T 27890/17 - Sufficiency of second medical use claim

 Key points

 

  • Claim 1 of the patent is a second medical use claim directed to: "1. Use of  an acid-beta-glucocerebrosidase (GBA) polypeptide ... in the preparation of a medicament for use in a method of treating a subject with a synucleinopathy, but not a clinically diagnosed lysosomal storage disease, wherein the polypeptide or polynucleotide is administered alone, and in an amount effective to reduce a level of alpha-synuclein in the subject's central or peripheral nervous system, or both."
    • As a little exercise, what do you know about the filing date of the patent from the (formally allowable) claim wording alone?"
  • "Examples of synucleinopathy conditions are listed in contested claim 3 and include certain types of Alzheimer's and Parkinson disease. "
  • "As acknowledged in Enlarged Board of Appeal decision G 2/21 (Reasons for the decision, point 74, second paragraph), it is established case law that in a second medical use claim such as contested claim 1, the [recited] therapeutic effect, in the present case the treatment of a synucleinopathy with GBA polypeptide, or a polynucleotide encoding a GBA polypeptide, is a functional technical feature of the claim, so that the issue of whether it has been shown that this effect is achieved is a question of sufficiency of disclosure under Article 83 EPC."
  • "[The appellant/opponent] argued that example 5 on which the respondent relied did not credibly demonstrate a causative relationship between GBA and a decrease in alphaS levels in the MES23.5 cell lines tested. In view of the absence of any further credible evidence that the effect had been achieved, the burden of proof lay with the respondent [proprietor], and had not been discharged. Furthermore, in view of the lack of credible evidence, post-published documents such as D17 and D23 could not be taken into account."
  • These arguments were presented in 2017 (!).  By now, G 2/21 would permit to focus the arguments, as the further parts of the present decision illustrate.
  • The Board goes into the details of the Western Blots to conclude that "in the absence of a credible explanation of these observations, a doubt arises as to the scientific validity of the Western blot results shown [in the application as filed], and whether any meaningful conclusions may be drawn therefrom."
  • "Hence, according to the conclusions of example 7, stated in the application as filed as being a more reliable method than that of example 5, the expression of GBA does not significantly change alphaS levels.
  •  Consequently, the functional technical effect mentioned in claim 1 is not credibly demonstrated on the basis of the data provided in the application as filed."
  • Turning to post-published evidence as a possible remedy: "Fifth, insofar as the respondent relied upon post-published evidence D17 and/or D23 in support of the alleged technical effect (e.g. reply to the statement of grounds of appeal, 6.9, 6.12, 6.21, 6.22 and 6.23), the board notes that according to Enlarged Board of Appeal decision G 2/21, reasons 77:

"...the scope of reliance on post published evidence is much narrower under sufficiency of disclosure (Article 83 EPC) compared to the situation under inventive step (Article 56 EPC). 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."

 

  • As set out above, even though experimental data is provided in the application as filed, it is not credible on the basis of this data that the claimed therapeutic effect is achieved. Hence, in the present case, post-published evidence D17 and D23 cannot be taken into account.
EPO

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

21 December 2023

T 2143/21 - Snip and Sketch with the Board

Key points

  • The appellant proprietor submits that the structure disclosed by Figure 2 of D1 does not satisfy the claimed proportions of 0.8D <= D1 <= 0.9D and L1 >= 0.06D. 
  • The Board: "It is readily apparent when considering the figures of D1 in the context of the whole disclosure that the figures 1-3 of D1 are not mere schematic drawings (defined as "an illustrative figure which gives an outline or general scheme of an object" (OED))."
  • The Board is also not convinced by the appellant proprietor's arguments that the figures' measurements of D1 contradict the teaching of its description. Figure 2 shows a circle with a substantially constant radius and thus represents a "generally spherical-shaped exterior surface 132 having a single, constant radius", as is described in para [0022] of D1. The manual three point method using a compass to find the centre of circle used by the proprietor is not accurate enough to prove that this is so [i.e. that there is a contradiction]."
  • " Using the Windows 10 Snip & Sketch tool, for example, a more accurate determination of the cross-sectional shape of exterior surface can be made and it is found to be circular as expected for a "generally spherical" surface as stated in D1, see screen-shot below. The figure in the screen-shot shows a circle fitting practically perfectly the cross-section of the spherical surface in Fig. 2. The Board adds that the Snip & Sketch tool is a standard, well known feature of the Windows operating system, and has been so at least from Windows 10 onwards.
    • Snipping Tool seems to be the current name in Windows 11.
  • " Insofar as the appellant proprietor is unfamiliar with the tool, instructions as to its use are freely available on the Internet. Insofar as the appellant proprietor's query at the oral proceedings before the board as to its functioning is meant to question or call into doubt its accuracy, such doubts, leaving aside the fact that they are late, constitute nothing more than unsubstantiated allegation and must fail.

    FORMULA/TABLE/GRAPHIC

    Using the same Snip&Sketch tool the angle theta of Figure 2 is found to be 83°. This again does not contradict para [0025] of D1 where it states "[F]or example... can be about 80 degrees" (emphasis added)."

  • "the Board holds that, contrary to the conclusions of the opposition division, the subject-matter of upheld claim 1 does not involve an inventive step, Art 56 EPC."

EPO 
The link to the decision is provided after the jump.

20 December 2023

J 0006/22 - (I) Treaty interpretation and Article 31(3)(c) VCLT

Key points

  • The Legal Board in this case (about re-establishment) did not hold oral proceedings, even though properly and timely requested by the appellant, and rejected the appeal (even without preliminary opinion in advance). The substance of the decision will be the subject of another post, possibly.  

  • As a preliminary point, the Legal Board develops the framework for interpretation of the EPC under the VCLT.
  • " Under Article 31(1) Vienna Convention [on the Law of Treaties], the starting point for the interpretation of the terms used in a trea­­­­ty provision [...] is their ordinary meaning in their context in light of the provision's object and purpose (...). However, it is necessary to go beyond the mere grammatical (literal) interpretation when a wording only superficially has a clear meaning. At any rate, a literal interpretation must not contra­dict the purpose of a provision (...).
  • "The jurisprudence of the boards has also reiterated the im­portance of a "dynamic" or "evo­lutive" interpretation of the EPC in light of its object and purpose, as de­rived from Article 31(1), in connection with Article 31(3) Vienna Convention. Article 31(3) (a) and (b) refer to subsequent developments, namely subsequent agreements and practice among the parties to a treaty, thus presupposing a forward-looking approach."
    • The underlying point is that the Legal Board wishes to depart from about 40 years of established case law, that oral proceedings are also held in cases that the Board a priori (i.e., before the oral proceedings) considers hopeless. 
    • It may be important to cite the relevant provisions in full here because Art.31(3)(b) does not refer to any 'practice among the parties' but to "any subsequent practice in the application of the treaty which establishes the agreement of the parties regarding its interpretation". As the EPC contracting states do not apply the EPC in a relevant context (only Art. 138), there can hardly be a practice of the EPC contracting states in the sense of paragraph (a) on Art. 116. Art.31(3)(a) refers to "any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions".

  •  "Article 31(3)(c) adds: "There shall be taken into account, together with the context: any relevant rules of international law applicable in the relations between the parties."
    • I believe this is the first time Art. 31(3)(c) VCLT is applied by the Boards. It is an interesting provision. 
  • "These "relevant rules of international law" are commonly understood in the legal literature as referring to the law applicable at the time of interpretation."
    • The Board cites: Linder­falk, On the Interpretation of Treaties (2007), 179 et seq., including references to the travaux prépa­ratoires to Article 31 Vienna Convention; 
      • Linderfalk, p.180, bottom, discusses that during the discussion on Art. 31(3)(c), there was a proposal to add the words "in force at the time of conclusion of the treaty" and a proposal to add "in force at the time of application of the treaty". Neither proposal was adopted, and the question was left open. Linderfalk then proposes, on p.182, that what matters is whether the thing to be interpreted is "a generic referring expression with a referent assumed by the parties to be alterable". Hence, Linderfalk proposes a very nuanced analysis. 
      • Gardiner, Treaty Interpretation, 2009, p.256 discusses the history of the provision in detail. It started as an attempt to address the issue of intertemporal application, but no consensus could be reached and the provision as adopted leaves it open.
      • See also McLachlan, infra: "as Waldock tellingly put it in the Commissionís Explanatory Report, when explaining the omission of any more detailed rule about inter-temporality, the Commission abandoned the attempts to cover the point in the draft, realising that it would have involved entering into the whole relationship between treaty law and customary law".
    • Polgári, The Role of the Vienna Rules in the Interpretation of the ECHR, 82 et seq.;
      • This may refer to the following article: Polgári, "The Role of the Vienna Rules in the Interpretation of the ECHR", Erasmus Law Review, 2, (2021):82-95" doi:
        10.5553/ELR.000193, (open access)
      • I don't see a relevant remark directly; the Legal Board does not identify the relevant page number in the article and does not quote the article. 
    • Thimm-Braun, Evolutionary Inter­pretation and Other Developments of the Vienna Conven­tion on the Law of Treaties; 
    • The Board: "on the dynamic/evolutive interpretation in general, see also, in­ter alia, International Law Commission, Conclusions of the Work of the Study Group on the Frag­mentation of Inter­national Law: Difficulties arising from the Diver­sification and Expansion of In­ter­national Law, pa­ragraph 478; 
      • Note, this may be the following document with the same title and published by the UN: https://legal.un.org/ilc/texts/instruments/english/draft_articles/1_9_2006.pdf 
      • This document does not have a paragraph 478. It contains the following remark, which seems the most pertinent:  "A treaty may convey whether in applying article 31 (3) (c) the interpreter should refer only to rules of international law in force at the time of the conclusion of the treaty or may also take into account subsequent changes in the law. "  (emphasis added)
    • Arato, Subsequent Practice and Evolutive Inter­pretation: Techniques of Treaty In­terpretation over Time and their Diverse Conse­quences, The Law and Prac­­tice of International Courts and Tribunals 9 (2010), 443 et seq.).
  • As a comment, the article following article seems to be frequently cited as an important contribution: McLachlan, The Principle of Systemic Integration and Article 31(3)(c) of the Vienna Convention,  International and Comparative Law Quarterly 54(02):279 - 320, open access at  https://www.researchgate.net/publication/231992295 : "This article starts from the proposition that Article 31(3)(c) expresses a more general principle of treaty interpretation, namely that of systemic integration within the international legal system. The foundation of this principle is that treaties are themselves creatures of international law. However wide their subject matter, they are all nevertheless limited in scope and are predicated for their existence and operation on being part of the international law system."
  • Article 31(3)(c) VCLT, therefore, seems to provide an (additional) legal basis for considering the ECHR in proceedings before the EPO, as well as TRIPS (under the dynamic interpretation of the provision and under EPC2000). See also G 2/02. 
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the decision text.

19 December 2023

T 0438/19 - (II) On the English travaux

Key points

  • The referral decision in case G 1/23 refers to the "Proceedings of the 1st meeting of the Patents Working Party held at Brussels from 17 to 28 April 1961 (LT 234/82, Section 5, IV/2767/61-E)" and cites that document in English.
  • This slightly puzzled me because, in 1961, English was no official language of the Working Party - England was no EU member then. However, it turns out that an English translation of the minutes of that meeting is contained in the "per article" collection of the travaux préparatoires to Article 54 EPC. Even though that translation can not be found in the "per document" travaux. Possibly, the translation was prepared in 1982?
  • The document discussed at that meeting is the Haertel draft, which is available in German and French only (in the published travaux). I'm not aware of a published English version of it.
  • Linking to the individual PDF  files of that travaux is no longer possible after the update of the EPO website, it seems. 
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the decision text.

18 December 2023

T 2735/19 - Post published evidence for sufficiency

Key points

  • Claim 1 is a second medical use claims, "1. A cancer therapeutic drug, which is a composition comprising[ the compound FTD]  and [another compound] in a molar ratio of 1:0.5, for use in the treatment of cancer in a human patient in need thereof by orally administering the drug at a dose, as a dose of FTD, of 20 to 80mg/m**(2)/day twice daily.""
  • The filing date was in 2006. (!)
  • D11 is D11|Summary of clinical data filed on 19 March 2018 |
  • "5. Sufficiency of disclosure - claim 1 of the main request
  • 5.1 The appellants questioned whether the skilled person could carry out the subject-matter of claim 1 without undue burden. They argued that the use defined in claim 1 could not credibly treat every type of cancer, let alone at any dose within the range defined in claim 1. The Board disagrees.  ... Example 2 and Figure 2 (Trials 3 and 4) of the English translation of the application as filed showed that the oral administration of TAS-102 at a total daily dose of 60 or 50mg/m**(2) FTD, provided in two daily doses, effectively treated more than 70% of breast cancer patients for whom standard therapy had not worked. In this context, effectively treating meant that at least tumour progression was stopped and the disease remained stable. 
  • The Board agrees with the respondent that, due to the direct action of FTD on DNA, TAS-102 could be expected to have a general effect on tumours and not to be limited to a single cancer type. Therefore, the consideration of the post-published evidence in document D11 confirming this effect on additional tumour types was in line with the principles established in G 2/21 (Reasons 77 and 93), namely that the purported effect is encompassed by the technical teaching of the application as filed and that it is embodied by the same originally disclosed invention."

  • "The Board therefore concludes that the appellants did not raise serious doubts that the skilled person could carry out the subject-matter of claim 1 without undue burden. Consequently, claim 1 of the main request fulfils the requirements of Article 83 EPC."

  • On inventive step: "In summary, the skilled person wanting to improve the efficacy and safety of the therapeutic indication disclosed in D4 would turn to D6. This combination would lead them to provide TAS-102 in multiple doses as an obvious solution. In particular, the skilled person would administer TAS-102 thrice daily, which is the regimen found in D6 to be optimum. The skilled person would have expected that administration twice daily, which was neither disclosed nor explicitly suggested in D6, would not be as good as thrice daily. It is even less likely that they would have expected twice daily administration to exhibit a comparable level of anticancer efficacy while considerably reducing the level of side effects. Therefore, the solution to the objective technical problem proposed in claim 1 was not obvious from the combination of D4 with D6. It constituted the selection of an undisclosed embodiment which was unexpectedly advantageous."

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