29 July 2022

T 1200/20 - Ex Div going rogue

Key points

  •  A patent application of Apple is refused.
  • " The annex to the summons to oral proceedings [before the Examining Division] which followed as the next official action is unusually short. In particular, it does not include a complete feature analysis for the version of claim 1 then on file. Regarding the aforementioned feature, it merely states (point 3) that: "However, the ESOP on point 2, identifies the input, the region and the handler. Again no reasons has been argued [sic]." To begin with, since this feature was not part of claim 1 at the time the ESOP was issued, it cannot have been dealt with in the ESOP. Furthermore, when an applicant adds a new feature to a claim and argues that this feature is novel, the onus lies on the examining division to argue that it is not. At the oral proceedings, when the applicant explicitly requested a more detailed feature mapping, the examining division rejected this request and referred to the feature mapping that had allegedly already been provided in writing" 
  • " . At the oral proceedings, the appellant repeated this argument and requested counter-arguments. The examining division refused any discussion and referred again to its written arguments (see the minutes of the oral proceedings, page 1, "Main Request"). However, since the appellant had not argued in its previous written submissions specifically in favour of the novelty of this feature, the written arguments of the examining division in previous communications could not have addressed the appellant's argument. Therefore, the appellant was left to guess what the outstanding objections were with regard to each of these features."  
  • On a further point: " At the oral proceedings, the appellant repeated this argument and requested counter-arguments. The examining division again refused any discussion and referred to its written arguments (see the minutes of the oral proceedings, page 1, "Main Request"), even though none of the written arguments of the examining division in previous communications had explained why the contested feature was considered to be implicit." 
  • :" As for auxiliary request 1, at the oral proceedings the examining division raised an inventive-step objection based on the combination of D1 with D5. The appellant then requested a 30-minute interruption to study D5 and the combination thereof with D1. The examining division refused this reasonable request, alleging that "D5 was already present in the procedure" (see the contested decision, point 9.1, and the minutes of the oral proceedings, page 2). However, this is factually incorrect. D5 had never been cited in the examination proceedings before; it was merely one of the documents listed in the Search Report. Thus, the appellant faced an inventive-step objection based on new evidence, D5, for the first time at the oral proceedings and was forced to prepare its case without even an interruption of the oral proceedings (cf. T 951/97, point 4 of the Reasons). Basing the decision on new evidence on which the appellant had not had sufficient opportunity to comment was a further violation of the appellant's right to be heard (Article 113(1) EPC)." 
  • "  These violations of the appellant's right to be heard amount to fundamental deficiencies constituting special reasons for remitting the case to the department of first instance under Article 11 RPBA 2020." 
    • As a comment, when reading such a decision I wonder whether anyone in the EPO's management notices (and bothers) or whether the three examiners will just get full marks for productivity. 
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

28 July 2022

T 0689/19 - (I) Dasatinib III (inventive step)

Key points

  •  This opposition appeal concerns dasatinib. It is (at least) the third appeal decision about dasatinib. It is the second appeal in the opposition proceedings. In the first appeal, T 0950/13, the Board found the recited medical use to be sufficiently disclosed without examples in the application as filed.
  • " The patent in suit aims at treating certain types of cancer, in particular chronic myelogenous leukemia, by oral administration of [dasatinib]" 
  • The decision under appeal and all appellants [opponents] rely, inter alia, on either document (5) or (18) as closest prior art.
  • It is common ground that the difference between the subject-matter of claims 1 or 3 of auxiliary request 2a and the disclosure of these two documents is the use of dasatinib as active agent.
  •  it is common ground between the appellants and accepted as one possibility by the respondent that the technical problem is the provision of an alternative treatment for CML.' 
  • " The board draws attention to the primary finding of T 950/13, namely that the subject-matter of claims 1 and 4 of the then-main request, which is identical to the subject-matter of claims 1 and 3 respectively of auxiliary request 2a, is sufficiently disclosed. These claims define the treatment of CML with dasatinib. The board in T 950/13 found that there was a plausible technical concept to support this treatment. The fact that the board went on to find that such a plausible technical concept was not disclosed for the treatment of a specific patient group, i.e. patients suffering from a cancer resistant to imatinib treatment, does not change this general finding." 
    • The Board in T 950/13: Claim 2 is directed to treatment of CML cancer that is resistant to imatinib. " The application as filed contains no information at all, neither in the form of experimental data nor in the form of a plausible technical concept, that dasatinib is suitable in the treatment of those patients with imatinib-resistant CML. The functional analogy to imatinib as BRC-ABL kinase inhibitor is not helpful in this context and cannot explain why dasatinib should be active, when imatinib is, or has become, inactive." "
    • The opponents argue that it is a problem that claim 1 encompasses this embodiment.
  • The Board " According to [G1/03, point 2.5.2], the inclusion of non-working embodiments is of no harm if there are a large number of conceivable alternatives and the specification contains sufficient information on the relevant criteria for finding appropriate alternatives over the claimed range with reasonable effort. In T 950/13, the board did not state that the imatinib-resistant patient could not be treated, rather, it concluded that there was no technical concept for such a treatment in the application as filed. In the context of the discussion of inventive step, the following applies. A lack of a plausible disclosure for one group of patients in the application as filed does not automatically lead to the finding that the treatment does not work for this group of patients. It seems to be paramount to distinguish in this respect between the concepts of lack of disclosure and non-working embodiments." 
  • "While a plausible technical concept might not be disclosed in the application as filed for a specific embodiment (in the present case imatinib-resistant patients), this does not automatically imply that this specific embodiment has to be classified as a non-working embodiment, or, seen in the context of the problem-solution approach, as an embodiment that does not solve the technical problem." 
  • " In the case at hand, the board identified (the disclosure in the application as filed of) a technical concept for the general treatment in T 950/13. No such technical concept could be identified in the application as filed for the specific embodiment concerning imatinib-resistant patients. However, the reasons underlying the failure of a treatment are not necessarily linked to the reasons for not accepting the disclosure of a technical concept. From this, it follows directly that a lack of disclosure of this concept does not automatically equate with a failure of treatment. " 
  • " In sum, the lack of a plausible disclosure regarding the imatinib-resistant patients cannot be equated with a finding that the claimed subject-matter includes non-working embodiments. No non-working embodiments have been identified by the appellants. Consequently, the problem is to be considered as solved over the whole scope of the claims." 
  • " It remains to assess whether its solution would have been obvious to the person skilled in the art."
  • " Document (1) relates to certain cyclic compounds and their use in treating protein tyrosine kinase (PTK)-associated disorders such as immunological and oncological disorders " 
  • " One of the cyclic compounds is dasatinib (example 455). In total, 580 compounds are exemplified and characterised by their HPLC retention time. For some of the compounds, information concerning the solid state and colour is given. Under the heading "utility", inhibition of members of the Src family is linked to diseases relating to immunological disorders, and inhibition of HER1 or HER2, which are receptor PTKs, is linked to anti-angiogenic uses such as the treatment of cancer and diabetic retinopathy (page 39, line 10 to page 40, line 9). A list of potential diseases to be treated is given on page 40, line 19 to page 43, line 25. It is stated that the compounds described in the examples have been tested in one or more of the enzyme assays (using Lck, Fyn, Lyn, Hck, Fgr, Src, Blk, Yes, Her1, Her2) and have "shown activity" (page 50, line 1 to page 51, line 30). The treatment of chronic myelogenous leukemia or the inhibition of Bcr-Abl is not disclosed. None of the exemplified compounds has been shown to have any activity for inhibiting any of the PTKs mentioned." 
  • " Document (1) [WO00/62778] lists various PTKs, belonging to both main families of PTKs. A Markush formula and several (580) specific compounds are disclosed. However, none of the compounds has been linked via its inhibitory activity to any of the kinases mentioned. Consequently, the person skilled in the art would have been faced with a screening project for "pairing" any of the compounds with one or more of the kinases mentioned. In the absence of any guidance as to which structure/compound might inhibit which PTK, such a screening project goes beyond the routine activities performed by a skilled person when trying to find alternative compounds inhibiting specific (either Bcr-Abl or dual Bcr-Abl and Src) kinases for the treatment of CML. The disclosure of document (1) can at best be seen as an invitation to perform a research programme." 
    • D1 was the PCT application leading to Dasatinib I, T0488/16, where the Board found the compound claim to lack inventive step for lack of plausibility. 
  • The claims are found to be inventive.
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

27 July 2022

T 1996/17 - The subclass trap revisited

Key points

  •  Claim 1 is directed to: ""1. A formulation comprising an exendin or exendin analog agonist, a biocompatible polymer and a sugar for use in a method of treating diabetes in a human, wherein said method comprises: (a) administering the formulation to the human once weekly; and (b) administering the formulation sufficient to maintain a sustained minimum plasma concentration of the exendin or exendin analog agonist of about 170 pg/ml to about 600 pg/ml for at least 1 month."
  • Dependent claim 4 as granted recites: "A formulation for use according to any one of claims 1 to 3, wherein the exendin or exendin analog agonist is exendin-4."
  • The patentee amends claim 1 in the main request to recite exendin-4.
  • The Board: "The amendment of part (b) in claim 1 of the main request and auxiliary request 1 now "only" requires the sustained minimum plasma concentration of exendin-4 to be within the range of about 170 pg/ml to about 350 pg/ml. Thus, the amended claim defines only the range of the sustained minimum plasma concentration of exendin-4 alone, not that of all exendins comprised in the administered formulation. Accordingly, the claims now entail embodiments which were not within the scope of protection conferred by claim 1 or any other claim of the granted patent."
  • As a supporting argument of the Board: " when reading the "comprising"-language of claim 1 [as granted], the skilled person would indeed also consider the presence of multiple exendins in the formulation. This implies that the total amount of all exendins or exendin analogue agonists, and not just the amount of exendin-4, administered with the formulation should result in the stated sustained minimum plasma concentration of about 170 pg/ml to about 350 pg/ml "
    • T1360/11, headnote, frequently cited but not in the present decision, provided that “Where a granted claim directed to a composition defined in an open manner and including the presence of a component belonging to a class or list of compounds in a quantity defined by a range is later amended by limiting the definition of the class or list of compounds, a possible infringement of the requirements of Article 123(3) EPC may be avoided by including in the amended claim a quantitative condition on the limited class or list of compounds and an additional constraint on the total amount of compounds belonging to the broader class or list” (further referring to older decisions).
  • The subclass-trap is not really a trap, of course,  the patentee just needs to formulate the claims appropriately, assuming that there is basis under Art. 123(2) for the appropriate claim (using the "additional constraint")  
  • In the present case, patentee was still trapped: "Auxiliary requests 2 to 7 were filed by the appellants in response to the board's preliminary opinion (see section VIII.) provided in the communication under Article 15(1) RPBA. The requests constitute an amendment to the appellants' case to which Article 13(2) RPBA 2020 applies." The requests were not admitted. 
  • As a comment, I don't see claim 4 as granted separately argued in the decision. I'm not sure if patentee tried a restriction to claim 4 as granted verbatim with additionally a narrower range recited.
EPO T 1996/17
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

26 July 2022

T 1891/20 (II) - Request for correction of the minutes

Key points

  • The patentee requests a correction of the minutes of the oral proceedings before the Board. The patent was revoked.
  • The Board's written decision was issued on 9 December 2021, the minutes were issued on 19 November 2021. The request for correction was filed 3 February 2022. 
  • A petition for review is pending.
  • The Board "[because] the request for correction of the minutes was only made afterwards, the board considers it appropriate to deal with the request for correction in a decision ancillary to the board's written decision of 15 November 2021".
  • "The board considers the present decision to be ancillary in that it cannot be challenged under Article 112a(1) EPC separately from the board's written decision of 15 November 2021 "
  • "Parties are obliged to submit a request for correction of the minutes of oral proceedings promptly after receipt of the minutes (R 6/14, Reasons 7; see also point 2.4 above). The board understands this to require an immediate action from a party, i.e. to submit a request for correction of the minutes in the shortest time possible after their receipt."
  • "Hence, if a party considers that the "essentials of the oral proceedings" or "relevant statements" within the meaning of Rule 124(1) EPC are incorrect or missing in the minutes of oral proceedings, they must file a request for correction of the minutes in the shortest time possible after their receipt. This ensures that the relevant facts and submissions are still fresh in the minds of the members of the deciding body and, if applicable, the other party or parties."
  • "The contents of the written decision following oral proceedings do not have any bearing on whether the minutes of oral proceedings are incorrect or incomplete. The respondent therefore errs when stating in its submission dated 10 May 2022 that it is "compulsory" to wait for the written decision before submitting a request for correction of the minutes. Rather, such conduct suggests that a request for correction of the minutes may be embedded in litigation tactics, the purpose of which may not be limited to ensuring that the minutes are indeed correct and complete."
  • "For the sake of completeness, the board points out that minutes may also be corrected ex officio (cf. T 231/99). Hence, while a party's request for correction of the minutes may be refused due to its late filing, a late-filed request for correction does as such not prohibit the competent body from correcting the minutes following that request."
  • On the merits: "The respondent [patentee] alleged to have stated during the oral proceedings that "the right to be heard has not been respected by the Board by the non-admittance of the new auxiliary request"."
  • "This is in contradiction to the unanimous recollection of the members of the board. The respondent did not at any time raise any objection related to any alleged procedural defect."
  • " Rather, the respondent had argued during the discussion before the deliberation by the board that it followed, in its view, from the right to be heard that the auxiliary request should be admitted into the proceedings, because of the allegedly "new" objection as to added subject-matter raised by the board in its preliminary opinion under Article 15(1) RPBA 2020, to which they had reacted by filing the auxiliary request."
  • "Presenting such an argument in favour of the admittance of a claim request does, however, not qualify as an objection under Rule 106 EPC and is, in fact, not recognisable as any kind of objection. Moreover, after the board had deliberated and had announced its conclusion not to allow the main request and its decision not to admit the auxiliary request into the proceedings under Article 13(2) RPBA 2020, the respondent did not make any reference whatsoever to the "right to be heard" or any other procedural issue."
    • As a question, does it make sense to raise an objection under Rule 106 after the Board orally announces "its decision not to admit the auxiliary request into the proceedings"? Can a Rule 106 objection be raised pre-emptively before the Board commits the (perceived) procedural defect?
EPO - T 1891/20 (II) 
The link to the decision is provided after the jump.

25 July 2022

T 0666/19 - Partial refund appeal fee for each appellant

Key points

  • Both the patentee and the opponent appeal. The proprietor announces that it will not attend the oral proceedings. Both appeal fees are refunded at 25%:  " it makes no difference that only one of the appellants actively withdrew its request for oral proceedings"
  • "The proprietor's announcement that it would not attend oral proceedings is equivalent to a withdrawal of its request that oral proceedings be held"
  • "The Board understands opponent 1's request, in the statement of grounds, that a date be set for oral proceedings, in the context of its previous conditional request. This understanding is corroborated by the reference, in opponent 1's latest submission, to the possibility that the oral proceedings might not take place"
  • "This means that opponent 1 asks that a date be set for oral proceedings if the Opposition Division's decision is not set aside and the patent revoked. In view of the conclusion under point 4 above [that the patent is to be revoked], this condition does not apply."
  • "Consequently, oral proceedings were cancelled and the decision is issued on the basis of the parties written submissions."
  • "Moreover, since the proprietor's withdrawal of its request for oral proceedings was made within one month of notification of the communication issued by the Board in preparation for the oral proceedings, both conditions of Rule 103(4)(c) EPC, that (with emphasis by the Board) any request for oral proceedings is withdrawn ... and no oral proceedings take place, are met; it makes no difference that only one of the appellants actively withdrew its request for oral proceedings. Consequently, each of the appeal fees is to be reimbursed at 25%. (cf. T 517/17, reason 6; T 202/18, reason 1; cf. T 488/18, reason 8)."

EPO T 0666/19 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

22 July 2022

T 0955/20 - (II) Better search results are not technical

Key points

  • The appeal is against the refusal of a patent application with applicant Google.
  • The Board, on inventive step: " Furthermore, even if distinguishing features (b) and (c) could be seen to plausibly improve the "quality" of the translated query in the sense that it leads to search results that are "better" in the sense of closer in meaning to the desired search results, this would not be a technical effect (see decisions T 1569/05, Reasons 3.4 to 3.7; T 598/14, Reasons 2.3 and 2.4)." 
    • T 1569/05: " The appellants regard the invention as belonging to the technical field of utilizing a natural language as a search input. In their view, the invention makes a technical contribution in a field not excluded from patentability," " In the Board's view, neither the mathematical model of meaning according to D3 nor the modified model according to the invention are within the technical area, since only the meaning of the words determines how they are represented, stored and selected, and since mathematical algorithms completely define the processing. In this respect the present invention is similar to the case T 52/85 - Listing of semantically related expressions/IBM (not published in OJ EPO), where the deciding board held that automatically generating a list of expressions semantically related to an input linguistic expression is basically not of a technical nature but a matter of the meaning of those expressions, ie of their abstract linguistic information content." 
    •  T 52/85: "Such a semantical relationship is basically not of a technical nature but a matter of the meaning of those expressions, i.e. of their abstract linguistic information content; it does not relate to any physical entity. A semantical relationship can be found by performing mental acts only, with no technical means involved. This does not necessarily mean that any system automatically concatenating, in place of a human being, semantically related expressions to a list is excluded from patentability. Rather, this will depend on whether the manner in which it is automated, involves features which make a contribution in a field outside the range of matters excluded from patentability under Article 52(2) and (3) EPC."
  • "the appellant's observation on document D1 does not call into question the board's finding that the distinguishing features provide no technical contribution over document D1. Hence, the subject-matter of claim 1 lacks inventive step (Article 56 EPC)."
EPO T 0955/20 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

21 July 2022

T 0955/20 - (I) Incorrect use of interlocutory revision

Key points

  •  "In its first decision, the examining division refused the application for lack of inventive step over document D1. It then allowed the appeal filed against this decision by granting interlocutory revision under Article 109(1) EPC. Subsequently, it issued a communication as an annex to a summons to oral proceedings, in which the objection of lack of inventive step over document D1 was maintained with only slightly modified reasoning."
  • The ED refuses the application again. "According to point 11 of the facts and submissions section of the second refusal decision, the examining division felt that it had not addressed the "probabilistic dictionary" feature of the invention in sufficient detail and had therefore rectified its first decision."
  • The applicant appeals. 
  • "[in] these second appeal proceedings, the appellant argued that the examining division had committed a substantial procedural violation by granting interlocutory revision under Article 109(1) EPC in relation to the appeal against the first refusal decision and then maintaining its objection of lack of inventive step against the unamended claims in its next communication. Article 109(1) EPC gave the examining division the power to rectify its decision if "the appeal is admissible and well founded" but not the right to "finesse" its previous objections at the expense of an appeal fee and three years of procedural delay."
  • The Board: "The purpose of Article 109(1) EPC is to cut short the appeal proceedings in clear and straightforward cases in the interest of procedural efficiency, in particular when the examining division can immediately recognise that the board of appeal, taking into account the statement of grounds of appeal, would set aside the decision (see decisions G 3/03, Reasons 3.4.1; T 919/95, Reasons 2 and 2.1). This purpose is contravened if, as here, the examining division grants interlocutory revision when it still agrees with the grounds for the refusal but considers that some aspect of the decision's reasoning can be improved. In this respect, the board notes that the examining division, when granting interlocutory revision, apparently found its first decision to be sufficiently reasoned within the meaning of Rule 111(2) EPC, since it did not ex officio order the reimbursement of the appeal fee under Rule 103(1)(a) EPC."
  • "Hence, the examining division applied Article 109(1) EPC for a purpose for which the provision is not intended and thus committed a procedural violation. In view of the considerable and unnecessary procedural delays which this has caused, the second refusal decision having been issued just over three years after the first refusal decision, the procedural violation must be considered to be a substantial one (see decision T 2707/16, Reasons 34)."
  • On the refund of the appeal fee: "the appellant was no longer able to request reimbursement of the first appeal fee when it became aware that the examining division might have committed a substantial procedural violation by granting interlocutory revision. To prevent the appellant from being deprived of the possibility to assert its rights under Rule 103(1)(a) EPC, the board considers therefore that the substantial procedural violation in the decision to grant interlocutory revision may justify the reimbursement of the second appeal fee."
  • "In the present case, the reimbursement of the second appeal fee is equitable. If the examining division had not granted interlocutory revision, there would have been no second appeal against what is essentially a copy of the first refusal decision"
  • "However, under Rule 103(1)(a) EPC the board cannot order the reimbursement of the second appeal fee if it does not allow this second appeal. This shows that a fully equitable solution in a situation such as the present one may not always be achievable."
  • "As a rule, a fundamental deficiency which is apparent in the first-instance proceedings constitutes a special reason for remitting the case to the department of first instance for further prosecution (Article 11 RPBA 2020) and consequently allowing the appeal. In the circumstances of this case, however, it is not an option to remit the case before the board has at least examined the main request, which was the subject of both refusal decisions."
  • " the subject-matter of claim 1 lacks inventive step (Article 56 EPC)."
  • The Board admits the Auxiliary Request, does not examine it in substance, and remits the case.
  •  "In the board's judgment, the need for an equitable outcome in the present case outweighs the interest of the EPO and the public in a swift conclusion of these grant proceedings."
  • " the case is to be remitted to the examining division for further prosecution on the basis of the auxiliary request, and the second appeal fee is to be reimbursed."

EPO T 0955/20
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

20 July 2022

T 1123/16 - Clinical trial document kills patent

Key points

  •  D1 is " D1: "The Prednisone-Sparing Effect of Anti-IL-5 Antibody (SB-240563)" details of Clinical Trial NCT00292877" 
  • " Document D1 describes a phase II clinical trial entitled "The prednisone-sparing effect of anti-IL-5 antibody (SB-240563)". The purpose of the clinical trial is "to determine if the treatment with anti-IL-5 antibody has a prednisone-sparing effect in patients with symptomatic eosinophilic bronchitis (with or without asthma)" (page 1, "Purpose"). ' 
  • " Like the opposition division and the parties, the board considers the disclosure of this phase II clinical trial to constitute an appropriate starting point for assessing whether the claimed subject-matter involves an inventive step. Indeed, it concerns the treatment of patients with the same medical condition (i.e. steroid-dependent EB) using the same substance (i.e. a humanised antibody to IL-5) with the same objective (i.e. a reduction in prednisone administration)." 
  • " The therapeutic application defined in the claim differs from the disclosure in document D1 in that (i) an effective treatment is not inferable from the document since it does not disclose any results of the clinical trial and (ii) whereas the claim specifies a minimum level of prednisone-sparing effect - 90% - none is specified in the document." 
  • " t was undisputed that the patent discloses the results of the clinical trial as known from document D1, including a prednisone sparing effect as required by the claim." 
  • " In the board's view, the disclosure of a clinical trial with the same substance for the treatment of the same medical condition, and having the prednisone-sparing effect as the primary outcome measure of the clinical trial, there being no other distinguishing characteristics of the therapeutic application claimed than the efficacy, provides the skilled person with an expectation of success for the treatment (see also decision T 2506/12, Reasons 3.10 and decision T 239/16, Reasons 6.5). It was therefore obvious for the skilled person to conduct the treatment in document D1 with a reasonable expectation of success, unless the state of the art provided the skilled person with reasons for not pursuing the solution envisaged in the clinical trial or, in other words, unless the state of the art provided the skilled person with an expectation of failure (see also decision T 2506/12, Reasons 3.11 and decision T 239/16, Reasons 6.5, second paragraph)." 
    • Compare T0108/21: "the board finds that the announcement of the phase III trial in document D10 would have given the skilled person hope of success but not a reasonable expectation of it. A mere hope of success does not suffice as motivation to render the claimed subject-matter obvious. As a consequence, the subject-matter of claim 1 involves an inventive step starting from D10's disclosure of the successful phase II trial with an oral daily dose of 1.25 mg fingolimod." However, inventive step is always fact-specific.
  • The Board reviews a number of other documents and then concludes: " In view of the above considerations, the skilled person had no reason to expect that the treatment described in document D1 would not succeed. The solution provided in the claim, specifying the level of reduction in prednisone to be 90%, is a consequence of pursuing the treatment described in document D1, for which the skilled person had a reasonable expectation that a prednisone reduction would be achieved without exacerbations. Therefore, the specific level of reduction of 90% recited in the claim does not play a role in the assessment of what the skilled person would do when faced with the problem formulated above, i.e. the provision of an effective treatment for prednisone-dependent EB with less side effects." 
  • Claim 1 is held to lack an inventive step.
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

19 July 2022

T 2471/17 - An inescapable reformatio in peius trap

Key points

  • In this case, Board 3.3.01 follows Board 3.4.02 in T 2242/18 and the non-appealing patentee is trapped by an amendment it made before the OD.
  • The patentee amended claim 1 by adding a feature (not a disclaimer) before the OD. The opponent objected that this amendment violated Art. 123(2). The OD found the amended claim to be allowable. The opponent appeals (only). 
  • The Board finds the amendment to lack basis in the application as filed.
  • The patentee submits a request deleting the feature at issue. 
  • The Board: "In G 1/99 (OJ 2001, 381), the Enlarged Board of Appeal considered it equitable, under certain circumstances, to deviate from the prohibition of reformatio in peius to give the patent proprietor the opportunity to mitigate the effects of an error of judgement made by the opposition division that would have the revocation of the patent as a direct consequence. The error of judgement of the opposition division dealt with in G 1/99 was to allow an amendment which had the effect of limiting the scope of the claims that was objected to in appeal (see point 14 of the Reasons)."
  • "the exception to the prohibition of reformatio in peius must be based on a new situation in the appeal proceedings (see G 1/99, Reasons point 12, "reasons which were not raised at the first instance"), which must be causal for the board's divergent opinion (see also T 61/10)."
    • To cite the relevant sentence in G 1/99: "However, in particular if the patent cannot be maintained for reasons which were not raised at the first instance, the non-appealing proprietor deserves protection for reasons of equity."
  • "The respondent [patentee] did not show, and it was not established, that new reasons against claim 1 of the main request, on account of the feature "increasing serum iron", arose on appeal which would have caused the revocation of the patent. For these reasons, the circumstances of this case do not justify an exception to the prohibition of reformatio in peius, and auxiliary request 1 must be rejected."
  • The patent is revoked.
EPO T 2471/17
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

18 July 2022

T 2344/19 - Weight gain related adverse events

Key points


  •  Claim 1 is directed to: " 1. [vortioxetine] for use in the long-term treatment of depression or anxiety in a patient who has previously received medication for the treatment of said disease which medication was ceased due to weight gain related adverse events, wherein long-term treatment refers to a treatment period above 12 weeks." 
  • The question is whether the feature in italics can provide for novelty, i.e. whether it specifies a valid second medical use under Art. 54(5) EPC. More in particular, whether the feature defines a patient group.
  • The Board: " The indication that the previous treatment was stopped due to weight gain related adverse events establishes the fact that the group of patients under consideration is known to develop weight gain related side-effects when administered medication active in the treatment of depression or anxiety. The development of certain side-effects reflects a certain physiological and/or pathological status of the patients concerned. The development of these side-effects during treatment for depression or anxiety creates a link between the patients, their physiological and/or pathological status, and the therapeutic treatment. The patient group under consideration is thus a technical feature of the claims." 
  • As to inventive step, D7 " describes weight gain as a common adverse effect of psychotropic drugs (abstract). In the concluding passages, it states that medication should be switched to another drug if weight increase due to a psychotropic drug cannot be stopped or reversed by measures relating to proper nutrition and eating habits, physical exercise and behaviour modification " 
  • " The difference between the subject-matter of claims 1 and 3 as granted and the disclosure of document (7) is the use of vortioxetine as the switch drug." 
  • " In view of the disclosure of document (7) []and the objective technical problem, it is clear that the person skilled in the art would have avoided the administration of any psychotropic drug for which long-term weight gain related side-effects had not been excluded. They would also have avoided any treatment potentially worsening the overall physiological condition of the patient, or, when leading to non-compliance, worsening the underlying psychiatric condition and potentially leading to relapse, hospitalisation or even fatal consequences. " 
  • " In summary, the person skilled in the art would have needed to count on success or, put differently, have a strong expectation of success. Any treatment undertaken with a mere hope to succeed, in the present case a treatment where short-term side-effects had been excluded but nothing was known on long-term side-effects, would not have been envisaged by the person skilled in the art." 
  • " Consequently, since no information on long-term weight gain related side-effects was known for vortioxetine, the person skilled in the art would not have considered vortioxetine for solving the technical problem stated above, and thus would not have arrived at the claimed subject-matter." 

EPO T 2344/19
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

15 July 2022

T 0625/21 - The Examiner uses email

Key points

  •  This is an appeal against a refusal decision.
  • "After reviewing the decision under appeal and the examination proceedings leading to it, the board notes that it is evident that the examiner entrusted with the examination of the application made some effort to engage in dialogue with the applicant. The examiner made use of different communication channels - written communications, emails and telephone conversations - and last but not least they offered the oral proceedings which the applicant had requested. All this can be seen from both the impugned decision and the appellant's statement setting out the grounds of appeal. The latter mentions the examiner's emails dated 10 October 2019 and 26 October 2020 which cannot be found in the public part of the file."
  • "anything not in the public part of the file cannot be reviewed by the board because this part of the correspondence, and what was allegedly discussed in that context, remains unknown. The board simply has no way of forming its opinion on these aspects."
    • I always thought the Board had access to the non-public part of the file. I suppose that back in the days of paper files, simply the whole folder was supplied to the Board.
    • I suppose that the emails at issue are not even part of the formal non-public part of the file.
  • As a separate issue, "The applicant decided not to attend the oral proceedings, arguing that an applicant should not have to attend oral proceedings just to know what the examining division's case is."
  • "The board has some sympathy for this argument. Nevertheless, oral proceedings give applicants the opportunity to address not only the examiner entrusted with the examination of the application but all members of the examining division simultaneously (Article 18(2), third sentence, EPC). Therefore, the case would have been discussed with the entire examining division."
  • "As explained in R 3/10 (reasons for the decision, point 2.11), the purpose of oral proceedings is to allow a party to make an oral presentation of its arguments, to allow the board (or the deciding instance) to ask questions, to allow the party to respond to those questions and to allow controversial and perhaps crucial issues to be discussed. 
  • "Therefore, by choosing not to attend the oral proceedings, the applicant missed an opportunity to advance the case in a discussion with the entire examining division."
    • As a comment,  G 4/92 "explicitly relates to inter partes proceedings only". (link)
    • As mentioned in CLBA III.B.2.7.2: " In T 1448/09 refusal of the European patent application was based on the common general knowledge as illustrated by document D3. That stance was first taken in the oral proceedings before the examining division, which the appellant did not attend. According to G 4/92, arguments could be presented at any time, even during oral proceedings in the absence of a party, but the same did not apply to new facts forming the basis for a decision. A reference to the common general knowledge could be presented as an argument, but the existence of that knowledge was a matter of fact. If its alleged existence was disputed, the facts relevant in that regard had to be established. That meant that the party against which this knowledge was cited had to have the opportunity to dispute or accept it. In the case in hand, the appellant had neither been aware of the examining division's invocation of the common general knowledge nor of the existence of document D3 until the decision was announced. This violated the appellant's right to be heard on the relevance of document D3 and, by extension, on the existence of the invoked common general knowledge." 
  • Still, there was a substantial procedural violation: "From the entire written file under scrutiny on appeal, there is no indication that the examining division carefully considered the applicant's (most) significant or central argument. In particular, there is no explanation as to why it is incorrect, not convincing or immaterial for other reasons. Instead, the examining division merely repeated its view that the feature of the last paragraph of claim 1 did not impose a restriction on the flavour additive."
  • Moreover: "The examining division did not explain the facts or considerations on which it based its conclusion []. What is more, by making this statement, the examining division presented yet another conclusion that failed to consider the applicant's (most) significant or central argument. Therefore, the division failed to explain, in a logical chain, the reasons for arriving at this conclusion."
EPO T 0625/21 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

14 July 2022

T 1820/18 - Relying on other opponent's evidence

Key points

  •  Fun with multiple opponents (and joint opponents, but that's less relevant).
  • "In the present appeal proceedings, joint opponents 1 [former respondent] took an active part, whereas opponent 2 (respondent) did not file any requests or submissions in the written proceedings. The day before the scheduled oral proceedings [] joint opponents 1 withdrew their opposition []. At the oral proceedings, the respondent [opponent 2] indicated that it intended to rely on the submissions of former joint opponents 1. The appellant [patentee] objected to this, arguing that presenting requests and arguments and raising objections for the first time at the oral proceedings was too late and that none of these submission should be admitted." 
  • " According to Article 99(3) EPC, opponents are parties to the opposition proceedings as well as the proprietor of the patent. It is clear from this provision that several admissible oppositions do not initiate a corresponding number of parallel opposition proceedings, but only a single set (T 270/94, point 2.1 of the Reasons; T 656/94, point 7 of the Reasons; T 620/99, point 1 of the Reasons). All grounds of opposition raised by the various opponents, as well as the facts, evidence and arguments presented by them, form the legal and factual framework within which the substantive examination of the opposition is to be conducted. 
  • " None of the parties involved in the opposition proceedings can be prevented from adopting facts, evidence and arguments presented in due time by another party (T 270/94, point 2.1 of the Reasons; T 620/99, point 1 of the Reasons; T 863/96, point 2 of the Reasons; see also T 154/95, point 2 of the Reasons: even documents originating from an opposition that has been declared inadmissible are allowed [)." 
  • " The same applies to opposition-appeal proceedings. All parties to the opposition proceedings are necessarily parties to any subsequent appeal proceedings (Article 107 EPC). It is therefore not possible to split the appeal proceedings into different procedures, each dealing separately with the grounds for opposition and the facts, evidence and arguments presented by the individual opponent concerned (T 790/03, point 2.1 of the Reasons). Therefore, each opponent can rely on any grounds, facts, evidence and arguments duly submitted by other opponents (T 620/99, point 1 of the Reasons; T 790/03, point 2.1 of the Reasons). Consequently, the board allowed the respondent to rely on the submissions made by former joint opponents 1 to the extent that these did not give rise to an objection of late filing." 

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

13 July 2022

T 2242/18 - Disclaimers and prohibition of reformatio in peius

Key points

  • A patentee adds a negative feature to claim 1. The claim is about an apparatus. The OD finds the amended claim allowable; the patentee makes it then its main request. The opponent appeals.
  • The Board finds that the feature is not disclosed in the application as filed as a negative feature.
  • The question is if the feature is a permissible undisclosed disclaimer (G2/03).
  • The Board concludes it is not, because it excludes more than necessary to restore novelty over the Art. 54(3) document. Moreover, it contributes to inventive step (makes a technical contribution) which is not permitted (G 1/16)
  • The patentee filed an auxiliary request wherein the which adds a condition to the disclaimer. Hence, it is a broadening claim amendment compared to the claims held allowable by the OD.
  • Hence, G 4/93, hn. II applies: ' If the opponent is the sole appellant against an interlocutory decision maintaining a patent in amended form, the patent proprietor is primarily restricted during the appeal proceedings to defending the patent in the form in which it was maintained by the Opposition Division in its interlocutory decision. Amendments proposed by the patent proprietor as a party to the proceedings as of right under Article 107, second sentence, EPC, may be rejected as inadmissible by the Board of Appeal if they are neither appropriate nor necessary." 
  • The patentee invokes the exceptions of G 1/99 to the prohibition of reformatio in peius (r.4.2).
  • The Board notes that G 1/99, hn. specifies t hat: " an exception to this principle may be made in order to meet an objection put forward by the opponent/appellant or the Board during the appeal proceedings, in circumstances where the patent as maintained in amended form would otherwise have to be revoked as a direct consequence of an inadmissible amendment held allowable by the Opposition Division in its interlocutory decision." 
  • The Board reasons " uring the appeal proceedings"  means that the relevant objection is raised for the first time in appeal proceedings, or is supported by new facts, i.e. was not raised (by the opponent) in the first instance proceedings (r. 4.3.1). The Board in particular cites G 1/99, r.12: ' Indeed, objections raised in the first instance may be supported by new facts and new objections may be raised in appeal proceedings with the consequence that the basis on which limitations have been made may still change and it would not be equitable to allow the opponent/appellant or the Board to present new attacks and to deprive the proprietor/respondent of a means of defence. " 
  • The Board, in translation:  " In this context, in the Board's view, the wording of the condition for an exception in the decision-formula of decision G 1/99 (cf. "to overcome an objection [...] raised in appeal proceedings") does not merely refer to objections raised in the complaints procedure must be taken into account, but must concern objections that are either only raised as such in the complaints procedure or at least substantiated with new reasons or new facts in the complaints procedure. An application of the exception rule of decision G 1/99 therefore presupposes that a new objection is introduced in the appeal proceedings or that an objection already raised in the first-instance proceedings is based on new grounds or new facts or that there is a causal connection between the restrictive objection to be deleted feature and a new fact in the appeal proceedings (see also e.g. decisions T 61/10, Reasons, point 1.4 and T 1033/08, Reasons, point 3, in particular the fifth to seventh paragraphs). This view of the board is moreover confirmed by the following statement in decision G 1/99: "But especially if the maintenance of the patent is opposed to reasons that were not brought forward in the first instance, the non-appealing patentee deserves protection for reasons of equity." (Reasons for the decision, No. 12, last sentence)." 
  • The Board finds that the objection to the disclaimer was already raised in the first instance proceedings, without a change of facts in appeal.
  • " Furthermore, neither the mere follow-up of an objection by the appellant [opponent] nor the fact that the board, unlike the opposition division, found that objection to be well-founded constitutes per se a reason which would justify such an equitable amendment of a claim in the present case . The objection raised here, as submitted by the appellant, was raised along with other objections during the first instance proceedings in relation to different versions of the disclaimer filed in the written and oral proceedings before the opposition division expect that even if the opposition division did not consider any of these objections to the final version of the disclaimer submitted during the first-instance oral proceedings to be valid, these objections could be pursued further in the appeal proceedings by the opponent in the event of an appeal." 
  • The Board, on the patentee making the claim with the disclaimer the main request at the end of the first instance proceedings: " For example, instead of leaving the patent as granted as the main request, the appellants decided to submit the version of claim 1 that the opposition division considered allowable as part of a main request. With this approach, the appellant deliberately waived the opportunity to file an appeal [*] and also accepted the possible procedural consequences of an appeal on the part of the opponent as the sole appellant. She also had to reckon with the fact that, in the event of such an appeal, the objections could be pursued by the appellant and that at least one of the objections could be considered valid by the board. In this context, the situation described here is, as submitted by the appellant, a direct consequence of the respondent's conduct of the proceedings, without - unlike in the cases set out in decision G 1/99 - there being special circumstances which, taking into account considerations of equity, warrant an exception from deterioration prohibition could justify." 
  • The patent is revoked. 
  • As a comment, multiple independent claims in the same category can be used by patentees in opposition, i.e. one independent claim with the disclaimer and another independent claim using normal features as amendments.
  • As a further comment, at *:  it is possible that the patentee saw simply no arguments for defending the main request and that the appeal would have been inadmissible. An inadmissible appeal may still lead to a prohibition of reformation in peius for the opponent as the sole admissible appellant.

EPO T 2242/18 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

12 July 2022

T 0419/16 - First medical use and Art.123(2)

Key points

  • " The [opponents] argued that the subject-matter of claim 1 (see section V) had no basis in the application as filed. In their view, the application as filed disclosed the claimed antagonist of IL-33 only for a specific medical use, but not for a first medical use [claim, i.e. "  An antagonist of IL-33 for use as a medicament"]." 
  • " The board recalls that Article 54(4) EPC provides for claims directed to a first medical use of a per se already known substance or composition and that such a claim confers broad (albeit purpose-limited) protection for substances or compositions, covering any use in a medical method, even if only one specific use is disclosed in the application (see Case Law of the Boards of Appeal of the European Patent Office, 2019, I.C.7.1.1 and decision T 128/82, OJ EPO 1984, 164). It is the board's view that it follows from this case law that the disclosure in an application of a substance or composition for a specific medical use is a basis for a claim directed to a first medical use." 
  • " Contrary to the appellants' submissions, the findings in decisions T 36/83 (OJ EPO 1986, 295) and T 128/82 do not support the view that a basis for a first medical use claim (in the sense of Article 123(2) EPC) can only be an identical or equivalent broad disclosure in the application as filed. In both decisions, it was held that a broad disclosure of a pharmacologically active substance for use as a medicament provided a basis for a corresponding broad (first medical use) claim. These decisions however did not consider other possible bases for such a claim nor rule out that the disclosure of a specific medical use can constitute a basis for a claim to a first medical use." 
    • T 128/82 hn: " Where a known compound is for the first time proposed and claimed for use in therapy, the fact that a specific use is disclosed in the specification does not in itself call for a restriction of the purpose-limited product claim to that use" 
    • To quote T 128/82 in the OJ translation from German,  further on Art. 54(5) EPC 1976 (now Art. 54(4) EPC): "[this provision] introduces, in respect of substances and compounds used in surgical and therapeutic treatment and in diagnostic processes carried out on humans and animals (hereinafter referred to briefly as "therapy"), a special concept of novelty unknown in other technical fields. This article was based on the French form of patent for medical preparations applying at the time of the Munich Diplomatic Conference. However, the history of Article 54(5) EPC does not reveal any uniform idea on the part of the negotiating States as to the breadth of the claim to be allowed for pharmaceutical inventions. The protection of inventions relating to therapy has under the EPC been incorporated in the general substantive patent law (Part II Substantive Patent Law, Chapter I - Patentability - Articles 52-57) and has thus been separately regulated, making it impossible clearly to decide which elements of the French form of protection for medical preparations it was intended to include in the EPC. On the other hand, the protection afforded by a French medical preparation patent was not restricted to a given pharmaceutical application (such as the combating of a certain disease). It is therefore impossible to derive from the travaux préparatoires any arguments in favour of limiting claim scope." 
    • Still: T 128/82 "  If an inventor is granted absolute protection in respect of a new chemical compound for use in therapy, the principle of equal treatment would require that an inventor who for the first time makes a known compound available for therapy should be correspondinlyg rewarded for his service with a purpose-limited substance claim under Article 54(5) EPC to cover the whole field of therapy. Any other treatment would only be justified were Article 54(5) EPC absolutely to forbid a broad protective scope. The fact that Article 54(5) EPC does not contain any requirement that protection should be broad is of itself no reason for refusing to grant such protection. As a general rule the usual practice as it relates to new compounds should be followed." 
    • " the practice of the European Patent Office hitherto has shown that substance and [pharmaceutical composition] claims [Stoff- und Arzneimittelansprüche] for therapeutically active compounds not limited to specific indications are allowed, even though as a rule only certain specific activities are [indicated] [note: i.e. in the description]." [obwohl in der Regel nur gewisse spezifische Aktivitäten konkret angegeben werden]
    • As the present Board notes in r.27, by the same token, this applies also to Art.83:  an enabling disclosure of a single medical use, provides an enabling disclosure for a first medical use claim reciting "for use as medicament". It may be added that this  applies by the same token to the technical effect under Art. 56.
  • The Board, citing T 128/82 later in the decision: " This objection fails because they are based on a misunderstanding of the first medical use claim format established by Article 54(4) EPC. As set out in decision T 128/82, Article 54(5) EPC 1973 (now Article 54(4) EPC) provides a special concept of novelty for any substance or composition, comprised in the state of the art, for use in a method referred to in Article 52(4) EPC 1973 (now Article 53(c) EPC), provided that its use for any method referred to in that paragraph is not comprised in the state of the art (see decision T 128/82, Reasons 9; confirmed by decision G 5/83, OJ EPO 1985, 65, Reasons 21). The decision further clarifies that "[i]f an inventor is granted absolute protection in respect of a new chemical compound for use in therapy, the principle of equal treatment would require that an inventor who for the first time makes a known compound available for therapy should be correspondingly rewarded ... with a purpose-limited substance claim under Article 54(5) EPC [1973 (now Article 54(4) EPC)] to cover the whole field of therapy" (Id., Reasons 10)." 
  • The Board clarifies that the same holds for priority: "  A logical consequence of the availability of purpose-limited substance protection for a first medical use is that the disclosure of a single therapeutic use of a compound is both sufficient to meet the requirements of Article 83 EPC and to serve as a basis for such a claim in the sense of Articles 87(1) EPC and Article 123(2) EPC, respectively." 
EPO T 0419/16
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

11 July 2022

T 1185/19 - No implied secrecy (automotive)

Key points

  • The claim is directed to a base fabric for an airbag. Public prior use is the issue. I focus on the issue of implied secrecy. 
  • " It was not contested by the proprietor that the yarn supplied by Toyobo Co. Ltd was woven into a base fabric at Shimizu Co. and stored at Chuo Warehouse Co as depicted in the flowchart D2. '
  •  " The proprietor argued instead [] that there was no evidence that Shimizu Co. had ever sold the base fabric and that there was at least an implicit secrecy agreement between Toyobo Co. Ltd, Shimizu Co., Chuo Warehouse Co. and the recipients of base fabric stored in the warehouse, namely Seiren Aucus, Toyoda Gosei, Ashimori Industry, Nikkou Rubber and Nihon Plast." 
  • " The Board does not find these arguments convincing. The cargo receipts D5 and D46/D46a show that several deliveries of large quantities of base fabric from the warehouse to Seiren Aucus (an airbag producer) among other recipient airbag producers took place as early as April 2008 (the priority date of the contested patent being 23 August 2010).' 
  • " Although no purchase receipts were filed demonstrating a money transaction had been made, the Board finds that the large quantities of fabric delivered could not reasonably have been supplied and used only for prototypes and pre-series runs and that the deliveries were thus at least meant to be used for the commercial serial production of airbag modules, not least due to the regular transactions which occurred between the companies. ' 
  • " In such a serial production phase of the airbags, the Board also cannot see any plausible reason for the companies involved to have had a secrecy agreement, since the airbags were destined to be mounted on production vehicles and sold to third parties/end customers which are under no secrecy obligations concerning the vehicle or its components." 
  • " Turning to the declaration D69 [of a person with a Japanese name] which the proprietor [a Japenese company, it seems] used as evidence to show that implicit secrecy was normal in the automotive industry, this states in paragraphs 8 and 9 that "airbag base fabrics are handled under implicit secrecy obligations" and that "its technology was not made freely available at any stage". However, D69 includes the explanation in paragraphs 11 to 13 that "airbags and their properties are not publicly known", that "it is not normal for customers to disassemble an airbag" and that "once an airbag module is obtained in the market, the public cannot access, let alone analyse, the base fabric for the airbag in the airbag module" and that for these reasons "the technology for a base fabric for an airbag in the automotive industry is under implicit secrecy and is even more so not made freely available at any stage", the latter expression being the same as used in paragraphs 8 an 9.  By stating in paragraph 12 that the technology of an airbag obtained in the market and thus in possession of the public is "under implicit secrecy and not made available at any stage" shows that the declarant is not aware of the conditions for public availability which are applied in the Boards case law, where it is not necessary to prove that an analysis of an airbag module has actually been carried out, but only that the airbag module has been made accessible to persons who are not bound to any secrecy agreement regardless of the technical skills required to do such an analysis.'"
  • The claim is found to lack an inventive step.

EPO T 1185/19 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

08 July 2022

T 0108/21 - Novel and inventive over Phase III announcement

Key points

  • This case is about the particular approach to novelty for 2nd medical use claims: such claims appear to be novel over public disclosure of the verbatim claim wording if the publication lacks Phase III clinical results. In this case, the claim is also found to be inventive over a prior art document disclosing the phase II clinical results and announcing the Phase III clinical study of precisely the medical use now being claimed. The patent application does not contain the Phase II results but the results of animal studies. (numbers in bold corrected)
  • The claim is directed to the therapeutic treatment of RRMS using an oral daily dose of 0.5 mg of fingolimod.
  • "Document D10 includes the following two technical teachings. (a) Results from a clinical phase II study showing sustained efficacy and good tolerability over 18 months in RRMS patients treated with an oral daily dose of 1.25 mg fingolimod (see point 4.2 above), immediately followed by (b) the announcement of a clinical phase III study including more than 1000 patients with RRMS to be equally randomised to receive either 1.25 mg or 0.5 mg of oral fingolimod or placebo once daily for up to 24 months (see page 2, third to fifth full paragraphs)." 
  • "The examining division considered (see point 16.2.11 of the impugned decision) that any prior art describing the therapeutic effect of an oral daily dose of 1.25 mg of fingolimod in the treatment of RRMS and then explicitly disclosing the use of an oral daily dose of 0.5 mg of fingolimod (albeit without data) anticipated the subject-matter of a claim directed to a therapeutic treatment of RRMS using an oral daily dose of 0.5 mg of fingolimod. " 
  • "The board does not agree. In accordance with the settled case law of the boards, for prior art to anticipate the subject-matter of a claim, it must, as a first requirement, disclose directly and unambiguously all the technical features of this claim in combination. As a further requirement, this disclosure must be enabling, in the sense that the skilled person must be able to carry out this disclosure on the basis of the information provided in this prior art, if required, by using common general knowledge, at the date of public availability of this prior art." 
  • " In the case at hand, document D10 does not anticipate the subject-matter of claim 1 for failure to meet the first requirement. As set out in point 6.2 above, document D10 discloses the claimed dosage regimen in the context of a phase III study involving the therapeutic treatment of RRMS patients with the claimed fingolimod dosage regimen. Page 2, fourth full paragraph of document D10 states that this study "has begun enrolling patients in several European countries". No further details are provided in this regard. In particular, no mention is made of the therapeutic efficacy of this dosage regimen in the treatment of RRMS. [] In view of the foregoing, the board concludes that document D10 does not directly and unambiguously disclose the effective therapeutic treatment of RRMS using the claimed dosage regimen. The subject-matter of claim 1 is thus novel pursuant to Article 54 EPC over this document." 
  • " this announcement [of the phase III clinical trial] would have provided the skilled person with a reasonable expectation of solving the objective technical problem with fingolimod at an oral daily dose of 0.5 mg, unless a teaching in the prior art would have dissuaded the skilled person from considering this dosage regimen as a solution to the technical problem posed. In the case at hand, the board is satisfied that the prior art teaches away from the claimed invention. As set out in point 5.4(b) above, the skilled person would have inferred from document D28 that a threshold of lymphocyte reduction of at least 70% was required for a therapeutic treatment of RRMS. Moreover, the board agrees with the appellant's position that the teachings of documents D26 and D27 taken in combination with the teaching of document D23 would have led the skilled person to conclude that an oral daily dose of 0.5 mg fingolimod would be insufficient for reaching this threshold and hence would not be therapeutically effective in the treatment of RRMS (see points 5.4(c) and 5.4(d) above). In light of these particular circumstances, the board finds that the announcement of the phase III trial in document D10 would have given the skilled person hope of success but not a reasonable expectation of it."
  • The claim is also inventive. " the board finds that the announcement of the phase III trial in document D10 would have given the skilled person hope of success but not a reasonable expectation of it. A mere hope of success does not suffice as motivation to render the claimed subject-matter obvious. As a consequence, the subject-matter of claim 1 involves an inventive step starting from D10's disclosure of the successful phase II trial with an oral daily dose of 1.25 mg fingolimod."
  • " For the reasons given above regarding sufficiency of disclosure, the board is satisfied that the claimed fingolimod dosage regimen provides an effective therapeutic treatment of RRMS." 
  • The Board found the application to be plausible based on the results of animal studies disclosed in the patent application.
  • " Under these circumstances, post-published evidence may be taken into account (see point 5.3 above). In this context, the appellant referred, inter alia, to document D11. This document discloses the results of a clinical study in 1153 patients with RRMS who had a recent history of at least one relapse. Patients received either oral fingolimod at a daily dose of either 1.25 mg or 0.5 mg or intramuscular interferon beta-1a (an established therapy for MS) at a weekly dose of 30 myg. Figure 2A illustrates a significantly greater reduction in the annualised relapse rates in both fingolimod groups than in the interferon group, confirming the results of the EAE study reported in the application.'" 
  • As a comment, the animal study results in the application seem to work as a kind of stepping stone to the post-published clinical trial results which make the claim patentable. 
  • As a comment, the District Court The Hague found the claim to be obvious in preliminary relief proceedings, in a decision issued 21 June 2022, after duly taking note of the Board's written decision issued on 3 June 2022 and submitted by the parties on 13 June. The case is unusual in that the patentee had initiated proceedings for an injunction even before the publication of the mention of the grant (but after the oral decision of the Board). Rechtbank Den Haag 21 juni 2022, ECLI:NL:RBDHA:2022:5898 and Rechtbank Den Haag 22 maart 2022, ECLI:NL:RBDHA:2022:2490. The President of the District Court The Hague essentially found that D28 did not amount to a technical prejudice in the field after a careful analysis of D28.
  • See also this Kluwer Patent blog post about PI proceedings in Denmark (based on the pending application) and this post about the proceedings in France.
EPO T 0108/21
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

07 July 2022

T 0910/18 - Grant after 20 years

Key points

  • The PCT application was filed in 2001, request for entry 2003, first communication Examining Division 2004, 2nd communication in 2011, summons in 2017, appeal filed end 2017, statement of grounds in 2018, summons oral proceedings Board 2022. The Board orders the grant of the patent
  • "Despite the expiration of the 20 year patent term, a patent can still be granted, as there may exist legal rights derived from it that would be affected by the grant of the patent, such as provisional protection rights conferred by Article 67 EPC upon the publication of the application." 
  • The Board's further reasoning on inventive step is actually interesting, though nothing out of the ordinary. 
    • In other words, I don't see any special circumstances in the decision (or in the file) justifying a 20-year grant procedure.
  • "  In the decision under appeal, the examining division concluded that claim 1 of the then Main Request did not involve an inventive step in view of documents D2 and D1." 
  • " [T]he board considers thus that D2 represents a rather remote starting point for the skilled person, who would have to carry out extensive modifications to its teaching in order to arrive at the claimed invention. The board takes the view that such modifications would change significantly the teaching of D2, for example transforming the described apparatus from a manually operated device to an automatically operated one. In the board's view, such modifications would go beyond what can be considered to to obvious for the skilled person." 

  • " Even if it were accepted - for the sake of the discussion - that the skilled person would have wished to automate the apparatus of D2 and would have added features for automatically transporting the certified papers within the apparatus, detecting the emitted light and determining the genuineness of the paper based on this detection, there is nothing in D2 or in the skilled person's common general knowledge that would incite the skilled person to implement the triggering of the activation of the alternating-current electromagnetic field according to claim 1 of the Main Request." 
  • " The examining division considered that it would have been obvious for the skilled person to conceive the idea to limit the application of the alternating-current electromagnetic field because "it [was] generally known to activate components in automated settings only when they are needed (e.g. energy savings, lifetime of components (MTBF))" (see point 19.5 of the Reasons of the impugned decision)." 
  • " The board notes that in the present case, the limitation of the application of the alternating-current electromagnetic field is related neither to energy savings nor to the lifetime of components of the apparatus."  
    • I understand that the Board is applying the rule of the PSA that the distinguishing feature must be obvious for solving the particular objective technical problem. This may be contrasted with the KSR approach of the USPTO where any motivation to combine is sufficient.
  • " According to the board's view and taking into account the context of D2 described above, the skilled person would not have considered the idea to limit the application of the electromagnetic field without hindsight." 

EPO T 0910/18 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

06 July 2022

T 0885/18 - Don't forget the rejoinder

Key points

  •  The OD revokes the patent. The patentee appeals. " With their reply to the statement of grounds of appeal, the respondent [opponent] raised inter alia a novelty objection based on D1."
  • "At the beginning of the oral proceedings, the appellant changed their appeal case concerning the novelty objection based on D1 without presenting exceptional circumstances which have been justified with cogent reasons"
  • "The respective objection of lack of novelty of the subject-matter of claim 7 in view of D1 had been raised by the respondent as early as in the notice of opposition, but more relevantly for the appeal proceedings, in their reply to the statement of grounds of appeal. Furthermore, the board had indicated specifically in their preliminary opinion that they found the objection persuasive."
  • " Nevertheless, the appellant did not comment on this objection until at the oral proceedings. When asked by the chairman, whether there were any special circumstances justifying this procedural behaviour, the appellant had no comment other than that the argument was very relevant."
  • "The board is of the opinion in view of the facts of the case that it would have been appropriate for the appellant to react to this objection in a timely manner allowing the respondent and the board to properly prepare. "
  • "For the same reason also an attempt to overcome the novelty objection based on D1 should have been made before, so that a further interruption of the oral proceedings for filing an amended request as requested by the proprietor was not justified."
  • "Furthermore, the board does not share the appellant's opinion that the new submission should be taken into account because it was very relevant, as according to Article 13(2) RPBA 2020, the relevance of a submission is not a decisive criterion for admitting it."
  • As a comment, the appeal was filed in 2018, well before the rejoinder was introduced in the explanatory remarks to the RPBA 2020. 
EPO - T 0885/18
The link to the decision is provided after the jump.

05 July 2022

T 0190/19 - Parties must formulate the claims with the greatest possible care

Key points

  •  In this examination appeal, the Board decides on admissibility of AR-1.
  • "In the appellant's view, this amendment corrected the lack of convergence objected to with respect to the first auxiliary request. According to the appellant's submission in the statement setting out the grounds of appeal, section III, sixth paragraph, it should be obvious that the appellant's intention was not to broaden claim 1. On the contrary, the previous omission of the gate-electrode facing portion 3a being of the first electroconduction type should now be reintroduced to correct the obvious error. In the appellant's view, the correction of an obvious error should be possible."
  • "Contrary to the appellant's opinion, the Board holds that the amendments of claim 1 of auxiliary request 1b do not concern an obvious error. Even if the statement of grounds of appeal indicated with respect to the first auxiliary request that claim 1 was amended in a certain way (see statement setting out the grounds of appeal, section III, sixth paragraph), the resulting contradiction between this indication and the wording of claim 1 does not automatically render the point in question an obvious error."
  • " In fact, it is not uncommon for parties to assert facts in their accompanying letters that are not reflected in the wording of the claims. Thus, a contradiction between the accompanying letter and the wording of the claims alone is not sufficient proof for an obvious error. In addition, it must be assumed that the parties formulate the claims with the greatest possible care. The Board must rely on the wording of the claim and cannot necessarily assume that the lack of convergence is merely an error, let alone an obvious error. Still less can it conclude that the actual intention is based on the information in the accompanying letter."
  • "Irrespective of whether or not the error was obvious, the Board notes that the lack of convergence was already objected to in the Article 15(1) RPBA 2020 communication. Therefore, auxiliary request 1b should have been filed directly in response to this communication as quickly as possible if this error was to be corrected. However, this did not happen."
  • The request is not admitted.
EPO 
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

04 July 2022

T 2196/19 - Unsubstantiated requests not considered - for novelty

Key points

  • "The board is convinced by the appellant's [opponent's] arguments and is therefore of the opinion that the subject-matter of claim 1 lacks novelty with respect to the disclosure of document D2." 
  • The auxiliary requests are not admitted. "The respondent [patentee] had filed the First, Second and Third Auxiliary Requests during the first-instance opposition proceedings and upheld them in the appeal proceedings. As indicated above (see point [2]), the respondent referred only in general to its submissions made during the opposition proceedings with regard to these requests." 
    • " In their submissions, both the appellant (see e.g. section VII) and the respondent (see pages 1 and 2) referred in general to their submissions made during the opposition proceedings.

      However, merely referring generally to submissions made during first-instance opposition proceedings cannot be seen as meeting the requirement of Article 12(2), second sentence, RPBA 2007 ... The board therefore does not take into account, pursuant to Article 12(4) RPBA 2007, the parties' submissions made during the opposition proceedings and referred to only in the appeal proceedings. As a consequence, this decision considers only the documents expressly referred to, the requests sufficiently substantiated, and the arguments expressly brought forward in the statement setting out the grounds of appeal or the reply thereto."  

  • " In view of the above, the board is of the opinion that the First, Second and Third Auxiliary Request have not been properly substantiated in the reply to the statement setting out the grounds of appeal, contrary to the requirements of Article 12(2) RPBA 2007. As a consequence, the board does not take into account the First, Second and Third Auxiliary Requests according to Article 12(4) RPBA 2007 " 
  • " Since none of the respondent's requests is allowable, the patent must be revoked (Article 101(2)and (3) EPC)." 
  • As a comment, the Board does not comment on whether the novelty of e.g. AR-1 over D2 is self-evident (cf. T 0032/16 r.1.5.2).
EPO T 2196/19
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

01 July 2022

T 1533/19 - Old document, so no CPA

Key points

  •  "  According to the case law (Case Law, supra, I.D.3.2) ideally the closest prior art should be a document that mentions the purpose or objective indicated in the patent in suit as a goal worth achieving. The aim thereof is that the assessment process should start from a situation as close as possible in reality to that encountered by the inventor, avoiding ex post facto considerations." 
  • " The Board's position is that the skilled person with a prospect of achieving the goals addressed in the patent in suit would need a valid reason to return to the teaching of D11 [published in 1977] and disregard the evolution in technology in the present field over the past twenty seven years, i.e. since the publication of D11, which evolution of technology is illustrated by the teaching of D7 and the background art depicted in both that document and the patent in suit.
  • Although as a matter of principle there is no prohibition to disregard evolution in technology and come back to an older state of the art when selecting the starting point for assessing inventive step, a decision concerning which starting point is appropriate to analyse inventive step requires in such a case to carefully consider both the goals addressed in the patent under examination and the disclosure of said older state of the art, in the present case D11." 
  • For a realistic and objective approach, inventive step has be considered from the skilled person's perspective at the date of filing of the patent in suit taking into account realistic goals to be achieved for the subject-matter claimed as they appear from the application documents as a whole. Faced with said goals, the notional skilled person would have the natural tendency to consider recent development in the technology of concern, unless said goals or some of them had already been addressed in a more ancient prior art, in which case said older prior art has also to be considered for an assessment of inventive step, since a claimed invention must be shown to be inventive in the light of the prior art as a whole." 

  • For a realistic and objective approach, inventive step has be considered from the skilled person's perspective at the date of filing of the patent in suit taking into account realistic goals to be achieved for the subject-matter claimed as they appear from the application documents as a whole. Faced with said goals, the notional skilled person would have the natural tendency to consider recent development in the technology of concern, unless said goals or some of them had already been addressed in a more ancient prior art, in which case said older prior art has also to be considered for an assessment of inventive step, since a claimed invention must be shown to be inventive in the light of the prior art as a whole." 

  • Under these circumstances Example 5 of D11, whose choice as closest prior art mainly relies on the similarity of structural features of that example with operative claim 1 as far as features (a) and (b) are concerned, does not constitute a realistic starting point for the present invention. On that basis, the reasoning on inventive step starting from Example 5 of D11 as the closest prior art which led to the revocation of the patent in suit and which was pursued by respondent 2 cannot convince as it lacks the required objectivity. The same reasoning also applies to Example 3 of D11 which is also proposed as possible closest prior art by respondent 2." 

  • The Board remits the case. 

  • "The various issues necessitated for an analysis of inventive step starting from D7 as the closest prior art, among others the assessment of the objective problem solved in the light of experimental report D15 and the obviousness of the solution, in particular in the light of D16, D17 and D18 (see pages 6 to 8 of letter of 29 March 2018 of respondent 2, to which it is expressly referred to in point 2.3 of respondent 2's rejoinder), were however not dealt with in the contested decision, nor were those issues discussed during the oral proceedings. This is confirmed by the fact that, since inventive step starting from D7 was not part of the decision, documents D16 to D18 were not admitted for the single reason that they were not relevant to the decision (point 3 of the reasons, last sentence). This situation is seen by the Board to constitute "special reasons" within the meaning of Article 11 RPBA 2020 to remit the case for further prosecution to the department whose decision was appealed." 

  • The decision seems remarkable to me. There is some case law saying that a claim should be obvious having regard to any prior art. As I understand it, Example 5 of D11 teaches a composition having features A and B of claim 1, feature C is optional (0 to 60 wt.% inorganic filler) and feature D (0.5 -8 wt.% of at least one synergist selected from a group including boehmite) was found to be obvious by the OD because D7 teaches the addition of boehmite. After reading the Board's decision, I can't find any reasoning why feature D was not an obvious modification of D11. However, that's possible not the same as a lack of inventive step, because an important consideration for composition claims is that in a way every chemical composition is non-functional outside its intended field of use. Inventive step of composition claims is to be acknowledged on the basis of the technical effect(s) achieved when the composition is put to its intended use (cf. BGH 27.02.1969 X ZB 11/98 Disiloxan; link to open access full text at Kluwer).

  • On the other hand, we should always strive for a "realistic and objective approach" to the inventive step rather than a mechanical one. 

  • Application filed in 2004, grant in 2016, opposition procedure finished just in the 18th patent year.

EPO T 1533/19
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.