T 1941/21 - Clinical trials; Novelty after inventive step

Key points

• "D4 discloses the protocol and design of a clinical trial for evaluating the efficacy and tolerability of [the compound] TUDCA in the treatment of ALS, wherein TUDCA is administered at 1g b.i.d (2g daily) for a year to 18-75 years old Caucasian male or female ALS patients who had first symptoms of ALS by no more than 1.5 years and were in treatment with a steady regime of riluzole and vitamin E for a minimum of three months (see D4: title; page 6, arms and interventions; page 7, outcome measures; page 7, eligibility). Further, document D4 describes in detail the rational for using TUDCA in these clinical trials. It mentions in particular that TUDCA is endowed with antioxidant, antiapoptotic and neuroprotective activities and describes the detailed pharmacological mechanisms of action for each activity (see D4, pages 5-6). The results of the trial announced in D4 have not been made available to the public."
• I.e., D4 discloses the method features of the second medical use claim at issue (""1. Tauroursodeoxycholic acid [TUDCA] or a pharmaceutically acceptable salt thereof for use in the treatment of a neurodegenerative disorder in a mammal, characterized in that said neurodegenerative disorder is amyotrophic lateral sclerosis."')
• "The problem [solved by the claim over D4] was defined by the opposition division in its decision as the provision of an effective treatment for ALS. "
• "The problem appears to be solved in view of the examples of the contested patent in paragraphs [0028]-[0038]. The patent shows for instance that the baseline-adjusted absolute ALSFRS-R score was significantly higher in TUDCA-treated than in placebo-treated patients "
• Note:  "This study shows that one year of treatment with TUDCA at the prescribed dose was associated with slower deterioration of function in ALS patients. This disease modifying effect is additional to that of riluzole, as both treatment groups [i.e. "placebo" and TUDCA] were under riluzole and vitamin E treatment. " (patent, para. [0036]
• "Clinical trials are usually initiated on the basis of encouraging results from preclinical experiments. Thus, the announcement of a phase II clinical trial protocol for a particular therapeutic agent and a disease may provide the skilled person with a reasonable expectation of success. "
• "Such reasonable expectation of success is, however, to be denied in a situation where a skilled person would have been discouraged from carrying out the clinical trials, such as when the state of the art provides the skilled person with reasons for not pursuing the solution envisaged in the clinical trial or provides the skilled person with an expectation of failure. Consequently, "a reasonable expectation of success" is linked with the specific circumstances of the case and requires a case-by-case evaluation of all the facts at hand at the priority date of the contested patent. In the present case, the Board holds that the state of the art suggested to the skilled person a clear expectation of failure."
• "The disclosure of document D9 demonstrates indeed that the skilled person could not base any reasonable expectation of success of the use of TUDCA in treatment of ALS on the announcement in document D4 of a phase II clinical trial for the treatment of ALS with TUDCA.

  D9 is a scientific article published in 2012 which gives a general review of the treatment of amyotrophic lateral sclerosis (ALS) at that time. D9 mentions 89 different drugs which, before the filing date of the opposed patent, had been used in clinical trials for ALS based on allegedly promising preclinical data [...]. 

• "Importantly, [D9] discloses that, for all the drugs listed in the document, promising preclinical data, such as biochemical or cellular assays, have been provided, but nevertheless the majority of the clinical trials failed"

• "Accordingly, the Board concludes that, starting from document D4 and in view of the further cited prior art, the skilled person would not have arrived at the claimed subject-matter in an obvious manner and that the subject-matter of claim 1 of the main request involves an inventive step."

Novelty after inventive step

• "D8 [EP 2 422 787 A1, being prior art under Art.54(2)] relates to compositions comprising low doses of diazoxide for use in the treatment of a mammal afflicted with ALS, in particular a human (see D8, claims 1 and 3). Further, D8 discloses in claim 9 that diazoxide can be combined with "an additional therapeutic agent useful in the treatment of amyotrophic lateral sclerosis" including TUDCA, which constitutes a single selection from a list. Consequently, a composition comprising diazoxide and TUDCA for use in the treatment of a mammal afflicted with ALS is derivable directly and unambiguously from D8."
• "Accordingly, even if D8 does not provide any in vitro or in vivo experiments with regard to the efficacy of TUDCA in the treatment of ALS, D8 provides an enabling disclosure for a combination treatment based on diazoxide and TUDCA, in view of the explicit disclosure in D8 of the efficacy of diazoxide. "
• "D8 supports the utility of low dose diazoxide in the treatment of ALS with experimental results, in particular in Example 2. This example shows that low doses of diazoxide improve survival in the SOD1-G93A transgenic mice model for amyotrophic lateral sclerosis. The utility of diazoxide in treatment of ALS described in D8 has not been disproved."
• Note, for D8, a pre-clinical experiment (animal study) is sufficient for an enabling disclosure. Cf. the remarks about D9 above.
• "As a general rule, a claim to the use of a known compound for a particular purpose or to a product for use in a particular medical purpose, which is aimed at obtaining a technical effect described in the patent, should be interpreted as including that purpose as a functional technical feature, and is accordingly not open to objection under Article 54(1) EPC provided that such technical feature has not previously been made available to the public. This functional feature has however been made public in the present case."
  
  
• "In the Board's view, the discovery of a new property of a particular ingredient of a known composition, i.e. here TUDCA in the composition comprising diazoxide and TUDCA, used for a known and identical general purpose, i.e here the treatment of a mammal afflicted with ALS, can indeed not confer novelty to the particular ingredient used for the same general purpose, namely TUDCA for the treatment of ALS. Novelty can only be recognized if this new property is applied in a new use."
• The claim does not specify "a composition comprising TUDCA for use in the treatment of ALS". The Board's reasoning is difficult to follow.
• Consequently, the disclosure in D8 of treatment of ALS based on diazoxide and TUDCA, wherein the efficacy of diazoxide is supported by experimental data and has not been disproven, anticipates the subject-matter of claim 1 of the main request.
• " Claim 1 of auxiliary request was amended by the addition of the feature " in a human, characterized in that it is administered for at least 30 weeks".
• "Since there is no disclosure of any duration of treatment in D8, the subject-matter of claim 1 of auxiliary request 2 is not anticipated, and auxiliary request 2 meets the requirements of Article 54 EPC."
• As a comment, there is no discussion at all of why the added feature of administration of 30 weeks provides for an inventive step over D8. I don't understand why, except that the opponent had no inventive step objections starting from D8. I understand ALS is a chronic disease?

EPO 

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

T 1177/17 - Plausible and burden of proof

Key points

• The concept of 'plausibility' is often applied in the context that the applicant may only rely on post-published evidence of the technical effect if the application as filed makes that effect at least plausible. 
• In the present opposition case, the concept is used in connection with the burden of proof.
• The opponents allege that the technical effect is not made plausible by Example 1 of the patent.
• The Board decides that the technical effect is not plausible. " there is no evidence on file to show that [the compound] 2-FL, by itself, achieves the required NK cell stimulation that is necessary to attain the claimed antiviral effects." 
• " the [patentee] did not substantiate its submissions with any evidence other than the data reported in example 1. By contrast, it argued that it was down to the [opponents] to demonstrate that 2-FL did not provide for the claimed antiviral effects by means of NK cell stimulation. However, this argument cannot succeed, since the technical effects invoked by the [patentee] are not plausible over the whole scope of claim 1 of the main request" 
• The patent is revoked.

EPO T 1177/17 -  link



4.2.5 The subject-matter of claim 1 differs from the closest prior art in that the fucosyllactose is 2-FL.


4.3 Objective technical problem and solution


4.3.1 In order to formulate the objective technical problem, it is necessary to establish the technical effect(s) achieved by the aforementioned distinguishing feature.


[...]

4.3.3 While the appellants [opponent] did not dispute the validity of the data contained in example 1 of the patent in suit, they submitted that there was no evidence supporting the alleged link between the immunomodulatory effects of 2-FL shown in the mentioned example and the compound's activity against infections caused by the list of viruses recited in claim 1 of the main request.


4.3.4 Accordingly, it needs to be established whether the disclosure of example 1 renders the alleged, indirect antiviral activity of 2-FL by means of NK cell stimulation (see point 4.3.2 above) credible or at least plausible over substantially the whole scope of claim 1 of the main request.


4.3.5 Example 1 of the patent in suit pertains to a study in mice vaccinated with Influvac (an influenza vaccine; see paragraph 0048). The test animals received either a control diet or a diet supplemented with the following respective oligosaccharides: [...]


Diet supplementation with 2-FL resulted in a significant increase in NK cell number and activity compared with control-fed animals (see experimental data in Table 1 in paragraph 0052). Hence, in the board's judgement, example 1 credibly shows that dietary 2-FL augments the NK-cell-stimulating effects of the Influvac vaccine in the tested animals and thus contributes to the effective protection of these animals against infections caused by influenza viruses.

T 1601/15 - CGK doesn't need a hint

Key points

• In this opposition appeal, the objective technical problem is how to provide an alternative 'friction prevention or friction reduction' (the claim is directed to an ‘actuating device for locking needles in injection molding tools’). The Board explains that the skilled person needs no hint or pointer to apply something that is part of his common general knowledge.
• The Board, in translation: “For the skilled person, who - prior to the priority date - started from the device of the prior use and set himself the task of finding an alternative type of friction prevention or reduction, it would be obvious, in view of his specialist knowledge, to use a diamond-like material.
• The Board in translation: “The argument that the skilled person would have had no reason to use his specialist knowledge is not convincing. The skilled person does not need any reason to apply his specialist knowledge. To a certain extent, his specialist knowledge forms the technical background for every activity of the skilled person and is incorporated into all his decisions. In this regard, the general specialist knowledge must be distinguished from the teaching of subject-specific publications.”.

EPO T 1601/15 - link





IV. Anspruch 1 des nunmehrigen Hauptantrags, von dem die Einspruchsabteilung der Auffassung war, dass er den Erfordernissen des EPÜ genüge, lautet wie folgt:

"Betätigungsvorrichtung (10) für Verschlussnadeln in Spritzgießwerkzeugen
a) mit Nadelverschlussdüsen,
b) mit einem Hubelement (20), [...]

Entscheidungsgründe

3.3 Fachmann

Im vorliegenden Fall ist der Fachmann ein Maschinenbauer mit Erfahrung auf dem Gebiet der Spritzgießmaschinen und -werkzeuge. Als solcher ist er mit Reibungs- und Bewegungsvorgängen, wie sie in solchen Vorrichtungen auftreten, vertraut.

3.4 Objektive technische Aufgabe

Die Einspruchsabteilung hat die technische Aufgabe darin gesehen, eine alternative Art der Reibungsverhinderung bzw. Reibungsverminderung vorzuschlagen.

[...]




3.5 Naheliegen

Für den Fachmann, der - vor dem Prioritätstag - von der Vorrichtung der Vorbenutzung ausging und sich die Aufgabe stellte, eine alternative Art der Reibungsverhinderung bzw. Reibungsverminderung zu finden, wäre es angesichts seines Fachwissens, wie es insbesondere durch die Druckschrift D15 belegt ist (vgl. Tabelle 2, Spalten 2.3, 2.4, 2.6 und 2.7), naheliegend gewesen, zu einem diamantähnlichen Material zu greifen und die verschleißgefährdeten Bauteile von Spritzgießwerkzeugen entweder zur Gänze aus einem solchen Material herzustellen oder eine entsprechende Beschichtung auf einem geeigneten Grundmaterial (z.B. Werkzeugstahl) aufzubringen.

T 0688/14 - The normal tasks of the skilled person and expectation of success

Key points

• In this opposition appeal, the Board concludes that the claim at issue is obvious. 
• The Board: “although the case law defines the skilled person as being cautious and having a conservative attitude [...], it also acknowledges that furthering the existing state of art belongs to the normal tasks of the skilled person and that routine adaptations or trials as well as the use of known alternatives do not go beyond what may be normally expected from an average person skilled in the art”
• “The question whether a skilled person would do something may be answered by assessing first whether there was any motivation or incentive for the skilled person to do it and, if this question is answered in the positive, to assess then the expectations of the skilled person for doing it.” (emphasis added). 
• This approach makes sense to me.
• As regards the expectations of the person skilled in the art, the board considers that they are always directly associated with the intended purpose and thus, intrinsically linked to the formulated technical problem.
  When the intended purpose or the technical problem are formulated in very ambitious terms, such as the achievement of a significant improvement or a surprisingly advantageous effect over the prior art, the expectations of the skilled person to succeed are correspondingly more difficult to be fulfilled.
  The expectations to succeed are certainly much greater, when the intended purpose or the technical problem are formulated in less ambitious terms, such as in the present case, namely the provision of a simple alternative to the method known from the prior art.
• About try-and-see: “the case law acknowledges that, in certain cases, a skilled person may adopt a "try and see" attitude and, in these cases, there is not need to have any sort of expectation” .

EPO T 0688/14 - link

[line breaks added for legibility]


25. The question whether a skilled person would do something may be answered by assessing first whether there was any motivation or incentive for the skilled person to do it and, if this question is answered in the positive, to assess then the expectations of the skilled person for doing it.

25.1 As regards the first question, although the case law defines the skilled person as being cautious and having a conservative attitude (cf. "Case Law", supra, I.D.8.1.3, 191), it also acknowledges that furthering the existing state of art belongs to the normal tasks of the skilled person and that routine adaptations or trials as well as the use of known alternatives do not go beyond what may be normally expected from an average person skilled in the art (cf. inter alia, T 455/91, OJ EPO 1995, 684, point 5.1.3.3 of the Reasons; T 659/00 of 1 July 2003, points 8 and 9 of the Reasons; T 769/03 of 23 September 2004, point 6 of the Reasons; T 1439/04 of 22 June 2006, point 3 of the Reasons).

In the present case, the skilled person was well aware of the commercial relevance of human factor VIII as reflected by the widespread interest for its industrial production (cf. document (3)). Thus, there is no doubt that a skilled person would be highly motivated to seek appropriate modifications, changes and alternatives to the methods for production described in the art.

In the present case, the proposed solution is part of the common general knowledge of the skilled person; it does not require the skilled person to turn to a particular prior art document, the combination of teachings from different technical fields, etc. Moreover, it neither takes incalculable risks nor goes against any prejudice, on the contrary, it relies on a basic technique that was widespread in the relevant technical field and, as put forward by  [opponent], was known to every undergraduate student.

25.2 As regards the expectations of the person skilled in the art, the board considers that they are always directly associated with the intended purpose and thus, intrinsically linked to the formulated technical problem. When the intended purpose or the technical problem are formulated in very ambitious terms, such as the achievement of a significant improvement or a surprisingly advantageous effect over the prior art, the expectations of the skilled person to succeed are correspondingly more difficult to be fulfilled. The expectations to succeed are certainly much greater, when the intended purpose or the technical problem are formulated in less ambitious terms, such as in the present case, namely the provision of a simple alternative to the method known from the prior art.

25.3 It is also worth noting the case law dealing with the assessment of an expectation of success for what in this case law has been called a "try and see" situation. According thereto, there is a difference between the expectation to succeed and the certainty to success, the latter not being required for deciding on a lack of inventive step (cf. "Case Law", supra, I.D.7.1, 185). Indeed, the case law acknowledges that, in certain cases, a skilled person may adopt a "try and see" attitude and, in these cases, there is not need to have any sort of expectation (cf. "Case Law", supra, I.D.7.2, 187). Whilst  [opponent] argues that this situation applies to the present case,  [patentee] argues that, in the present case, the skilled person would have adopted a sceptical attitude and not a "try-and-see" attitude.

25.4 The board agrees with   [patentee] that document (8) discloses that vWF not only overcomes the tendency of the recombinant factor VIII to associate with the CHO membrane but also to stabilize and protect it from proteolysis by acting, in the words of [patentee],  as a blanket or chaperone (cf. page S10, left-hand column, last full paragraph of document (8)). However, contrary to [patentee], the board does not consider that, in view of the effects of vWF, there were reasons for a skilled person to adopt a sceptical attitude when looking for a method for the production of recombinant human factor VIII without co-expression of vWF.

In the board's view, document (8) not only informs the skilled person of the presence of several problems when trying such a method but it also provides means and measures to overcome them, such as the selection of available host cell lines with low proteolytic activity. Indeed, these problems were already known in the art and means and measures to solve them were also provided therein, such as the use of protease inhibitors in document (22). None of these means and measures is excluded from the scope of claim 1 of the auxiliary requests. There was no reason for a person skilled in the art to ignore all the information at hand and to select the worst possible known system or method when facing a "try-and-see" situation. It is worth noting here that, in the present case, the skilled person was not looking for an improvement or a surprisingly advantageous effect, but only for an alternative method.

26. It follows from the above that the person skilled in the art could and, in the board's view, would have modified the system described in document (8) by applying conditions of high ionic strength, i.e. increasing the concentration of at least one of the ionic substances listed in claim 1.

27. As a further argument to support inventive step, [patentee] referred to document (18) as providing an alternative for replacing the vWF in the method disclosed in document (8) which was much closer to the co-expression system disclosed in document (8), namely a co-expression of human factor VIII with the antibody BO2C11 whose binding site for factor VIII includes or overlaps the factor VIII binding site for vWF. The board does not agree and considers that, as stated in the case law, "the mere fact that it is possible to imagine other, more or less obvious solutions does not necessarily imply that an invention involves an inventive step, or can be regarded as an inventive selection" (cf. T 214/01 of 7 March 2003, point 3.11 of the Reasons; T 190/03 of 29 March 2006, point 14 of the Reasons). In the present case, the alleged presence of another possible obvious solution is not relevant and does not change the findings of obviousness for the proposed solution, i.e. the method of claim 1.

28. [Patentee] has also referred to what has been called in the case law "secondary indicia" for supporting an inventive step (cf. "Case Law", supra, I.D.10, 243). The board is however not able to follow this argumentation.

28.1 Although the case law acknowledges that, in certain situations, a simple solution may be indicative of inventive step (cf. "Case Law", supra, I.D.10.7, 249), this is not always the case. In the decisions dealing with this situation, the simple solution did not lower the yield of the method and/or the quality of a product known in the art; the product being of commercial interest and produced in industrial settings. Moreover, in most cases, the simple solution brought about a surprising (functional) improvement and/or resulted in an improved effect. However, even though the commercial interest of human factor VIII was well-known (inter alia, document (3)) and reference is made in the patent to 10 L bioreactors (cf. paragraphs [0076] and [0150]; see also page 24, Example 11 of the patent), the claimed method is neither limited to the large-scale production in an industrial setting nor does it require to achieve any surprising effect or improvement at all.

28.2 [Patentee] has also referred to what has been called in the case law the "time factor", namely the time lapsed between the publication of the closest prior art (document (8), 1994) and the filing date of the patent (2006), as an additional indication of inventive step. Again, even though the case law acknowledges that the time factor may in certain cases be indicative of inventive step (cf. "Case Law", supra, I.D.10.3, 246), this is not always the case. The failure to adopt an obvious solution has been associated with a variety of possible causes, in particular, those related to commercial reasons such as the avoidance of investment costs involved in the adoption of a new technique on an industrial scale (cf. T 123/97 of 10 September 1998, point 2.4.5 of the Reasons; T 516/08 of 16 December 2009, point 10 of the Reasons). Moreover, in the present case, the time lapsed between the publication date of the industrial production of recombinant human factor VIII in serum-free conditions (mid- or in the late nineties; cf. documents (3) and (8)) and the priority date of the patent (early 2005) does not compare with the time lapsed in most of the cases underlying the relevant decisions referred to in the case law (over 20, 60, up to 100 years).

29. In view of all these considerations, the board arrives at the conclusion that the auxiliary request does not fulfil the requirements of Article 56 EPC.

Conclusion

30. In the absence of a request that fulfils the requirements of the EPC, the patent must be revoked.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.

T 0939/16 - AR's not decided on by the OD

Key points

• This decision concerns an opposition appeal. The decision touches upon numerous interesting aspects.
• Firstly, the admissibility of AR-1 to 3, which correspond to requests filed before the OD (one month before the oral proceedings before the OD). The OD had found the Main Request allowable and therefore the OD did not consider these requests. Article 12(4) RPBA 2007 applies. The Board considers that for such a scenario, Article 12(4) RPBA 2007 does not provide a ground for holding the requests inadmissible; the Board also sees no other grounds for excluding these requests. 
• I note that the Board does not assess whether the requests were late-filed or not before the OD.
  
• About admissibility of AR-8 filed at the end of the oral proceedings before the Board: this request can not be held inadmissible only because it was filed late in the procedure, because the matter of how a particular claim feature was to be interpreted, was only raised in the appeal proceedings during the oral proceedings before the Board. Importantly, the Board adds that an earlier discussion of precisely hat issue already before the OD is not relevant for the admissibility.  
• The Board: “Grundsätzlich sollte der Beschwerdegegnerin [patentee], die erst während der mündlichen Verhandlung mit diesem Einwand konfrontiert wurde, daher die Gelegenheit gegeben werden, diesen Einwand auszuräumen. Somit kann allein der Umstand der späten Einreichung eine Nichtzulassung des Hilfsantrags 8 nicht rechtfertigen.”
• However, AR-8 is not admitted because it prima facie raises issues of Article 123(2).
  
• For inventive step, the Board considers the minimum temperature recited in the claim (which is a distinguishing feature) to be an arbitrary choice (or arbitrary variation) which does not contribute to inventive step because choosing arbitrarily is routine.
• “Da insbesondere nicht gezeigt wurde, dass diesem Wert von 90 °C eine besondere Bedeutung zuzumessen ist, ist das Merkmal M2 weder zielgerichtet noch kritisch, sondern als rein willkürlich gewählt zu betrachten. Diese willkürliche Wahl einer hohen Temperatur bei der Polyesterschmelzstrangzerteilung stellt jedoch wegen ihrer Beliebigkeit lediglich eine Routinetätigkeit dar, die im Rahmen des handwerklichen Könnens des Fachmanns liegt, ohne dass es ein erfinderisches Zutun seinerseits bedürfte.” (emphasis added).
  
• The Board also notes that for the question whether the CPA document  D2 discloses a certain claim feature, the broadest technically meaningful interpretation of the claim feature is to be used.
• Was den Begriff "Dosiereinrichtung" gemäß Merkmal M7 betrifft, wurde von der Beschwerdegegnerin nicht gezeigt, dass dieser eine eindeutige Bedeutung hat. Somit ist dieser Begriff in seiner breitesten, technisch sinnvollen Bedeutung zu verstehen.
  [...] Schließlich teilt die Kammer die Meinung der Beschwerdegegnerin nicht, wonach dem Begriff "Dosiereinrichtung" im Hinblick auf die Gesamtoffenbarung der Patentschrift eine eingeschränkte Bedeutung zuzuordnen sei. Wie im vorherigen Absatz ausgeführt, muss diesem Begriff seine breiteste technisch sinnvolle Bedeutung gegeben werden.

EPO T 0939/16 -  link

Entscheidungsgründe

Entgegenhaltung D8 - Zulassung

1. Während der mündlichen Verhandlung vor der Kammer nahm die Beschwerdeführerin, bei der Erörterung der Frage der erfinderischen Tätigkeit Bezug auf die Entgegenhaltung D8, um ihre Argumentation zu stützen, dass das Merkmal M2 des erteilten Anspruchs 1 im Beispiel 3, Variante B, der D2 implizit offenbart sei.

1.1 Jedoch beantragte die Beschwerdegegnerin, die Entgegenhaltung D8 nicht ins Verfahren zuzulassen.

1.2 Was die Zulassung der D8 betrifft, ist zunächst zu klären, wann diese Entgegenhaltung im Verfahren zum ersten Mal herangezogen wurde, was zwischen den Parteien strittig war.

In diesem Zusammenhang brachte die Beschwerdeführerin vor, dass D8 bereits seit dem Beginn des Beschwerdeverfahrens im Verfahren sei, da sie einerseits in D2 zitiert und anderseits das Prioritätsdokument der D3 sei, wobei D2 und D3 zweifellos im Verfahren seien. Jedoch spielt die Tatsache, dass D8 in D2 zitiert ist, oder dass D3 im Verfahren ist, für die Frage, ob das Dokument D8 bereits im Verfahren ist, keine Rolle, und dies, unabhängig davon, ob D8 das Prioritätsdokument von D3 ist oder nicht. Es ist lediglich zu klären, wann die Entgegenhaltung D8 per se zum ersten Mal von einer der Parteien herangezogen wurde. Diesbezüglich kam die Kammer in der mündlichen Verhandlung im Einklang mit den Parteien zu dem Ergebnis, dass die Entgegenhaltung D8 von der Beschwerdeführerin zum ersten Mal in der mündlichen Verhandlung vor der Kammer herangezogen wurde.

T 1248/12 - Data privacy is not a technical problem

Key points

• This examination appeal concerns a patent application for a computer-implemented "privacy-preserving data mining protocol". This involves collecting data from sources, e.g. patient records, and aggregating the data together, as well as removing individually identifiable information. For details, I must refer to the - somewhat unusual - claim 1 below ("the Board had doubts whether claim 1 defined the data processing performed by the various processors in a sufficiently clear manner").
• Turning to inventive step, "it is established case law that non-technical features cannot contribute to inventive step. Therefore, non-technical features may legitimately be part of the problem to be solved (T 641/00 - Two identities/COMVIK), for example in the form of a requirement specification given to the skilled person to implement."  
• According to the Board, "de-identifying data, by removing individually identifiable information, and by aggregating data from a plurality of sources, is not technical. It aims to protect data privacy, which is not a technical problem. The problem of data privacy is not synonymous with data security. Data privacy concerns what information to share and not to share (and making sure that only the information that is to be shared is shared), whereas data security is about how to prevent unauthorised access to information."
• As a comment, a feature is indeed excluded under the Comvik approach if it "contributes only to the solution of a non-technical problem, e.g. a problem in a field excluded from patentability" (GL G-VII,5.4). However, I'm as of yet not convinced that features which are more elegant than "removing individually identifiable information" (e.g. adding carefully calibrated noise data) should be excluded for inventive step. 
• As a further comment, the Board could have explained in more detail why data privacy is not a technical problem. The Board's observation that it is not synonymous with data security, is, of course, correct as such but does not fully exclude that it is a technical problem; clearly, data security is not the only technical problem. In the same way, the observation that "data privacy concerns what information to share and not to share" does not seem to provide fully conclusive reasoning, in particular, it seems to assume some rule or case law stating that considerations about sharing information are never technical (i.e. the major premise in the syllogism is stated at least not explicitly). 

EPO T 1248/12 -  link

VI. Claim 1 of the main request reads:

A Privacy Preserving Data-Mining Protocol, operating between a secure "aggregator" data processor and at least one of "source-entity" data processor, wherein the "aggregator" and the "source-entity" processors are interconnected via an electronic data-communications topology, and the protocol includes the steps of:

A) on the side of the "aggregator" processor:
(i) from a user interface--accepting a query against a plurality of the predetermined attributes and therewith forming a parameter list,
(ii) via the topology--transmitting the parameter list to each of the "source-entity" processors,
(iii) via the topology--receiving a respective file from each of the "source-entity" processors,
(iv) aggregating the plurality of files into a data-warehouse,
(iv[sic]) using the parameter list, extracting query relevant data from the data-warehouse,
(vi) agglomerating the extract, and
(vii) to a user interface--reporting the agglomerated extract; and
B) on the side of each processor of the at least one "source-entity" processors:
(i) accumulating data-items wherein some of the data-items have privacy sensitive micro-data,
(ii) organizing the data-items using the plurality of predetermined attributes,
(iii) via the topology--receiving a parameter list from the "aggregator" processor,
(iv) forming a file by "crunching together" the data-items according to the parameter list,
(v) filtering out portions of the file which characterize details particular to less than a predetermined quantity of micro-data-specific data-items, and
(vi) via the topology--transmitting the file to the "aggregator" processor.

IX. Claim 1 of the third auxiliary request adds to the second auxiliary request:

"which may include specific individuals' names or IDs" at the end of feature A)(i);
"including de-identified results" after the word "file" in feature A)(iii);
"wherein 'crunching together' includes de-identifying results by aggregating results to a tabular report" at the end of feature B)(iv).

3. Main request, inventive step

3.1 The examining division found that the data mining protocol in claim 1 was an administrative scheme, which, when considered on its own, constituted excluded subject-matter according to Article 52(2) and (3) EPC. The examining division could not identify any technical problem solved by the data mining. In the examining division's opinion, the aim of the data processing was rather to comply with legal requirements.

3.2 The Board shares the examining division's view that de-identifying data, by removing individually identifiable information, and by aggregating data from a plurality of sources, is not technical. It aims to protect data privacy, which is not a technical problem. The problem of data privacy is not synonymous with data security. Data privacy concerns what information to share and not to share (and making sure that only the information that is to be shared is shared), whereas data security is about how to prevent unauthorised access to information.

3.3 It is established case law that non-technical features cannot contribute to inventive step. Therefore, non-technical features may legitimately be part of the problem to be solved (T 641/00 - Two identities/COMVIK), for example in the form of a requirement specification given to the skilled person to implement.

T 0787/14 - Plausibility and patient subgroup

Key points

• In this opposition appeal, the issue is inventive step of the vaccine of claim 1 over D10.
• "[claim 1] differs from the disclosure of document D10 as regards the composition used, namely in that [details of the composition] and further in that the patient has been pre-immunised at least six months previously and within 1 year of the patient's birth with a conjugate of a capsular saccharide of an organism other than N. meningitidis and a diphtheria toxoid or CRM197."
• " the board notes that the patent is silent on the pre-immunisation status of the patients enrolled in the clinical trial V59P2 [described in the examples of the patent]"
• "Thus, from the information provided in the patent for clinical trial V59P2, the skilled person cannot conclude that the patients [...] represented the subgroup of patients to be treated according to the embodiment under consideration."
• " Accordingly, any advantageous effect of the composition that may be seen in clinical trial V59P2 cannot be taken into account in assessing inventive step. "
• About plausibility: "Nor can the appellant rely on post-published documents D14, D30, D34 and D35: The assessment of inventive step is to be made at the effective date of the patent on the basis of the information in the patent together with the common general knowledge then available to the skilled person. The verification of whether or not the claimed solution actually solves the problem, i.e. whether the claimed subject-matter actually provides the desired effect, must be based on the data in the application in order to avoid that an invention is based on knowledge available after the effective date only. "
• The Board then deals with the question of whether the distinguishing features relating to the composition are obvious and considers that the skilled person is "well aware" of these features based on prior art documents. Finally, the particular combination of features does not make the claim inventive.
• "The specific vaccine considered here by the board (see point 14 above) would be one of these vaccines. However, no surprising technical effect is linked to this vaccine in the specified patient population. Thus, in terms of its technically relevant effects, this vaccine is not distinguished from any of the other possible vaccines, i.e. it is a selection of one of several equally available alternative solutions to the problem formulated. Such a situation is referred to in the jurisprudence as an "arbitrary selection". Arbitrary selections are considered to be obvious"

EPO T 0787/14 - link

Closest prior art

6. In the decision under appeal, document D10 was considered to represent the closest prior art (see Reasons, point 1.3). The appellant maintains that document D26 rather than document D10 is the closest prior art.

[D10 Rennels M. et al., The Pediatric Infectious Disease Journal (2002), vol. 21, pages 978 to 979]

7. In accordance with established jurisprudence, the closest prior art for assessing inventive step is normally a prior art document disclosing subject-matter conceived for the same purpose or aiming at the same objective as the claimed invention and having the most relevant technical features in common, i.e. requiring the minimum of structural modifications (see Case Law of the Boards of Appeal of the EPO, 8th edition 2016, section I.D.3.1).

8. The invention concerns vaccines against Neisseria meningitidis (N. meningitidis) (also referred to hereinafter as "meningococcal vaccines" or "meningococcal conjugates"), in particular vaccines based on conjugated capsular saccharides from multiple meningococcal serogroups (see paragraph [0001] of the patent). [...]

T 1317/13 - Examples already published / bonus effect

Key points

• In this examination appeal, D1 is a PCT application "published shortly before the priority date of the present application. The applications have two inventors in common. The disclosure content of document D1 is largely identical to that of the latter, and in particular, all three examples are identical." Hence, the complete experimental disclosure of the application at issue was already prior art by D1.
•  Claim 1 is directed to a medicament for the treatment of  " gout, gouty arthritis or pseudogout" using an antibody, the antibody ACZ885 was used in the examples of the application and also in D1.
• The closest prior art is D5 about the colchicine standard therapy of gout.
• " the board is satisfied that document D5 teaches the skilled person that: (i) increased production of IL-1beta is the trigger for the auto-inflammation in gout as in other auto-inflammatory diseases; (ii) administration of colchicine completely blocks the crystal-induced production of IL-1beta and leads to greatly reduced inflammation and, (iii) gout patients were anticipated to benefit from treatments designated to block IL-1beta." 
• " Document D1 discloses compounds suitable for blocking IL-1ß in patients suffering in general from auto-inflammatory syndromes, in particular also the ACZ885 antibody as an embodiment of the antibodies defined in claim 1." 
• The Board concludes that claim 1 is obvious. 
• The applicant argues a surprising further effect. " The appellant further argued that anti-IL-1beta antibodies had an additional effect on pain perception which was not reported in any of the cited prior art, in particular not in documents D1 and D5, which was however an effect which was indeed achieved by the antibody ACZ885 as demonstrated by the results in the post-published document D9." 
• The Baord considers this a bonus effect.
• The applicant "has further submitted that "arguments about a 'bonus effect' were often used when there was effectively a 'one-way-street' situation", which according to the appellant was a situation "in which the skilled person was inevitably guided towards a particular destination, such that any surprising effects would be a 'bonus' which would have been achieved anyway." However, the present situation was not a one-way-street situation since document D20 described various different approaches to inhibiting the IL-1 system." 
• This argument does not convince the board to change its conclusion in point 22 above either. In fact, decision T 21/81, supra, considers a situation in which it was already obvious that the skilled person would arrive at something falling within the terms of a claim, because an advantageous effect was expected to result from the combination of teachings of the prior art documents, resulting in a situation in which an extra effect cannot establish inventive step. Accordingly, a "one-way-street" situation in the sense defined by the appellant cannot be inferred as a mandatory prerequisite for the principle established in this decision.

EPO T 1317/13 - link

Main request - claim 1

3. The claimed subject-matter (see section II) is a medicament for use in the treatment of auto-inflammatory syndromes, namely gout, gouty arthritis or pseudogout (for the ease of reading the three disorders will in the following be referred to as "gout"). The medicament is defined as comprising a human interleukin (IL)-1beta binding antibody characterised by comprising a first and second domain defined by particular amino acid sequences. The anti-human IL-1beta monoclonal antibody ACZ885, an example of an antibody falling under this definition, was used in the examples of the application. The antibody ACZ885 was known to the skilled person from the disclosure in document D1.

Closest prior art

4. A frequently applied line of therapy for treating patients suffering from auto-inflammatory diseases such as gout at the priority date of the application was the oral administration of colchicine. This treatment is in particular able to resolve the initial inflammatory phase of gout but was also known to be poorly tolerated because of predictable gastrointestinal side-effects (see e.g. document D5, page 238, right-hand column, lines 15 to 17; page 239, right-hand column, lines 10 to 12, and document D12, e.g. abstract, last sentence, and Table 1, final part).

5. The appellant agreed with the board and the examining division that document D5, disclosing inter alia the colchicine standard therapy of gout (see point 4), represented the closest prior art for the assessment of inventive step for the claimed subject-matter.

T 1045/12 - Equally likely options

Key points

• " The appellant further argued that the solution to the objective technical problem taught by D3 was one of several, equally likely options, the others being  [...]. In the presence of several, equally likely options, the board had to provide a reason why the skilled person would have selected the claimed option. The board is not persuaded by this argument because the fact that there are other options has no bearing on the obviousness of one specific option. Furthermore, if all options are equally likely, then the invention merely results in an obvious and consequently non-inventive selection among a number of known possibilities"
• The Board then refers to " Guidelines for Examination, G VII 3.1 (i), November 2018" However, that paragraph is about common general knowledge and does not seem very relevant.
• The Board gave this decision publication code [C] but did not highlight a particular paragraph. I find the paragraph about 'equally likely options' the most interesting. I am not sure why the Board refers to the Guidelines and not to the Case Law Book (e.g. I.D.9.18.9). 

EPO T 1045/12 -  link

4. Inventive step, Article 56 EPC 1973

4.1 According to the reasons for the appealed decision regarding the then third auxiliary request (the same as the previous version of the claims in these appeal proceedings), the subject-matter of claim 1 differed from the disclosure of D4 in that the controller responded to the user logging out by allowing data processing to finish if the log out took place during said data processing. No technical problem could be derived from the difference feature, as it was merely a security policy. The skilled person would have implemented the policy with "the tools at hand", for instance by applying the teaching of D3, relating to implementing this security policy in UNIX.

T 2057/12 - Closest prior art and technical field

Key points (I)

• This decision is about the meaning of the closest prior art and was already discussed here. 
• The Board: " [The problem-and-solution] approach presupposes that the skilled person would have indeed possibly been confronted, in the framework of his activities, to the item of prior art selected as closest prior art, and would have then recognised the existence of the objective problem to be solved." 
• " It is, however, hardly conceivable that the skilled person would decide to ignore the purpose of an object or process he is using during his normal activity to modify said object or process by getting rid of one of the features essential for said purpose." 
• The Board agrees with T2201/10 (same Board different composition), that " if the claimed invention distinguishes from the [a prior art document] only in the modification of a feature disclosed as essential in the context of said prior art [document]", this is "sufficient as such to conclude that the invention is not obvious vis-à-vis this prior art"

Key points (II)

• More important is the Board's analysis of whether claim 1 is obvious over A6 (or A11), which is about an electrical connecting system on a printed circuit board, whereas the claimed connection element is fixed to a glass pane of a motor vehicle.
• " The question arises then whether document A6, or A11, may indeed be considered to illustrate the closest prior art ". The Board acknowledges that "the closest prior art normally discloses an item of prior art which shares a common purpose with the claimed subject-matter". The Board notes however that the claimed invention can be defined as a glass panel with an electrical connection, or as an electrical arrangement installed on a glass panel. The Board : "the principles [of established case law] recalled above would then make the decision on obviousness dependent on the manner the independent claims are drafted and would be clearly contrary to an objective assessment of the inventive merits of a claimed invention" .
• The Board notes that "it can indeed not be excluded, beforehand, that real-world circumstances would have led a skilled person in a certain technical field to have given attention or even used an item of prior art from a completely different technical field. Such a scenario, rather unusual, cannot rely on mere speculation, but must be supported by sufficient evidence and argumentation." 
• The Board proposes to do the inventive step analysis in two ways: "arguments or evidence should be provided as to why the skilled person in a specific technical field would have indeed envisaged selecting a document in a remote field of technology as closest prior art or, alternatively, whether he would have indeed considered adapting a prior art disclosure originating from his technical field to implement it in a remote technical field." 
• The Board then assess, firstly "whether the skilled person in the art of glass panes for motor vehicles would have considered documents pertaining to the field of PCBs such as A6, or A11, as possible starting points." (and finds that this is not the case)
• The Board secondly assess: "the skilled person to be considered would be the skilled person in the field of PCBs. In that situation, the selection of A6, or A11, as closest prior art is justified by the mere fact that both documents belong to his field of activities. The question to be elucidated is then whether the skilled person in the field of PCBs would have indeed envisaged modifying the prior art disclosures of A6, or A11, so as to use them on glass panes for motor vehicles. Relying on the technical effects provided by a glass pane identified above (cf. section 3.2.1) this would imply that the skilled person would concern himself with the protection of passengers of a vehicle from the effects of the wind. Here again, in the absence of evidence or convincing argumentation as to why the person in the field of PCBs would have tackled such issues, the objection of lack of inventive step fails as unrealistic, under the circumstances." 
• As a comment, the somewhat weaker point is that the Board does not explain how to identify "the skilled person". In the first approach, the skilled person (in the art of glass panes) depends on the "the manner the independent claims are drafted". I think that the second approach is correct, but in order to be consistent, the sentence about "the selection of A6, or A11, as closest prior art is justified by the mere fact that both documents belong to his field of activities"  should have been omitted. It mixes the first and second approach. In the second approach, any arbitrary document can be taken as "starting point" for the problem-and-solution approach, great care must be given to the requirement that "sufficient evidence" must be given that the skilled person would give attention to the different technical field. But if there would have been some evidence on file that PCB engineers are frequently thinking about "the protection of passengers of a vehicle from wind", the claim could have been obvious starting from A6. 

EPO T 2057/12 -  link

3.1.3 Plugs or clamping systems of the kind used according to the present invention are known from A6, or A11. In order to arrive at the claimed subject-matter, the skilled person would however have to renounce to the amplification function provided by the high frequency body of A2 and to replace it by the connector means known from A6, or A11. This would imply renouncing to a feature presented as essential in the context of A2.

In the appellant's view, these findings are not relevant in the context of the invention where the presence of an amplifier is not addressed and not even required, though the invention also covers the field of antennas. The definition of the objective technical problem to be solved by the claimed invention is the only aspect that really matters when deciding on how the closest prior art is to be modified. The purpose which leads to modifying the closest prior art is, in this respect, irrelevant.

T 0765/12 - Two strontiums salts

Key points

• In this opposition appeal. the Board agrees with inventive step of a product claim for a pharmaceutical tablet, being a tablet or capsule, "comprising only two strontium salts, wherein said strontium salts consists (sic) of strontium carbonate and strontium chloride" . Good to see that you can still get a pharmaceutical product claim (i.e. for any disease) with two inorganic salts as active ingredient.
• The Board is also careful about what the closest prior art D6 teaches, and does not stop at the abstract.
• " The title of [D6] is "Effects of Low Doses of Strontium on Bone Quality and Quantity in Rats". In the abstract it is stated that strontium has been shown to increase bone mass when given at low doses (abstract, first and last sentences). However, the information gained from the experimental section of D6 does not support such a finding:" (follows an analysis of the experimental results in D6). In sum, from the data provided by D6, which partly show non-significant findings, it is not clear how strontium, especially strontium chloride, will influence bone and cartilage disorders, specifically those that require strengthening of the bone material. D6 merely conveys the message that administration of strontium chloride may affect bone formation and resorption..
• Therefore, the claimed subject-matter is inventive in view of D6. 

Claim 1 of the Main Request
"1. A pharmaceutical composition comprising only two strontium salts, wherein said strontium salts consists (sic) of strontium carbonate and strontium chloride for oral administration in the form of a tablet, a capsule, or a dissolvable tablet."



EPO T 0765/12 - link

3.2 Inventive step

The present invention relates to pharmaceutical compositions intended for use in the treatment of cartilage and bone disorders, especially for use in the treatment of osteoporosis (paragraphs [0001] and [0009]). Specific strontium salts are used to provide an active ingredient having high availability and fewer side-effects (paragraph [0012]). In particular, the combination of strontium chloride and strontium carbonate has been found to be advantageous (paragraph [0050], examples 2 to 4, 6, 7, 11, 12 and 17, claims 5 to 8 as granted).

T 2570/11 - Prior art establishing as potential drug target

Key points

• Claim 1 is a second medical use claim for the use of (any kind) of antibody against IL-17, for the treatment of multiple sclerosis (MS). 
• The closest prior art D2  establishes IL-17 as a potential drug target for the treatment of MS. Furthermore, skilled person would have all the necessary tools to proceed since animal models for MS were available as were [...] IL-17 antibodies, which had already been successfully tested as therapeutics for other diseases.
• The patentee strongly contests the Board's finding of obviousness in view of D2, raising the following points, which are considered by the Board:

• o   Is up-regulation of the IL-17 protein in MS disclosed in document D2?
  o   Was the role of IL-17 in the "cytokine puzzle" understood?
  o   Was it known that IL-17 was a "bad" cytokine?
  o   Could in the absence of proper testing IL-17 be identified as a drug target?
  o   Was the knowledge that IL-17 was a pro-inflammatory cytokine sufficient to identify it as a drug target in MS?
  o   Were the animal models used in the patent for testing particular?
  o   Would the skilled person have dismissed using the tools [antibodies] disclosed in document D4?
• Patentee also points out that clinical tests with anti-TNF-alpha for MS had failed, even if such antibodies were (similarly) known in the art as a pro-inflammatory cytokine with damaging effect in MS.
• 
  
  The Board “As far as the failure of an anti-TNF-alpha therapy for MS is concerned, the board concurs with the respondents that TNF-alpha is not IL-17 and that failure of a MS therapy based on one validated target for treatment of MS, here TNF-alpha, would not prevent the skilled person from persisting and to consider testing other validated targets for the treatment of MS, here IL-17.” 

T 2570/11 - link

Reasons for the Decision

Main Request - claim 1 (as granted)

3. The claimed subject-matter is in the form of a Swiss-type medical use claim, the therapeutical agent being "an inhibitor of IL-17 activity", e.g. an antibody binding to IL-17 or its receptor[;] and the therapeutic indication being multiple sclerosis (MS; see section I).

Closest prior art

4. To assess whether or not a claimed invention meets the requirements of Article 56 EPC, the boards of appeal apply the "problem and solution" approach, which involves the identification of the closest prior art, the formulation of the objective problem to be solved in view of the closest prior art and the effects achieved by the claimed invention and its solution.

5. In accordance with the established case law of the boards of appeal, the closest prior art is a teaching in the prior art providing a promising springboard towards the claimed invention, being normally a document disclosing subject-matter conceived for the same purpose or aiming at the same objective as the claimed invention (Case Law of the Boards of Appeal of the European Patent Office, 8th edition 2016, I.D.3.1).

T 0790/11 - Preliminary results clinical trial not prejudicial

Key points

• The compound sorafenib was known for treatment of cancer. The Board finds a claim directed to a composition of sorafenib tosylate with a cytotoxic agent or a cytostatic agent to be novel. The Board considers the subject-matter to involve selections from three lists, firstly of the compound sorafenib from a list, secondly of the tosylate salt form, and thirdly of the presence of  an additional ingredient.  
• The Bard acknowledges that combination therapy is known in cancer treatment. Still the claims is considered non-obvious, even directed to combination therapy with sorafenib tosylate in general (not restricted to specific additional active ingredients) because advantageous effects are shown for " the results provided in the examples of the patent in suit which demonstrate improved efficacy and acceptable tolerability of sorafenib with a variety of different cytostatic or cytotoxic compounds in a number of different types of cancer "
• A separate inventive step attack was based on announcement of clinical trials. The document reports on preliminary results of an ongoing phase I clinical pharmacokinetic and pharmacodynamic study of a compound BAY 43-9006. BAY 43-9006 is described as a potent raf-kinase and, based on first preliminary results, so far appears to be effective and well-tolerated. 
• The key reason of the Board "irrespective of whether the structure of BAY 43-9006 was known to be sorafenib free base, in the board's judgement, based on the limited preliminary results of a still ongoing clinical study, no conclusion can be drawn as to the potential behaviour of this compound or any of its salts in combination therapy. Based on the available information, the skilled person could not have reasonably expected that sorafenib tosylate in combination with cytostatic/cytotoxic agents would exhibit such a good balance between efficacy and tolerability."

EPO T 0790/11 -  link

Summary of Facts and Submissions

Claim 1 of auxiliary request 2 reads as follows:

"1. A composition comprising an aryl urea compound which is a raf kinase inhibitor and (a) a cytotoxic agent or (b) a cytostatic agent (c) or a pharmaceutically acceptable salt of (a) or (b) wherein said aryl urea compound is a tosylate salt of N-(4-chloro-3-(trifluoromethyl)phenyl-N'-(4-(2-(N-methyl-carbamoyl)-4-pyridyloxy)phenyl)urea." (hereinafter sorafenib tosylate)

IX. At the beginning of the oral proceedings before the board, appellant 1 withdrew the main request and auxiliary request 1 (see point III above). Auxiliary request 2 (see point III above) was its new main request, and auxiliary request 3 (see point VIII above) was the sole auxiliary request. That the version as considered allowable by the opposition division had become appellant 1's new main request amounted to a withdrawal of appellant 1's appeal and to a change of its main procedural request into the dismissal of appellant 2's appeal (for practical reasons, the designation of the parties as appellant 1 and 2 was maintained).

Reasons for the Decision

1. The appeal is admissible.

2. Admission of documents (14) to (21) - Article 12(4) RPBA

[...] 2.3 Hence, the board decided to admit documents (14) to (21) into the proceedings pursuant to Article 12(4) RPBA.

Main request

[] 4. Novelty (Article 54 EPC)

4.1 In the decision under appeal, the opposition division decided that the subject-matter of auxiliary request 2 was novel over document (1). This finding was challenged by appellant 2.

4.2 Claim 1 of the main request is directed to a composition comprising a tosylate salt of sorafenib and a cytotoxic or cytostatic agent or pharmaceutically acceptable salts thereof. The claimed compositions are useful in the manufacture of medicaments for the treatment of cancer (see claims 12, 25 and 26).

T 0259/15 - Reasonable expectation of succes and clinical trials

Key points

• In this opposition appeal for a patent directed to a buprenorphine patch for use in treating pain with a dosing interval of at least 7 days, the buprenorphine patch as such was known. The main argument of patentee in support of the presence of inventive step was that the skilled person would not have started such clinical tests (with 7 day intervals) in the absence of a reasonable expectation of success.
• The Board notes that the concept of " reasonable expectation of succes" comes from the case law in the field of biotechnology. In connection with pharmaceutical inventions as claimed, the Board notes that " the concept of "reasonable expectation of success" does not apply when the implementation and the testing of an approach suggested by the prior art do not involve any particular technical difficulties. In such situations the skilled person would prefer to verify whether the potential solution that he has conceived works, rather than abandon the project because success is not certain." 
• The fact that human clinical trials are necessary does not change this in the abstract. For the clinical trials necessary in the present case, the Board notes that " the experimentation required to verify whether the patch of D1 can be used effectively for convenient pain therapy is relatively simple and does not involve major risks for the volunteers." 

EPO T 0259/15 -  link

Reasons for the Decision

MAIN REQUEST (PATENT AS GRANTED)

1. Inventive step

The invention underlying the patent in suit relates to a transdermal delivery device for the administration of buprenorphine, an opioid analgesic agent.

Thus, in the Board's opinion, the skilled person would have observed that the device of example 3 of D1 could be used for a dosing interval of at least 7 days by performing tests which simply require applying the patch of D1 and monitoring the level of buprenorphine in the blood.

1.3.4 In line with the appealed decision, the main argument of the respondent [patentee] in support of the presence of inventive step was that the skilled person would not have started such clinical tests in the absence of a reasonable expectation of success.
[...]

T 1658/12 - Novelty based on omitting a step

Key points

• In this case, novelty was based on omitting a step arguably used in D2, namely by essentially specifying in the claim that the presentation of a user-identifier to the reader leads directly to the dispensing of a user-appropriate item, without any further intervention by the user. The Board holds the fact that in some claims of D2, no such further intervention by the user is mentioned, not prejudicial to novelty, essentially because in all the examples of D2 a further user intervention is used.
• The Board acknowledges inventive step for claim 1 below, wherein essentially "user-appropriate" item, e.g. a promotional item, is dispensed based on the costumer identity read from e.g. a personal card, and on "pre-determined criteria", without further input from the customer. The Board considers that " user-appropriate item" means an item that " the operator wants to dispense to the user" .

EPO Headnote
In determining what is made available to the public within the meaning of Article 54(2) EPC by a prior art patent document, it must be borne in mind that it is the description which chiefly serves to disclose the invention in a manner that it may be carried out, whereas the chief function of the claims is to define the subject-matter for which protection is sought. Where a combination of features is found only in the claims (or only in the claims and a "Summary of the Invention" which merely recites the features of the claims), it must be very carefully considered whether this combination truly corresponds to the technical teaching of the document as it would be understood by a skilled person, or whether it is merely an artefact of the claim drafting process aimed at obtaining maximal scope of protection [...].


EPO T 1658/12 - link

Claim 1

"A system to dispense at least one user-appropriate item on-site, said system comprising:
a. a reader (300) capable of reading user-specific information  from a user-identifier associated with a user;
b. coded instructions to dispense at least one user-appropriate item based on predetermined criteria and said user-specific information ;
c. at least one storage means  capable of storing a plurality of items;
d. a dispensing means coupled with respective at least one storage means ; and
e. a processor coupled to said dispensing means () and to said reader, said processor  capable of executing said instructions to actuate the dispensing means  to dispense at least one user-appropriate item based on said user-specific information and said predetermined criteria, the system being configured such that once the processor accepts the user-specific information, it executes an instruction to actuate said dispensing means ."

Reasons for the Decision

3. Differences over document D2

3.1 Document D2 was taken as the closest prior art in the the contested decision.

The analysis of the difference over document D2 in the contested decision is based on features which are no longer present in claim 1, and therefore does not need to be discussed here.

T 1523/11 - Skilled person and inventive step

Key points

• In this examination appeal, the Board adds further evidence of the publication date of the document used as closest prior art of its own motion (" In the EPO's database, the Board has located document D13, which is another copy of the same document [D1]." 
• In connection with inventive step, the Board finds that the technical field of the skilled person can be defined by the problem addressed.
• " According to the appellant, the skilled person starting from document D1 would not look for a solution to this problem in the technical field of database searching. The Board considers, however, that if the technical problem relates to index structures for searches, then the skilled person on the basis of whose knowledge and ability the obviousness of the solution is to be assessed is a person with knowledge of index structures, i.e. a person skilled in the field of database management systems. " 

EPO T 1523/11 - link

3. Document D1

3.1 Document D1 bears the heading "SP003 V1.3 part B - System issues" but mentions neither an author nor a date. The Examining Division cited it as "1st Draft of Metadata Specification SP003v1.3", authored by "EVAIN J P" and published on 11 June 2002. It apparently assumed that it corresponded to the document cited in the application as disclosing a single key index structure (see point 2.2 above).

3.2 In the EPO's database, the Board has located document D13, which is another copy of the same document. Its bibliographic details suggest that document D1/D13 is indeed the document cited in the application and was published in June 2002 in connection with the 17th TV-Anytime Forum meeting (see document D17). These details are consistent with the information on "SP003v13" given on page 2 of document D14, which reports on the meeting.

3.3 The Board further notes that document D18 confirms that TV-Anytime Forum specifications at all stages of their development have been publicly available from the Internet address "ftp://tva:tva@ftp.bbc.co.uk/Specifications/" (page 2, section "Relevant ancillary documentation"). The Board notes that document D17 mentions the same address.

3.4 In view of these findings, the Board considers the content of document D1 to be part of the prior art under Article 54(2) EPC. The appellant has not contested this and in its letter of 16 December 2016 in fact stressed that it accepts the document's publication date to be 11 June 2002.

T 2478/12 - Apple overscroll patent

Key points

• This an examination appeal of a patent application of Apple relating to the (now quite famous) overscroll.
• This patent application claims the combination of overscroll with a vertical scroll bar. The Board finds this combination not obvious, essentially because a vertical scroll  bar already provides information about when the end of document is reached.
• " D7 discloses a display apparatus with means for navigating through a displayed list of items or a document (). In order to indicate when the end of the list is reached, one or more items are temporarily displaced (). () The board points out that a scroll bar as used in D4 and D3 (or D2) already indicates that the end of a document has been reached when the vertical bar, or "thumb" () arrives at the top or bottom of the displayed document. Therefore, the skilled person would have no compelling motivation to look for further ways of indicating that the end of a document has been reached, such as by seeking to incorporate features of D7. The board considers that the incorporation of these features is not obvious but requires the benefit of hindsight." 

EPO T 2478/12 - link

Reasons for the Decision

[] 2. Claim 1 - inventive step

2.1 The present invention relates to touch-screen operated mobile devices in which scrolling through a displayed content, e.g. a document, is performed by having an object (usually a finger) make contact with the screen and moving (swiping) the object across the screen.

2.2 D4 discloses such a device. In D4 (cf. the abstract), as is common when text documents are displayed on computer devices, a vertical scroll bar is provided on the right-hand edge of the document indicating to the user the position of the displayed part in the overall document. The length of the vertical bar represents the size of the displayed portion in relation to the entire document.

2.3 The technical problem to be solved with respect to D4 can be seen as how to provide enhanced operation of the device with regard to scrolling through a displayed content piece.

2.4 In accordance with claim 1, this solution is in essence solved by:

(i) in response to detecting the object on the displayed portion of the content piece, displaying the vertical [scroll] bar overlaying the displayed portion of the content piece;
(ii) after a predetermined condition is met (e.g. when the device ceases to detect the object), ceasing to display the vertical bar while continuing to display the displayed portion of the content piece; and
(iii) after scrolling to a top of the content piece, in response to continuing to detect downward movement of the object that attempts to scroll the content piece beyond the top of the content piece, revealing a background beyond the top of the content piece and starting to reduce the length of the vertical bar.