T 0294/20 - Sufficiency (plausibility) for second medical use claim

 Key points

• "Claim 1 is drafted in the form of a purpose-limited product claim, pursuant to Article 54(5) EPC, and is directed to a compound that reduces the activity or expression of a Programmed Cell Death-1 (PD-1) polypeptide (in the following "PD-1 inhibitor") for use in the treatment of nodular lymphocyte predominant Hodgkin lymphoma (NLPHL)"
• Sufficiency of disclosure in the sense of G 2/21 is at issue (i.e., former plausibility).
• "According to decision G 2/21 (OJ EPO 2023, A85, point 77 of the Reasons), "[i]n order to meet the requirement that the disclosure of the invention be sufficiently clear and complete for it to be carried out by the person skilled in the art, the proof of a claimed therapeutic effect has to be provided in the application as filed, in particular if, in the absence of experimental data in the application as filed, it would not be credible to the skilled person that the therapeutic effect is achieved. A lack in this respect cannot be remedied by post-published evidence." 
• This intermediate conclusion of the Enlarged Board of Appeal can be understood as confirming the established case law that post-published evidence cannot be used to remedy a lack of sufficient disclosure in respect of a medical use (cf. T 609/02, headnote).
• By this statement, the Enlarged Board of Appeal can also [i.e., additionally] be seen to have endorsed the jurisprudence of the boards of appeal that attaining a claimed therapeutic effect is a limiting functional technical feature of a claim directed to the use of a substance or composition in a method of treatment (see also G 2/21, point 74 of the Reasons). 
• [...]  in decision G 2/21 the Enlarged Board of Appeal focussed on the issue of whether or not post-published evidence can be used by an applicant or patent proprietor in the assessment of Articles 83 and 56 EPC, but did not address the question of the level of proof in an application as filed required to substantiate a therapeutic effect as a prerequisite for using post-published evidence for assessing the requirements of Article 83 EPC."
• "The board therefore does not understand G 2/21 to have quashed the principles established by leading decision T 609/02 despite having qualified the term "plausibility" merely as a generic catchword. Indeed, as decision T 609/02 clearly sets out, a balance should be struck between enabling early patent protection for therapeutic uses and avoiding that the claimed invention is only completed at a later point in time. As a consequence, in order to fulfil the requirements of Article 83 EPC, the suitability of the product for the claimed therapeutic application must be derivable from the application, unless this is already known to the skilled person at the priority date (see T 609/02, point 9 of the Reasons and T 895/13, points 3 to 5 of the Reasons)."
• "The board cannot accept the appellants' [proprietors'] line of argument, that "plausible" in this context means that the "technical concept" and hence the suitability of the claimed compounds for the claimed therapeutic application is "plausible" as long as it is not shown to be "implausible". That would be in direct contradiction with the principles set out in decision T 609/02. 
• The current Board then adds some reasoning: "The burden to show the suitability is on the applicant (see G 1/03, OJ EPO 2004, 413, point 2.5.3 of the Reasons: "When an application for a patent is filed, the process of making the invention has to be completed. The requirement of sufficiency of disclosure ensures that a patent is only granted if there is a corresponding contribution to the state of the art. Such a contribution is not present as long as the person skilled in the art is not able to carry out the invention. Therefore, the decisive date for fulfilling the requirement has to be the date of filing or priority, as the case may be. Deficiencies in this respect cannot be remedied during the proceedings before the EPO."). This burden cannot be discharged or shifted to the EPO or the public by merely alleging that a claimed therapeutic effect has to be regarded as having been demonstrated as long as it has not been disproven."
• Cited point 2.5.3 of G 1/03 (about non-disclosed disclaimers) may not directly address the issue of the burden of proof. The current Board uses "see", probably in the strict legal sense of that term  ("See [] is used when the cited authority clearly supports a proposition but there is an inferential step between the proposition as stated and the cited authority." - link) 
• It would have been useful if the Board had spelt out the 'inferential step' since the case at hand is an opposition appeal, and the general case law is that attacks under Article 100(b)  EPC require serious doubts substantiated by verifiable facts. 
• "The board therefore assesses below what can be inferred from the information provided in the patent as to a direct effect of a PD-1 inhibitor on a metabolic mechanism specifically involved in NLPHL."
• The Board, after reviewing the technical details, "the appellants [proprietors] on the one hand argued that tumours are characterised by T cell exhaustion and on the other hand that PD-1 expression is concomitant with T cell exhaustion. This explanation would lead to the conclusion that all cancers may be treated by PD-1 blockade, which manifestly is not the case. This is acknowledged in the declaration D55 submitted by the appellants: "All cancers are distinct and it is not possible to predict that a specific pathway, such as the PD-1 pathway, is present in any given type of cancer".
• The Board concludes that the application as filed does not provide support for the second medical indication in the sense of G 2/21, r.77. 
• The argument that post-published evidence shows that the compound works (allegedly), therefore, "must fail".

EPO

The link can be found after the jump. 

T 2353/22 - Traversing a data structure

Key points

• The real surprise is at the end of this decision against a refusal.
• "The invention concerns a method, [...] for supporting the storage of, access to and display of lineage metadata about data stored in a storage system. The lineage metadata of a data object provides information about the sources from which the data object was derived. For instance, how the data object was generated, from which source it was imported, how it has been used by applications, how it relates to other datasets or how its modification will affect tables"
• The claim is lengthy.
• "The method according to the claimed invention includes a first step of receiving metadata from a data source, the metadata describing nodes and edges. Each node represents a metadata object, which can be a data element or a transformation. An edge represents a one-way effect of one node upon another node. According to the description, page 10, first paragraph, the data elements can represent, for instance, "datasets, tables within datasets, columns in tables, and fields in files, messages, and reports". An example of a transformation is "an element of an executable that describes how a single output of a data element is produced"."
• After reading the decision, I don't see any limitation to technical data. I understand the metadata could be metadata of pension contracts or insurance contracts, for example. The method is just generic.
• "After the step of receiving metadata from a data source, the claimed method further includes steps of generating a data structure representing the received metadata and receiving a query for lineage metadata. In response to receiving the query, the data structure is accessed and a response to the query is generated and sent to a computer system for display. The response includes the lineage metadata responsive to the query."
• The claim also includes: "in response to receiving the query (114, 126), traversing the data structure (134) in accordance with the walk plan (130) to collect lineage metadata stored in the data structure (134) that is responsive to the query (114)," 
• The walk plan is about following edges from node to node and is included in the query, i.e. preparing the walk plan is not a part of the claimed method.
• I understand graph theory, a mathematical theory, is used by the features of the edges and nodes.
• The Board: "It is true that since computer programming involves technical and non-technical aspects, it is difficult to distinguish between the "programmer as such" who, as long as they only develop abstract algorithms, are not a skilled person within the meaning of the case law, and the "technical programmer" (see also T 697/17, reasons 5.2.4). "
• "The subject-matter of claim 1 differs from the method of D2 in that it includes features (c1) to (f), (f2), (g) and (g1). These features specify details of the data structure (features (c1) to (c4)), the step of receiving a query for lineage metadata including the identification of a data element, a type of lineage and a walk plan (features (d) to (d2)), the steps of traversing the data structure and collecting data using the data structure and the walk plan (features (d3), (d4) and (e) to (e4)), the step of generating a response including lineage metadata responsive to the query ((f) and (f2)) and the steps of sending the response to a computer system and displaying the lineage data (features (g) and (g1))."
  
• "None of the cited prior-art documents disclose the combination of distinguishing features (c1) to (f), (f2), (g) and (g1). In the board's opinion, it would be within the ordinary skills of the computer expert to arrive at the data structure specified in the distinguishing features, which corresponds directly to the non-technical lineage structure. However, the board is not convinced that the skilled person would arrive at the combination of all the distinguishing features, including a walk plan to direct the way the data structure is traversed and the data is collected as claimed."
• "Therefore, the subject-matter of claim 1 of the main request involves an inventive step (Article 56 EPC)."
• Now, as a question to readers, this decision was issued by Board 3.5.07. Would Board 3.5.06 have decided differently (see yesterday's post about T1998/22 Wide and deep machine learning) ? 
• 
  
• 
  

EPO 

The link to the decision can be found after the jump.

T 1998/22 - Machine learning

Key points

• "It is noted that the use of a "cross-product feature transformation" in the "wide machine learning model" [as specified in the amended claims] may contribute to establishing that the advantages recited in paragraph [13] are actually achieved, as emphasised by the appellant (statement of grounds appeal, pages 10 and 11), but these advantages [see below] remain of a non-technical nature."
• "According to the description [paragraph 13], "in general, a wide machine learning model can memorize feature interactions through a wide set of cross-product feature transformations and a deep machine learning model can generalize unseen feature combinations by applying embedding functions to the input features", and "by including both [a] deep machine learning model and [a] wide machine learning model, the wide and deep machine learning model can obtain both benefits of memorization and generalization and thus can perform better on predicting an output from a set of input features" (paragraph [13])."
  
  
• "As to the argument that only a "technical expert" could have devised the features of the invention [i.e. the CardinalCommerce test], the board notes, as a general word of caution, that this kind of enquiry may be helpful in some cases to separate non-technical features from technical features - in particular to identify business-related features - but does not constitute a definite test as it only concerns which kind of considerations underlie some features of the invention and not which kind of effects are achieved by it. For instance, a claim to a computer-implemented simulation may involve features which are based on expertise in the technical field of the technical system that is being simulated. This alone would however not be sufficient to conclude that these features contribute to the technical character of the claim (G 1/19, reasons 122, 125, 141 and 142)."
• "In any case, the board tends to consider that claim 1 does not reflect any considerations beyond computer programming (which encompasses the design of algorithms) and mathematics."

EPO 

The link to the decision can be found after the jump.

T 0956/19 (II) - Res judicata and interlocutory appeal decisions

Key points

• Application filed in 2005. Grant in 2013. Interruption of the opposition at the end of 2013 (bankruptcy). Resumed in 2015. First OP OD in March 2017. Second OP in November 2018. Decision OD in 2019.  First decision Board in February 2023. Second decision Board in February 2024, issued in writing on 23.12.2024 (!)
• No communication about the delay under Art. 15(9) RPBA is visible in the online file.
• In the first appeal decision, the Board had held that (in translation): "the subject-matter of claim 1 of auxiliary request 1 is not new [over D35] within the meaning of Article 54 EPC. " Furthermore, "The examination of the other requests (see point IX) could not be completed and, therefore, after a decision has been taken on the above-mentioned aspects, the procedure must be continued for the points not yet decided." (the oral proceedings lasted to 18:35)
• Now, the Board considers that AR-2 is novel over D35. 
• "The claimed subject-matter thus differs from that disclosed in document D35 (as well as from that of claim 1 of the first auxiliary request, see point 29) in the concrete definition of the route of administration ("and wherein the glucocorticoid is administered intraperitoneally, intravenously, intraarterially, intramuscularly, intradermally, subcutaneously, intratumorally or selectively in or via a defined organ"). 
• "It is clear from [a paragraph in the patent itself]  that the defined routes of administration, which essentially represent all common routes of administration, are nothing other than those which the person skilled in the art would have routinely used."
• "Appellant I [the proprietor] has not made any submissions, either in writing or at the oral proceedings before the Board, on the inventive step in relation to the specific differences between the subject-matter of claim 1 of auxiliary request 2 and the subject-matter disclosed in document D35. In particular, it has not expressed any view as to why the route of administration which represents the difference between the subject-matter disclosed in D35, as set out in the Board's interlocutory decision on novelty in the present case, and the subject-matter of claim 1 of auxiliary request 2, should be considered inventive. At the oral proceedings before the Board, Appellant I's submissions on this issue were limited solely to arguments which presupposed that the subject-matter of document D35 did not anticipate that of claim 1 of auxiliary request 1."
• "Neither in the written procedure nor at the oral proceedings did Appellant I make any separate submissions on inventive step by reference to technical features of the claims of these auxiliary requests [3-9 and 11-13]. Rather, it relied on its arguments in relation to auxiliary request 2. "
• AR-10 is rejected as unclear.
• The patent is revoked.
• The Board running out of time during the first oral proceedings, therefore, gave the proprietor about one more year of patent lifetime in appeal (and about two years until the written decision), even though the Board does not seem to decide any substantive issue on the allowability of the claims in the present decision.
• There is the interesting development of a Board member retiring between the first and second oral proceedings, in particular one week after the first appeal decision was issued. This is covered by Article 8 RPBA.
• The proprietor would like to reopen the debate as to what D35 discloses. However, this is barred by the res judicata status of the first appeal decision: "a substantive decision was also taken [in the first appeal decision] on the objection of lack of novelty in relation to document D35, which also includes the factual finding that document D35 discloses a subject-matter which anticipates the subject-matter of claim 1 of auxiliary request 1 in a way that is detrimental to novelty and consequently has all the features of that subject-matter. This finding that document D35 discloses a subject-matter which corresponds to the subject-matter of claim 1 of auxiliary request 1, i.e. which discloses all the claimed features, is irrevocable and can no longer be called into question when assessing auxiliary requests 2 to 13. Arguments and evidence aimed at having the Board in its amended composition reassess this matter cannot be taken into account due to the binding effect which, pursuant to Article 8(2) RPBA, also applies to the substitute member."
• 
  

EPO 

The link to the decision can be found after the jump.

T 2620/19 - An email as a combination document (ARPES)

Key points

• "Reference is made to the following documents:
• O2D1: User manual for the Scienta Electron Spectrometer SES 200, dated 96-04-15 []
• O2D7: compilation of Email exchanges, labeled individually X1 to X5"
• "In the present case, the e-mails summarised under X4 all refer to the same subject (PO K0000030433) and thus can be considered to represent one single e-mail thread."
• " X1 to X4 together do not belong to one single E-mail thread; however, they all relate to the idea, first formulated apparently by the author of X1 and X3, to put a deflector in an existing Scienta analyser to deflect electrons perpendicular to the slit in order to avoid sample rotation."
• "The Board notes that the persons involved in X1 to X4, except for one person who was an employee of the patent proprietor, have worked for a number of different research institutes (Brookhaven National Laboratory, University of Missouri - Kansas City, Forschungszentrum Jülich) when these e-mails were sent.
• "Further, X1 to X4, in accordance with O2D8, do not comprise any indication that their content was to be treated in a confidential manner, as accepted by the proprietor in its letter of 21 December 2023."
• "the information contained in X1 to X4 was available to a number of people working for different organisations, and without any explicit indication that it should be kept secret.
• "The Board notes that there is also no indication that any special relationship existed between them other than that they were all working in the same research area, which could be interpreted as a kind of implicit confidentiality obligation as set out for a different case in decision T 1081/01"
• The 'which' refers to the special relationship, I think, i.e.: "there is also no indication that any special relationship existed between them (other than that they were all working in the same research area) that could be interpreted as a kind of implicit confidentiality obligation".
• Hence there is no implicit confidentiality.
• "The subject-matter of claim 1 of the main request thus differs from O2D1 by the features relating to the second deflection of the particle beam"
• "This problem is mentioned in both X2 and X3. Both documents propose to use a deflector before the entrance slit of a Scienta ARPES analyser to solve that problem (X2: second paragraph; X3: idea 1 in the attached figure). The skilled person would therefore be prompted by any of these documents to use a deflector instead of moving the sample."
• "It follows from the above that the subject-matter of claim 1 of the main request is not inventive under Article 56 EPC in view of O2D1 combined with any of X2 or X3 and the common general knowledge of the skilled person."

EPO 

The link to the decision can be found after the jump.

T 2157/21 - Embodied by the same originally disclosed invention

Key points

• The Board  applies G2/21, hn.2, the part about  "would derive said effect as being [...] embodied by the same originally disclosed invention." (without mentioning the decision).
• A crystalline form of a compound is claimed. After some amendments, the claim meets Article 123(2) EPC and defines the crystalline form quite specifically in terms of XRD peaks.
•  "Claim 1 of auxiliary request 12, which is identical to claim 1 of auxiliary request 12A, claims a crystalline form designated as "Form II" which is characterised by an XRPD pattern comprising lines at 2Theta values measured using CuKa radiation, wherein the X-ray powder diffraction pattern is the same as that shown in Figure 7." (i.e. the claim refers to Figure 7 that is also included in the claim and shows the XRD spectrum as an image.
• "Thus, the question that is decisive for the acknowledgement of an inventive step is whether the claimed polymorph provides an unexpected advantage in comparison with forms disclosed in the prior art. The patent proprietors relied, in this regard, on the data presented in Examples 14 to 16 of the patent in suit."
• "Examples 14 and 15 of the patent in suit compare "Form II" of the patent in suit with the so-called "patent form" disclosed in US8877938B2 (i.e. the US equivalent of D3) in terms of moisture uptake and flowability. It was not in dispute that the comparative experiments reported in Examples 14 and 15 represent a comparison of "Form II" with the crystalline form of trisodium valsartan sacubitril as disclosed in document D3. The reported outcome is that "Form II" showed better flowability (Example 15) and less moisture uptake when exposed to humidity (Example 14). "
• So far, so good.
• "However, it is not disclosed in the patent specification whether the samples tested according to Examples 14 to 16 were obtained according to the process of preparation described in Example 6, or according to the process described in Example 7. In both Examples 6 and 7, the respective product that was prepared is designated as "Form II"."
• "it cannot be confirmed on the basis of the available evidence that the crystalline products of Example 6 and Example 7 are indeed identical, as argued by the patent proprietors. As a consequence, the exclusive use of the term "Form II" in Examples 14 to 16 does not permit the reader to infer that, specifically, the product according to Example 6 and corresponding Figure 7 and Table 4 was tested in these examples. For this reason, it cannot be confirmed that the specific product claimed in claim 1 of auxiliary requests 12 and 12A, which is characterised by the diffractogram in Figure 7, indeed exhibited the favourable properties described in Examples 14 to 16."
• Inventive step is denied.
• For the lower-ranking auxiliary request, the claim refers to Figure 8 instead of Figure 7.
• "By analogy, the same reasoning applies: since it cannot be confirmed that the crystalline product prepared according to Example 7, as characterised by Figure 8 (and Table 5), was used in the experiments described in Examples 14 to 16, it has not been conclusively shown that the claimed product has superior properties in comparison with the crystalline form of D3. Accordingly, the same objective technical problem and the same conclusions regarding obviousness apply as those set out above with respect to auxiliary requests 12 and 12A."
• In other words, likely the compound of Example 14 was either the one of Figure 7 or Figure 8, but the ambiguity prejudices basing inventive step on the effects shown in Example 14. 

EPO 

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

T 0479/22 - Video inspection of a CD-ROM

Key points

• "the opposition division found the two public prior uses alleged by the opponent (the respondent), relating respectively to the "sleep safe" dialysis machine and the "PatientOnLine" (POL) software, to be proven. With regard to the latter, two witnesses, Mr Guido Neyer and Ms Claudia Wolfers, were heard and a CD was inspected during the oral proceedings, which were held by videoconference."
•  D6 is a user manual for the "PatientOnLine" (POL) software sold by the respondent which enables the creation and management of prescriptions for the "sleep safe" dialysis machine. D6a and D6d are affidavits stating that D6 was made publicly available during the installation of this software in a hospital in June 2007. In relation to this alleged prior use, the authors of the affidavits were heard as witnesses and a CD, presented by the respondent as an original installation CD of the POL software and allegedly containing a copy of D6, was inspected during the oral proceedings before the opposition division, which were held by videoconference."
• I assume it is a CD-ROM, not an audio CD.
• "The inspected CD was filed after the expiry of the opposition period. However, as noted by the opposition division (see point 2 on page 10 of the decision under appeal), the respondent did not submit it as evidence of a new set of facts but to support the alleged prior use of the POL software and in accordance with the opposition division's order to take evidence of 21 January 2021, according to which evidence was to be taken on this prior use, inter alia, "by inspecting an original installation CD of the POL software in the version 4.2" (see page 2). This prior use had already been invoked in the notice of opposition (see point VI.3 on page 16). In such a situation, the opposition division had no discretion not to admit the CD into the opposition proceedings. In any case, its decision to admit it did not suffer from an error in the use of discretion as set out in G 7/93, point 2.6 of the Reasons.'" 

• "the Board does not have any discretionary power of its own under Article 12(4) RPBA not to admit the CD into the appeal proceedings as it forms part of the evidence on which the decision under appeal is based within the meaning of Article 12(2) RPBA."

• "The appellants also objected that it had been inappropriate to inspect the CD and to hear the two witnesses in oral proceedings held by videoconference. In their view, this format of oral proceedings was incompatible with the high degree of complexity of the case."

• "The Board disagrees. The fact that taking of evidence may be conducted by videoconference is expressly mentioned in Rule 117 EPC. It is also immaterial that the appellants themselves did not have physical access to the inspected CD. The inspection of the CD did not concern its haptic feel, texture or handling experience, but only its content - in particular the file "PatientOnLine User Manual" with which D6 was alleged to be identical - and the fact that the inspection of the CD was carried out by videoconference did not prejudice the proper inspection of that content. The inspection was carried out by a member of the opposition division, assisted by a technician who presented the CD to the camera. The minutes also show that the parties were able to follow the inspection in real time during the videoconference and that the content of the CD, including some of its directories, was displayed to the videoconference participants. Moreover, all the pages of the user manual requested by the parties and the opposition division, as well as the contents of several other files, were also displayed, with corresponding screenshots being included in the minutes. The fact that some of the files were corrupted and therefore could not be opened is not related to the format of the oral proceedings."

• "The Board also sees no reason to consider that the hearings of the two witnesses by the opposition division were compromised by holding the oral proceedings by videoconference. The minutes of both hearings show that precautions were taken to ensure that the witnesses were alone in front of the camera and that they had no document in front of them from which to read their statements."

• Good to know about this. I wonder if the EPO sends practical instructions to witnesses?
•  The Board is satisfied that this evidence is sufficient to establish that D6 was made available to the public in June 2007, i.e. before the earliest priority date of the contested patent. D6 therefore belongs to the state of the art for assessing the novelty and inventive step of the subject-matter claimed in the patent.
• The case is remitted to the OD.

 

EPO 

The link to the decision can be found after the jump.

T 2029/22 - Clear beverage/CARGILL

Key points

• Today's decision is a bit fact-specific but still is illustrative of the examination of inventive step.
• Claim 1 reads: "1. A clear beverage having a turbidity of less than 5 NTU, said beverage comprising an oil-in-water emulsion wherein the oil is an essential oil, wherein said emulsion comprises [...] n-octenyl succinic anhydride (nOSA) starch, wherein the nOSA starch and essential oil are in a ratio of between 1.2:1 and 8:1 (wt.%) and wherein the essential oil comprises citrus oil."
• "The opposed patent relates to a clear beverage having a turbidity of less than 5 NTU which comprises an emulsified essential oil, namely citrus oil. Furthermore, it relates to a process for manufacturing that beverage. "
• "The parties did not contest the opposition division's finding that D1 is the closest prior art. The board has no reason to diverge from this choice. Like the opposed patent, D1 relates to a process for preparing a clear beverage comprising emulsified essential oils such as lemon, orange, clove, mint and cinnamon oil. The process involves the use of an emulsifier and entails emulsification, homogenisation, dilution and pasteurisation steps"
•   The only two practical examples of the disclosed invention [of D1] are the beverages of examples 1 and 2. These contain a citrus oil (from orange or lemon) and sucrose monopalmitate in a 2:1 ratio. The turbidity of these beverages is "around 3 FTU", which corresponds essentially to 3 NTU and is therefore within the claimed range."" 
• "D1 suggests a long list of alternative surfactants for preparing the disclosed beverages. Among these surfactants, mention is made of nOSA starch (see the list in Table 1 on pages 2 and 3 and the reference to "sodium octenyl succinate starch"). However, D1 does not describe even one beverage comprising the surfactants enumerated in this long list, let alone nOSA starch."
• " the claimed beverage differs from the beverages exemplified in D1 in that:

  - nOSA starch is used as the emulsifier [and]  the ratio between the nOSA starch and essential oil is between 1.2:1 and 8:1"

• "The appellant [opponent] argued that nOSA starch was not a distinguishing feature because it was disclosed in Table 1 of D1. This argument is not persuasive. As mentioned above, the beverages of examples 1 and 2 of D1 are the starting point for assessing inventive step.
• Note, for the PSA, indeed the disclosed embodiments are the starting points / reference points for determining the distinguishing features of the claim, not the whole document.

• "the [objective] technical problem is the provision of an alternative clear beverage containing an essential citrus oil and a process for making it."

• "The appellant [opponent] argued that, when confronted with the [] technical problem, the skilled person would have found in D1 the incentive to replace the sucrose monopalmitate used in the beverages exemplified in this document with nOSA starch and to use this emulsifier in the claimed ratio with essential oil. Paragraphs [0008], [0009], [0010] and [0012] of D1 taught that a variety of emulsifiers could be used to prepare clear emulsions, and Table 1, which listed them, mentioned nOSA starch."

• "The board is not persuaded by the appellant's arguments."

• "It is undisputed that, as noted by the appellant, D1 mentions the possibility of using other emulsifiers and adjusting the oil-to-emulsifier ratio. However: - as stated in paragraphs [0002] to [0010] of the patent, at the filing date, the production of clear beverages comprising emulsified essential oils was still challenging and required complex washing procedures to remove insoluble terpenes; 

  - the technical information presented in D1 on the use of surfactants other than sucrose monopalmitate is very limited

  - D1 consistently refers to a 2:1 essential-oil-to-emulsifier ratio, and this is the only ratio mentioned in this document

  Thus, the board is of the opinion that even if the skilled person had decided to replace sucrose monopalmitate with nOSA starch, they would not have considered significantly increasing the surfactant-to-oil ratio and deviating considerably from the ratio disclosed in the examples of D1, which are the starting point for assessing inventive step "

• The claims are held to be inventive. 

• The case shows that the provision of an alternative solution can be ambitious or not, depending on the facts of the case, and the more ambitious the problem, the stronger the required incentive in the prior art (see also T939/92, r.2.4.2: "the answer to the question what a skilled person would have done in the light of the state of the art depends in large measure on the technical result he had set out to achieve")

EPO 

The link to the decision can be found after the jump.

T 2269/22 - Beverages/COCA-COLA

Key points

• The proprietor is The Coca-Cola Company.
• Claim 1: "A beverage comprising the rare sugar D-psicose and the high potency sweetener Rebaudioside M; wherein the Rebaudioside M is greater than 95% pure; the D-psicose is present in an amount from 0.1% to 2% by weight; and the weight ratio of Rebaudioside M to D-psicose is from 1:25 to 1:100."
• The Board: "The subject-matter of claim 1 differs from D1 on account of the combination of Reb M with D-psicose in an amount of 0.1 to 2 wt.%."
• "To acknowledge an improvement over the closest prior art it must be credible that the effect originates from the distinguishing feature over that prior art. As outlined below, there is no evidence in the patent (either in the example shown in Table 14 or in paragraph [0211]) that there is an improvement over the beverage disclosed in D1. "
• "The board does not agree with the opposition division that an improvement over D1 is plausible in view of paragraph [0211] of the patent, in which certain properties of the zero calorie lemon-lime set out in Table 14 of the patent are mentioned. Paragraph [0211] of the patent mentions that "the evaluation of the zero calorie lemon lime CSD by the expert panel showed that it had a faster and more rounded sweetness and flavor profile, with very low sweet lingering and no bitterness or licorice aftertaste, showing that D-psicose helped reduce or eliminate these unwanted characteristics"; however, it does not specify with which beverage this assessment was compared. The reference point cannot be the beverage disclosed in D1. For this reason alone, the example in Table 14 of the patent is not suitable for demonstrating an improvement over D1."
• I think this pertains to evidence of a technical effect in the sense of T 939/92, not to 'plausibilty' in the sense of (the questions referred in ) G 2/21.
• However, the Board also notes that: " the experimental data submitted by letter of 5 May 2022 pertain to a completely different composition from the zero calorie lemon-lime in Table 14 of the patent. Therefore, it is not suitable for confirming the example according to Table 14 of the patent, which as such is not suitable for demonstrating that there is an improvement resulting from the difference over D1."
• " Even if it is assumed, for the sake of argument, that the data filed with the reply to the appeal were admitted on appeal, this data similarly fails to demonstrate an improvement over D1 for the same reasons as outlined above."
• The claim is held to lack an inventive step.

EPO 

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

T 1295/22 - Crumb chocolate flavor composition/MARS

Key points

• "The opposed patent relates to the preparation of a chocolate capturing the distinct aroma and creaminess of a crumb chocolate, without the need to prepare a chocolate crumb. As noted by the appellants, paragraphs [0010] to [0012] of the patent teach that the chocolate can be produced by including, in a dry mix chocolate, the flavors which impart the aroma and creaminess on a chocolate crumb. To this end, the flavors common to crumb chocolate were identified and quantified in the experiments described in the patent. The identified flavor compounds are listed in Tables 10 to 13. The claimed flavor compounds are among those identified in those tables. "
• I selected the case simply because it is Food and Beverages Week at Just Patent Law Blog.
• Still, the decision contains some interesting procedural aspects (in addition to some interesting points about novelty and inherent features)
• " With its statement setting out the grounds of appeal, appellant 2 filed D43, an experimental report aimed at supporting its novelty objection over D4. According to appellant 2, D43 showed that methanethiol was present in the crumb chocolate described in example 3 of D4 despite not being mentioned in this document."
• The claim requires the presence of that compound in some defined amount.
• "As noted by the respondent, although D4 had already been filed by opponent 1 with its notice of opposition, opponent 2 (appellant 2) had raised the novelty objection based on this document for the first time at a late stage of the opposition proceedings, namely with its reply to the opposition division's communication issued under Rule 116 EPC."
• " Appellant 2 argued that D43 had been filed to address the opposition division's unexpected finding during the oral proceedings that the crumbs and chocolates of D4 did not contain methanethiol. It also argued that before the oral proceedings held before the opposition division, the proprietor had not contested the presence of methanethiol in the crumbs and chocolates of D4. Up to that point, it had defended novelty by relying on the [claim features] "extraneous flavor composition" and "flavor composition". Hence, in appellant 2's opinion, the experimental report D43 had been filed in due time. " 
• The question is whether D43 should have been filed before the OD (Art. 12(6)(s.2) RPBA)
• " The board does not agree. As noted by the respondent during the oral proceedings, it is immediately evident that the claims as granted and as amended during the opposition proceedings characterise the claimed compositions by specifying that they comprise methanethiol and other specific compounds. It is also immediately evident that D4 does not even mention methanethiol and the other relevant compounds."
• " The principle that a party must contribute to the conduct of the proceedings by substantiating its own requests and objections in a minimum way is a general procedural principle underlying the EPC and not limited to appeal proceedings (for claim requests, see T 1776/18, Reasons 4.5.7, second sentence). Hence, when raising its new novelty objection based on D4 at a late stage of the opposition proceedings, appellant 2 should have fully substantiated its attack, setting out why the entirety of the claimed subject-matter was allegedly directly and unambiguously disclosed in D4 and providing already at that time any additional evidence that may be required for that purpose. In particular, appellant 2 should have addressed the fact that D4 does not mention the compounds characterising the claims by providing an explanation for this and filing any additional evidence to support its view that these compounds were nevertheless (at least implicitly) disclosed in D4. In any case, it cannot be considered objectively surprising that it emerged during the oral proceedings before the opposition division that D4 did not mention the claimed compound methanethiol, regardless of the fact that, until then, the respondent [proprietor] had addressed the novelty attacks by relying on a different argument. 
• "Furthermore, the experimental report D43 raises new complex technical issues and, regarding prima facie relevance, does not provide conclusive evidence that methanethiol was present in the compositions of D4. 
• The document is not admitted.
• The claims are held to be patentable.

EPO 

The link to the decision can be found after the jump.

T 0228/23 - The requirements for a technical effect

Key points

• This decision illustrates that there are four requirements for acknowledging a technical effect: procedural admissibility, support in the application as filed (G2/21, hn.2) and proof of the effect; the support requirement in turn comprising two requirements: same technical teaching and same invention.
• "The appellant - patent proprietor relied [during the oral proceedings] for the first time in the entire proceedings on an alleged improvement of friability (even if based on data contained in the documents on file) as a technical effect in the context of inventive step. In particular as argued by appellants - opponents 2 and 4 during oral proceedings friability and hardness are two different properties evaluated by different methods (see D33, paragraphs 17.5.3 and 17.5.4). Moreover, none of these two properties was relied upon by the appellant - patent proprietor as a technical effect for the issue of inventive step in the present proceedings before. This argument therefore constitutes an amendment to the case of the appellant - patent proprietor (Article 12(4) RPBA, 1**(st) sentence). Since this amendment was filed after notification of the communication under Article 15(1) RPBA, its admittance is to be decided on the basis of Article 13(2) RPBA."
• "the Board does not admit the submission of the appellant - patent proprietor of 30 July 2024 in section B.6 concerning friability into the appeal proceedings (Article 13(2) RPBA)."
  
  
• Turning to a further technical effect: "According to the appellant - patent proprietor, the use of dry granulation to prepare the present tablets would result in a faster and more complete drug release compared to tablets prepared by direct compression. This technical effect would be substantiated by the experimental data provided in document D61. Post-published evidences could be taken into account in the present case in line with G 2/21."
• "In the present case, the Board considers that the alleged specific effect of faster and more complete release profile is indeed derivable from the original application in view of the references to immediate release, desired dissolution profiles and dissolution performance (see e.g. Title and page 2 of the original application). In particular, as underlined by the appellant - patent proprietor during oral proceedings, the description of the immediate release profile in the context of the invention on page 4 lines 21-31 of the original application defines an increase of the release percentage and/or a reduction of the release time. This passage suggests that a faster and more complete release profile constitutes a purpose of the invention. This technical effect is thus encompassed by the technical teaching of the original application as required by G 2/21."
• "It remains to be determined whether the second criteria set in G 2/21 was met, i.e. whether the effect is embodied by the same originally disclosed invention. The Board agrees with the appellants - opponents that the original application discloses that the tablets can be prepared by direct compression or dry granulation and does not indicate whether one of these methods is preferred over the other in relation to its effect on the release profile of the tablet. However, the fact that all the examples of the original application concern dry granulation indicates that dry granulation would be preferred over direct compression in general in the context of the application. Moreover, the original application describes merely two preparation processes (dry granulation and direct compression). In this specific case of a very limited number of embodiments defined in the original application, one of these being also the subject-matter of the closest prior art and the other one being generally preferred, and in the absence of any legitimate reason at the effective date to doubt that the alleged effect could be achieved with the claimed subject-matter (see T 116/18, reasons 11.14), the Board is of the opinion that the appellant - patent proprietor should be entitled to specify a preference for one of said originally disclosed embodiments over the other in connection with said effect. In the present case, the alleged effect of faster and more complete release profile for tablets obtained by dry granulation compared to direct compression does thus not change the nature of the claimed invention, as defined in G 2/21 (see last sentence of paragraph 93), so that it is embodied by the same originally disclosed invention in the sense of G 2/21."
• "In line with G 2/21, the alleged technical effect of faster and more complete release profile in so far as it is supported by the post-published experimental data on file is thus to be taken into account when assessing the inventiveness of the claimed subject-matter. "
• "Each of the parties provided comparative experiments based on different reworkings of the example disclosed on page 19 of D1 (see D61 submitted by the appellant - patent proprietor and D40, D66, D56 and D71 submitted by the appellants - opponents). Varying results were obtained, showing: - either a faster and more complete release of the drug when using dry granulation (D61 [filed by the proprietor]), - or no significant difference in the release rates between tablets obtained by dry granulation or direct compression (D40/ D66 and D71, in particular in case of experiments 1 and 4 of D71 [filed by the opponents]).
•   The Board observes that the comparative examples referred to by each party appear to fulfil the standard criteria to appropriately substantiate an effect of the distinguishing feature (the preparation method - dry granulation or direct compression - being the sole difference between each comparative example). The Board considers that the lack of certain details in the example of document D1 required the parties to fill the gaps, leading to different comparative compositions."
• " Furthermore, as argued by appellant - opponent 7, variants of the prior art are usually permitted for comparative tests as long as the features common with the claimed invention are identical and the sole difference remains the distinguishing feature. There is therefore no fundamental reason to consider the experiment of document D61 as having a higher probative value than those of documents D40/D66 and D56/D71."
• "when taking into account all the experimental data on file, an improvement of the release rate for tablets obtained by dry granulation compared to direct compression has not been convincingly substantiated throughout the tested compositions. Hence, the alleged technical effect cannot be considered to credibly occur over the whole breadth of the claims. "
• This is the proof of the technical effect (across the whole scope of the claim) as required by T 939/92 (see also G/03 r.2.5 for the case of a few non-working embodiments).
• The patent is revoked. 


EPO

The link to the decision can be found after the jump.

T 0708/21 - The technical problem of matching foundation and skin tone

Key points

•  "The invention is about recommending make-up foundations that match a person's skin tone, [0002] and [0003] of the published application."
• The issue is inventive step. 
• "Method for selecting a foundation intended for a person, comprising the steps of:

  - acquiring (100) an image of a complete view of a person's face in a controlled lighting environment,  ... [digitally processing data and] presenting (420) to the person the foundation(s) comprised in the personalized color matrix"

• The Board does not comment on whether the method is industrially applicable. The Board dismisses the appeal of the applicant against the refusal of the application for lack of inventive step. Therefore there was no need to comment on Art. 57. Perhaps it was not even an objection of the Examining Division. Still, I think that in 1973, or perhaps 20 - 30 years ago, a method of "recommending make-up foundations that match a person's skin tone" would perhaps not be treated as an industrial method. 

• Regarding inventive step: "Therefore, the Board considers that the differences may be assessed separately for inventive step, as the examining division did in the decision under appeal.

• 2.6.1 Concerning feature 1), lightness and hue define a 2D colour space that is simpler than the 3D colour spaces mentioned in D1 (HSV and RGB), yet still suitable for representing human skin tones and foundation shades (see also page 10, first paragraph of the published application). Therefore, the Board considers that the technical problem solved by this feature is to find a simpler colour space for representing skin tones and foundation shades."

• "Hence, the skilled person seeking a simpler colour space would apply the teaching of D5 to the method of D1, and thereby arrive at feature 1) in an obvious manner."

• "The appellant submitted that human skin appeared desaturated under illumination, while suitable foundations typically had higher saturation levels to create a more radiant effect. If saturation was taken into account in the matching process, the selected foundations would be less saturated, resulting in a duller appearance, which was undesirable. By ignoring the saturation from the colour matching, the invention eliminated unwanted noise and provided more relevant matches. During the oral proceedings, the appellant supported this argument with experimental data showing significant differences between the saturation levels of skin and foundation measurements, and the impact of saturation on the recommended products."
• "However, according to the jurisprudence of the Boards of Appeal, an alleged technical effect cannot be considered for inventive step unless it is at least hinted at in the original application, or can be deduced by the skilled person from the application as filed considered in relation to the nearest prior art (Case Law of the Boards of Appeal, I.D.4.4.3 b, second paragraph). This is not the case here since the application as filed does not suggest that saturation is a noise factor and that ignoring it leads to more accurate results. It merely states that lightness and hue are chosen for simplicity, and that saturation can be disregarded since it is less important for foundation colours (page 10, top). Simplifying a process by removing irrelevant data does not imply or suggest an improvement in accuracy."


• Is this an application of G 2/21, headnote 2?

EPO 

The link to the decision  can be found after the jump.

T 1318/22 - Rule 137(3) and anticipated fallback positions

Key points

• " the Board agrees with the Examining Division that claim 1 of the first auxiliary request lacks inventive step, Article 56 EPC."
• [AR-2] does not define the objects [to be imaged] to be human or animal organs [as in AR-1], but specifies instead that the reflectance measurements are collected using integrating spheres."

• The Examining Division did not admit this request because (decision, point 6)

  [...]- the Appellant did not "build on" the previous request but "trie[d] out this feature as a different direction for specifying what the invention is", which direction was not compatible with the previous one,

  - an integrating sphere was not claimed in the original set of claims and was not considered to be a likely fallback position, and 
  - an integrating sphere was commonly known for measuring material reflectance so that its use in D1 was, "prima facie, not based on an inventive step".

• "The Board notes that [...] the points made by the Examining Division to justify their non-admittance are correct."

• The Examining Division held the request inadmissible under Rule 137(3) EPC. The applicant had filed it by the deadline for written submissions of Rule 116 EPC. 

• Under Rule 137(3) EPC, the amendment is not a voluntary amendment and adding a feature is normally a suitable amendment to address an inventive step issue. Hence, it is not clear that the amendment can be held inadmissible under Rule 137 (3) EPC (without violating the applicant's right to be heard).

• Moreover, the auxiliary request was filed in time under Rule 116.

• Under Rule 137(5) EPC, it might be relevant that the applicant that submitted that "the subject-matter of claim according to the second auxiliary request related to the same invention as the main request,"

• The Board: "while this request may be a limitation of the main request, it shifts the focus of the invention from a method of optimizing illumination to details related to measurements. This, in principle, constitutes a new perspective in the examination of novelty and inventive step, which the Examining Division did not consider up to that point, i.e. it was not an anticipated fallback position."

• However, under Rule 137(5) EPC, the question is whether the feature (in the description) has unity of invention with any of the claims pending at the time of the search by the EPO or was actually searched by the EPO, not so much whether it was "a new perspective in the examination of novelty and inventive step". Is the rule then different under Rule 137(3)? Is Rule 137(5) not applicable to submissions under Rule 116 in the sense that a stricter or different rule applies for submissions under Rule 116 ?

EPO 

The link to the decision can be found after the jump.