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) ? 
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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."
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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.