T 0694/23 - Statistical significance as shown in the examples

Key points

• Claim 1: "A method for predicting whether a cancer patient with a solid tumor is responsive to treatment with chemotherapy comprising the steps: ..."
• "The sole distinguishing feature between the method described in D2 and the one being claimed is that D2 only suggests that a correlation exists between TIL densities at the invasive margin of liver metastasis and the time to progression under chemotherapy, but considers that, due to the small patient cohorts in the study, these conclusions are not statistically significant."
• So far, this does not identify a feature of the claim; it discusses the teaching of D2.
• "In contrast, the patent shows that the correlation underlying the method as claimed is statistically significant, at least for colorectal cancer, which is what is assessed in the Examples of the patent. "
• This describes the content of the patent application, in particular, the examples. It does not define a feature of the claim.
• "The technical effect underlying this difference is that the (statistical) robustness of the method for predicting whether a cancer patient is responsive to chemotherapy treatment is achieved."
• I assume that 'this difference' refers to the information contained in the examples of the patent. It is unusual to treat that information as a distinguishing feature (outside the scope of second medical use claims)
• Admittedly, the Board finds the claim to be obvious, even with the statistical significance as the difference.
• "Starting from the disclosure of document D2 and faced with the technical problem identified above, the skilled person would have been motivated to confirm D2's prediction and the correlation between the cell densities and the response to chemotherapy. For this, it had simply to follow D2's explicit suggestion and increase the number of samples in order to arrive, with a reasonable expectation of success, at a statistically significant correlation and thus at the method of claim 1. The claimed subject-matter thus lacks an inventive step from D2 alone."
• The claim is not a second medical use claim but a normal method claim and, hence, does not benefit from the 'it works' functional feature that is read into second medical use claims as a matter of law. The claim does not explicitly recite statistical significance either. 

EPO 

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

T 0589/22 - Plausibility and in vitro diagnostic method claims

Key points

• G 2/21  was rather vague about inventive step but very clear about second medical use claims: the application as filed must make the therapeutic indication, recited in the claim, "credible".
• The present case is about a method claim directed to an in vitro diagnostic method.
• Claim 1: " In-vitro diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of mortality potentially being induced by the administration of an antibiotic to said subject" 
• The Board: " Claim 1 is directed to an in vitro diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of mortality potentially being induced by the administration of an antibiotic to said subject. Being a diagnostic claim, the purpose of the method is a technical feature of the claim."
• It is not entirely clear what the Board means by the last sentence. 
• "Article 83 EPC requires that the application discloses the invention in a manner sufficiently clear and complete for it to be carried out by the skilled person. Since claim 1 is directed to a diagnostic method, the purpose of the method (i.e. "identification of a subject suffering from a primary non-infectious disease having an increased risk of mortality potentially being induced by the administration of an antibiotic to said subject") is an effect that has to be achieved and thus is a functional technical feature of the claim (G 1/03, OJ 2004, 413, point 2.5.2 of the Reasons). Hence, for the requirements of Article 83 EPC to be fulfilled, the patent has to provide suitable evidence that the claimed method allows the diagnosis to be made, or this must be derivable from the prior art or common general knowledge (CLBA, C.II 7.2.1, in particular T 814/12 clarifying that the requirements of Article 83 EPC for a medical use claim apply by analogy to diagnostic use claims)."
• G 2/03 is about undisclosed disclaimers and point 2.5.2 of the reasons is about non-working embodiments: " If an effect is expressed in a claim, there is lack of sufficient disclosure. Otherwise, ie if the effect is not expressed in a claim but is part of the problem to be solved, there is a problem of inventive step (T 939/92, OJ EPO 1996, 309)." It is not about diagnostic methods, let alone diagnostic methods as opposed to methods in general.
• "Under Article 83 EPC, the proof of a claimed therapeutic effect must 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 effect is achieved. A deficiency in this respect cannot be remedied by post-published evidence (decision G 2/21, point 77 of the Reasons). By analogy, the same applies to a claimed diagnostic effect (T 814/12, points 26 and 27 of the Reasons). Hence a reference to the BACH (Biomarkers in Acute Heart Failure) trial in post-published document D1 is of no help in this context. "
• T 0814/12:  "27. The board considers that by analogy thereto the same requirements of Article 83 EPC apply for diagnostic use claims."
• Note, the claim in that case was a Swiss-type use claim for a diagnostic compound: "Use of protein kinase N beta or a fragment thereof, whereby such fragment realises the effects of protein kinase N beta, for the manufacture of a diagnostic agent for the diagnosis of a disease"
  
• Note that for second medical use claims using the magic wording of Art.54(5) (or formerly, a the magic wording of a Swiss type claim), we impart the magical implicit feature of "effective" into the claim so that the claim is held novel even over a verbatim disclosure of it (typically: in the annoucnement of a clinical trial giving all details of the medical use being tested but not the results; see e.g. T2506/12). I'm not aware of the same case law applying to method claims or specifically in the case of diagnostic method claims. 
• Which is not to say that the decision is wrong. That depends a bit on how broadly the requirement of credibility is to be applied - will it apply to first medical use claims? Second non-medical use claims? Beyond use claims to method claims reciting a purpose?

EPO 

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

T 1390/22 - Novelty of 2nd medical use based on omitting diagnostic step

Key points

• "Claim 1 as granted [reads]: "[pibrentasvir] thereof for use in a method of treatment for HCV, comprising administering an effective amount of Compound 1 or a pharmaceutically acceptable salt thereof to an HCV patient, regardless of the specific HCV genotype(s) that the patient has, wherein said patient is not genotyped for said treatment."
• "The assessment of the HCV genotype in treatment of HCV prior to the administration of antiviral therapy was standard practice at the time of the priority date for the patent. Document D19 indicates that such assessment formed part of the standard of care in order to select the appropriate type of antiviral therapy, including the dose of the medication and the duration of the treatment"
• "The intentional omission of the HCV genotyping as defined in claim 1 of the main request therefore represents a technically meaningful characteristic of the defined therapeutic treatment."
• "It follows from the considerations in G 2/08 (see Reasons 5.10.9), which refer to the wording "any specific use" in Article 54(5) EPC and confirm the seamless fit between the exclusion from patentability of methods of treatment by therapy and the special provisions regarding the novelty of a substance or composition for use in such a method, that this technically meaningful characteristic of the defined therapeutic treatment involving the use of pibrentasvir is suitable to characterize the claimed subject-matter in terms of a specific use as intended in Article 54(5) EPC."

EPO 

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

T 1741/22 - Displaying medical data

Key points

• The case was given publication code [B] by the Board, i.e. of general interest.
"Claim 1 of auxiliary request 10 contains the following limiting features (board's labelling):
(a) A system for analysing glucose monitoring data indicative of a glucose level in a bodily fluid, comprising: an input device, a data processing device, an output device, a display device, and machine-readable instructions that are executed by the data processing device,
(b) [wherein the machine-readable instructions cause the data processing device to] receive continuous glucose monitoring data via the input device, the continuous glucose monitoring data indicating a glucose level sampled for a person in a bodily fluid at a plurality of sample times over a measurement time period in a continuous glucose level measurement, and comprising a plurality of continuous glucose profiles, each of the glucose profiles comprising a plurality of glucose values with a glucose value for each of the plurality of sample times over the measurement period, wherein the plurality of glucose profiles is determined on different days by sampling the glucose level on each day over the measurement period, wherein the measurement period is 24 hours;
(c) [wherein the machine-readable instructions cause the data processing device to] for the plurality of continuous glucose profiles, determine a plurality of minimum glucose values and/or a plurality of maximum glucose values for a selected group or each of the plurality of respective sample times
(d) [wherein the machine-readable instructions cause the data processing device to] provide first display signals representing the plurality of minimum glucose values and/or the plurality of maximum glucose values for the selected group or each of the plurality of respective sample times;
(e) [wherein the machine-readable instructions cause the data processing device to] output the first display signals via the output device to the display device; and display a first graphical representation according to the first display signals on the display device."
• Essentially, the system has a display to display minimum and maximum values from 24 hours of received "continuous glucose monitoring data" (from a wearable glucose measurement device,  I guess). The system itself is not a continuous glucose monitor.
• "The appellants [proprietors] argued that the distinguishing features of claim 1 of auxiliary request 10 over D1 were features (c) and (d), i.e. determining and displaying minimum/maximum glucose values. [D1 shows percentiles]. [The proprietors] stated that the technical effect of the distinguishing features was to provide an "improved analysis of glucose monitoring data". In particular, "the plurality of minimum/maximum glucose values may correspond to medically relevant outlier values", which "would otherwise be averaged out in the context of known methods employing percentiles as in D1". "
• The question is whether these features provide for an inventive step. The Board approaches it from the question of whether the features provide a technical contribution ("contribute to the technical character of the invention").
• As an aside, a test of the Board's reasoning is if it makes sense if the distinguishing feature was "calculating the third harmonic eigenvalue" (instead of minimum/maximum, just making up a fancy term here) and the clear and convincing evidence is that this value, hidden in what was considered random noise before the invention, turns out to be life-saving information. That helps to distinguish between 'this is obvious for any scientist in the field but I don't have the right prior art at hand' and 'it is very smart but not technical'.
• The Board: "if the mere generation of "new data" were sufficient to contribute to the technical character of the invention, Article 52(2) and (3) EPC would contain meaningless limitations of patentable subject-matter, as e.g. mathematical methods are supposed to constantly generate "new data"."
• The Board then sets out that steps C and D are not actual measurement steps and are not, for that reason, technical.
• Note that even including a technical measurement step may not necessarily mean that the further steps of processing the resulting data are automatically technical in the sense of G1/19 (T 0489/14, r.7.4). 
• "The appellants [proprietors] referred to T 2681/16 and to the Guidelines for Examination in the EPO in support of their view. "
• Dealing with the argument based on the GL first in this post: "the Guidelines for Examination in the EPO (in its applicable version of March 2022 and also in its current version of March 2024), section G-II, 3.3, which relates to the technical contribution of mathematical methods, lists "providing a medical diagnosis by an automated system processing physiological measurements" among "examples of technical contributions of a mathematical method". As providing a "medical diagnosis" - whether done by a physician or by an automated system - is devoid of any technical character (see e.g. G 1/04, Reasons 5.3 and 6.3), this example is clearly erroneous. As there is no further explanation, let alone a reference to any case law, the board sees no reason to speculate on how the Guidelines came up with this example (cf. Article 20(2) RPBA)."
• I will quote the relevant parts in G1/04 in full. It would have been helpful if the TBA had identified the relevant sentences - especially because G 1/04 was about Art. 52(4) EPC 1973, i.e. about industrial applicability, not about non-inventions of Art. 52(2) EPC 1973. 
• I will highlight below some parts of G1/04, cited paragraphs, that are at first sight a bit at odds with the TBA's reasoning based on the same paragraphs of G1/04, to the extent I can understand the TBA's reasoning in all its brevity. 
• G 1/04: "5.3 Since diagnostic methods referred to in Article 52(4) EPC are inventions within the meaning of Article 52(1) EPC (cf. point 4 above), it follows that, in a situation where the deductive medical or veterinary decision phase is a purely intellectual exercise, i.e. a step of a non-technical nature, such a method must necessarily further include preceding steps (cf. point 5 above) of a technical nature, in order to satisfy the requirements of Article 52(1) EPC. The subject-matter of a claim including technical and non-technical features may satisfy the requirements of Article 52(1) EPC if the non-technical features interact with the technical features in order to bring about a technical effect (cf. T 603/89 (OJ EPO 1992, 230), point 2.5 of the Reasons). 
• "6.3 In the judgment of the Enlarged Board of Appeal, the qualification of an activity as having a diagnostic character may not depend on who is involved. The wording of Article 52(4) EPC is unequivocal in that the exclusion relates only to the method, and not to the person carrying out the method. Furthermore, no indication can be found in the preparatory documents to the EPC which would restrict the exclusion of diagnostic methods from patentability to a certain group of persons such as medical or veterinary practitioners. Also, as already mentioned under point 6.1 above, defining the medical or veterinary practitioner on a European level within the framework of the EPC is difficult if not altogether impossible. To allow the grant of a European patent to depend on the involvement of such a person would therefore introduce legal uncertainty into the patent granting procedure. Thus, whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or non-medicinal support staff, the patient himself or herself or an automated system. This also reflects the well-known fact that technological advances penetrate human and veterinary medicine and the medical and veterinary profession. Today, and more than at any time before, technology is about to fundamentally alter how and by whom health care is administered, with the result that human and veterinary medicine is gradually being reshaped by technology. In a changing medical or veterinary environment brought about by technological progress, the need for reconsidering the relationship between medical or veterinary practitioners and non-medicinal support staff will become more pressing than ever before. This will have implications for the non-medicinal support staff in terms of profile and expansion in that a great variety of diagnostic and other information will have to be procured and gathered by these persons. Moreover, no distinction should be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it. The reason for this judgment lies in the fact that, again contrary to the requirement of legal certainty, the assessment of the factual and legal situation in connection with these issues could change considerably in time. As has been mentioned under point 6.1 above, consideration might be given to exploring the possibility of protecting the activities of medical and veterinary practitioners by other means on the national level."
• The Board also " disagrees with the finding in T 2681/16 that providing an overall "measure" of the glucose variability and a prediction of glycemic events amounts to a technical effect.". "In the present case and in the case underlying T 2681/16, where the "physical reality" is typically the "patient's blood", the interaction with the physical reality ends once blood glucose measurements are carried out, directly on the relevant physical entity "blood", or indirectly e.g. on another bodily fluid [note; and these physical steps are not claimed in the patents] The [note: actually claimed steps of the ] provision of overall glucose variability and a prediction of glycemic events are mathematical steps or intellectual activities which take place in the absence of this interaction with the physical reality and are therefore not "measurements" in this sense."
• "generating (and displaying) further data by an evaluation or interpretation of these measurements (as done according to features (c) and (d) here) amounts to "measurements" generated merely by a cognitive or mathematical exercise that is inherently non-technical. "
• G 1/19 r.98: "Calculated status information or physical properties concerning a physical object are information which may reflect properties possibly occurring in the real world. However, first and foremost, they are mere data which can be used in many different ways. There may exist exceptional cases in which such information has an implied technical use that can be the basis for an implied technical effect. Still, in general, data about a calculated technical effect is just data, which may be used, for example, to gain scientific knowledge about a technical or natural system, to take informed decisions on protective measures or even to achieve a technical effect. The broad scope of a claim concerning the calculation of technical information with no limitation to specific technical uses would therefore routinely raise concerns with respect to the principle that the claimed subject-matter has to be a technical invention over substantially the whole scope of the claims"
• G 1/19, r.128 mutatis mutandis: " In the Enlarged Board's view, calculated numerical data reflecting the physical behaviour of a system [from measurements] usually cannot establish the technical character of an invention in accordance with the COMVIK approach, even if the calculated behaviour adequately reflects the behaviour of a real system underlying the [measurement]. Only in exceptional cases may such calculated effects be considered implied technical effects (for example, if the potential use of such data is limited to technical purposes"
• See also r.98: "calculated status information or physical properties concerning a physical object are information which may reflect properties possibly occurring in the real world. However, first and foremost, they are mere data which can be used in many different ways. There may exist exceptional cases in which such information has an implied technical use that can be the basis for an implied technical effect. Still, in general, data about a calculated technical effect [?] is just data, which may be used, for example, to gain scientific knowledge about a technical or natural system, to take informed decisions on protective measures or even to achieve a technical effect. The broad scope of a claim concerning the calculation of technical information with no limitation to specific technical uses would therefore routinely raise concerns with respect to the principle that the claimed subject-matter has to be a technical invention over substantially the whole scope of the claims (see point E.I.b above, referring to T 939/92)."
• See also the broken technical chain fallacy as reviewed in T 1670/07: "the Board sees something of a well known argument that could be termed the "broken technical chain fallacy" after decision T 1741/08 - GUI layout/SAP. This decision dealt with the fairly common situation that arises in connection with graphic user interfaces (GUIs) where a technical effect might result from the user's reaction to information. The decision essentially concluded (see point 2.1.6) that a chain of effects from providing information to its use in a technical process is broken by the intervention of a user. In other words, the possible final technical effect brought about by the action of a user cannot be used to establish an overall technical effect because it is conditional on the mental activities of the user. This applies to the present case because any possible technical effect depends on the user's reaction to the itinerary."
• These observations are without prejudice to the question of whether claims involving the display of medical diagnostic data should benefit from the exception of G1/19 r.98 and r.128 of an implied technical use and effect of the calculated or displayed data, the possible argument being the potential use of the data is (practically, realistically) limited to medical purposes (methods of treatment of patients) and that medical purposes are technical purposes.

EPO 

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

T 2046/19 - Combining in vivo and in vitro diagnostics

Key points

• Claim 1 reads as follows: ""1. A method for the prognosis .... of patients with COPD the method comprising the steps of:

  i) providing a sample of a bodily fluid from said patient, ii) determining in said sample the level of at least one biomarker, selected from the group consisting of proadrenomedullin (proADM), pro-natriuretic peptide, pro-Vasopressin (proAVP) and Procalcitonin (PCT) or fragments thereof of at least 12 amino acids in length, [and]

  iii) determining the BODE-index parameters according to one of the following steps:

  iii-a) determining the BODE-index parameters body-mass index (BMI, parameter B), degree of airflow obstruction (FEV1, parameter O), and dyspnea (parameter D), omitting the BODE-index parameter exercise capacity (parameter E);

  iii-b) determining the BODE-index parameters body-mass index (BMI, parameter B) and dyspnea (parameter D), omitting the BODE-index parameters exercise capacity (parameter E) and degree of airflow obstruction (FEV1, parameter O);

  iv) correlating said level of said at least one biomarker determined in step ii), in combination with said BODE-index parameters determined in step iii-a) or in step iii-b) to the prognosis and/or risk assessment and/or monitoring of therapy and/or management of patients with COPD."'

• The patent was opposed. The Board considers the claim to be insufficiently disclosed.
• However, my question initially was, how is a claim reciting 'determining dyspnea' (shortness of breath) not a diagnostic method under G 1/04? 
• The answer is probably r.9 of G1/04: "The grant of a European patent in respect of a diagnostic method which includes preceding method steps of a technical nature carried out by a device (cf. point 6.4.3 above) does not contravene [Article 53(c) EPC 2000] because the performance of the respective method steps does not satisfy the criterion "practised on the human or animal body". However, in the event of patent protection, it will normally be sufficient to purchase the device in question in order to be entitled to carry out such a method [*]. In cases where the same diagnostic conclusions can be attained by a method not including the use of the device, those carrying it out will not be inhibited by the patent. Therefore, the medical or veterinary practitioners cannot be considered to be hampered by the existence of such a patent."
• [*] - the Enlarged Board refers to the national case law and rules about exhaustion and implied licenses. 
• Hence, according to this decision, it seems that a method of in vitro diagnosis is still patentable even if combined with an in vivo diagnostic test.
• "the so-called "BODE index" was known as a tool for the prognosis of mortality and hospitalisation for COPD in patients with COPD."
• 
  

EPO 

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

T 1920/21 - A tutorial on diagnostic methods

Key points

• "The Enlarged Board of Appeal stated in G 1/04 (Conclusion 1) that to be excluded from patentability [under the diagnostmic method prong of Art. 53(c)] the claim is to include the features relating to: (i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise, (ii) the preceding steps which are constitutive for making that diagnosis, and (iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature." 
• "the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practised on the human or animal body" [in order to be excluded]

• The preceding method steps which are constitutive for making the diagnosis for curative purposes include:  (i) the examination phase involving the collection of data, (ii) the comparison of these data with standard values, (iii) the finding of any significant deviation, i.e. a symptom, during the comparison

• " To determine whether claim 1 is directed to a diagnostic method within the meaning of  Article 53(c) EPC and thus excluded from patentability, it must first be established whether all of the necessary method steps (see point 3. above) are included in the claim."

• The Board finds that this is the case.

• The claimed method is a breath test.

• "the Enlarged Board held that activities falling within steps (ii) and (iii) are predominantly of a non-technical nature, and in any event, are not normally practised on the human body (G 1/04, Reasons 6.4.1). Therefore, in most cases only the first phase which relates to the examination phase and the collection of data can be of a technical nature and, therefore, concerned with the criterion "practised on the human or animal body"."

• "to satisfy the criterion "practised on the human or animal body" it is however not required that a preceding step of a technical nature be invasive. It suffices that its performance implies any interaction with the human or animal body, necessitating the presence of the latter (G 1/04, Conclusion 4). Collecting a breath sample necessarily requires the presence of the patient from which the breath sample is collected. The two technical steps of claim 1 relating to the collection of breath samples (see point 11. above) therefore satisfy the criterion "practised on the human or animal body"."

• "the board is however satisfied that the further method step of a technical nature of phase (i), i.e. "measuring the content of **(13)C in the CO2 of the first and second sample and determination of a **(13)C/**(12)C ratio by spectroscopy in the respective samples" does not meet the criterion "practised on the human or animal body"."

• The devices for measuring the ¹³C content " include devices for gas isotope ratio mass spectroscopy or infrared spectrometer (see also paragraph [0013] of the application) and are in any case devices which analyse the collected breath samples without any interaction with the patient or necessitating its presence."

• Hence, the method escapes the exclusion by reciting one in vitro step.

• "the Enlarged Board held in G 1/04 that since a narrow interpretation of the scope of the exclusion from patentability under Article 52(4) EPC 1973 [Art. 53(c) EPC 2000] in respect of diagnostic methods was equitable, it was justified to require that the performance of each and every one of the method steps of a technical nature of a diagnostic method should satisfy the criterion "practised on the human or animal body" (Reasons 6.4.4)."

EPO 

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

T 0758/12 - Genotype and business method

Key points

• In this examination appeal, claim 1 is directed to a method for selecting medication for a patient, comprising the steps of (essentially) providing the patient's genotype wherein the genetype has a specific allele (i.e. selecting patients having that allele) and the step of selecting the medication based on the genotype.
• " Without further limitation, the term "providing a patient's genotype" includes the provision, i.e. the making available, of patient data, for instance, in the form of a print-out on a piece of paper when such data have been obtained in a step preceding the steps of the claimed method. Under these circumstances, the claimed method is reduced to a scheme, rule or method for performing a mental act or doing business with those data which as such is excluded from patentability (Article 52(2)(c) EPC)."

EPO T 0758/12 - link

V. Claim 1 of the main request reads:

"1. A method for selecting a psychotropic medication for a patient, said method comprising
(a) providing said patient's genotype for a panel of genes, wherein said panel comprises a CYP2D6 gene, a CYP2C19 gene, a CYP1A2 gene, a serotonin transporter gene, and a serotonin receptor 2A gene; wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele; and
(b) selecting said psychotropic medication based on said genotype."

Reasons for the Decision

Extent of examination in appeal proceedings

1. In an appeal from a decision of an examining division, the board is not limited to examine issues on which the examining division decided adversely, in the present case issues under Articles 123(2) and 56 EPC. Rather, the board is empowered to examine whether or not the claims on file and the invention to which they relate fulfil all requirements of the EPC and, accordingly, raise new objections if it considers it necessary (see Order of decision G 10/93, OJ EPO 1995, 172). In the present case, the board considers that issues under Articles 52(2)(c) and 84 EPC must be addressed.

Article 113(1) EPC - right to be heard

2. As announced in writing, the appellant did not attend the oral proceedings. Nor did it file substantive arguments in reply to the board's communication pursuant to Article 15(1) RPBA (cf. point III, above). By neither replying to the board's communication in substance nor attending the oral proceedings, the appellant effectively chose not to avail itself of the opportunity to comment or present its observations on the board's provisional opinion (Article 113(1) EPC). As a consequence of appellant's course of action, there are no submissions on file as regards the patentability of the claimed subject-matter (Article 52(2)(c) EPC) or the compliance with the requirements of Article 84 EPC, issues mentioned in points 6 to 10 of the board's communication pursuant to Article 15(1) RPBA and relating to the main and the auxiliary request.

Article 52(2)(c) EPC

3. As presently worded, claim 1 of the main and the auxiliary request encompasses subject-matter excluded from patentability. Claim 1 of both requests defines a method for selecting a psychotropic medication for a patient comprising the steps of (a) providing a patient's genotype, and (b) selecting said medication. Without further limitation, the term "providing a patient's genotype" includes the provision, i.e. the making available, of patient data, for instance, in the form of a print-out on a piece of paper when such data have been obtained in a step preceding the steps of the claimed method. Under these circumstances, the claimed method is reduced to a scheme, rule or method for performing a mental act or doing business with those data which as such is excluded from patentability (Article 52(2)(c) EPC).

Article 84 EPC

4. Step (a) of claim 1 of both requests is ambiguous and therefore unclear within the meaning of Article 84 EPC.

The step comprises the provision of a patient's genotype for a panel of genes which comprises the CYP2D6 gene and "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele". This wording allows three possible interpretations:

(i) the feature "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele" is interpreted as merely stating that the 2D6 alleles which can possibly be identified in said patient include or comprise the 2D6*41 allele, or

(ii) the feature "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele" specifies that the patient carries said 2D6*41 allele. The claimed method is thus limited to selecting a psychotropic medication (step (b) of claim 1) for a patient who is already known to be a carrier of at least one 2D6*41 allele, or

(iii) the feature "wherein said genotype for said CYP2D6 gene comprises the 2D6*41 allele" is interpreted as requiring that "providing said patient's genotype" comprises determining experimentally if said patient comprises the 2D6*41 allele.

5. In view of this ambiguity, neither claim 1 of the main request nor claim 1 of the auxiliary request provide a clear definition of the claimed subject-matter.

6. Furthermore, claim 1 of both requests lacks essential technical features.

According to the established case law of the Boards of Appeal, Article 84 EPC has to be interpreted as meaning not only that a claim must be comprehensible from a technical point of view, but also that it must define the object of the invention clearly, that is to say indicate all the essential features thereof. All features which are necessary for solving the technical problem with which the application is concerned have to be regarded as essential features (see "Case Law of the Boards of Appeal of the EPO", 8th edition 2016, II.A.3.2, page 272).

7. The goal of the method of claim 1 is the selection of a "psychotropic medication for a patient". The method comprises the determination of the patient's genotype for a panel of five genes (CYP2D6, CYP2C19, CYP1A2, a serotonin transporter gene (5-HTT), and a serotonin receptor 2A gene (HTR2A)) (step(a)), followed by the selection of said medication based on said genotype (step (b)). Step (b) does however not define any rules, criteria, parameters or properties for the selection of a psychotropic medication based on a patient's genotype of the five genes. The claim therefore lacks essential technical features.

8. Moreover, according to Article 84 EPC, the claims must not only be clear but also supported by the description. This requirement reflects the general legal principle that the extent of the patent monopoly, as defined by the claims, should correspond to the technical contribution to the art in order for it to be supported, or justified (see decision T 409/91, OJ EPO 1994, page 653, point 3.3 of the Reasons for the decision).

9. The patent application does not provide instructions how to select a psychotropic medication if a patient is a carrier of a 2D6*41 allele, either in combination with a second 2D6*41 allele or in combination with a different 2D6 allele, and particular alleles of the other genes mentioned in the claim.

Although the patent application discloses allelic variants of several cytochrome P450 genes (Table 1), there is no information on the activity level of any of the mentioned alleles except for some CYP2D6 alleles (Table 10). Nor is there any information on the activity levels related to or associated with the polymorphisms of the serotonin transporter and the serotonin receptor 2A listed in Table 2.

The application contains also no information on the (exclusive) substrate and conditions to be used for determining the activity level of the CYP2D6 alleles. There is no reference to a "standard assay" (well known and generally accepted in the art) for measuring such activity levels, let alone to "standard assays" for measuring the activity of each and every allele of the other genes listed in the claims. Nor is there any information on the criteria (threshold) used for classifying a CYP2D6 allele as a poor, intermediate, extensive or ultra-rapid metabolizer.

10. Thus, claim 1 of the main and the auxiliary request, directed to a method for selecting a psychotropic medication, relates to subject-matter which, after reading the description, is not at the disposal of the person skilled in the art.

11. The subject matter of claim 1 of the main and the auxiliary request is neither clearly defined nor supported by the description (Article 84 EPC).

Conclusion

12. In the absence of an allowable request, the appeal must be dismissed.

Order

For these reasons it is decided that:

The appeal is dismissed.