T 0649/20 (Monitoring thrombin inhibition/HAEMONETICS) 13-10-2022

1. The appeal is admissible.

2. The oral proceedings before the board took place in the absence of the opponent (respondent), who was duly summoned but decided not to attend.

According to Rule 115(2) EPC, if a party duly summoned to oral proceedings does not appear as summoned, the proceedings may continue without that party. As stipulated by Article 15(3) RPBA, the board is not obliged to delay any step in the proceedings, including its decision, by reason only of the absence at the oral proceedings of any party duly summoned; that party may then be treated as relying on its written case.

3. Admission of document D17

3.1 According to Article 12(2) RPBA, a party's appeal case shall be directed to the requests, facts, objections, arguments and evidence on which the decision under appeal was based. Article 12(4) RPBA gives the board the discretion not to admit an amendment to the party's case, i.e. any part of a party's appeal case which does not meet the requirements in paragraph 2, unless the party demonstrates that this part was admissibly raised and maintained in the proceedings leading to the decision under appeal. With regard to the admission of requests, facts, objections or evidence which should have been submitted, or which were no longer maintained in the proceedings leading to the decision under appeal, Article 12(6) RPBA stipulates that these should not be admitted unless the circumstances of the appeal case justify their admission.

3.2 Document D17 was filed for the first time by the respondent with the reply to the statement of grounds of appeal. Its admission is thus at the board's discretion, pursuant to Article 12(4) and (6) RPBA.

3.3 In the board's communication pursuant to Article 15(1) RPBA, the board indicated that it was inclined not to admit document D17 into the proceedings and provided reasons for this. The respondent has not made any further submissions as regards the admission of D17. The board thus had no reason to change its preliminary opinion and accordingly decided not to admit D17 into the appeal proceedings; however, in view of the outcome of the appeal, the board sees no need to further substantiate this part of the decision.

4. Status of D1 as prior art

4.1 The patent in suit claims priority from a US patent application filed on 25 May 2006. Document D1 is a scientific article which was published in 2006 in volume 102 of the journal Anesthesia & Analgesia. The exact publication date of D1 is not available in the document itself. As evidence for its publication date being before the priority date of the patent, the respondent provided the following documents during the opposition proceedings: D1a, D14, D15 and D16.

4.2 D1a is a printout of an online entry entitled "Archive of 2006 Online Issues". The web address is "http://www.anesthesia-analgesia.org/content/by/year/2006". The document lists all 12 monthly issues of the journal. It is apparent that volume 102 includes the May issue, for which the following information is given: "May 1; 102(5): 1304-1600". The May issue was actually the last one of the issues belonging to volume 102 and in view of the page numbers covered by this issue, it clearly included the article corresponding to D1 (pages 1316-1319).

4.3 In addition, D14 is an extract from the public database from the Central Library for Medicine of the Leibniz Life Sciences Information Center (Zentralbibliothek für Medizin des Leibniz-Informationszentrum Lebenswissenschaften), wherein the dates of receipt of subscribed journal issues are listed, i.e. the journal Anesthesia & Analgesia in the present case. On page 4 of the extract, it can be seen that the May 2006 issue of volume 102 of the journal (labelled in D14 as "102.2006,5") was received twice ("2x") by the library on 19 May 2006.

4.4 Finally, documents D15 and D16 are two printouts of email exchanges between the respondent's professional representative Mr Stephan Tatzel and Ms Nancy Lynly (D15) and Mr Kivmars Bowling (D16). The email exchanges consist of enquiries by the above-mentioned professional representative on the publication date of the May 2006, volume 102 issue of the Anesthesia & Analgesia journal and the respective replies by Ms Lynly, Senior Managing Editor at "Anesthesia & Analgesia", and Mr Bowling, Senior Publisher in the department of Health Learning, Research & Practice at Wolters Kluwer (publisher of the Anesthesia & Analgesia journal). Both Ms Lynly and Mr Bowling indicate the same date, 21 April 2006, as the "official date for public availability of the May 2006 issue" (Ms Lynly) and as the date when the "article went live" (Mr Bowling).

4.5 Accordingly, the board concludes that, although D1 does not feature any publication date other than the year of 2006, there is evidence on file indicating that the issue to which D1 belongs has the date of 1 May 2006 (D1a) and that it had been published on 21 April 2006 (D15 and D16). Moreover, there is evidence that the printed edition of the journal issue was publicly available on 19 May 2022, as this was the date of receipt at one public library (D14). There is no evidence on file contradicting this evidence.

4.6 The board is not persuaded by the appellant's arguments that the evidence on file is contradictory and does not make it possible to clearly establish when D1 was published. The fact that both a senior managing editor and a senior publisher of the journal independently indicate the same date as the date of publication for the issue in question makes it possible to conclude with a high degree of certainty that this is the correct publication date. The board fails to see any good reason to doubt the credibility of Ms Lynly and Mr Bowling, and the appellant has not provided any evidence to support such allegations. Moreover, it is sufficient to establish that the document was available to the public before the priority date in order to conclude that it is prior art. D14 is already considered to provide sufficient evidence that D1 was in fact publicly available before the priority date. Contrary to the appellant's arguments, it is not relevant whether or not a member of the public indeed had access to it; the librarian that received the issue and registered it in the database from which D14 has been obtained is a member of the public in any case for the purposes of Article 54(2) EPC (see e.g. T 834/09, points 5.1 to 6.3 of the Reasons).

4.7 Document D1 is thus prior art pursuant to Article 54(2) EPC for the claimed subject-matter.

5. Main request, novelty

5.1 Document D1 discloses the measurement of patients' bivalirudin levels by a thrombelastograph ecarin clotting time assay (TEG® ECT); see e.g. the title. It is not disputed that such an assay is used to determine a "clot strength related quantitative indication of a (...) blood sample hemostasis characteristic" as defined in the claim; this is also the assay that is used in the patent (e.g. paragraphs [0027] and [0029]). D1 explicitly states that "The reaction time until detectable clot formation (R) was chosen as the comparative parameter" (page 1318, left-hand column, lines 4 to 6), which is also a feature of the claim. Moreover, D1 discloses measurements of said hemostasis parameters both before and after anti-coagulation hemostasis therapy (see Figures 1 and 2 of D1), as also required in the claim. Finally, D1 discusses Figure 2 as follows (page 1318, right-hand column, lines 1 to 5): "A typical set of patient TEG® tracings before and after bivalirudin treatment is shown in Figure 2. The R value shows the greatest change in response to bivalirudin with smaller reductions in time after the R point ...". The board thus agrees with the opposition division's conclusions and the respondent's arguments that D1 does disclose the method step of determining a parameter indicative of the efficacy of the anti-coagulation therapy based upon the first and the second quantitative indication.

5.2 For the above reasons, the board disagrees with the appellant's arguments that the feature "determining a parameter indicative of the efficacy of the anti-coagulation hemostasis therapy based upon the first and the second quantitative indications, the second quantitative indication demonstrating a contribution to clot formation delay in comparison to the first quantitative indication" is not directly and unambiguously disclosed in D1, because such a parameter was not implicitly, let alone explicitly, disclosed in D1. As explained above, said parameter is indeed at least implicitly disclosed in D1, even if it is not defined in the same way as in the claim. As argued by the respondent, the passages in D1 disclosing said feature (Figure 1 and page 1318, right-hand column, first paragraph) correspond to the disclosure in the patent in paragraph [0064] and Figures 14a and 14b, which are the passages on which the appellant relies in the context of sufficiency of disclosure (appellant's letter of 7 December 2020, page 3, first paragraph of section 4.2).

5.3 Claim 1 of the main request thus lacks novelty over D1 (Article 54(2) EPC).

6. Auxiliary request 1, novelty and inventive step

6.1 The board agrees with the appellant and the opposition division that the added feature that the method further comprises "comparing the first and the second quantitative indications to correlation data and determining a dosing parameter of the anti-coagulation hemostasis therapy in view of the correlation data" is not disclosed in document D1. The subject-matter of claim 1 of auxiliary request 1 is thus considered novel over D1 (Article 54(2) EPC).

6.2 According to the opposition division and the respondent, the technical effect linked to said distinguishing feature was that the method made it possible to determine a desired dose of an anti-coagulation therapeutic and the objective technical problem could thus be formulated as that of providing a method for determining a desired dose of an anti-coagulation therapeutic in view of correlation data. The appellant formulated the problem differently, namely as the provision of an improved thromboelastographic method for monitoring anti-coagulation therapy and in particular for determining on a patient specific basis the attainment of therapeutic levels of a direct thrombin inhibitor in whole blood, thereby determining a desired dose of a direct thrombin inhibitor (appellant's letter of 7 December 2020, page 13, fourth paragraph).

6.3 The board fails to see any evidence on file for an improvement to the thromboelastographic method over the method in D1, being that the thromboelastographic method is the same in D1 and in the patent. As argued by the respondent, the added step of comparing the quantitative indications with correlation data makes it possible to determine a dosing parameter, and hence the problem is to be formulated as proposed by the opposition division and the respondent. Although D1 does not specifically teach using correlation data in order to determine an individual anti-coagulation therapy dosing, it does teach that such individualised dosing could be determined based on the TEG® ECT test (page 1319, left-hand column, lines 4 to 7). This is in fact the aim of D1. Moreover, in Figure 4 of D1 correlation data is provided between plasma bivalirudin levels on the x axis and clotting time (as measured by the TEG® ECT test) on the y axis. Hence, the skilled person would just have to follow the suggestion of D1 and use the correlation data provided in this document in order to arrive at the claimed subject-matter.

6.4 The appellant's argument for non-obviousness was essentially that, at most, document D1 suggested using correlation data as regards the second quantitative indication but not the first quantitative indication, because both Figures 1 and 4 of D1 only related to data obtained after treatment. The board disagrees and notes that Figure 1 in fact relates to clotting time before and after bivalirudin treatment (see legend of the figure). Moreover, it would be obvious to the skilled person that, in order to determine a therapy dosing, the effect of the therapy first has to be established in relation to the absence of therapy. This is also clearly stated in D1 (e.g. page 1318, right-hand column, first paragraph).

6.5 Claim 1 of auxiliary request 1 is thus considered to lack an inventive step (Article 56 EPC).

7. Auxiliary request 2, inventive step

7.1 Two features were added to claim 1 of auxiliary request 2, namely the use of hemostasis analyzer and "wherein the correlation data is contained in a database included or linked to the hemostasis analyzer". The appellant argued that the claimed subject-matter was inventive because there was no pointer in D1 or in the remaining prior art for the second feature, and the respondent had not provided evidence for its assertion that it was common general knowledge, either.

7.2 As argued by the respondent, the use of a hemostasis analyzer is already disclosed in D1 (page 1316, left-hand column, paragraph 2, line 1, and page 1318, left-hand column, paragraph 1, last sentence). The difference between the claimed subject-matter and the disclosure of D1 is that the correlation data is contained in a database included or linked to the hemostasis analyzer. The technical effect linked to said distinguishing feature is that the method can be automated, and the technical problem is to provide an automated analysing system for providing a patient-specific anti-coagulation therapy using correlation data.

7.3 In view of the information already provided by D1, the skilled person, motivated to automate the method in D1, would just need to use common general knowledge to store the correlation data from Figure 4 in the form of a database in the hemostasis analyzer system and use this database for comparison purposes in the process of determining the anti-coagulation therapy dose.

7.4 With regard to the appellant's argument that there was no pointer to such a feature in D1, and such a feature was not known in connection with a method as claimed, either, the board notes that, as argued by the respondent, such a feature belonged to the common general knowledge and was thus a trivial modification that the skilled person would envisage. The board is not convinced by the appellant's argument, raised for the first time at oral proceedings, that such a measure would not be part of the common general knowledge, and the board does not agree that evidence is required to demonstrate that it is indeed common general knowledge since the use of a database is notorious knowledge when automating the use of (correlation) data.

7.5 Claim 1 of auxiliary request 2 is considered to lack an inventive step (Article 56 EPC).

8. Auxiliary request 3, admission

8.1 Auxiliary request 3 was filed with the statement of grounds of appeal and thus its admission is at the discretion of the board, pursuant to Article 12(4) and (6) RPBA (see also section 3.1).

8.2 When filing auxiliary request 3 with the statement of grounds of appeal, the appellant did not submit any arguments as to why this request should be admitted. In a subsequent letter, filed in response to the respondent's objection against the admission of auxiliary request 3, the appellant argued that the request could not have been filed earlier because it was filed in direct response to the reasoning of the opposition division's decision. The same argument was also submitted at oral proceedings. At the oral proceedings, the appellant also argued that no complexity had been added to the case and that the claims were filed as a fair attempt to overcome the objections on file.

8.3 As argued by the respondent, auxiliary request 3 contains amendments originating from the description and on which the appellant relies for inventive step. The board fails to see how these amendments constitute a response to the reasoning of the opposition division's decision; the decision was based on the arguments already on file before the oral proceedings, and there was no unexpected turn of events at the oral proceedings that would justify these amendments being filed in appeal proceedings. Moreover, the appellant failed to indicate which part of the reasoning in the decision caused it to submit this request. Instead, these amendments appear to be another attempt to further distinguish the claimed subject-matter from the prior art by inserting additional features. By choosing not to file such a request at an earlier stage, i.e. during opposition proceedings, the appellant in fact prevented the opposition division from deciding upon such subject-matter. The appellant then filing the request at appeal proceedings is contrary to the purpose of appeal proceedings, which is to review the decision of the department of first instance. Moreover, since the added features come from the description and were not part of the claims as granted, it cannot even be assumed that the opponent or the opposition division has performed any search whatsoever in respect of said features.

8.4 The board thus considers that auxiliary request 3 could and should have been filed earlier, during opposition proceedings, and decides to exercise its discretion under Article 12(6) RPBA not to admit it into appeal proceedings.