T 2157/21 20-06-2024

1. Amendments (Articles 100(c) and 123(2) EPC)

1.1 The objections raised in relation to added subject-matter were mainly concerned with the characterisation of the claimed crystalline "Form II" in the claims in question.

Technical background

1.2 Crystalline solids are often characterised by X-ray powder diffraction (XRPD) patterns (or diffractograms), such as those rendered in Figures 7 and 8 of the patent in suit and the application as filed, which show a plot of the intensity of the lines observed over a continuous range of 2Theta values, wherein Theta is the scattering angle. As for terminology, these lines are called "peaks" in both the application as filed and the patent in suit.

1.3 Lists of 2Theta values, associated in the accompanying text with "Form II", are disclosed in Tables 4 and 5 and in paragraphs [0037] to [0040] of the patent in suit (corresponding to Tables 4 and 5 and page 8, lines 1 to 13, of the application as filed). Such lists are combinations of certain selected lines that are considered characteristic of the product in question. They do not contain the complete information from the corresponding diffractogram. In particular, it cannot be derived from a list of 2Theta values whether further lines at other 2Theta values are present or absent in the corresponding diffractogram. The lists in Table 4 (showing eighteen 2Theta values) and Table 5 (showing twenty-one 2Theta values) include d-spacing and line intensities, whereas the lists on page 8 of the application as filed do not.

Legal background

1.4 According to the established jurisprudence of the boards of appeal, and as summarised and confirmed in decision G2/10 (OJ EPO 2012, 376; Reasons 4.3) with reference to G3/89 and G11/91, the following basic principle (the so-called "gold standard") applies:

Any amendment to the parts of a European patent application or of a European patent relating to the disclosure (the description, claims and drawings) is subject to the mandatory prohibition on extension laid down in Article 123(2) EPC and can therefore, irrespective of the context of the amendment made, only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, and seen objectively and relative to the date of filing, from the whole of these documents as filed.

1.5 What can be derived directly and unambiguously has to be determined according to the circumstances of the individual case.

Main request

1.6 Claim 1 as granted (main request) defines the claimed crystalline product by an X-ray powder diffraction pattern which, as the sole requirement, must comprise lines at the following 2Theta values, measured using CuKa radiation: 4.3°+/- 0.2°, 10.9°+/- 0.2°, and 14.6°+/- 0.2°.

1.7 The specific combination consisting of these three values is not disclosed anywhere in the application as filed. There is thus no teaching that this particular combination might suffice for characterising the crystalline "Form II" of the application.

1.7.1 Combinations of 2Theta values intended to describe the crystalline "Form II" are set out in the application as filed on page 8, in claims 7 to 9 and in Tables 4 and 5 as follows:

(a) 4.3°, 5.0° and 12.8°, each +/-0.2 (see claim 7 and page 8, line 3)

(b) 4.3°, 5.0°, 5.5°, 5.8°, 12.8° and 18.9°, each +/- 0.2 (see claim 8 and page 8, lines 4 to 6)

(c) 4.3°, 5.0°, 12.8°, 14.6°, 18.5° and 20.1°, each +/1 0.2 (see claim 9 and page 8, lines 7 to 9)

(d) 4.3°, 5.0°, 5.5°, 5.8 , 12.8°, 14.6°, 18.5°, 18.9° and 20.1 , each +/- 0.2 (see claim 9 and page 8, lines 7 to 9 and 10 to 13)

(e) eighteen 2Theta values with corresponding d-spacings and relative intensities, without error ranges (Table 4 on pages 19 to 20)

(f) twenty-one 2Theta values with corresponding d-spacings and relative intensities, without error ranges (Table 5 on pages 20 to 21)

1.7.2 The combinations of 2Theta values disclosed in Table 5, on page 8 of the description and in claims 7 to 9 as filed do not contain the value 10.9°+/- 0.2°. All but one of these lists also combine more than three values. Table 5 shows a combination of twenty-one 2Theta values including line intensities.

The combination with only three values is "4.3°+/- 0.2°, 5.0°+/- 0.2°, and 12.8°+/- 0.2°" (see page 8, lines 1 to 3 and claim 7), thus deviating in two of the specified values from claim 1 as granted.

Hence, none of these passages specifically discloses the combination of lines as defined in claim 1 as granted.

1.7.3 Table 4 in the application as filed shows a combination of eighteen 2Theta values, including 10.9°, 4.3° and 14.6°. However, the table also includes line intensities (absent in claim 1 as granted) and requires the presence of fifteen more lines which are not mandatory according to claim 1 as granted.

1.8 In these circumstances, neither the specific combination of 2Theta values in claim 1 as granted, nor the information that this combination may serve to characterise the product designated as "Form II" is derivable directly and unambiguously, using common general knowledge, from the application as filed. Contrary to the patent proprietors' argument in this regard, it is not implicit that any selection from a table listing eighteen characteristic values, such as the combination of any three values, will suffice to characterise the compound in question.

1.9 In line with the "gold standard" set out in section 1.4 above, a combination of 2Theta values used to characterise a crystalline form in any pending claim request has to be specifically disclosed in the application as filed. If that is not the case, the new combination constitutes added subject-matter.

1.10 The opposition division mentioned decisions T 1684/16 and T 1442/18 in its reasoning.

In the case underlying T 1684/16, the claim under consideration defined the crystalline form in question by a list of five 2Theta values (these are called "peaks" in the decision), whereas it was defined in the application as filed by two lists of fifteen and twenty-four 2Theta values.

In the case underlying T 1442/18, the claims under consideration defined the crystalline form in question by lists of eleven or seventeen 2Theta values, whereas the application as filed defined it by a list of thirty-nine 2Theta values.

In both cases, the respective case board, applying the standard of direct and unambiguous disclosure, did not allow claim amendments that defined a claimed crystalline form by new sets of 2Theta values that were not specifically disclosed in the application as filed (T 1684/16, sections 2.1 to 2.5 of the Reasons; T 1442/18, section 14.1 of the Reasons). The opposition division's reference to these decisions regarding this point is thus correct.

The patent proprietors' reading of T 1684/16 is not correct. In that decision, the board held that the amendment in question was not allowable because the list of five 2Theta values in the claim under consideration was not specifically disclosed in the application as filed. It was not even disclosed that five 2Theta values could suffice for characterising the claimed crystalline form. This last point is, however, not crucial for the outcome. It cannot be interpreted (as the patent proprietors did) in the sense that the proposed amendment would have been allowed if it could have been inferred from the application as filed that the crystalline form could be characterised by (any) five 2Theta values. As is made clear by the board in T 1684/16, the relevant requirement is that the specific list of five values should be disclosed in the application as filed, in line with the standard set out in sections 1.4, 1.8 and 1.9 above.

Thus, the board states in section 2.4 of the Reasons:

"[...] the list of five peaks in claim 1 of the patent as granted, and more specifically the fact that Form I can be characterised (and possibly distinguished) by just these five specific peaks, amounts to technical information which is not directly and unambiguously derivable from the whole content of the application as filed."

1.11 The circumstances underlying decision T 325/16 (cited by the patent proprietors) are different from those in the case at hand since the four 2Theta values recited in the claim under consideration were identified as characterising lines in Example 3 of the application as filed, in the same specific set of four values (see T 325/16, section 9 of the Reasons). In contrast, in the case at hand, the patent proprietors relied in their reasoning on sets of 2Theta values in the application as filed which are different from the list in claim 1 as granted.

1.12 For the reasons set out in sections 1.2 to 1.11 above, the ground of opposition under Article 100(c) EPC prejudices the maintenance of the patent as granted.

Auxiliary requests 1, 2, 2A, 3, 3A, 6, 6A, 7 and 7A

1.13 The finding according to section 1.8 also applies, for analogous reasons, to claim 1 of each of auxiliary requests 1, 2, 2A, 3, 3A, 6, 6A, 7 and 7A, as all of these define the claimed "Form II" product by varied combinations of a number of up to ten 2Theta values including the three values listed in claim 1 as granted. None of these combinations is specifically disclosed in the application as filed as characterising "Form II".

1.14 As a consequence, the subject-matter of claim 1 of each of auxiliary requests 1, 2, 2A, 3, 3A, 6, 6A, 7 and 7A extends beyond the content of the application as filed (Article 123(2) EPC).

Auxiliary requests 10, 10A, 11 and 11A

1.15 Claim 1 of auxiliary requests 10, 10A, 11 and 11A characterises the claimed "Form II" product by eighteen 2Theta values that are identical to those in Table 4 of the application as filed.

1.16 However, in Table 4 of the application as filed, these values were disclosed together with the respective line intensities. As this limitation is not present in claim 1 of auxiliary requests 10, 10A, 11 and 11A, the claims in question contain added subject-matter. The relevant criterion for the allowability of the amendment is disclosure in the application as filed, irrespective of any considerations relating to the reproducibility of line intensities observed with XRPD.

1.17 Moreover, error ranges of 0.2 , which are not present in Table 4 of the application as filed, were added in auxiliary requests 10 and 10A. The board is not convinced by the patent proprietors' argument that the person skilled in the art would have inferred, by context and on the basis of common general knowledge, that error ranges of +/- 0.2 are inherent and must apply to all 2Theta values provided in the application as filed.

1.17.1 The disclosures and comments in D4 and D5 (relied on by the patent proprietors) do not warrant such a categorical conclusion.

D5, an expert declaration provided by the patent proprietors, states that the standard variation for characteristic peaks in XRPD measurements is typically reported as +/- 0.2 degrees 2Theta, and in this context refers to D5b.

Both D4 (European Pharmacopoeia 8.0) and D5b (USP 35), state the following in their chapters on XRPD measurement:

"For most organic crystals, when using CuKa radiation, it is appropriate to record the diffraction pattern in a 2Theta-range from as near 0° as possible to at least 40°. The agreement in the 2Theta-diffraction angles between different specimen and reference is within 0.2 for the same crystal form, while relative intensities between specimen and reference may vary considerably due to preferred orientation effects."

1.17.2 While D4 and D5b may thus suggest that the error range of +/- 0.2 is typical, there is no common-general-knowledge evidence that no other error range can apply in individual cases. Indeed, in decision T 325/16 cited by the patent proprietors, the error range was indicated as +/- 0.1 (see sections 1 and 9 of the Reasons). The declaration D5 itself mentions several factors that may influence 2Theta measurements (see D5: section III.2, which mentions zero calibration, the height at which the sample sits in the diffractometer, and the surface planarity of the sample).

1.17.3 The application as filed does not define at any point that the range of +/- 0.2 is to be applied to all 2Theta values where no error range is indicated, in particular the values as combined in Tables 4 or 5.

1.18 A further objection relates to claim 2 of auxiliary requests 10 and 11 (see section X. above).

1.18.1 This claim, by reference to the product of claim 1, combines the process of preparation as described in Example 7 with the 2Theta values from Table 4. Table 4 is disclosed in the application as filed in the context of Example 6, however, where the material described was obtained with a different process of preparation (see the application as filed, Example 7, page 20, lines 5 to 15 and Example 6, Table 4 bridging pages 19 and 20). The process described in Example 6 is as follows:

"To 11.0 mL of Methanol/Toluene (1/10; v/v) was dissolved 66.7 mg of trisodium [3-((1S,3R)-1-

biphenyl-4-ylmethyl-3-ethoxycarbonyl-l-butyl-carbamoyl)propionate-(S)-3'-methyl-2'-(pentanoyl {2"-(tetrazol-5-ylate)biphenyl-4'-ylmethyl}amino) butyrate] hemipentahydrate in a glass vial. Filtered the solution through a 0.45 mym filter and put to room temperature (RT) for slow evaporation with a pin-holed parafilm. The solid was isolated [...]"

This differs in all process steps from the process according to claim 2 of auxiliary requests 10 and 11 and Example 7 in the application as filed, where a different concentration of the complex in methanol (no toluene present) was heated to 80 C, after which toluene was added.

1.18.2 Thus, Table 4 is not directly and unambiguously disclosed in the application as filed together with the process of preparation from Example 7.

1.18.3 The mere fact that both the product obtained according to Example 6 and the product obtained according to Example 7 are designated as "Form II" in the application as filed does not prove that they were indeed the same material, since by itself, this amounts to no more than an assertion. Contrary indications are that these products were obtained by different processes and showed certain differences in their XRPD diffractograms, which can be seen when comparing the process descriptions in Examples 6 and 7, the diffractograms in Figures 7 and 8 and the tabulated lists of 2Theta values in Tables 4 and 5. Obvious differences are the absence/presence of a number of lines both in the diffractograms and in the tabulated lists, most prominently the absence of the line at 12.4 in the case of the product of Example 6. These differences are not explained in the application as filed, and they cannot just be ignored. A comparison of Table 4 with Table 5 and of Figure 7 with Figure 8 does not permit the conclusion to be drawn that the materials are identical as regards the crystal form, especially in view of the different processes of preparation.

1.18.4 In the context of their submissions on inventive step, the patent proprietors presented a further argument in support of their view that the crystalline products prepared according to Example 6 and Example 7 were identical. This argument will be dealt with in the following, as it is relevant for concluding the issue of added subject-matter.

Basically, the patent proprietors argued that the only relevant difference was the line at 12.4 that occurred in Figure 8 (associated with Example 7) but not in Figure 7 (associated with Example 6), and that this could be explained by suboptimal measurement conditions.

In particular, the patent proprietors hypothesised that the line observed at 12.4 for the product according to Example 7 was due to a "preferred orientation effect" or was associated with the sample holder employed. The process of preparation according to Example 3 of the priority document (which corresponds to the process according to Example 7) and the XRPD measurement had been repeated with a new sample holder. As demonstrated by the diffractograms presented in the corresponding test report (D9), no line at 12.4 had been observed.

This argument is not convincing. The patent proprietors were responsible for carrying out their measurements correctly in the sense of analysing for and eliminating potential sources of systematic measurement error. The data in Figure 8 and Table 5 is presented in the application as filed without qualification. As the differences between the data associated with Examples 6 and 7 are not addressed, it cannot be inferred from any passage in the application as filed that the line shown at 12.4 for the product prepared according to Example 7 was believed to be an artefact, or that the further differences between Tables 4 and 5 were believed to be irrelevant.

1.19 For the reasons set out in sections 1.15 to 1.18.4 above, the subject-matter of auxiliary requests 10, 10A, 11 and 11A extends beyond the content of the application as filed (Article 123(2) EPC).

Auxiliary requests 4, 5, 8 and 9

1.20 The combinations of 2Theta values in claim 1 of auxiliary requests 4, 5, 8 and 9 are not specifically disclosed anywhere in the application as filed.

1.21 The claims in question disclose combinations of five or ten 2Theta values taken from Table 5 of the application as filed. However, the disclosure of Table 5 is that of a combination of twenty-one values together with the respective line intensities. This does not constitute a direct and unambiguous disclosure of combinations of a selection of only some values from this table, without the associated line intensities.

1.22 Moreover, error ranges of 0.2 , which are not present in Table 5 of the application as filed, were added in auxiliary requests 4 and 8. Analogous reasons to those set out in section 1.17 above apply in relation to this difference.

1.23 For these reasons, the subject-matter of auxiliary requests 4, 5, 8 and 9 extends beyond the content of the application as filed (Article 123(2) EPC).

Auxiliary requests 14 and 15

1.24 The combination of 2Theta values in claim 1 of auxiliary requests 14 and 15 corresponds to that in Table 5 of the application as filed. In both claims, the line intensities are absent. In claim 1 of auxiliary request 14, error ranges of 0.2 were added, which are absent in Table 5.

1.25 For analogous reasons to those set out above in relation to auxiliary requests 10, 10A, 11 and 11A (see sections 1.16 and 1.17 above), the subject-matter of claim 1 of auxiliary requests 14 and 15 therefore extends beyond the content of the application as filed (Article 123(2) EPC).

Summary

1.26 To summarise the findings above, neither the main request nor any of auxiliary requests 1, 2, 2A, 3, 3A, 4, 5, 6, 6A, 7, 7A, 8, 9, 10, 10A, 11, 11A, 14 and 15 is allowable, because the subject-matter defined in claim 1 of each of these requests extends beyond the content of the application as filed (Articles 100(c) and 123(2) EPC).

2. Inventive step - auxiliary requests 12 and 12A (Articles 100(a), 52 (1) and 56 EPC)

Patent in suit and claimed subject-matter

2.1 The patent in suit relates to crystalline forms of a trisodium supramolecular complex comprising valsartan, which is an angiotensin receptor blocker, and AHU-377 (also called sacubitril), which is a neprilysin inhibitor, as well as pharmaceutical compositions and medical uses thereof and processes for preparing the crystalline forms.

2.2 As reported in the patent in suit (paragraph [0006]) and the application as filed (page 2), a supramolecular complex comprising valsartan and sacubitril, called LCZ696, had been approved by the FDA under the brand name "Entresto" for the treatment of heart failure with reduced ejection fraction.

2.3 The patent in suit identifies a need for new crystalline forms, in particular stable polymorphs with superior pharmacological activities suitable for formulation, and convenient methods for preparing them (paragraph [0010]).

2.4 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.

Starting point in the prior art

2.5 As in the decision under appeal, inventive step is assessed starting from the disclosure of document D3.

2.6 It was not in dispute that D3 discloses a crystalline form of trisodium valsartan sacubitril which differs from "Form II" as defined in the current claim requests (see D3, page 24, second full paragraph).

Distinguishing technical feature

2.7 Thus, the feature distinguishing the subject-matter of claim 1 of auxiliary requests 12 and 12A from the disclosure of D3 is the crystal form, as characterised by Figure 7.

Technical problem and solution

2.8 According to the established jurisprudence of the boards of appeal of the EPO, the mere provision of a further polymorph does not involve an inventive step, since screening for polymorphs is a routine activity in the context of pharmaceutical development (see Case Law of the Boards of Appeal of the European Patent Office, 10th edition 2022, I.D.9.9.5). 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.

2.9 The patent proprietors relied, in this regard, on the data presented in Examples 14 to 16 of the patent in suit.

2.10 Examples 6, 7, 14, 15 and 16 of the patent in suit are present identically in the application as filed. The board's considerations in section 1. above in relation to Examples 6 and 7 also apply to the identical examples in the patent in suit.

2.11 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). Samples of "Form II" also showed storage stability (retaining the same crystal form) at varying humidity and temperature conditions (Example 16, not realised as a comparative test).

2.12 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".

2.13 As established above (see sections 1.18.3 and 1.18.4), 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.

2.14 As a consequence, it has not been shown that the claimed crystalline product has superior properties in comparison with the crystalline form of D3.

2.15 The objective technical problem is, therefore, the provision of a further crystalline form of trisodium valsartan sacubitril.

2.16 The solution to this problem is the crystalline form according to claim 1 of auxiliary requests 12 and 12A.

Obviousness of the solution

2.17 For inventive step to be acknowledged, the selection of a specific crystalline form must not be arbitrary.

2.18 The skilled person in the field of pharmaceutical drug development would have been aware of the fact that instances of polymorphism were commonplace in molecules of interest to the pharmaceutical industry, and would have routinely screened for polymorphs early on in the drug development process. In the absence of any technical prejudice and in the absence of any technical advantage such as superiority of properties in comparison with known polymorphs, the mere provision of a further crystalline form of a known pharmaceutically active compound cannot be regarded as involving an inventive step.

2.19 For these reasons, the subject-matter of claim 1 of auxiliary request 12 and of the identical claim 1 of auxiliary request 12A does not involve an inventive step within the meaning of Article 56 EPC.

3. Inventive step - auxiliary request 13

3.1 Claim 1 of auxiliary request 13 differs from claim 1 of auxiliary request 12 by characterising the claimed crystalline product by reference to Figure 8 instead of Figure 7.

3.2 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.

3.3 As a consequence, the subject-matter of claim 1 of auxiliary request 13 does not involve an inventive step within the meaning of Article 56 EPC.

4. Inventive step - auxiliary requests 16, 16A and 17

4.1 The claimed crystalline form in claim 1 of auxiliary request 16 and the identical claim 1 of auxiliary request 16A is characterised by a table of 2Theta values, d-spacings and relative line intensities which is identical to Table 4. Like Figure 7, Table 4 is used in Example 6 to characterise the crystalline product prepared according to the process of Example 6.

4.2 The same considerations and conclusions regarding inventive step apply as those set out in the case of auxiliary requests 12 and 12A (see section 2. above).

4.3 The claimed crystalline form in claim 1 of auxiliary request 17 is characterised by a table of 2Theta values, d-spacings and relative line intensities which is identical to Table 5. Like Figure 8, Table 5 is used in Example 7 to characterise the crystalline product prepared according to the process of Example 7.

4.4 The same considerations and conclusions regarding inventive step apply as those set out in the case of auxiliary request 13 (see section 3. above).

4.5 As a consequence, neither the subject-matter of claim 1 of auxiliary requests 16 and 16A nor that of claim 1 of auxiliary request 17 involves an inventive step within the meaning of Article 56 EPC.

5. Admittance of documents D7, D8 and D9

5.1 Documents D7, D8 and D9 were filed by the parties in the context of a debate on the validity of the priority of the patent in suit. The patent proprietors also referred to D9 in their reasoning on inventive step.

5.2 The patent proprietors' arguments in relation to inventive step based on D9 were taken into account by the board (see sections 1.18.4 and 2.13 above). Since the outcome of the inventive-step assessment is in the opponent's favour, it is not necessary to address the admittance of D9 in this context.

5.3 As the priority issue is not relevant to the board's decision, it is not necessary to address the admittance of D7, D8 and D9 in the context of the priority issue.

6. Admittance of new auxiliary requests

6.1 The admittance of auxiliary requests 2A, 3A, 6A, 7A, 10A, 11A, 12A and 16A need not be addressed, in view of the negative conclusions reached in sections 1.14, 1.19, 2.19 and 4.5 above on the compliance of these requests with Articles 123(2) and 56 EPC.

7. Patent proprietors' request for remittal of the case (Article 111(1) EPC)

7.1 The subject of remittal did not arise in relation to the main request and auxiliary requests 1, 2, 2A, 3, 3A, 4, 5, 6, 6A, 7, 7A, 8, 9, 10, 10A, 11, 11A, 12 and 12A. This is because the board's conclusion that none of these requests is allowable is based, in each case, on objections that were also considered in the decision under appeal in relation to the same subject-matter, namely non-compliance with Article 123(2) EPC or Article 56 EPC.

7.2 The remittal of the case to the opposition division on the basis of any of the remaining auxiliary requests was not considered appropriate for the following reasons.

7.2.1 The considerations concerning the compliance of auxiliary requests 14 and 15 with Article 123(2) EPC were, by analogy, the same as those set out in relation to auxiliary requests 10, 10A, 11 and 11A (see section 1.25 above). As a consequence, there was no occasion for remittal in respect of these claim requests.

7.2.2 In the case of auxiliary requests 13, 16, 16A and 17, the definition of the crystal form in each of these requests is based on Figure 7 or Table 4, or alternatively on Figure 8 or Table 5. As a consequence, the claimed subject-matter could be assessed for inventiveness on the basis of the same considerations, or the same considerations by analogy, as those set out with respect to auxiliary requests 12 and 12A (see sections 3. and 4. above). Indeed, the patent proprietors' arguments in support of inventive step were identical for all requests (see the patent proprietors' grounds of appeal, sections 4.4, 5.3, 6.4, 7.4, 8.5, 9.4, 10.4, 11.4, 12.4, 13.4, 14.4, 15.4, 16.4, 17.4, 18.4, 19.4, 20.4, 21.4, 22.3, 23.4, 24.4, 25.4, 26.4, 27.4, 28.4 and 29.3, and the patent proprietors' reply to the opponent's appeal, section 4).