T 1642/22 27-03-2025

1. The appeal is admissible.

2. Amendments - main request

Claim 1 of the main request relates to a composition having an elastic modulus of between 500 Pa (+/- 50 Pa) and 900 Pa (+/- 90 Pa) and an extrusion force of between 4N (+/- 0.4N) and 15N (+/- 1.5N).

Claim 1 of the granted patent differs from claim 1 of the application as originally filed by the features in brackets, which replaced the modifier "about".

At the oral proceedings before the board, the respondent relied on its written submissions. According thereto, claim 1 had a basis in both claim 1 and paragraph [00028] of the application as originally filed, which disclosed that "about" modified a value by +/- 10%.

However, in the application as filed, the meaning of "about" in the context of numerical values, i.e. that values could be modified by +/- 10%, does not apply to endpoints of ranges. According to paragraph [00028], the lower endpoint may be reduced by 10% and the upper endpoint increased by the same percentage. Claim 1 of the patent defines that the lower endpoint may be increased by 10% and the upper endpoint reduced by 10%, and therefore the claim defines a range that was not originally disclosed.

Article 100(c) EPC precludes the maintenance of the patent as granted for this reason alone.

3. Objections against auxiliary request 1 - Article 13(2) RPBA

3.1 Facts of the case

The opposition division rejected the opposition. The appellant contested this decision for a number of reasons as set out in its statement of grounds of appeal.

The respondent replied by arguing against those reasons and by filing auxiliary requests. Its reply to the appeal explains why in its view these auxiliary requests overcome the various issues.

The appellant filed no further arguments in writing.

3.2 The respondent argued that any objection made against auxiliary request 1 with respect to added subject-matter or insufficiency of disclosure at the oral proceedings before the board would constitute an amendment of the appellant's case, which could only be admissible in exceptional circumstances (Article 13(2) RPBA).

3.3 The board disagrees.

Claim 1 of auxiliary request 1 only differs from claim 1 of the patent as granted by the absence of the tolerance ranges in parentheses. The subject-matter of claim 1 of auxiliary request 1 is thus just about the same as that of claim 1 of the main request.

3.3.1 On sufficiency, the appellant had already submitted arguments in the context of an almost identical request. The board fails to see that the appellant's case has been amended for this reason alone.

3.3.2 The object of Article 123(2) EPC is that a patent proprietor should not be allowed to improve its position in a way that could damage the legal security of third parties relying on the content of the original application (Case Law of the Boards of Appeal, 10th ed., 2022, II.E.1.1).

This requirement is of fundamental importance and the board has the power to examine it ex-officio for its implications on third parties and on society at large. The board does not see this duty limited by the Rules of Procedure.

4. Auxiliary request 1 - amendments

Other than not including original claims 8 to 13, the claims of auxiliary request 1 differs from the application as originally filed by the fact that it does not include the feature "about".

Paragraph [00028] of the application as originally filed discloses that the modifier "about" in connection with numerical values or ranges can be deleted. The claims of auxiliary request 1 thus have the required basis (Article 123(2) EPC).

The appellant argued at the oral proceedings that removing all of the instances of "about" created a combination that was not originally disclosed. However, the board fails to see what technical information not present in the application as originally filed has been generated in view of paragraph [00028]. This argument is therefore not convincing.

5. Auxiliary request 1 - sufficiency of disclosure

5.1 Claim 1 relates to a sterile composition. The composition is defined by the starting materials, proportions and properties, namely by its elastic modulus, cohesivity and extrusion force.

5.2 The respondent did not dispute that compositions having the required elastic modulus, cohesivity and extrusion force are not to be prepared merely by crosslinking the starting materials set out in claim 1. However, these properties could be obtained by adjusting variables taught in the patent. Example 1 provided general guidance towards embodiments of claim 1. Paragraph [0017] disclosed that a high proportion of low molecular weight hyaluronic acid increased cohesivity and elasticity. Preferred amounts and molecular weights of hyaluronic acid were disclosed in paragraphs [0030] and [0031], fitting those in Example 1. Paragraph [0036] further disclosed that the addition of uncrosslinked hyaluronic acid facilitated injection. Thus, the patent sufficiently disclosed how the properties in claim 1 could be achieved.

5.3 At the oral proceedings before the board, the appellant added to its written arguments that a skilled person could only obtain the required properties with undue burden. It questioned whether the composition in Example 1 of the patent had the properties set out in claim 1 and whether the general disclosure sufficiently taught how to achieve those properties.

5.4 The board considers the claimed invention to be sufficiently disclosed.

Absent any proof to the contrary, there is no reason to conclude that the product in Example 1 lacks the properties set out in claim 1. Thus, the argument of the appellant in this regard is not convincing.

The appellant's argument that finding further embodiments of the claimed composition represented an undue burden is also rejected absent any supporting evidence and in view of the teaching in the patent (see section 5.2 above).

5.5 The appellant also argued that cohesivity was an ill-defined property for which no standard method of measurement existed, and that the indications in the patent were not clear enough to measure it. For example, it was not apparent when to measure it or whether one point or more than one were required. The appellant concluded that the claimed invention was not sufficiently disclosed also for this reason.

However, even if the cohesivity could not be measured accurately as the appellant argues, the sufficiency issue to be resolved is whether the alleged inaccuracy is enough to prevent a skilled person from carrying out the invention. The board is of the view that this is not the case. Paragraphs [0039] to [0041] disclose a seemingly reproducible measurement protocol and there is no proof that this would provide values so dissimilar that the claimed invention could not be carried out.

5.6 The appellant also argued that the claims did not limit the meaning of high molecular weight hyaluronic acid and of low molecular weight hyaluronic acid. In addition, it was not clear in the patent whether the molecular weight should be considered as weight average molecular weight or as viscous average molecular weight. The claimed invention was not sufficiently disclosed also for these reasons.

However, according to paragraph [0030] of the patent molecular weights are weight average molecular weights, unless otherwise indicated. This paragraph also discloses the molecular weight of high molecular weight hyaluronic acid. Paragraph [0031] discloses the molecular weight of the low molecular weight equivalent. The appellant's argument in this regard is therefore not convincing.

6. Auxiliary request 1 - novelty

6.1 At the oral proceedings before the board, the appellant merely referred to its written submissions. In view of this, the board sees no reason to depart from its preliminary view.

6.2 D1 is silent on the cohesivity of the composition in Example 4. For this reason alone, and in the absence of any evidence that the cohesivity of that composition must inevitably have fallen within the limits set out in claim 1, the claimed composition is novel.

7. Auxiliary request 1 - inventive step

7.1 The claimed invention relates to a sterile composition of crosslinked hyaluronic acid suitable for subdermal or supraperiostial implantation in the chin area (claim 1) and facial sculpturing (claim 9).

7.2 Closest prior art

The opposition division concluded that D2 came closest to the claimed invention.

The appellant argued in writing that D1 was also a suitable starting point for examining inventive step.

The respondent argued that the closest prior art should be a document relating to the same objective as that set out in paragraph [0001] of the patent, i.e. chin augmentation. The board informed the parties in its communication in preparation for oral proceedings that it was of the same view. A document relating to chin augmentation, such as D12, would appear to come closer to the claimed invention than D1 or D2.

At the oral proceedings, the appellant argued on inventive step starting from D12 and referred to its written arguments starting from D1 and D2.

Document D1 relates to a process for producing an injectable composition comprising crosslinked hyaluronic acid (see the abstract). D1 merely indicates that hydrogels obtained by crosslinking polysaccharides can be used as filling materials in plastic, cosmetic and dental surgery, and in ophthalmology and orthopaedics for preventing tissue adhesion, and for repairing vocal cords (see paragraph [0005]). D1 provides no further details as to these applications or the polymers that could be used for each application.

Document D2 discloses hyaluronic acid compositions as dermal and subdermal fillers (see the abstract). D2 discloses minimising wrinkles and lines (see page 3, lines 15 to 17) and the claims relate to a soft-tissue filling.

Thus, neither D1 nor D2 discloses the augmentation of the lower face, let alone of the chin and jaw. These documents are thus further from the claimed invention than D12.

7.3 Document D12 as the closest prior art

Document D12 discloses chin augmentation with different commercial products including Juvéderm Voluma.

The parties agreed that Juvéderm Voluma differs from the claimed composition by:

- the HA concentration (20 mg/mL)

- the elastic modulus (ca. 400 Pa at 5 Hz in view of Table 1 of D6, third entry)

- the cohesivity (40 gmf in view of Table 1 of D6, third entry) and

- the extrusion force

7.4 Problem underlying the claimed invention

It was not disputed that the problem underlying the claimed invention was to provide an alternative composition for facial sculpting in the chin and jaw area, with suitable lifting properties.

7.5 Solution

The claimed solution is the composition in claim 1, characterised by its HA concentration, elastic modulus, cohesivity and extrusion force.

7.6 Success

It was not disputed that the composition in claim 1 successfully allows facial contouring in the chin and jaw area.

7.7 It remains to be examined whether the claimed solution would have been obvious to a skilled person in view of the prior art.

Elastic modulus and cohesivity were known to be linked to the lifting ability of hyaluronic acid fillers (see D8, page 24, third full paragraph). However, the prior art does not teach what values of these properties make a composition suitable for a specific use, let alone which combination of values.

D12 discloses that Juvéderm Voluma has an increased cohesivity and thus reduced extrusion and flow (see page 135, last paragraph) but neither quantifies this nor teaches that it could be further enhanced without compromising its use. D12 is silent on elastic modulus. The elastic modulus and cohesivity of Juvéderm Voluma are disclosed in document D6, which is not prior art; both are outside the ranges set out in claim 1.

A skilled person seeking an implantable composition suitable for chin and jaw augmentation could have considered the values of elastic modulus and cohesivity in claim 1, but there is no reason why they would do so.

The appellant argued that D1 and D2 taught the claimed solution. However, neither of these documents refers to cohesivity. This argument of the appellant is not convincing for this reason alone.

Since the board has arrived at the conclusion that the claimed subject-matter is inventive in view of two of the features distinguishing it from D12, it is not necessary to elaborate on the relevance of the two others.

The claimed composition is thus inventive (Article 56 EPC), as are the kit in claim 8 and the non-therapeutic method in claim 9 requiring the composition in claim 1.

8. Auxiliary request 1 is allowable.