- Claim 1 of the Main Request is directed to a composition comprising an anti-adherant material selected from a list.
- The Board: " It is firstly noted that materials known to exhibit adherent rather than anti-adherent properties are included within the listed anti-adherent materials in claim 1"
- " Hence, the skilled person is unable to identify suitable materials displaying anti-adherence due to the large number of potential materials listed"
- "In summary therefore the invention according to claim 1 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, contrary to the requirements of Article 83 EPC 1973. "
- In AR-9, the feature is added that " the anti-adherent material comprises a material selected from the group consisting of inulin". This does not save the patent.
- The Board: " The anti-adherent material must thus at least include inulin but may, through the use of the expression 'comprises', include an unspecified number of further materials in addition to inulin. As a consequence, as was the case for the main request, the skilled person is again presented with an extensive number of potential materials which should meet the anti-adherent material requirement for which no guidance is included in the patent."
- " Claim 1 states that 'the anti-adherent material comprises a material selected from the group consisting of inulin' i.e. any number and amount of further materials in addition to inulin may be included as the anti-adherent material. The skilled person is thus placed in the same quandary as existed in at least the main request, only still worse since no limit whatsoever is placed on which materials are included in the possible anti-adherent materials."
T 2070/13 - link
VII. Claim 1 of the main request reads as follows:
"A topical viscoelastic fluid modifying composition for topical application to the skin and hair in the perianal and/or labial areas comprising at least one viscoelastant material and an anti-adherent material, wherein the viscoelastant material comprises a material selected from the group consisting of enzymes, linked enzymes, alkyl polyglycosides having 8-10 carbon atoms in the alkyl chain, bovine lipid extract surfactant, dextrans and dextran derivative; and wherein the anti-adherent material comprises a material selected from the group consisting of casein, farnesol, flavones, fucans, galactolipid, kininogen, inulin, iridoid glycosides, perlecan, poloxamer 407, sulphated exopolysaccharides, and combinations thereof."
Claims 1 and 2 of auxiliary request 8 read as follows:
"1. A topical viscoelastic fluid modifying composition for topical application to the skin and hair in the perianal and/or labial areas comprising at least one viscoelastant material and an anti-adherent material, wherein the viscoelastant material comprises a material selected from the group consisting of enzymes, linked enzymes, alkyl polyglycosides having 8-10 carbon atoms in the alkyl chain, bovine lipid extract surfactant, dextrans and dextran derivative; and wherein the anti-adherent material comprises a material selected from the group consisting of inulin.
2. The composition of claim 1, wherein the composition comprises between 0.01% to 25% by weight of the viscoelastant material and between 0.01% and 25% by weight of an anti-adherent material."
Claim 1 of auxiliary request 9 reads as claim 1 of auxiliary request 8. The request further includes inter alia the deletion of claim 2 of auxiliary request 8.
Reasons for the Decision
1. Main request - Article 83 EPC 1973
1.1 The invention according to claim 1 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
1.2 It is firstly noted that materials known to exhibit adherent rather than anti-adherent properties are included within the listed anti-adherent materials in claim 1 (e.g. casein is used as a binder in paints).
1.3 The skilled person is thus in the position of having to establish, without any guidance from the patent, which composition(s) in the defined group of the listed materials exhibit(s) anti-adherence. Not only are 12 materials listed as members of the group, but combinations of these are claimed and, moreover, many of the materials (in particular flavones, fucans, galactolipid, iridoid glycosides, sulphated exopolysaccharides) describe large families of compounds which still further extends the potential materials for inclusion in the claimed composition. In the absence of a test method in the patent for determining the anti-adherence of a material, the skilled person is unable to establish, even qualitatively, suitable materials from the extensive group of materials listed in claim 1 which will meet the claimed anti-adherence.
1.4 Still further, claim 1 does not limit the amount of anti-adherent material to be included in the composition such that this can range from a fraction of 1% to approaching 100%, this adding another level of complexity to the skilled person identifying a suitable anti-adherent material. The skilled person would thus be faced with an experimental programme of unreasonable proportion in order to establish which materials of the claimed group satisfied the claimed anti-adherence.
1.10 Hence, the skilled person is unable to identify suitable materials displaying anti-adherence due to the large number of potential materials listed, several of these listed materials also describing large families of compounds; the skilled person would be faced with an experimental programme in order to establish which of the listed materials satisfied the claimed criterion of anti-adherence. This is particularly the case since the patent also lacks a single example which could be regarded as guidance to the skilled person of a composition satisfying the invention.
1.11 Burden of proof
The board had already indicated in its preliminary opinion that an adequate test method was lacking and that no suitable compounds were defined within the claimed families of compounds. Accordingly, serious doubts were set out concerning whether the skilled person's common general knowledge would be sufficient to enable him to carry out the invention. As a consequence, the burden of proof - which in a first attempt to attack the underlying requirement of the EPC in opposition lies with the opponent - had shifted to the patentee who could rebut these arguments by providing appropriate information and evidence. The mere assumption that anti-adherence of the claimed groups of compounds was known, and the reference to post-published D16 referring to a particular bacterial non-adhesion, is not convincing evidence that could discharge the respondent from its burden of proof with regard to the subject-matter claimed. Also the reference to D10 could not overcome this issue in that D10 - also being a patent specification - fails to disclose a standard test method but rather sets out a very specific test procedure, the relevance of which to the present measurement of anti-adherence cannot be assessed.
1.12 In summary therefore the invention according to claim 1 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, contrary to the requirements of Article 83 EPC 1973. The main request is thus not allowable.
2. Auxiliary requests 1 to 7 - Article 83 EPC 1973
Regarding auxiliary requests 1 to 7, the respondent submitted no further arguments in support of sufficiency of disclosure beyond those already presented with respect to the main request. The Board thus sees no reason to find differently to its conclusion in the main request such that the invention according to claim 1 of auxiliary requests 1 to 7 is also not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.
3. Auxiliary request 8 - Admittance (Article 13(1) RPBA)
3.1 In appeal proceedings, the Rules of Procedure of the Boards of Appeal (RPBA) apply. Article 12(2) RPBA specifies that the statement of grounds of appeal, respectively the reply thereto must contain the party's complete case. After filing the grounds of appeal or reply, any amendment to a party's case may be admitted and considered at the Board's discretion, as set out in Article 13(1) RPBA, such discretion being exercised inter alia in view of the need for procedural economy. As is established case law of the Boards of Appeal, such procedural economy implies that amended requests should at least be prima facie allowable in order to be admitted.
3.2 The respondent filed auxiliary request 8 with letter of 29 March 2018. The request thus represents a change to the respondent's complete case.
3.3 Firstly it is to be noted that the subject-matter of claim 2 (the combination of the features of claims 1 and 2) is not a simple combination of claims 1 to 4 as granted since, save for inulin, all anti-adherent materials listed in claim 4 as granted have been omitted. It thus follows that, contrary to the opinion of the respondent, the claims of this request must be examined as to their compatibility with all the requirements of the EPC (see G0010/91, reasons 19), inter alia Article 123(2) EPC.
3.4 As regards compliance with Article 123(2) EPC, it has to be noted that claims 3 and 4 as originally filed were dependent on respectively claim 1 or on claims 1 or 3. Thus the combination of features in claim 2 as filed with those features of claims 3 and 4 as filed was not originally disclosed. Accordingly, the subject-matter of claim 2 (the combination of features of claims 1 and 2) in auxiliary request 8 lacks basis in the originally filed application.
3.5 Contrary to the respondent's opinion, paragraphs [0010] and [0034] as filed also fail to provide a prima facie direct and unambiguous basis for the claimed combination of features, not least since the disclosed weight percentage range in paragraph [0010] applies only 'optionally' and to anti-adherent materials generally, and not unambiguously to just inulin. Furthermore, in paragraph [0035] the desired function is stated without any confirming data or reference to inulin in particular.
3.6 The subject-matter of claim 2 thus fails to meet the requirement of Article 123(2) EPC. The auxiliary request 8 is therefore not prima facie allowable, which would be necessary for fulfilling the need for procedural economy and consequently admitting the request into the proceedings. Accordingly, the Board exercised its discretion under Article 13(1) RPBA not to admit this request.
4. Auxiliary request 9 - Admittance (Article 13(1) RPBA)
4.1 Having been filed after the filing of the respondent's complete case, the admittance of this request is also subject to the discretion of the Board according to Article 13(1) RPBA.
4.2 This request was filed to overcome the objection under Article 123(2) EPC in the previous request, at least claim 2 therefore being deleted. The subject-matter of claim 1 was also prima facie limited to inulin as the group the anti-adherent material should be selected from, the respondent arguing that the skilled person would no longer be required to carry out an experimental programme in order to provide an appropriate anti-adherent material.
4.3 Contrary to the opinion of the appellant that significant experimentation would still be required, the claimed group consisting of inulin does not represent such a large number of compositions of distinct characteristics that the skilled person would be unable to establish which members of the group should be tested in order to meet the requirement of exhibiting anti-adherent properties.
4.4 The language reading 'the group consisting of inulin' was also prima facie considered to meet the requirements of Article 84 EPC since the skilled person knew that inulin covered a family of compounds which could be understood as 'a group' of compounds.
4.5 The Board thus exercised its discretion in admitting this request (Article 13(1) RPBA).
4.6 Article 83 EPC 1973
4.6.1 For the above consideration of the admittance of this request, only a prima facie compliance with the requirements of the EPC had been carried out. However, when subsequently considering the request in greater detail, the discussion had to include any further objections in relation to sufficiency of disclosure.
4.6.2 Despite claim 1 explicitly listing solely the group consisting of inulin as the anti-adherent material in the claimed composition, the claim is not limited to just 'the group consisting of inulin' due to the use of the expression 'comprises' as follows:
'... wherein the anti-adherent material comprises a material selected from the group consisting of inulin.'
The anti-adherent material must thus at least include inulin but may, through the use of the expression 'comprises', include an unspecified number of further materials in addition to inulin. As a consequence, as was the case for the main request, the skilled person is again presented with an extensive number of potential materials which should meet the anti-adherent material requirement for which no guidance is included in the patent.
4.6.3 The respondent's contention in this regard that any other material to inulin was not important for the claimed anti-adherence is not convincing. Claim 1 states that 'the anti-adherent material comprises a material selected from the group consisting of inulin' i.e. any number and amount of further materials in addition to inulin may be included as the anti-adherent material. The skilled person is thus placed in the same quandary as existed in at least the main request, only still worse since no limit whatsoever is placed on which materials are included in the possible anti-adherent materials.
4.6.4 Thus, the invention according to claim 1 of auxiliary request 9 is not disclosed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art (Article 83 EPC 1973). Hence, the request is not allowable.
No comments:
Post a Comment
Do not use hyperlinks in comment text or user name. Comments are welcome, even though they are strictly moderated (no politics). Moderation can take some time.