|Date of decision:||09 April 2021|
|Case number:||T 2944/18|
Auxiliary request shifts the category of the claims from product claims to first medical use claims. Since the novelty of medical use claim had never been discussed throughout the proceedings, a decision to review in this respect was lacking. The board considers these circumstances to represent “special reasons” within the meaning of Article 11 RPBA 2020 and remits the case to the examining division for further prosecution.
The appellant defends the product claim as it is a selection invention by defining a thershold (4 to 9 amino acids) for the motif constitued in the claimed peptide. However, the board finds the claim of a Article 54 (3) EPC document does not exclude from also being present in the claimed of the main request.
Macromolecular peptide drugs generally suffer from some drawbacks such as problematic delivery into cells. The invention of EP 11775737.7 presents peptides comprising short S100A1 (a calcium binding protein) fragments that exhibit inotropic effects. A 4 amino acid core motif derived from S100A1 (amino acids 79-82 of the S100A1 protein) was also identified as the minimum requirement for functionality of the peptide.
The examining division (ED) refused the application because they held that the subject-matter of claim 1 lacked novelty over the disclosure of D3 (WO2010/118878), a document pursuant to Article 54(3) EPC.
Claim 1 of (Main Request)
1. A positive inotropic peptide comprising or consisting of . a hydrophilic domain . and/or one or more membrane penetration enhancing domains, and . a domain derived of a S100A1 protein with the amino acid sequence of SEQ ID NO 38 - wherein said S100A1 protein derived domain consists of 4 to 9 consecutive amino acids of the inotropic motif: Φ1-Φ2-Φ3-Φ4-X5-Ψ6-L7-[T/A]8-Ψ9-Ψ10 and comprises at least the core motif Φ4-X5-Ψ6-L7 - wherein Φ and Ψ are in each instance independently selected from the group consisting of alanine, methionine, isoleucine, leucine, and valine, and X is any amino acid, . wherein said peptide: (a) has a length of between 10 to 40 amino acids, and (b) exhibits a positive inotropic action, and - wherein said peptide: (i) does not contain more than 9 continuous amino acids of SEQ ID NO: 39; or (ii) differs from the amino acids of SEQ ID NO: 39 by at least 80% outside of said S100A1 protein derived domain.
Claim 1 of (Auxiliary Request) – First Medical Use
With the statement of grounds of appeal, the appellant (the applicant) also submitted Claim 1 and claim 2 of auxiliary request were amended compared with claims 1 and 2 of the main request by inserting at the end of the wording of these claims the feature:
“wherein the positive inotropic peptide is for medical use”.
In appeal proceedings, Board reads the claim 1 of the main request as:
A positive inotropic peptide is claimed, comprising or consisting of
A) a domain derived from the S100A1 protein (SEQ ID NO:38) and
– consisting of a peptide of defined length (4 to 9 amino acids) and
-comprising at least a particular core motif (positions 4, 5, 6 and 7),
B) a hydrophilic domain and/or
C) (a) membrane penetration domain(s).
Claim 1 of D3:
1. A peptide comprising a muscle function enhancing amino acid sequence comprising or consisting of the amino acid motif: Φ4 -X-Ψ-L-[T/A]-Ψ2, - wherein Φ and Ψ are in each instance an independently selected hydrophobic non-aromatic amino acid, and X is any amino acid, - wherein the muscle function enhancing amino acid sequence does not contain more than 18 continuous amino acids of the carboxy-terminal amino acids of an S100A1 protein, the peptide has a total length of maximally 100 amino acids, and the peptide exhibits a positive inotropic action.
- Board analyses Claim 1, Claim 6, Claim 7, Claim 8, Claim 9, Claim 12 and Claim 16 of D3 and concludes that claim 1 of main request lacks novelty.
Claims 8 and 9 of D3:
8. The peptide of any one of claims 1 to 7, wherein said muscle function enhancing amino acid sequence comprises or consists of the amino acid sequence: [V/I]-[V/I]-[L/M]-[V/I/M]-[A/G/S]-[A/V]-L-[T/A]-[V/A/I]-[A/M/V]
9. The peptide of any one of claims 1 to 8, wherein said muscle function enhancing amino acid sequence comprises or consists of an amino acid sequence selected from the group consisting of the amino acid sequences V-V-L-V-A-A-L-T-V-A (SEQ ID NO: 4), V-I-L-V-A-A-L-T-V-A (SEQ ID NO: 6), V-V-M-V-A-A-L-T-V-A (SEQ ID NO: 7), I-I-L-V-G-A-L-T-V-A (SEQ ID NO: 95), V-V-L-I-A-A-L-A-A-A (SEQ ID NO: 263), V-I-L-V-S-V-L-T-V-A (SEQ ID NO: 186), I-I-L-M-G-A-L-T-V-A (SEQ ID NO: 334), and V-V-M-V-A-A-L-T-V-V (SEQ ID NO: 50).
The first argument of the appellant regarding the various 10-mer peptides of claims 8 and 9 of D3, is that disclosed 10-mers were derived from S100A1 as a whole and therefore failed to comply with the predefined structural features of the domain derived from S100A1 in the claim of main request.
“In particular, they comprised all 10 consecutive amino acid sequences of the 10-mer motif referred to in the claim, and not just the 4 to 9 which it stipulates.”
However, board doesn’t agree with the appellant’s arguments.
The board considers the peptides disclosed in claim 9 (e.g. SEQ ID Nos 4, 6, 7 and 50) and on pages 29 to 34 (e.g. SEQ ID Nos 100 and 102) of D3 to be constituted of
– core motif (Φ4-X5-Ψ6-L7) of the 10- mer inotropic motif defined in the claim,
-fused to two 3-mers.
e.g SEQ ID NO: 4 (see claim 9 of D3)
So that claim 9 of D3 does not exclude from also being present in the claimed peptide (due to the wording “comprising”).
The board notes that the claim in fact does not define, and thus restrict, the sequence of the amino acids present in addition to the “core motif”, and nor do the claims of D3 refer to any of the domains and motifs referred to in these claims as “being derived from S100A1” either.
In its second argument, the appellant submits that D3 failed to disclose that peptides comprising less than 10 amino acids of the muscle function enhancing motif of the claim possessed a positive inotropic action. Therefore the claimed peptides had to be held novel.
However, the board is of the opinion that this claimed positive inotropic peptide is not defined as to be excluded from comprising, in addition to the 9 or fewer amino acids of the muscle function enhancing motif recited in the claim, further amino acid sequences surrounding this motif.
The appellant’s functionality argument, which is in fact based on a peptide seen in isolation from the structural context, thus fails.
In view of the above considerations board concludes that the subject-matter of claim 1 lacks novelty.
Auxiliary request 1
Amended claim 1 and claim 2 of auxiliary request 1 are “for medical use” of the positive inotropic peptide.
The appellant argued that document D3 failed to disclose a therapeutic effect of peptides comprising less than 10 amino acids derived from the inotropic motif of an S100A1 protein as claimed in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, and that therefore document D3 could not anticipate the therapeutic effect of the peptide as claimed for use in medicine.
The board concurs with the appellant that the reasons given in the decision under appeal for lack of novelty of subject-matter of structural product claims do not apply to claims for a first medical use of such products.
Remittal (Article 111(1) EPC, Article 11 RPBA 2020)
Since the decision under appeal deals exclusively with the requirement of novelty of the subject-matter of product claims, and is silent on the novelty assessment of first medical use claims the board would thus, for the first time in the proceedings, have to examine sufficiency of disclosure of D3, as a decision to review in this respect was lacking.
The board considers these circumstances to represent “special reasons” within the meaning of Article 11 RPBA 2020.
The board remits the case to the examining division for further prosecution.
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