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Case law 30 Nov 2021

Substantial clarity requirements in pharma/chemistry claims

Patent application no. 14150998.4 was refused by Examining Division (ED) for, inter alia, lack of clarity. Claim 1 of the application was basically directed to a composition comprising a Toll-like receptor (TLR) agonist adsorbed via an “adsorptive moiety” to an “insoluble metal salt”. The applicant appealed the refusal and filed counterarguments against the reasoning of the ED, which addressed the clarity objections. The Board also found the claims unclear but for different reasons. The Applicant did not file a reply to the specific clarity objections of the Board, hence, as expected, the appeal was dismissed. Despite the rather predictable outcome of not responding to the Board, the view the latter took on clarity remains interesting and can serve as a general teaching to all EP Applicants.
The Board took a more conservative approach and found lack of clarity not only in the main claim 1 but also in dependent claims 2-5

ED objected only the terms present in the main claim. In particular, the term “TLR agonist” was objected to for being a functional definition embracing a plurality of structurally-unrelated compounds with specificity to different members of the Toll-like receptor family, and potentially covering still non-existing compounds that will only in the future be identified as having a TLR agonist function. In view of this, ED also objected the term “adsorptive moiety” as unclear for encompassing different unrelated structures.

Conversely to the above, the Board took a more conservative approach and found lack of clarity not only in the main claim 1 but also in dependent claims 2-5. In the main claim, the Board interestingly objected to the term “insoluble metal salt”, noting that claim 1 did not specify a solubility threshold (!) according to which a particular salt could be qualified as "insoluble" and under which conditions, including e.g. the pH range etc., said insolubility is to be assessed. It is noted that the original specification of the refused application appeared not to contain adequate definitions of the term or similar information for possibly remedying the issue.

Then, with regard to claim 2 specifying that “at least 80% of the total TLR agonist in the composition is adsorbed onto insoluble metal salt”, the Board noted that said claim does not specify whether the percentages were meant to be wt.-% or mol-%, even though the specification as filed never mentioned molarity and always related to %-values “by mass” in this specific context.

Further, claims 3 and 4 were objected to for being formulated as results to be achieved and for missing details on how to achieve said results such as ensuring the presence of the TRL agonist in the injection site after a specific period, or obtaining a lower peak serum concentration as compared to non-adsorbed TLR agonist.

Lastly, in claim 5, the Board objected to a seemingly unsuspicious term “according to claim 1”, which, by virtue of an unfortunate positioning of the comma just before it, was seen as unclear with regard to which term in claim 1 it was referring to.

All the above remarks show the importance of rethinking and possibly fine-tuning the wording of the claims before launching an appeal, especially when clarity objections were raised during the examination by the first instance.

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