T 2565/19 - Functionally defined receptor

Key points

•  This is an examination appeal.
• "The claim is for an isolated TRH receptor, i.e. a product. The claimed receptor is defined only by locational and functional features, i.e. the tissue from which it can be isolated: "from human CNS tissue" and its ability to bind the compounds defined in the claim"
• Claim 1 at issue: "An isolated TRH receptor subtype from human CNS tissue, the receptor displaying selective binding to a compound having the structure:- Glp-W-Pro-X [with further definition of X and W] wherein the compound having the structure Glp-W-Pro-X binds to the TRH receptor sub-type in human CNS tissues but does not bind to the TRH receptor sub-type in human pituitary tissue".
  

• "Neither of these features conveys any structural information about the claimed product. In other words, the language of the claim does not include or imply anything about the structure of the claimed chemical entity, for instance whether it is a protein or not, or if it were a protein, what its sequence might be."

• "28. In the absence of any structural features, the claim cannot be considered as clear because it fails to "enable the protection conferred by the patent (or patent application) to be determined" (Id.) and it does not define the claimed subject-matter in a manner which allows a meaningful comparison with the state of the art to be made.Neither of these features conveys any structural information about the claimed product. In other words, the language of the claim does not include or imply anything about the structure of the claimed chemical entity, for instance whether it is a protein or not, or if it were a protein, what its sequence might be."

• As a comment, see also recent decision T 1708/18 in an opposition case, where a patent was granted with a claim directed to: "An isolated antibody that binds specifically to the isolated polypeptide of SEQ ID NO:2 or SEQ ID NO:4". The patent in that case was granted in 2015.

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EPO 

The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.

https://www.epo.org/law-practice/case-law-appeals/recent/t192565eu1.html

Clarity (Article 84 EPC)

24. Under Article 84 EPC "The claims shall define the matter for which protection is sought. They shall be clear and concise and be supported by the description".

25. According the Enlarged Board of Appeal (EBA) in decision G 2/88 (OJ 1990, 93), "The purpose of claims under the EPC is to enable the protection conferred by the patent (or patent application) to be determined (Article 69 EPC), and thus the rights of the patent owner within the designated Contracting States (Article 64 EPC), having regard to the patentability requirements of Articles 52 to 57 EPC. It follows that the technical features of the invention are the physical features which are essential to it" (see reasons 2.5). Furthermore, "the claims of a European patent should clearly define the technical features of the subject invention and thus its technical subject-matter, in order that the protection conferred by the patent can be determined and a comparison can be made with the state of the art to ensure that the claimed invention is inter alia novel." (see reasons, 7)

26. The case law has further established that "Claims lack clarity if the exact distinctions which delimit the scope of protection cannot be learnt from them" (see Case Law of the Boards of Appeal of the European Patent Office, 10th edition, II.A.3.1 and the decisions cited there).

27. The claim is for an isolated TRH receptor, i.e. a product. The claimed receptor is defined only by locational and functional features, i.e. the tissue from which it can be isolated: "from human CNS tissue" and its ability to bind the compounds defined in the claim: "wherein the compound having the structure Glp-W-Pro-X binds to the TRH receptor sub-type in human CNS tissues but does not bind to the TRH receptor sub-type in human pituitary tissue". Neither of these features conveys any structural information about the claimed product. In other words, the language of the claim does not include or imply anything about the structure of the claimed chemical entity, for instance whether it is a protein or not, or if it were a protein, what its sequence might be.

28. In the absence of any structural features, the claim cannot be considered as clear because it fails to "enable the protection conferred by the patent (or patent application) to be determined" (Id.) and it does not define the claimed subject-matter in a manner which allows a meaningful comparison with the state of the art to be made. Indeed, in the absence of any structural information about the claimed subject-matter, it is not possible to determine if the claimed product is novel. For instance, there is no way of ruling out that the functional and locational features defined in the claim do not simply re-characterise a known molecule.

29. The appellant argued that a receptor can be defined solely by its binding properties to its ligand. It was argued that this was in line with "the definition of a receptor from a number of online scientific dictionaries, all of which show that in the art a receptor is defined in terms of its specific binding to a ligand". Moreover, it argued that it was not a requirement of the EPC, that an applicant had to sequence a protein in order to be entitled to claim it.

30. It is of course correct that the EPC does not set any specific requirements as to which features are required to meet the requirements of Article 84 EPC for clarity in any particular technical field. Instead, the Boards, in the case law, have developed the criteria to be used to determine whether or not a claim is clear. Applying these criteria leads to the conclusion that the claim lacks clarity, as set out in point 28. above.

31. In view of the above considerations, the board concludes that claim 1 lacks clarity and does not meet the requirements of Article 84 EPC.