Key points
- Claim 1 is directed to: ""1. A formulation comprising an exendin or exendin analog agonist, a biocompatible polymer and a sugar for use in a method of treating diabetes in a human, wherein said method comprises: (a) administering the formulation to the human once weekly; and (b) administering the formulation sufficient to maintain a sustained minimum plasma concentration of the exendin or exendin analog agonist of about 170 pg/ml to about 600 pg/ml for at least 1 month."
- Dependent claim 4 as granted recites: "A formulation for use according to any one of claims 1 to 3, wherein the exendin or exendin analog agonist is exendin-4."
- The patentee amends claim 1 in the main request to recite exendin-4.
- The Board: "The amendment of part (b) in claim 1 of the main request and auxiliary request 1 now "only" requires the sustained minimum plasma concentration of exendin-4 to be within the range of about 170 pg/ml to about 350 pg/ml. Thus, the amended claim defines only the range of the sustained minimum plasma concentration of exendin-4 alone, not that of all exendins comprised in the administered formulation. Accordingly, the claims now entail embodiments which were not within the scope of protection conferred by claim 1 or any other claim of the granted patent."
- As a supporting argument of the Board: " when reading the "comprising"-language of claim 1 [as granted], the skilled person would indeed also consider the presence of multiple exendins in the formulation. This implies that the total amount of all exendins or exendin analogue agonists, and not just the amount of exendin-4, administered with the formulation should result in the stated sustained minimum plasma concentration of about 170 pg/ml to about 350 pg/ml "
- T1360/11, headnote, frequently cited but not in the present decision, provided that “Where a granted claim directed to a composition defined in an open manner and including the presence of a component belonging to a class or list of compounds in a quantity defined by a range is later amended by limiting the definition of the class or list of compounds, a possible infringement of the requirements of Article 123(3) EPC may be avoided by including in the amended claim a quantitative condition on the limited class or list of compounds and an additional constraint on the total amount of compounds belonging to the broader class or list” (further referring to older decisions).
- The subclass-trap is not really a trap, of course, the patentee just needs to formulate the claims appropriately, assuming that there is basis under Art. 123(2) for the appropriate claim (using the "additional constraint")
- In the present case, patentee was still trapped: "Auxiliary requests 2 to 7 were filed by the appellants in response to the board's preliminary opinion (see section VIII.) provided in the communication under Article 15(1) RPBA. The requests constitute an amendment to the appellants' case to which Article 13(2) RPBA 2020 applies." The requests were not admitted.
- As a comment, I don't see claim 4 as granted separately argued in the decision. I'm not sure if patentee tried a restriction to claim 4 as granted verbatim with additionally a narrower range recited.
EPO T 1996/17
The link to the decision is provided after the jump, as well as (an extract of) the text of the decision.
source http://justpatentlaw.blogspot.com/2022/07/t-199617-subclass-trap-revisited.html
