T 0910/21 - New purpose of treating same disease

Key points

•  Claim 1 is a second medical use claim directed to "a composition for use in improving executive function of a subject in need thereof, ... wherein said subject suffers from a memory or cognitive disorder, memory decline or cognitive dysfunction, such as Age Associated Memory Impairment (AAMI), Alzheimer's Disease, multiple sclerosis, vascular dementia, frontotemporal dementia, semantic dementia or dementia with Lewy bodies, and/or psychiatric and developmental disorders, including obsessive-compulsive disorder, Tourette's syndrome, depression, schizophrenia , attention-deficit/hyperactivity disorder, and autism (asperger)."
• The Board seems to refer to  refers to "executive function" by the abbreviation EXEC.
• The Board "[prior art] documents D6 and D28 describe the beneficial effect of a formulation with the same components as defined in claim 1 as granted on activities which are influenced by EXEC, in particular the [instrumental activities of daily living]IADL, but do thereby not explicitly disclose the beneficial effect on EXEC itself as defined in claim 1 as granted."
• "Documents D6 and D28 describe compositions ...  for improving activities in which the operational and the executive brain functions play an important role, i.e. the instrumental and/or basic activities of daily living (IADL/BADL), and for supporting and enabling those complex activities where initiation, planning and effective operation performances play a role "
• "The benefit of treatment with respect to IADL as described in documents D6 and D28 does therefore not necessarily imply an improvement in EXEC, because the reported benefit may well have resulted from an improvement in MEM [memory]." 
• The decision does not explain what MEM is.   "MEM"  is memory.
• It is evident from document D22 that a decline in EXEC, and thus also the need for treatment intended to improve EXEC, can be specifically diagnosed in patients who develop dementia and that the change in EXEC over time, and thus also the response to treatment, can be specifically monitored. As confirmed in for instance document D3 (see page 555) the Trail Making Test B (TMT-B) described in the patent (see paragraphs [0033]-[0035] and [0105]) is commonly known as suitable for this purpose. The Board therefore considers that the purpose of improving EXEC defines a specific clinical situation which characterizes the therapeutic use as defined in claim 1 as granted."
• "in line with the considerations in T 836/01 (see section 10) the purpose of improving EXEC distinguishes the treatment defined in claim 1 as granted from the treatment of patients with AD as described in documents D6 and D28 even without the explicit definition of a new patient group."
• T 0836/01: "Turning to the present case, the conclusion cannot be drawn that the technical effect relied upon by the claimed invention, namely the direct influence of interferon-ß2 on the tumor cell growth and (terminal) differentiation is a mere explanation of how interferon-ß2 heals cancer. Rather, this effect identifies a new clinical situation, namely one in which it could be preferable to target the cancer cells themselves, not lymphoid cells or the immune system as in document (D1), in order to heal cancer. But since a new clinical frame is not separable, as an abstract concept, from a patient suffering under it, it must be concluded that this new clinical situation also identifies a new sub-group of subjects being treated.": 
• "the Board concludes that the patent as granted meets the requirement of novelty."
• The Board also considers the claim to be inventive. 
• "It was not in dispute that EXEC is compromised in patients with AD and that EXEC plays an important role in IADL. However, as pointed out in section 2.2 above, changes in MEM and EXEC are according to document D26 independently associated with the rate of change in IADL. Without any further specific indication from the prior art the improvement in IADL reported in document D28 does not provide a reasonable expectation of a beneficial effect on EXEC, because the improvement in IADL could well have resulted from an improvement in MEM.
• Moreover, the results reported in the patent (see Figure 2) indicate that the effect of administration of the defined composition on EXEC may only become clearly recognizable after twelve weeks from the start of the administration. The skilled person who further investigates the effects on IADL from the twelve week treatment as reported in document D28 may thus not recognize the improvement in EXEC as disclosed in the patent. On the contrary, when investigating the effect on IADL from twelve week administration of the composition as described in document D28 the skilled person would on the basis of the results from the administration of such a composition for the duration of twelve weeks as described in document D8, which concerned improved verbal recall scores (see D8, page 6, Figure 2 and page 7, Table 3; see also Abstract), likely conclude that the reported improvement in IADL was due to an improvement of MEM.
• The prior art did therefore not provide the skilled person with reasonable expectation that the defined composition would be useful for improving EXEC in the defined group of patients."
• Turning to sufficiency, and the list of diseases in claim 1: " The Board considers that the opponent's objection that the patent does not sufficiently disclose the suitability of the claimed composition for improving EXEC in other patients than those suffering from mild AD remained without substantiation."
• "The Board considers that the mere reference to the diverse nature of the disorders defined in claim 1 as granted does not further substantiate the opponent's objection. The claim is specifically directed to the improvement of EXEC, which may be compromised in patients afflicted by the defined disorders and for which the patent exemplarily demonstrates efficacy in patients with mild AD."

EPO 

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

https://www.epo.org/en/boards-of-appeal/decisions/t210910eu1