T 0141/15 - Medical method

Key points

• In this decision taken 03.03.2020, the Board finds a method to be excluded from patentability as medical method.
• A petition for review is pending as R 7/20
• Claim 1 as granted is directed to " A method for measuring the adequacy parameters that are achieved during a kidney substitution treatment".
• " The claim wording "the kidney substitution treatment [i.e. the dialysis treatment] is provided..." makes it unequivocally clear that a dialysis treatment is indeed performed. Feature [1.2] of claim 1 specifies, moreover, that the treatment is carried out by pumping the patient blood at a set blood flow rate through the blood chamber of a dialyser, the dialysing fluid collecting the waste products from the patient after flowing through the dialysing fluid chamber of the dialyser."
• " dialysis is a blood manipulation process involving the continuous removal of blood from the patient, its subsequent flowing through a circulating line of an extracorporeal circuit and its re-delivery to the patient, which, in accordance with T 1695/07 (points 8 to 12), is considered to be a treatment of the human body by surgery." 
• " According to the established case law of the Boards of Appeal, a multi-step method falls under the exception clause of Article 53(c) EPC if it includes at least one feature that constitutes a method step for treatment of the human body by therapy or surgery (G 1/04 [and G1/07])"
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EPO T 0141/15 - link

III. Claim 1 of the granted patent (main request) reads as follows (feature numbering in square brackets added by the Board):
"1. [1.1] A method for measuring the adequacy parameters that are achieved during a kidney substitution treatment,
- [1.2] wherein the kidney substitution treatment is provided by a machine, which has an extracorporeal blood system pumping the patient blood at a set blood flow rate through the blood chamber of a dialyzer, divided by a semi-permeable membrane into the blood chamber and a dialyzing fluid chamber, the dialyzing fluid flows at a preset flow rate through the dialyzing fluid system of the machine and collects the waste products from the patient after flowing through the dialyzing fluid chamber of the dialyzer,
- [1.3] wherein a device able to measure continuously a kidney substitution treatment related waste product is mounted in the dialyzing fluid system of the kidney substitution treatment machine,
- [1.4] wherein the data provided by the kidney substitution treatment machine is used to measure the adequacy parameters at the end of the kidney substitution treatment,
- [1.5] wherein the data provided by the device able to measure continuously any kidney substitution treatment waste product is split in subsets to be used to determine the adequacy parameters achieved during the kidney substitution treatment with an algorithm,
- [1.6] wherein a data interface is implemented between the kidney substitution treatment machine and the measuring device in order to register machine events to be considered in the algorithm for the determination of the adequacy parameters, and
- [1.7] wherein the measuring algorithm is based on a kind of non linear fitting procedure for each of the data subsets with or without considering any kind of event happening on the dialysis machine."

Reasons for the Decision

1. The appeal is admissible.

2. The method of claim 1 (of all requests) is addressed at a "method for measuring the adequacy parameters that are achieved during a kidney substitution treatment" (feature [1.1]), that is, a method for measuring parameters reflecting the adequacy of a dialysis treatment, such as Kt/V, as explained in paragraphs [0001] and [0002] of the patent (K is the effective clearance for urea, t is the treatment time and V is the urea distribution volume which matches the total body water).

3. The claimed method recites a first step (feature [1.2]), according to which "the kidney substitution treatment is provided by a machine, which has an extracorporeal blood system pumping the patient blood at a set blood flow rate through the blood chamber of a dialyzer, divided by a semi-permeable membrane into the blood chamber and a dialyzing fluid chamber, the dialyzing fluid flows at a preset flow rate through the dialyzing fluid system of the machine and collects the waste products from the patient after flowing through the dialyzing fluid chamber of the dialyzer".

The appellant considered this definition to merely state the operational conditions of the dialysis machine under which the claimed measuring method takes place. According to the appellant, the latter did not comprise any therapeutic or surgical step.




The Board disagrees. The claim wording "the kidney substitution treatment [i.e. the dialysis treatment] is provided..." makes it unequivocally clear that a dialysis treatment is indeed performed. Feature [1.2] of claim 1 specifies, moreover, that the treatment is carried out by pumping the patient blood at a set blood flow rate through the blood chamber of a dialyser, the dialysing fluid collecting the waste products from the patient after flowing through the dialysing fluid chamber of the dialyser.

4. The claimed method goes on to recite various measuring and determination steps (features [1.3] to [1.7]), such as measuring "continuously a kidney substitution treatment related waste product" and, using this data, determining "the adequacy parameters at the end of the kidney substitution treatment".

5. The Board considers, therefore, that the claimed method comprises, in essence, a first step of performing dialysis treatment and a second step of measuring a parameter reflecting the adequacy of this treatment.

The step of providing dialysis to a patient enables the removal of water, solutes and toxins ("waste products") from the patient's blood. Consequently, it is a method step for treatment of the human body by therapy.

Moreover, dialysis is a blood manipulation process involving the continuous removal of blood from the patient, its subsequent flowing through a circulating line of an extracorporeal circuit and its re-delivery to the patient, which, in accordance with T 1695/07 (points 8 to 12), is considered to be a treatment of the human body by surgery.

6. According to the established case law of the Boards of Appeal, a multi-step method falls under the exception clause of Article 53(c) EPC if it includes at least one feature that constitutes a method step for treatment of the human body by therapy or surgery (G 1/04, point 6.2.1; G 1/07, point 3.2.5).

In view of the above, this is the case for the method of claim 1. The therapeutic and surgical nature of the claimed method is not changed by the fact that claim 1 is formally addressed at a "method for measuring the adequacy parameters that are achieved during a kidney substitution treatment". This opening line in claim 1 is essentially a summary of the measuring steps defined in the claim. It may be seen merely as a label for the claimed method. It certainly does not detract from the fact that the claimed subject-matter is a multi-step method comprising, apart from the parameter-measuring step, the mentioned therapeutic and surgical step. The possible intention or aim of the invention mentioned by the appellant - determining parameters reflecting the adequacy of a dialysis treatment - is not relevant for establishing the subject-matter of the claim.

7. The appellant argued, referring to decision T 245/87, that the Boards of Appeal had constantly held that a method which was only concerned with operating a device without any functional link between the claimed method and the effects produced by the device on the body did not qualify as a method for treatment within the meaning of Article 53(c) EPC (see also G 1/07, point 4.3.2). In the present case there was no functional link between the method steps for determining the adequacy parameters and the treatment. As defined in feature [1.4], these parameters were determined at the very end of the treatment, which made it clear that there was no feedback or control mechanism affecting the treatment based on the determination of the adequacy parameters. Therefore, the claimed method was only concerned with operating a device for determining the adequacy parameters of the treatment.

The Board disagrees with these conclusions.

The case underlying T 245/87 concerns a method for measuring the flow rate of a small fluid volume inside a duct. According to the description of the application in that case, the method may be applied to an implantable dosage apparatus delivering a medicament, such as insulin, to a patient's body. Although the claim in that case could be interpreted as encompassing an embodiment in which a medicament such as insulin is implicitly delivered to the patient, it was decided in T 245/87 (point 3) that there was no functional link between the claimed method and the effects produced by the device on the body and that the claimed method was merely directed to operating a device.

In the present case, however, the determination of the adequacy parameters is carried out by processing data gathered from continuous measurements of the waste products which are directly produced by the dialysis treatment (features [1.3] and [1.4]). In contrast to the case underlying T 245/87, the claim defines a continuous measurement of the effects produced by the therapeutic and surgical treatment. Therefore, the measurement step and the dialysis treatment step are inextricably linked with each other, establishing a functional link between the claimed measurement steps and the effects of the dialysis treatment on the patient's body. It is thus of no relevance that the claim does not contain a feedback mechanism between the adequacy parameters and the treatment, as argued by the appellant. In the present case, the claimed method is concerned not just with operating a device for determining the adequacy parameters of the treatment, but also with performing the treatment and measuring its effects for determining the parameters.

8. The Board thus concludes that claim 1 (of all the requests) defines a method for treatment of the human body by therapy and surgery which is excluded from patentability under Article 53(c) EPC.

Order

For these reasons it is decided that:

The appeal is dismissed.