T 1695/07 () of 28.9.2011

European Case Law Identifier: ECLI:EP:BA:2011:T169507.20110928
Date of decision: 28 September 2011
Case number: T 1695/07
Application number: 95902560.2
IPC class: B01D 61/32
A61M 1/36
Language of proceedings: EN
Distribution: B
Download and more information:
Decision text in EN (PDF, 211.114K)
Documentation of the appeal procedure can be found in the Register
Bibliographic information is available in: EN
Versions: Unpublished
Title of application: Blood flow measurement method in hemodialysis shunts
Opponent name: Fresenius Medical Care Deutschland GmbH
Board: 3.3.07
Headnote: -
Relevant legal provisions:
European Patent Convention Art 53(c)
European Patent Convention Art 56
European Patent Convention Art 111(1)
European Patent Convention Art 123(2)
European Patent Convention 1973 Art 52(4)
European Patent Convention 1973 Art 84
Keywords: Exception to patentability (yes) - Main Request and Auxiliary Request 1
Disclaimer admissible (no) - Auxiliary Request 2
Exception to patentability (no) - apparatus - Auxiliary Requests 3 and 4
Amendments - Clarity (no) - Auxiliary Requests 3 and 4
Amendments - allowable (yes) - Auxiliary Request 5
Inventive step (yes) - non obvious solution - Auxiliary Request 5
Remittal (yes) - description yet to be adapted

I. A blood manipulation process involving the continuous removal of blood from a patient, its subsequent flowing through a circulating line of an extracorporeal circuit and its re-delivery to the patient is a method of treatment of the human body by surgery excepted from patentability under Article 53(c) EPC. It does not belong to the kind of methods which should not be covered by the exception clause according to the "narrower understanding" suggested by the Enlarged Board of Appeal in decision G 1/07, because the process is not performed in a "non-medical, commercial environment" and cannot be considered as a "minor intervention" being performed on "uncritical parts of the body" (Reasons, 8 to 10).

II. Such an in vivo process requires "professional medical expertise" and belongs to the kind of interventions representing the "core of the medical profession's activities", even when performed by paramedical support staff (Reasons, 11).

III. Even when the process is carried out with the required medical professional care and expertise, it involves "substantial health risks" for the patient. A health risk is considered to qualify as "substantial" whenever it goes beyond the side effects associated with treatments such as tattooing, piercing, hair removal by optical radiation, micro abrasion of the skin as mentioned in G 1/07. A factual analysis of absolute or relative risks and their likelihood of occurrence based on objective evidence is hardly feasible and should therefore not be required (Reasons, 12).

Cited decisions:
G 0001/03
G 0002/03
G 0001/04
G 0001/07
T 0182/90
T 0712/93
T 0329/94
T 0775/97
T 0035/99
T 0067/02
T 0663/02
T 1075/06
Citing decisions:
G 0001/16
T 1407/08
T 1798/08
T 2003/08
T 0475/12

26 references found.

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EPC Articles

Offical Journal of the EPO

Case Law Book: I Patentability

Case Law Book: II Conditions to be met by an Application

Case Law of the Enlarged Board

General Case Law