European Patent Office

T 1695/07 of 28.09.2011

European Case Law Identifier
ECLI:EP:BA:2011:T169507.20110928
Date of decision
28 September 2011
Case number
T 1695/07
Petition for review of
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Application number
95902560.2
Language of proceedings
English
Distribution
Distributed to board chairmen and members (B)
OJ versions
No OJ links found
Other decisions for this case
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Abstracts for this decision
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Application title
Blood flow measurement method in hemodialysis shunts
Applicant name
TRANSONIC SYSTEMS, INC.
Opponent name
Fresenius Medical Care Deutschland GmbH
Board
3.3.07
Headnote
-
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
Catchword
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).

ORDER

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The case is remitted to the department of first instance with the order to maintain the patent on the basis of the claims of Auxiliary Request 5 filed with letter dated 5 September 2011 and a description to be adapted thereto.