Friday 16 April 2010

T 1224/06 – Would You Please Hide The Bloodshed


Claim 1 of the main request read:
A method of extracorporeal blood processing for collection of blood components from blood from a donor, said method comprising: providing a blood processing vessel containing blood; separating platelets from said blood within said blood processing vessel; collecting at least a portion of said platelets in a platelet collection reservoir separate from said blood processing vessel; separating red blood cells from said blood within said blood processing vessel; collecting at least a portion of said separated red blood cells in a red blood cell collection reservoir separate from said blood processing vessel, wherein said platelet separation and collection steps are completed separate from said red blood cell separation and collection steps.
[2] Claim 1 as originally filed has been amended by replacing the words “flowing blood into a blood processing vessel” in original claim 1 by the words “providing a blood processing vessel containing blood” in new claim 1. This amendment was effected in order to remove the step of flowing blood into a blood processing vessel which the examining division (ED) considered to be a surgical step.

The gist of the invention is in the separate collection of red blood cells and platelets from blood within a blood processing vessel. The entire process is performed outside of the body, as is made clear by the word “extracorporeal” in claim 1, and the manner in which blood is supplied to a blood processing vessel in order to carry out the claimed method is irrelevant to the invention. Therefore, the step of flowing blood into the blood processing vessel is not an essential feature of the invention and the amendment does not require any modification of the other steps. The amendment is not objectionable under A 123(2), accordingly. 

[3] Since claim 1 now clearly does not contain the step of flowing blood into a blood processing vessel, the ED’s objection, that this step inevitably involves removing blood from a donor via a needle and is therefore a surgical step, no longer applies. The remainder of the claim defines only technical steps applied to the blood within the vessel, in order to solve a technical problem, so that the claim is free from objection under A 52(4).

[4] The decision under appeal is based solely on A 52(4), and since the appeal is allowed, it is appropriate pursuant to A 111(1) to remit the case to the ED for further prosecution.

This decision was taken some days before the Enlarged Board issued its decision G 1/07. I wonder if the ED would have taken the same decision in the light of G 1/07. I guess flowing blood into a processing vessel would now be considered to be a “safe routine technique, even [though] of invasive nature” and would not be understood as being of surgical nature within the meaning of the EPC. In any case, it seems difficult to argue that this step is an invasive step representing a substantial physical intervention on the body which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise”.

To read the whole decision, click here.

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