Wednesday, 29 May 2013

T 1407/08 – Only A Product

In this revocation appeal Board 3.2.02 inter alia examined claim 1 of the fourth auxiliary request as to its compliance with A 53(c). The claim read:
An aortic graft for treatment of abdominal aortic aneurysms, the graft comprising a tubular hollow material for intraluminal insertion in the aorta, the aorta having an upper proximal aortic neck and a lower distal aortic portion forming an iliac bifurcation dividing into two iliac arteries, the graft characterized by:
a compliant graft main portion (13, 33, 59) made entirely of a knitted compliant flexible fabric material and having a generally cylindrical shape with an upper end (18, 39, 60) for secure attachment to the aortic proximal neck (5), and a lower free end (20, 41, 42, 61, 75, 76) constructed so as to wholly reside at a position inside the aneurysm above the iliac bifurcation (3, 4), the upper end of the main portion being stented with a balloon expandable stent fixed only at the upper end thereof for anchoring to the aorta neck, and the lower free end of the main portion having a thread (65, 74) for restricting a diameter of a lower edge of the compliant graft main portion to a predetermined maximum value, and
at least one compliant graft iliac portion (14, 34, 35) entirely made of compliant flexible fabric material and having a generally elongated cylindrical shape with a lower end (24, 47, 53) for secure attachment to one of the iliac arteries, and an upper end (23, 46, 52) for secure attachment in fluid communication to the lower end (20, 41, 42, 61, 75, 76) of the graft main portion, the graft iliac portion also having one balloon expandable stent attached at the upper (23) end and one balloon expandable stent attached at the lower (24) end thereof,
wherein in an expanded state, said upper end of the graft iliac portion has a diameter larger than said predetermined maximum value of the diameter of the lower edge of the graft main portion.
[4] The respondent considered that claim 1 was a so-called product-by-process claim and that it fell under the exception of A 53(c) because the process used to manufacture the product claimed was executed on the patient, i.e. was of a surgical nature.

It is clear that in the present case the aortic graft will effectively only be in its final assembled state in the human body. This is however of no relevance for the allowability of the product claim under A 53(c).

The Board points out that according to established case law, a so-called product-by-process claim must be considered to be nothing else but a product claim in which a particular way of defining the product is chosen, namely by describing steps of its manufacturing process. The use of such a way of defining the product is not to be understood as implying that something different from a product is meant to be defined or protected. In other words, it is only a way of defining a product, but the manufacturing steps are not protected and do not fall under the scope or ambit of the claim (T 219/83 [10]; T 748/98 [2]; T 248/85 [6.4]).

In the present case this means that even if the final aortic graft is normally obtained after assembly in the body of the patient during surgery, the surgical steps of introducing the different parts or portions of the graft into the body and assembling them while in the body do not fall under the scope of the claim and therefore cannot lead to an objection under A 53(c). The claim does not define any method falling under the exception of A 53(c), it defines a product which, according to established case law (T 1695/07, T 1798/08), does not fall under the exception clause.

For the sake of completeness the Board notes that it may also be possible to assemble the different parts of the claimed graft in an artificial aorta, should it become necessary to test whether a product falls under the scope of the claim or not.

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