Tuesday, 22 January 2013

T 1798/08 – No Disguise

Both the patent proprietor and the opponent appealed the decision of the Opposition Division to maintain the opposed patent in amended form.

The Board found the main request on file to violate A 123(2) and then went on to examine the first auxiliary request claim 1 of which read:
A visual prosthesis, comprising:
a) means for perceiving a visual image, said means producing a visual signal output in response thereto;
b) retinal tissue stimulation means comprising an electrode array (22) capable of stimulating retinal cells to produce phosphenes in a pattern to stimulate vision, said electrode array (22) adapted to be operatively attached to a retina of a user; and
c) visual signal communication means for transmitting said visual signal output to said retinal tissue stimulation means, comprising a primary coil (16) for wirelessly transmitting a radio frequency encoded image signal and a secondary coil (18) for receiving the radio frequency encoded image signal transmitted via the primary coil (16), wherein
I. the electrode array (22) and the secondary coil are in communication via a decoding and demultiplexing circuit block (20) to which the radio frequency encoded image signal is passed from the secondary coil (18) and which communicates said signal to the electrode array (22) and wherein
II. a) the secondary coil (18) and the decoding and demultiplexing circuit block (20) are suitable to be located on the body of the user outside a wall of the sclera and attached to the sclera, or
b) the decoding and demultiplexing circuit block (20) is suitable to be located on the body of the user outside a wall of the sclera and attached to the sclera and the secondary coil (18) is suitable to be located implanted in the eye behind the iris.
In what follows the Board examines the question whether this subject-matter is excluded from patentability.

[3.2] Although all claims are directed to a visual prosthesis, i.e. an apparatus, they were objected to under A 53(c) as relating to a surgical method. The features “suitable to be located on the body of the user outside a wall of the sclera and attached to the sclera”, “suitable to be located on the body of the user outside a wall of the sclera and attached to the sclera” and “suitable to be located implanted in the eye behind the iris” in part II of feature c) of claim 1 were regarded as relating to a method for treatment of the human or animal body by surgery, thus transforming the claim into a “disguised” method claim, even though it was notionally directed to a device.

The Board dismisses this objection for the following reasons.

A 53(c), second sentence, specifies that the provision does not apply to products, e.g. substances and compositions, for use in the methods falling under the exception clause. In addition to substances and compositions, the claim category “products” includes apparatus. Accordingly, the provisions of A 53(c) do not normally apply to apparatus claims.

The fact that some features of the claimed apparatus are functionally defined in relation to the body of the patient does not itself transform the apparatus claim into a method claim (T 712/93 [3]; T 1695/07 [17]). It is true that the actual implantation of components of the prosthesis would constitute a surgical intervention in the patient’s body, but this is not what is claimed in claim 1. The claim merely defines that certain components of the prosthesis are “suitable to be located” at various locations in the patient’s body. Such a definition does not except the claimed apparatus from patentability under A 53(c).

The reasoning of T 775/97 [2.6] is not applicable to the present case, as the underlying situation is entirely different. Claim 29 of the main request at issue in that case related to the use of two tubes for the manufacture of a device for use in a surgical method. Since said device was assembled inside the body by a surgical method, it was found to constitute a surgical treatment. In the present case, however, the claim is not directed to a use but to an apparatus and does not refer to any manufacturing steps. No surgical step is needed to make any of the components of the claimed prosthesis. The present claim is comparable to the device claims of the auxiliary request in decision T 775/97 [3.1] which were found not to fall under the exclusion clause of A 52(4) EPC 1973.

The reasoning of T 82/93 [1.5-5] is not applicable to the present situation either. In that case the claim objected to was directed to a method of operating a pacer including a number of features which were physical entities and a number of features defining physical activities or actions (referred to as a “hybrid claim”). At least one of these actions, viz. the use of certain sensed parameters to control the pacer rate, was considered to constitute a method of treatment of the human body by therapy, resulting in the claim defining subject-matter excluded from patentability under A 52(4) EPC 1973. The present case is different in that claim 1 is not directed to a method and in that it does not comprise any features defining physical activities or actions, still less any steps defining a surgical or therapeutic treatment of the human body.
G 5/83 deals with claims directed to the use of a substance or composition for the treatment of the human or animal body and is thus also of no relevance in the present context.

The statement cited by the appellant opponent from G 1/04 [6.2.1] that a claim falls under the prohibition of A 53(c) “if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy” explicitly refers to method claims, and not to device claims as in the present case. Furthermore, as explained above, claim 1 does not include any such method step for treatment.

It follows that claim 1 of auxiliary request 1 does not fall under the exception clause of A 53(c).

The issue of exception from patentability has to be decided on the basis of the given wording of the claim as indicated above (possibly taking into consideration additional information provided in the description, which was not necessary in the case at issue). Any possibly necessary interpretation of certain features of the claim (i.e. suitability of components to be located on or attached to parts of the body) for the assessment of novelty should not play a role in the decision as to whether or not a given claim falls under the exception clause, since novelty is a separate and independent patentability requirement (“Case Law”, 6th ed. 2010, I.A.1.2).

Also the issue of possible patent infringement, i.e. the question of whether a surgeon implanting components of the claimed device might be confronted with the problem of patent infringement and thus be hampered in his freedom when treating his patients, has to be left aside in this decision.

According to opinion G 2/88 [3.3] a distinction is to be made between the protection conferred by a patent as determined by the claims according to A 69(1) and the rights conferred on the patent owner in the designated Contracting States according to A 64. The rights conferred on the proprietor of a European patent under A 64(1) “are the legal rights which the law of a designated Contracting State may confer upon the proprietor, for example, as regards what acts of third parties constitute infringement of the patent, and as regards the remedies which are available in respect of any infringement”, and “the “rights conferred” by a patent are a matter solely for the designated Contracting States” [emphasis added].

This is confirmed in G 1/07 [], where it is stated that “any issues of infringement ultimately depend on the construction of the applicable national laws”, and that there is “no term in A 53(c) which would allow concluding that hampering of the practitioner’s freedom is a prerequisite for the exclusion to apply in the individual case considered. The only condition defined in A 53(c) for a claim to be excluded from patentability is that it contains subject-matter being a method for treatment of the human or animal body by surgery or therapy or a diagnostic method. If so, it is excluded from patentability and it is then irrelevant whether in the individual situation under consideration a medical practitioner would or could infringe the claim” [emphasis added]. Since the issue of possible infringement by a medical practitioner is not decisive in case of a claim directed to a method, this must a fortiori be the case for a claim to an apparatus, such as a visual prosthesis. It is well established that product protection is available for medically-related products even though it may hamper the medical practitioner’s freedom to operate.

NB: There are other interesting items in the decision, such as the request for a legal hint by the Board.

Should you wish to download the whole decision, just click here.

The file wrapper can be found here.