The applicant appealed against the decision of the Examining Division (ED) refusing the application under consideration. The ED was of the opinion that the subject-matter of claim 1 contained surgical steps and as such was excluded from patentability.
Claim 1 of the main request before the Board read (in English translation):
Method for determining the change or change in length of a first object (b) which is connected in an initial state to a second object (d) via a joint (k) and which has been changed after having been detached from the second object (d), wherein a reference system (e1) is attached to the second object (d) and the first object is attached to a second reference system (e2) that is not directly fixed to the first object (b), [wherein] at least one reference mark (f) is gathered (erfasst) on the first object (b) and the relative position between the at least one reference mark (f) and the reference system is determined and/or stored, wherein, after the first object has been disconnected from the second object (d), the first object (b) has been treated and the treated first object (b) and the second object have been assembled, the first object (b) is oriented with respect to the first reference system (e1) attached to the second object (d), using the position determined by the second reference system (e2), and a change of the first object (b) is determined by gathering anew the position of the at least one reference mark (f), or another reference mark the relative position of which with respect to the latter is known, with respect to the first reference system (e1) and by comparing it with the relative position between the at least one reference mark (f) and the first reference system (e1) gathered in the initial state.
Claim 1 of the auxiliary request read:
Method for determining the change in length of a femur (b) which is connected in an initial state to a pelvic bone (d) via a joint (k), consisting in a first reference system (e1) which can be directly and preferably tightly attached to the pelvic bone (d), a second reference system (e2) comprising a ribbon (j) which can be attached to a skin (c), which surrounds the femur (b) and which is movable with respect to the femur (b), by means of the ribbon (j), as well as a pointer (g) allowing to gather the position of at least one characteristic point (f) on the femur, and a navigation system (m) allowing to gather the positions of the first reference system (e1), the second reference system (e2) and the pointer (g), and to determine the change in length of the femur (b).
The appellant also requested the following question to be referred to the Enlarged Board of appeal (EBA):
Does A 53(c) prohibit the grant of patents for any method having a preceding surgical intervention as a prerequisite for achieving the objective of the method?
Here is what the Board had to say:
*** Translation of the German original ***
[2.1] Pursuant to A 53(c) European patents shall not be granted in respect of methods for treatment of the human or animal body by surgery.
In decision G 1/07 ([headnote 1]) the EBA has answered the question of whether an imaging method for a diagnostic purpose, which is to be carried out before or during a surgical intervention and which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body, was to be excluded from patent protection under A 53(c) even if this step did not per se aim at maintaining life and health, as follows:
A claimed imaging method, in which, when carried out, maintaining the life and health of the subject is important and which comprises or encompasses 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, is excluded from patentability as a method for treatment of the human or animal body by surgery pursuant to A 53(c).
[2.2] A similar situation underlies the present case. Here, too, the claim is directed at a method that is carried out in the context of a surgical intervention. As can be seen from the description, the claimed method is in particular designed to determine the change in length of a femur when, for instance, a damaged femur head is cut off during a hip replacement surgery and is replaced by an implant. This allows to determine the length of the operated femur as compared to its original length so that the reassembled hip joint differs as little as possible from a healthy joint […]. As a consequence, the recovery of the health of a human or animal body is relevant when the claimed method is carried out.
An indispensable requirement for carrying out the claimed method consists in that in the initial state, i.e. before the hip replacement surgery has begun, or at its beginning, a first reference system is, preferably directly, attached to a pelvic bone, for instance by screwing it into the bone […]. As admitted by the appellant, the desired determination of the change in length of the femur cannot be obtained without a reference system that is firmly attached to the pelvic bone.
Attaching the reference system to the pelvic bone 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. This has not been questioned by the appellant.
However, the appellant is of the opinion that the attachment of the reference system to the pelvic bone is carried out before the claimed method has begun and that, consequently, the claimed method as such does not comprise an invasive step. This has been underlined in claim 1 according to the main request by the wording that the first reference system is attached to the second object.
[2.3] However, a claimed method is excluded from patentability pursuant to A 53(c) even if it only encompasses (umfasst) a surgical step (G 1/07 [first headnote]).
In the present case claim 1 of the main request neither expressly indicates that the claimed method is designed to determine the change or the change in length of a femur, nor that the first reference system is to be attached to the pelvic bone. However, the description clearly expresses that the claimed method is designed to determine the change or change in length of a femur. It does not describe any other application. Moreover, it clearly follows from it that the attachment of the first reference system to the pelvic bone is indispensable for the claimed method and represents an essential feature of this method because it is required for solving the problem underlying the claimed method.
The method claimed in claim 1 of the main request starts from a known method for determining the change or change in length of a femur, wherein a reference system (reference star) is directly attached both to the pelvic bone and to the femur, e.g. by screwing into the respective bone (EP-A-1 911 421, paragraph [0003]).
According to paragraph [0004] the present invention aims at providing a method allowing a more simple measurement of the change, in particular the change in length of a joint part (femur).
As a consequence, a claimed method that is proposed for solving this problem has to comprise all features or method steps that are indispensable for obtaining a simplified determination of such a change. One of the requirements for this is that a first reference system is firmly attached to the second object (pelvic bone), a second reference system is directly attached to the first object (femur) and a reference mark is attached to the second (sic) object (femur). As already mentioned above (see second paragraph of [2.2]) it is impossible to determine the change or the change in length of the first object (femur) with the claimed method without these measures.
According to EP-A-1 911 421 […], contrary to the closest prior art mentioned above, the invention does not require a second reference system to be directly attached to the femur, so that there is no need for a surgical intervention at this point. If follows, in reverse, that it is not possible not to directly attach the first reference system to the pelvic bone.
Therefore, the attachment of the first reference system to the second object (pelvic bone) is an indispensable step of the method according to the invention, which is encompassed by the method claimed in claim 1 of the main request, even if it is not mentioned in the claim. (The ED has referred to this step as being “implicit” in the claim.)
[2.4] If such a step is not encompassed by the claim the requirements of A 84 (EPC 1973) are not complied with. As a matter of fact, A 84 (EPC 1973) together with R 29 (EPC 1973) requires a claim to give all the essential features that are necessary for defining the invention.
This requirements has also been affirmed in decision G 1/07 [4.2.2; 3.3.1 – should read 4.3.1]. According to this decision, the assessment of whether a method step that is excluded from patentability may be omitted (ausgeklammert) from a claim, whether by leaving it out or by wording [the claim such that it] indicates that this step is carried out outside the claimed method, depends on whether the claimed invention is fully and completely defined by the remaining features of the claim without that step.
As already explained, in the present case, the attachment of the first reference system to the second object (pelvic bone) is to be considered to be an indispensable and thus essential feature of the claimed method without which the invention is not fully and completely defined.
[2.5] Therefore, the method according to claim 1 is not patentable pursuant to A 53(c), so that the main request of the appellant is to be dismissed.
[2.6] In decision T 836/08 cited by the appellant claim 1 was directed to a method for determining the distal end of a bone guidance wire by means of a medical-technical optical tracking and navigation system. This was done – in a way similar to the present situation – by means of reference apparatus situated both on the proximal end of the wire and on the bone. However, in this decision the Board has assessed the method steps that are mandatorily required in a different way and has, therefore, come to the conclusion that claims 1 to 3 only define the way in which a technical device operates and that, as a consequence, the method was optical rather than surgical (see T 836/08 [3]).
It may well be that the different assessment results from the fact that the Board has attached more importance to the claim category than the Board in that decision. However, this shows that finally there is some margin of assessment in any individual decision and that there is no entitlement to identical decisions. Such margins of assessment, which are necessary when decisions are to be taken, are only infringed if the principles of logic or essential basic facts have been disregarded or if some other logic (Denkgesetze) has been violated. This appears not to have been the case and has not been invoked by the appellant.
The Board then dealt with the auxiliary request, which it found to comply with A 123(2), A 84, A 54 and A 56. It remitted the case to the ED with the order to grant a patent based on this request.
Finally, the Board dismissed the request to refer the appellant’s question to the EBA:
[4] In order to ensure uniform application of the law, or if an important point of law arises, the Board of appeal shall, during proceedings on a case and either of its own motion or following a request from a party to the appeal, refer any question to the EBA if it considers that a decision is required for the above purposes (A 112(1)(a) EPC 1973).
[4.1] As explained under [2.6], decision T 836/08 is based on the fact that that Board had assessed the method steps that are mandatorily required in the respective method in a different way and has, therefore, come to a conclusion in favour of the applicant, which is the same as in the present case. The reason for this was that the margin of assessment – to which any deciding body is entitled in its decision – for technically assessing the claimed features, and not a deviant use of the relevant general decision parameters developed by case law. This follows from the mere fact that this decision also applied the principles of G 1/07.
[4.2] The question proposed by the appellant does not correspond to an important point of law either. As a matter of fact the question of whether A 53(c) prohibits the grant of patents for any method having a preceding surgical intervention as a prerequisite for achieving the objective of the method is so broad and indefinite that the answer to it is not necessary in order for the referring board to be able to decide on the appeal (cf. Case Law, 6th edition, 2010, VII.E.14.2). In particular, the expressions “any method” and “for achieving the objective of the method” are too indefinite to allow for a meaningful answer to the question which would allow to develop higher principles to be used in individual decisions.
NB: The Board has also provided a headnote:
If a method designed to gather data on the human or animal body mandatorily requires a surgical step for fixing a measuring element that is indispensable for carrying out the method to the human or animal body, this step is to be considered as an essential feature of the method which is comprised by such a method, even if there is no feature in the claim that is expressly directed to this step. Such a method is excluded from patentability pursuant to A 53(c).
The omission of such a surgical step, whether by wording [the claim] such that [it indicates that] the surgically attached measuring element was already attached to the body before the beginning of the method or by means of a disclaimer violates A 84 EPC (1973) because such a method claim then does not contain all essential features of the claimed invention.
To download the whole decision (in German), click here.
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1 comments:
After second reading, the motivations of the decisions in caselaws G1/07 and T923/08 really point out significative differences.
The problem in caselaw T923/08 lies especially in the category of the relevant claim. The article 53 CBE is clear concerning the exclusion of surgical methods but does not provide the exclusion of products for the implementation of said methods. Indeed, the article 53 EPC does not forbids, in principle, the protection of products for industrial firms.
Many PCT application for therapeutic methods based on products, are eventually granted in European phase claiming said products for the implementation said therapeutic methods. It is however preferable that the product itself is at least new.
By analogy it is likely, according to me, that the application of caselaw T923/08 could be granted claiming a "system comprising a reference device intended to be attached.... for a method..." as a product claim.
Eric Tzeuton.
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