The patent relates to heart valve prostheses, namely implantable replacement heart valves.
Brief outline of the case
The proprietor and the opponent appealed the maintenance in amended form according to AR 2.
The proprietor requested maintenance as granted and filed AR 1-8
The opponent requested revocation of the patent.
Then board decided that
- claim 6 as granted was infringing Art 53(c)
- claim 1 as granted lacked N over D7=US 2008/0228263 A1
- claim 1 as maintained was also lacking N over D7
- all the other requests were either not allowable or not admitted.
The patent was thus revoked by the board.
The case is interesting in that an objection under Art 53(c) was raised against a method of using a device.
Claim 6 reads:
A method of collapsing a heart valve prosthesis, the method comprising:
– providing a prosthesis as defined in any preceding claim;
– pulling on the apexes of the prosthesis when in the expanded state, to commence collapse into the compressed state; and
– drawing the prosthesis into a sheath (44) having an inner radial dimension smaller than the radial dimension of the support structure (10) in the expanded state.
Figs. 6(c) show the of retrieving the heart valve back into the sheath, thanks to the filiform material 42, when it needs to be repositioned during implantation in the heart of a patient.
The objection under Art 53(c)
The proprietor’s position
The proprietor disagreed with the assumption of the OD that the skilled person reading claim 6 would unambiguously identify claim 6 as a surgical method. This technical assumption was incorrect because claim 6 did not specify any interaction with the human or animal body.
The proprietor further argued that none of the steps of the method claims 6 comprised any surgical step:
- “pulling on the apexes of the prosthesis when in the expanded state, to commence collapse into the compressed state” related to an action (pulling) performed on part of the apparatus, and a respective reaction (collapse) of the apparatus. Such manipulation of an apparatus did not constitute a method step for treatment of a human or animal body by surgery.
- “drawing the prosthesis into a sheath having an inner radial dimension smaller than the radial dimension of the support structure in the expanded state” related to the interaction between the prosthesis and another piece of apparatus, namely the sheath. Interaction between the prosthesis and the sheath of the delivery system did not constitute a method step for treatment of a human or animal body by surgery.
Furthermore, there was no surgical nature of the method steps of claim 6 and no evidence (e.g. a risk matrix) was provided that could justify why health risks associated with the method of claim 6 were substantial.
Claim 6 of the patent as granted should not be excluded from patentability merely for the reason that it did not explicitly exclude the possibility of a surgical step being performed temporally at the same time as the claimed method.
Finally, it was not typically required for a claimed method to specify that it was performed ex vivo, regardless of whether or not the method could in theory be performed inside a human or animal body.
The board’s position
Following G1/07, the board held that the OD correctly considered that claim 6, defining a method of collapsing a heart valve prosthesis in vivo is prima facie a method for treatment of the human body by surgery.
While dependent claim 10 limits the method on the heart valve to be performed ex vivo, claim 6 covers both performing the method in vivo and ex vivo. This interpretation is further supported by paragraph  of the description, which discloses the possible need of the heart valve to be repositioned during endovascular surgery.
For the board, the OD has correctly applied the criteria for considering whether a method claim is a method for treatment of the human body by surgery.
Indeed, the method of claim 6 in which, when carried out in vivo, 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.
In the present case, “pulling on the apexes of the prosthesis in the expanded state” in vivo, so when the prosthesis is located into the human body, is a surgical step. Indeed, there is an implicit direct interaction between the valve and the heart of the patient.
Therefore, the OD has rightly concluded that the method of claim 6 was excluded from patentability pursuant Art 53(c).
About the method claim as such
When it comes to substances or compositions to be used in a method according to Art 53(c), where therapeutic aspects and non-therapeutic aspects are clearly distinguishable or easy to tell apart, a claim seeking protection for the non-therapeutic aspect is patentable. There are even older decisions to support this stance: e.g. T 36/83, T 144/83, T 582/88 and T 469/94.
Where therapeutic aspects and non-therapeutic aspects are indistinguishable or difficult to tell apart, the method should be considered as essentially therapeutic. Here as well, there are also older decisions to support this stance: T 116/85, T 290/86, T 780/89, T 438/91, T 820/92 and T 1077/93.
Decisions in which the method of use of a device falling under the prohibition of Art 53(c) a rather rare.
Two older decisions can be mentioned here: T 775/97 (in situ manufacturing of a vascular prothesis) and T 1005/98 (manufacture of a knee prothesis).
More recent decisions which can be mentioned are T 944/15 ( method for controlling a process of monitoring the position of at least a part of a patient’s body during a radiation treatment), T 1731/12 (method of controlling brain activity needs the implantation of electrodes in the brain) or T 475/12 (in vivo imaging by swallowing a small camera).
The present decision shows that, what is valid for substances and compositions when their therapeutic aspects and non-therapeutic aspects are indistinguishable or difficult to tell apart, is valid for methods of use of devices when the surgical aspects of the method are indistinguishable or difficult to tell apart from its non-surgical aspects.
Adding a dependent claim for an ex-vivo use does not appear very helpful. It directly and unambiguously implies that an in-vivo use is clearly envisaged. The OD and the board were quick to notice it.
It also does not help to keep a surgical step outside a method claim, when it is manifest that a surgical step has to be carried out when using the device.
About the procedure leading to revocation
Claim 6 and 10 as granted corresponded to claims 11 and 16 as filed.
In spite of claim 16 as filed and the comment in the description, no objection under Art 53(c) has ever been raised during search and examination.
On the search and examination
Although the ISR carried out by the EPO mentions 2X,Y-1X-2A documents, and the fact that that the examiner has added a further document during examination, D7 has never been retrieved during the original search.
Yet, D7=US 2008/0228263 A1, which has also been published under EP 2 129 332 A1 and EP 2 129 333 A1 were all classified in IPC class A61F2/24, which is the same as that of the present application/patent.
Having worked myself in the field, which is a difficult one, I am not blaming anybody. Examining and opposition divisions have to keep a high level of production. However, that decisions of ODs are set aside by a board, is not at all infrequent. Here we have a further example.
It is however a pity that an application filed in 2010, a patent granted in 2017 was revoked in 2023.
All the money spent for the grant and thereafter by a subsidiary of the University College of London was in vain.