This is another examination appeal. The Examining Division (ED) had refused the application as contrary to A 53(c).
Claims 1 and 10 of the main request before the Board read:
1. A method of controlling the enabling of an enteral feeding pump for which a feeding set having an interlock device is adapted to be inserted into a recess of the enteral feeding pump, said method comprising:inserting the interlock device into the recess of the enteral feeding pump;emitting electromagnetic radiation in a direction for striking the inserted interlock device; anddetecting at least a portion of the electromagnetic radiation striking the interlock device when the interlock device is properly inserted in the pump recess;such that operation of the enteral feeding pump to pump nutrient liquid in the feeding set in response to the detected electromagnetic radiation is enabled.10. The method as set forth in claim 1, wherein emitting electromagnetic radiation comprises operating a first electromagnetic radiation source and wherein detecting the electromagnetic radiation striking the interlock device comprises operating a first electromagnetic radiation detector, and further comprising disabling operation of the enteral feeding pump in response to the first detector detecting electromagnetic radiation emitted by a source other than the first source.
The Board came to the same conclusion as the ED:
[2] Claim 1 […] comprises the feature “operation of the enteral feeding pump to pump nutrient liquid in the feeding set in response to the detected electromagnetic radiation is enabled”. Besides encompassing numerous embodiments where the pump is merely put in a state where it is permitted to operate […], this feature also encompasses embodiments where the pump is actually operated. This becomes evident from the description of the sixth embodiment of Figure 11 […] where it is stated […] that “the controller 77 will sense a “SET LOADED” condition and initiate operation of the pump” [emphasis added]. Further on, it is stated that “[d]uring operation of the pump, ... the safety interlock status is continuously monitored and if the status changes from “SET LOADED” TO “FAULT”, the controller will stop operating the pump” [emphasis added]. Similarly, in the description of the fifth embodiment of Figure 9, […] it is stated […] that the IR detector 239 “sends a signal to the controller to disable operation of the pump” [emphasis added]. Disabling operation of the pump is also part of dependent claims 10 and 12. In the Board’s view, this means that the pump, being in a state where it pumps fluid, is directly set into a state where it does not pump any more, i.e. it is switched off. It is not disclosed in this context that there are any intermediate steps between these two states. With regard to the output filtering 1418 referred to by the appellant, it is explicitly mentioned […] that such output filtering can be omitted. Accordingly, in view of dependent claims 10 and 12 and the cited passages of the description, claim 1 encompasses embodiments where the enteral feeding pump is actually operating to pump nutrient liquid.
From the beginning of paragraph [0035] it becomes clear that the feeding set 5 (comprising the safety interlock device mentioned in claim 1) comprises tubing providing a fluid pathway between a source of fluid and a patient, i.e. the nutrient liquid in the source of fluid and in the tubing is in direct connection to the patient. Accordingly, the operation of the pump results in nutrient liquid being pumped into the patient. It follows that there is a functional interaction with the patient, having a direct effect on his or her treatment. In this respect, the present situation is different from that considered in the decisions T 245/87, T 329/94 and T 238/06, referred to by the appellant.
Enteral feeding is used to provide nutrition to patients who cannot obtain nutrition by mouth or are unable to swallow safely. Such patients are suffering from an incapacity or disease. Even though enteral feeding does not cure the underlying cause, it clearly alleviates and lessens the symptoms thereof. It further prevents malnourishment. According to the established case law of the EPO (“Case Law”, 6th edition 2010, I.B.4.4.1, first two paragraphs), the meaning of the term “therapy” is not restricted to curing a disease and removing its causes. It also includes in particular symptomatic and prophylactic therapy. Accordingly, enteral feeding is considered to fall under the meaning of the term “therapy”. The question of whether or not the nutrition fluid also comprises medicine as mentioned at the beginning of paragraph [0002] dealing with the background of the invention can thus be left aside.
The appellant’s argument that the patient can operate the enteral feeding pump himself, without a medical practitioner being involved, is not decisive with respect to the exception clause of A 53(c). In G 1/04 [6.3], it is clearly stated that “whether or not a method is a diagnostic method within the meaning of A 52(4) EPC [1973] should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or non-medicinal support staff, the patient himself or herself or an automated system”. This finding is also applicable to therapeutic methods. It is noted that many forms of medicaments, e.g. in the form of tablets or pills, can be administered by the patient himself.
As stated at the beginning of G 1/07 [4.1], “[i]t is established in the jurisprudence of the boards of appeal that a claim encompassing an embodiment which is excluded from patentability under now A 53(c), then A 52(4) 1973, cannot be left unamended”. Since claim 1 of the main and the first auxiliary requests encompasses embodiments falling under the exception clause of A 53(c) as explained above, these requests cannot be allowed.
The Board refused to refer certain questions to the Enlarged Board and then considered the third auxiliary request claim 1 of which read:
1. A method of controlling the enabling of an enteral feeding pump for which a feeding set having an interlock device is adapted to be inserted into a recess of the enteral feeding pump, said method comprising:inserting the interlock device into the recess of the enteral feeding pump;emitting electromagnetic radiation in a direction for striking anthe insertedinterlock device inserted into the recess of the enteral feeding pump; anddetecting at least a portion of the electromagnetic radiation striking the interlock device when the interlock device is properly inserted in the pump recess;such that operation of the enteral feeding pump to pump nutrient liquid in the feeding set in response to the detected electromagnetic radiation is enabled wherein the method does not include the step of controlling the operation of the enteral feeding pump to pump nutrient liquid. (amendments with respect to claim 1 of the main request are highlighted)
The Board considered the A 53(c) objection to have been overcome by this amendment:
[4] […] Since embodiments in which the pump is actually operated, thus being in functional interaction with the patient, are no longer encompassed, the claimed subject-matter does not fall under the exception clause of A 53(c).
Since the fulfilment of the further requirements of the EPC has not yet been examined, the Board finds it appropriate to remit the case to the ED for the continuation of the examination procedure (A 111(1)).
Should you wish to download the whole decision, just click here.
The file wrapper can be found here.
6 comments:
This demonstrates how artificial it can be sometimes to have to claim an invention without covering the therapeutic method part. What is encouraging is how often useful protection can be gained by thoughtfully excluding certain steps. And also how unfair it seems when it is not possible to do this.
Suleman, Oliver, others, I need help with the notion of "encompassing" and how the Aux 3 disclaimer makes the decisive difference to allowability.
Look at Claim 1 of the Main. It ends with a sub-para that specifies:
"such that.....the pump...is enabled"
To me, that falls short of actually running the pump.
Suppose that Art 52 EPC forbids patents involving driving motor vehicles and the claim is to a method of controlling the enabling of the car for driving it. Your claim thus recites such steps as: fill tank with fuel, fill battery with charge, fill tyres with air....to enable the driving of the car". Does that claim "encompass" driving the car?
Can anybody help me to see the logic of this Board? Would be grateful.
In response to MaxDrei, yes, this is not very clear. It seems that claims 10 and 12 of the Main Request and at least the embodiment shown in Fig 9 had the mechanism operating to stop the working of the pump, and so it forced an interpretation of claim 1where embodiments in which the pump was working were covered. So it cannot be understand by reading claim 1 in isolation. You'll see from the version of the Third Aux Request attached to the minutes (see entry of 18 June 13 on the online file) that claims 10 and 12 had to also be deleted to sort this out.
To me, it appears that the board was failing to distinguish enabling and disabling from operating and stopping operation. While these may coincide, logically they are different states. Putting that asise though, from a policy point of view, a method diected to the internal operation of a physical device should, in my opinion, not be affected by the provisions of A53(c). The problem arises through the case law based on the heart pace maker cases.
Thanks both.
Suleman, you write:
"...the embodiment shown in Fig 9 had the mechanism operating to stop the working of the pump, and so it forced an interpretation of claim 1where embodiments in which the pump was working were covered."
which is at the centre of my discontent. It is the "forced" I don't like. Since when is it necessary to do violence to the plain meaning of the plain words of the claim, subordinating the plain meaning of the claim to imaginative extrapolations of the meaning of the text describing one illustrated embodiment? When I try that line, at the EPO, I am admonished, that the claim means what the claim says, and is not to be changed into some other meaning by mere stray recitations in the description!
OK, Art 84 EPC demands strict conformity between the Invention defined in the claim and the one described in the description, but taking Art 84 to the extremes exhibited by the Board here strikes me as over-zealous at least.
Now, thinking about the scope of protection of the claim of the allowed 3rd Request, the one that explicitly recites that the claimed method "does not include" running the pump. If I were a competitor, I would argue that I never infringe because I always run my pump!
I agree with MaxDrei, but part of the patent attorney's art is to use dependent claims to 'enhance' the coverage independent claims.
Post a Comment