Thursday, 21 April 2011

T 1027/08 – Measuring Well-being

The present decision deals with the refusal of an application by the Examining Division (ED).

Claim 1 before the Board read (my translation from the German) :
Device for therapeutically influencing at least parts of a living being by means of an irradiation device for irradiating [the living being] with electromagnetic waves, consisting in
a high frequency oscillator stage for generating a high frequency wave train, wherein the high frequency oscillator stage generates a frequency that can be tuned in the range from 130 MHz to 170 MHz;
a low frequency oscillator stage, which generates a tuneable modulation frequency;
a modulation unit, to which the high frequency oscillator stage and the low frequency oscillator stage output are fed, so that a modulated wave train is generated; and
a final amplifier, to which an transmitting antenna can be connected in the emitting range of which tissue to be treated or a person can be positioned,
characterised in that the frequency of the low frequency oscillator stage(4) can be tuned in a frequency range from 0.5 to 40 Hz,
in that the device for influencing (1) further comprises a device for acoustic irradiation (Beschallung) (13) for simultaneously and additionally acoustically influencing [the living being], by means of which a low frequency that can be generated in a low frequency oscillator stage (4), amplified by an amplifier (16) and tuned in frequency, can be fed to an loud speaker (17) acting as an acoustic source and can be radiated as an acoustic signal to the tissue to be treated or a person (12), respectively,
in that the frequency of this acoustic signal corresponds to a low frequency modulation frequency that is tuned in a frequency range from 0.5 to 40 Hz, or an integer multiple thereof, up to 3000 Hz at most, and
in that the low frequency oscillator stage (4) of the irradiation device (2) is also used as low frequency stage having a downstream frequency multiplier for multiplying by an integer, for the acoustic irradiation device (13), so that the electromagnetic modulation frequency and the acoustic signal frequency are automatically coupled.
(Click to enlarge)

In the following paragraphs the Board examines the presence of an inventive step:

*** Translated from the German ***

[2.2.1] Starting from D1, the problem indicated in the application […] consists in the development of the known irradiation device in order to increase the therapeutic influence, and in particular the physical well-being. This problem may appear to be reasonable at first sight, but it raises the question of how the increase of the therapeutic influence can be objectively proven.

The [applicant] is of the opinion that the essential advantage of the invention lies in the fact that an increased therapeutic effect is obtained with respect to irradiation according to D1 by providing an additional acoustic irradiation as claimed. This was to be explained by the synchronisation of acoustic and electromagnetic waves that simultaneously acted on a living being, which was the outcome of coupling the irradiation device and the acoustic irradiation device as claimed.

The [applicant] further submitted that effects obtained with devices for therapeutically influencing could, as a matter of principle (grundsätzlich), not be measured with technical means. Therefore, it was difficult to formulate a technical problem in this domain, although the subject-matter of the claim was a technical device.

In this context it was pointed out that the ED’s requirement to provide convincing evidence for the effect obtained was inappropriate (unangebracht). As a matter of fact, none of the other patent offices dealing with the present application had requested [such evidence], nor had the EPO in the proceedings that had let to the grant of a patent on the basis of D1.

In the present case, the alleged effect of increasing the therapeutic influence, in particular of the physical well-being, with respect to D1, has not been proven or at least made credible. The explanation of the [applicant] according to which the effect was related to a “synchronisation” of the emitted radiation and acoustic waves, which synchronisation was not defined in more detail, is not convincing, because one can assume that, unless specific measures are taken, normal synchronisation obtained by means of a common low frequency stage will be lost as a consequence of phase shifts in the irradiation device and in the acoustic irradiation device. Moreover, there is no plausible hint that there is a causal relationship between the claimed subject-matter and the problem according to the application. Therefore, it cannot be excluded that a possible subjectively improved well-being is based on a sort of placebo effect.

The Board is well aware of the difficulty mentioned by the [applicant] to objectively prove therapeutic effects. However, it is the applicant’s duty to prove or at least make credible the alleged effect of the claimed subject-matter, with respect to the closest prior art, over the whole claimed domain, e.g. by providing appropriate (sachgerecht) and reproducible comparative trials which are as objective as possible.

According to the case law of the Boards of appeal, alleged effects to which the applicant merely refers with respect to the closest prior art, for which there is not sufficient evidence, cannot be taken into consideration in determining the problem underlying the invention and, therefore, in assessing inventive step (Case Law of the Boards of appeal of the EPO, 6th edition, 2010, I.D.4.2). There is no reason to deviate from this case law, which is based on the understandable principle that a solution that is claimed to be non obvious can only justify the grant of a patent if it is indeed obtained (Singer/Stauder, EPÜ, 5th edition, A 56, marginal number 42).

Therefore the problem exposed in the application cannot be deemed to have been solved and has to be modified (Singer/Stauder, EPÜ, 5th edition, A 56, marginal number 46).

Starting from D1 as closest prior art the problem underlying the present invention is seen in extending the usability of the known irradiation device such that other forms of therapy than irradiation can be carried out.

You will not be surprised to hear that, based on this alternative problem, the invention was found not to comply with the requirements of A 56. The appeal was dismissed.

To read the whole decision (in German), click here

The file wrapper can be found here.


Anonymous said...

I would have addressed this "thing" on the basis of Articles 83 and 57. Using Art. 56 is intellectually much less satisfying, but at least this nonsense did not make it any further, unlike the Free World Trust v. Électro-Santé infringement case which made it all the way to the Supreme Court of Canada and became a landmark decision on claims interpretation. Sigh.

oliver said...

Hey, beware of bad karma! ;-)

Myshkin said...

Well, the claimed device when manufactured can probably be marketed ("patent pending"!) and sold, so I see no objection under Art. 57 EPC.

When briefly looking at the claim, I don't see a clear reason why manufacturing the device would be problematic. Such a device seems at least suitable for "influencing" at least parts of a living being. I'm not sure that "therapeutically influencing" represents a restriction over "influencing". Refusing under Art. 83 EPC seems problematic to me.

Turning to inventive step, the device seems to be more or less a juxtaposition of known parts, each part performing its normal function. The applicant claims a surprising synergistic effect in that it improves "well-being", but this effect is not acknowledged. So there is lack of inventive step.

oliver said...

I would agree with Myshkin. There are, however, some exceptions. I plan to post on this matter soon.