Friday, 19 February 2016

T 475/12 - Medical examination may be a treatment

Camera unsuitable for in-vivo use
Can a method or examination become a treatment just because some of its steps may have a therapeutic effect? Claim 1 of the main request is a medical examination method that comprises administering a laxative to a subject, before the subjects swallows an in-vivo imaging device.

According to the applicant the laxative enables a better collection of data through the in-vivo imaging device. Administering the laxative should not be seen as a therapeutic step.

The board has a different opinion. If the subject happens to have constipation, the examination method might be therapeutic. Moreover, the laxative may prevent complications.

The applicant tries to save the claims by inserting the word non-therapeutic, but the Board does not accept this either (see the end of the decision).




Reasons for the Decision

1. The appeal is admissible.

2. Methods of treatment by therapy

2.1 Main request

Claim 1 comprises the steps of substantially emptying a subject's colon from content by administering a laxative to the subject and the subject taking a booster laxative.

Claim 7 comprises the step of ingesting laxatives and stimulants.

Claim 9 comprises the step of releasing a stored laxative and/or a stored stimulant stored in the imaging device when it reaches a predefined area of a body lumen of the subject.

Claim 10 comprises the step of administering to the subject a prokinetic agent.

Numerous examples of laxatives are indicated in the description at page 3, lines 6 to 10, e.g. Soffodex**(TM) or Meroken**(TM). From lines 26 to 29 of page 9, lines 16 to 17 of page 10 and the sentence bridging pages 10 and 11 it can be derived that the term "booster laxative" is to be understood as an additional dose of laxative. Examples of stimulants are mentioned in lines 11 to 12 of page 3, e.g. Bisacodyl**(TM). Examples of prokinetics are listed in the next two lines, e.g. Tegaserod**(TM) or Domperidone**(TM).

These (booster) laxatives, stimulants and prokinetic agents are pharmaceutically active substances. When administered to the human body, they interact with the body and cause certain reactions, e.g. encouragement of bowel movements or increase of muscle contractions, as mentioned in lines 24 to 25 of page 7. Accordingly, certain physiological functions are altered. These effects occur inevitably when the substances are administered to the body, irrespectively of whether or not they are explicitly mentioned in the claim wording.

The induced bowel movements and muscle contractions promote the emptying of the bowels. As mentioned in lines 12 to 14 of page 10, this may, at the initial stage before the imaging device is swallowed, constitute a mere colon-cleansing procedure. It is clear that such cleansing is necessary and desired before the imaging device is swallowed. Depending on the state of health of the "subject" to whom the laxative is administered, this procedure may have further (desired or undesired) effects. If the subject is for instance a patient suffering from constipation, the administration of a laxative effects a curative treatment of this disorder and thus constitutes a therapeutic step, as correctly observed by the Examining Division. Moreover, the induced emptying of the bowels results in a loss of essential electrolytes. In order to prophylactically counteract the danger of an electrolyte deficiency, most laxatives also comprise electrolytes. For instance, the laxative Meroken**(TM) serves inter alia as an electrolyte replenisher for the treatment of hypokalemia (it is noted that the administration of substances counteracting negative side effects of a method, itself non-therapeutic, was nevertheless found to be prophylactic and thus therapeutic in T 820/92). Stimulants and prokinetic agents are also used to treat certain diseases or disorders, e.g. Bisacodyl**(TM) for managing neurogenetic bowel dysfunction or Domperidon**(TM) serving as an antiemetic. If the subject suffers from any of these disorders, the administration of these pharmaceuticals necessarily has a therapeutic effect. On the other hand, there may also be negative side-effects, as is the case with most pharmaceuticals. In order to assure an adequate analysis of the underlying benefits and risks, these substances usually have to be prescribed by a medical doctor.

Accordingly, the administration of laxatives, stimulants or prokinetics has a cleansing effect, which may be non-therapeutic, as well as certain therapeutic effects, as mentioned above, depending on the health state of the subject to which they are administered. The Board does not consider it possible as a matter of law to draw a distinction between applying these method steps to a possibly healthy subject as opposed to a patient suffering from a disorder that is treatable using these substances. According to established jurisprudence as cited in "Case Law of the Boards of Appeal of the EPO", 7th edition 2013, I.B.4.4.2, if the scope defined by the wording of the claim encompasses a use comprising a non-therapeutic element which is inseparably associated with a therapeutic element, the method is non-patentable under Article 53(c) EPC. The present situation is in particular comparable to the case underlying T 290/86, where it was found that the use of a certain composition for cleaning plaque and/or stains from human teeth inevitably had a therapeutic as well as a cosmetic effect (point 3.2).

A further aspect of the claimed method is that the above-mentioned substances are not only administered for cleansing purposes before the imaging device is swallowed, but also in order to propel the device once it is within the colon (page 2, lines 11 to 13 and page 10, lines 12 to 14). As long as the imaging device remains within the gastro-intestinal tract of the subject, it constitutes a foreign object within the subject's body. This represents a non-physiological condition. As conceded by the appellant, there is even the risk that the device is not egested naturally at all ("capsule retention"). Even though this risk seems to be relatively low, it represents a major complication, requiring endoscopic or even conventional surgical intervention. By promoting propulsion of the imaging device in the gastro-intestinal tract, the above-mentioned substances also have a prophylactic effect in that they contribute to avoiding a pathological situation, viz. the device's retention in the subject's body after swallowing. It is established jurisprudence as cited in "Case Law of the Boards of Appeal of the EPO", 7th edition 2013, I.B.4.4.1a that a prophylactic treatment aimed at maintaining health by preventing ill effects that would otherwise arise amounts to a method of treatment by therapy.

The above-mentioned therapeutic effects are inevitably associated with the claimed administration of the respective substances. It is not necessary that these effects be explicitly mentioned in the claim for its subject-matter to fall under the exception clause. Also, the stated overall purpose of the claimed method, i.e. "in vivo examination", is not decisive if one of its features constitutes a step for treatment by therapy, which is the case here as explained above. As stated in point 6.2.1 of the reasons of opinion G 1/04, and explicitly confirmed in point 3.2.5 of decision G 1/07, a claim comprising one single therapeutic step falls under the exception clause of Article 53(c) EPC.

Referring to points 3.4.2.2 and 3.4.2.3 of G 1/07, the appellant argued that something as "uncritical and minor" as administering a laxative could certainly not be seen as constituting a therapeutic step. The cited passages belong to the introductory part of section 3.4.2 entitled "Interventions being 'treatment by surgery' by their nature", where certain criteria regarding the definition of term "treatment by surgery" are set out subsequently in points 3.4.2.4 et seq. The reference to "uncritical methods involving only a minor intervention" in point 3.4.2.3 must hence be seen in the context of treatments by surgery (where the nature of the intervention plays a decisive role) and cannot be simply transposed to methods of treatment by therapy. In this latter respect, criteria such as "uncritical" or "minor" are not applicable - what is decisive is whether a therapeutic effect is achieved by the administered substance in the recipient's body.

Since the above-mentioned steps in independent claim 1 as well as those of dependent claims 7, 9 and 10 constitute steps for treatment by therapy, their subject-matter is excepted from patentability under Article 53(c) EPC. Under these circumstances it is not necessary for the Board to decide if the claimed method possibly also comprises or encompasses steps for treatment of the human body by surgery.

2.2 First to third auxiliary requests

(...)

3. Clarity - amended versions of the main request and first to third auxiliary requests
The amended versions of the claims of the main request and the first, second and third auxiliary requests correspond to the above-cited sets of claims, with the term "non-therapeutic" inserted before the word "method" at the beginning of claim 1. Even though it was held in point 2.4.1 of decision G 1/03 that an undisclosed disclaimer may be allowable to disclaim subject-matter excepted from patentability under Article 53(c) EPC, it was emphasised in the third paragraph of point 3 (and in point 2.4 of the order) of that decision that a claim containing a disclaimer must meet the requirement of clarity of Article 84 EPC.

In view of the fact that some of the claimed method steps do indeed constitute steps of treatment by therapy, as explained in points 2.1 and 2.2 above, the inserted term "non-therapeutic" contradicts the inherent therapeutic character of these steps. The present situation is analogous to those dealt with in point 5 of T 1635/09 and in point 2.1 of T 67/02, and similar to that underlying point 16 of T 1695/07, where such contradictory claims were held to be unclear. The claims of the amended versions of the main request and the first, second and third auxiliary requests therefore do not meet the requirement of clarity of Article 84 EPC.

Order
For these reasons it is decided that:
The appeal is dismissed.


This decision   T 0475/12 (pdf) has European Case Law Identifier: ECLI:EP:BA:2015:T047512.20151111. The file wrapper can be found here
 
Photo "Coffee & Camera Tests" by Christopher Michel obtained via Flickr under CC BY 2.0 license. (no changes made).

1 comment :

  1. According to the applicant, the claimed method according to all requests was restricted to being a method of examination, and a method of examination is not a method of treatment. This might be true on the face of it, but the method comprised as an essential step the administration of a laxative. And this is undoubtedly a therapeutic step. Whether a patient takes a laxative to obviate constipation or to allow coloscopy, has in any case a therapeutic purpose.

    The decision is interesting in that the BA considered that administrating a laxative is a therapeutic step which led to the method not being allowable under Art 53, c). The therapeutic step could not be distinguished from the non-therapeutic aspects, in this case the imaging aspects. This is in line with old decisions of the BA in which the fact that a therapeutic step could not be distinguished from other non-therapeutic steps rendered the method as a whole to fall under the prohibition of Art 53, c). E.g. T 116/85, T 780/89 or T 438/91.

    A similar situation to the present one, therapeutic method of using a device, is to be found in T 1592/11, Auxiliary request XIII, Point 6 of the reasons, in which a method for administering a medicament with a specific device was considered as a therapeutic method as a whole, and hence not allowable under Art 53, c).

    Although a disclaimer was in principle possible under G 1/03, it is not possible to disclaim what is inherent in the method. There was no other application of the method disclosed than in the human body. Visualising the inside of piping might also need the injection of a cleaning product, so that it can be properly visualised.

    A similar situation is to be found in T 1592/11, Auxiliary request XIIIi, Point 7 of the reasons, in which the disclaimer stated that the medicament was not administered to the human or animal body. As by essence a medicament is administered to the human or animal body, the BA held this disclaimer to be unclear, like in the present decision.

    Last but not least, without the laxative, i.e. just swallowing the video pill, it is clear that the BA would have deemed the method to be surgical in the meaning of G 1/07. See the annex to the summons, last § of Point 1. The BA did not have to decide on this point, as the laxative offered a much more easy way to deal with the situation.

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