CABINET CHAILLOT
PATENTS TRADEMARKS DESIGNS
French Patent & Trademark Attorneys - European Patent Attorneys - Representatives before EUIPO
ISO 9001 CERTIFIED
T 1920/21
The appeal is filed by the applicant (appellant) against the examining division's decision refusing European patent application No. 15 190 192.3.
The appellant had been informed that the examining division intended to grant a European patent on the basis of the set of claims, wherein claims 1 and 3 had been reworded by the examining division to avoid an objection under Article 53(c) EPC.
In reply, the appellant submitted that rewording of claim 1 of the set of claims was unnecessary since the claimed method was not excluded from patentability under Article 53(c) EPC.
The examining division maintained that the method of claim 1 of the set of claims was a diagnostic method practiced on the human or animal body excluded from patentability under of Article 53(c) EPC.
The Enlarged Board of Appeal stated in G 1/04 that to be excluded from patentability the claim is to include the features relating to:
(i) the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise,
(ii) the preceding steps which are constitutive for making that diagnosis, and
(iii) the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature.
In addition, the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu must satisfy the criterion "practiced on the human or animal body".
A preceding step of a technical nature satisfies the criterion "practiced on the human or animal body" if its performance implies any interaction with the human or animal body, necessitating the presence of the latter.
The preceding method steps which are constitutive for making the diagnosis for curative purposes include:
(i) the examination phase involving the collection of data,
(ii) the comparison of these data with standard values,
(iii) the finding of any significant deviation, i.e. a symptom, during the comparison.
Claim 1 at issue relates to a method for diagnosing a Helicobacter pylori (H. pylori) infection in a patient treated with proton-pump-inhibitors comprising the steps of administering to the patient a mixture of acids, collecting a first breath sample, administering to the patient **(13)C-labeled urea, thereafter collecting a second breath sample from the patient, measuring the content of **(13)C in the CO2 of the first and second sample and determination of a **(13)C/**(12)C ratio by spectroscopy in the respective samples.
To determine whether claim 1 is directed to a diagnostic method, it must first be established whether all of the necessary method steps are included in the claim.
The board agrees with the examining division that the method of claim 1 includes features relating to phases (i) to (iv). The method of claim 1 therefore satisfies the first requirement for a method to constitute a diagnostic method.
A diagnostic method is only excluded from patentability if all the method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis for curative purposes stricto sensu satisfy the criterion "practiced on the human or animal body".
The appellant submitted that the method of claim 1 is not a diagnostic method practiced on the human body because the steps of collecting a breath sample were not invasive and because measuring the content of **(13)C in the CO2 of the first and second sample was isolated from taking the breath samples.
To satisfy the criterion "practiced on the human or animal body" it is however not required that a preceding step of a technical nature be invasive. It suffices that its performance implies any interaction with the human or animal body, necessitating the presence of the latter. Collecting a breath sample necessarily requires the presence of the patient from which the breath sample is collected. The two technical steps of claim 1 relating to the collection of breath samples therefore satisfy the criterion "practiced on the human or animal body".
The board is however satisfied that the further method step of a technical nature of phase (i), i.e. "measuring the content of **(13)C in the CO2 of the first and second sample and determination of a **(13)C/**(12)C ratio by spectroscopy in the respective samples" does not meet the criterion "practiced on the human or animal body".
In the board's opinion, the skilled person familiar with **(13)C-urea breath tests is furthermore aware from their common general knowledge of the devices used for "measuring the content of **(13)C in the CO2 of the first and second sample and determination of a **(13)C/**(12)C ratio by spectroscopy in the respective samples" in breath samples. These include devices which analyses the collected breath samples without any interaction with the patient or necessitating its presence.
The Enlarged Board held that a claim is not excluded from patentability if at least one of the preceding steps which are constitutive for making a diagnosis comprises a method step of a technical nature which does not satisfy the criterion "practiced on the human or animal body".
The board concludes from the above considerations that not all steps of a technical nature belonging to phase (i) in claim 1 of the main request satisfy the criterion "practiced on the human or animal body". The method of claim 1 therefore does not satisfy the second requirement for a method to constitute a diagnostic method within the meaning of Article 53(c) EPC. Accordingly the board concurs with the appellant that the subject-matter of claim 1 is not excluded from patentability under Article 53(c) EPC.
The board decides to remit the case to the examining division for further prosecution.