EP 2 839 277 A2 relates to “Methods for diagnosing a neurodegenerative condition”, more precisely to a “Method of determining if an individual is transitioning from a healthy state to an unhealthy state”.
It was originally filed as PCT application PCT/US2013/020496 and published under WO 2013/133904.
Brief outline of the case
The application was refused and the applicant appealed.
The ED found all requests to comprise added subject-matter and to be unclear. Additionally, the then MR as well as AR1-2 were found to be diagnostic methods excluded from patentability under Art 53(c).
The applicant requested that a patent be granted on the basis of the MR, filed as AR 5 with the statement of grounds of appeal.
The board remitted the case to the ED for further prosecution.
We will focus on the problems linked with Art 53(c).
Claim 1 of the main request reads as follows.
“A method of determining if an individual is transitioning from:
(i) a healthy state to an unhealthy state, the method comprising:
- (a) monitoring breath taken from the individual and measuring a relative amount of a first isotope to a second isotope ….., wherein the individual is healthy ……,
- (b) identifying a healthy functional oscillation pattern in the relative amount of the first isotope to the second isotope therein ……,
- (c) identifying a test functional oscillation pattern in the relative amount of the first isotope to the second isotope therein …., and
- (d) determining that the individual is transitioning from a healthy state to an unhealthy state when the healthy functional oscillation pattern and the test functional oscillation pattern are distinct in period of oscillation, oscillations per unit time, and/or variability in oscillation period,
(ii) an unhealthy state to a healthy state, the method comprising:
- (a) monitoring breath taken from the individual and measuring a relative amount of a first isotope to a second isotope therein ….., wherein the individual is unhealthy …..
- (b) identifying an unhealthy functional oscillation pattern in the relative amount of the first isotope to the second isotope therein …..,
- (c) identifying a test functional oscillation pattern in the relative amount of the first isotope to the second isotope therein …., and
- (d) determining that the individual is transitioning from an unhealthy state to a healthy state when the unhealthy functional oscillation pattern and the test functional oscillation pattern are distinct in period of oscillation, oscillations per unit time, and/or variability in oscillation period,
wherein the first and second isotopes are a pair of C13 and C12.”
The application also explained that oscillation patterns could be used to distinguish between bacterial and viral infections.
The applicant’s point of view
Detecting a change from a healthy state to an unhealthy state, or vice versa, amounted to determining whether or not there was a deviation from the healthy state, i.e. whether a symptom had developed.
The method of claim 1 did not include a step of attributing the finding of a deviation to a clinical picture, let alone a particular clinical picture. The term “unhealthy” was broad and did not fall under a particular clinical picture.
While the description mentioned disease states and conditions, these were not included in the claim.
The board’s decision
The ED based its finding on two aspects.
First aspect
Firstly, according to the Guidelines, identification of the underlying disease was not required, see Guidelines G-II.4.2.1.3.
Regarding the first aspect, step (iv) requires attribution to a particular clinical picture. It is true that this should not be construed as requiring the specific disease to be identified, see T 1016/10, Reasons 2.6.
However, the term “unhealthy” does not provide any information whatsoever as to the nature of the underlying medical condition; hence, it cannot represent a “particular clinical picture“. Consequently, determining that an individual is unhealthy does not represent attribution to a particular clinical picture.
Step (ii)(d) of claim 1 includes determining that the individual is transitioning from an unhealthy state to a healthy state.
The board was aware of the fact that, according to decision G 1/04, Reasons 5.1, diagnosis also includes a negative finding, namely in the sense that a particular condition can be ruled out.
However, an “unhealthy state” is not a particular clinical picture. Accordingly, in the context of claim 1, a “healthy state” does not refer to any particular clinical condition either, nor does it rule out any particular condition.
In other words, the attribution to a healthy state does not constitute a negative finding in the sense that a particular condition can be ruled out.
Second aspect
Secondly, the application focused on diagnosis of catabolic or infected states and mentioned several medical conditions.
Regarding the second aspect, the description refers in the field of the disclosure and in the background, paragraphs [0002] and [0003], to the catabolic state, which can arise due to various causes.
The description also mentions several medical conditions that could potentially be distinguished from one another using the oscillation patterns, e.g. bacterial infections and viral infections in paragraphs [0027] to [0029]. However, these passages of the description do not mean that further limitations should be read into the claim.
Claim 1 does not refer, either explicitly or implicitly, to a catabolic state, a bacterial infection or a viral infection.
Nor is it claimed that a deviation is attributed to any of those states or conditions. At most, the term “unhealthy” may encompass these states and conditions as well as virtually any other conceivable condition. However, it still does not represent a particular clinical condition.
For the board it follows that claim 1 does not include attribution to a particular clinical picture. Consequently, claim 1 does not define a diagnostic method practised on the human or animal body within the meaning of Art 53(c).
Comments
The objection that the claimed method was a diagnostic method was first mentioned in the ISR as well as in the IPER, both established by the EPO, and pursued during examination.
The board is actually playing with words.
In view of G 1/24, which is not mentioned in the present decision, the decision is open to critic.
When Interpreting the independent claim according to G 1/24, and since the description mentioned disease states and conditions, the aim of a method was clearly to establish a diagnostic.
If transitioning from a healthy to an unhealthy state and vice versa is not a diagnostic method, one wonders what a diagnostic could at all be when reading G 1/04.
If allowing to distinguish between a bacterial and a viral infection is not a diagnostic, one also wonders what a diagnostic could at all be when reading G 1/04. Both infections need a totally different therapeutic approach!
In § [0054] one reads: In a further embodiment, a method of determining the severity of an infection in an individual comprises… If determining the severity of an infection is not a diagnostic method, one wonders what a diagnostic could at all be when reading G 1/04.
In § [0074] one reads: In establishing the protocol for data analysis, the following diagnostic scenarios were taken into consideration. ……. The goal is to collect data for a short period of time from the target and decide if the target is sick or healthy……
The whole application is based on mathematical assessments of oscillation patterns.
Such an a decision is an open door for applicants to clad methods of diagnostic in harmless wording, but specify some diseases which can be diagnosed in the description. We are far from what is required in G 1/24,
The claimed method cannot be compared to the first medical use of a known product. Art 54(5) does not extend to diagnostic methods under Art 53(c).
That the exclusion under Art 53(c) has to be interpreted narrowly, is not at stake. The present decision goes way to far in selecting specific passages in the description and leaving aside those which could be disturbing for the board’s position.
T 1016!710 taken by the same board, but in a previous composition, is the decision to follow and certainly not the present one.
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