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.
Comments
8 replies on “T 1884/23-Is determining the passage from healthy to an unhealthy, or distinguishing between bacterial and viral infections, a diagnostic method?”
Is the method even practised on the human body? In vitro blood tests are fine under Art. 53(c)
Dear Plu,
If it would have been an in-vitro diagnostic method, I would never have commented the decision.
The important aspect of the method is that breath taken from the individual is monitored. The human being is clearly in the loop, i.e. the method is applied to the human or animal body (clearly envisaged in the description).
The evaluation might be made outside the body, but allows for instance to directly differentiate between bacterial and viral infections in real time. If this is not a diagnostic method practiced on the human or animal body, what will then be considered as a diagnostic practiced on the human or animal body?
It is different from a method of measuring blood pressure, where the data has to be interpreted by a physician. The claimed methods allows for instance the early detection of sepsis for intubated patients, cf. § [0050].
The difference between the functional oscillation pattern for the individual and the average functional oscillation pattern for the reference populations determines the severity of the infection, cf. § [0054]. If this is not a diagnostic method practiced on the human or animal body, what will then be considered as a diagnostic practiced on the human or animal body?
The description is full of information/interpretation leading to the necessary conclusion that the whole application is about diagnostic methods practiced on the human or animal body. This is also the reason why I queried in the decision the absence of any reference to G 1/24.
Claim 1 requires “monitoring breath taken from the individual”.
I do not know whether that can be done “in vitro” (for lack of a better word), that is, by somehow storing a sample of each exhalation for later analysis.
But even if that can be done, the claim apparently still encompasses embodiments where the individual has to be physically present. A reference to G 1/24 wouldn’t have hurt indeed.
@ Extraneous attorney,
Even if the monitoring could be done in vitro, like for a blood sample, this possibility has never been envisaged in the description. Rather the contrary is true.
I will quote some revealing § from the description
“[0025] In one embodiment, the methods disclosed herein are used to detect an unhealthy state, such as a disease state or an infected state of an individual. Fighting infections, for example those that are bacterial in origin, requires rapid protein breakdown supply the high energy and raw material requirements (e.g., amino acids) for antibody production and other anti-infection responses…..”
“[0030] Similar to what is observed in infection, trauma, burns and surgery can also affect the disease/health state of a subject, particularly the acute phase of disease, and can result in distinct changes in the isotope ratio amounts…..”
“[0033] In the methods disclosed herein, breath taken from the individual over time is used to measure the relative amount of a first isotope to a second isotope…”
“[0044] One advantage of the methods disclosed herein is that breath isotope data can be taken for shorter periods of time than in the prior methods where only the slope of the changes was measured. In one embodiment, the time period t is less than 2 hours, less than 90 minutes, less than 1 hour, less than 45 minutes, less than 35 minutes, less than 20 minutes, less than 10 minutes, to as little as 5 minutes. Data collection need be done only over a time period that is sufficient to establish the oscillation pattern. While 30 minutes is generally a suitable time period for data collection in humans and mice under normal conditions, the time period can be shortened depending on the stage of infection, the sensitivity and precision of the instrument, the level of established prior data to be used as comparative template, and other factors (e.g., early infection may require a longer sampling period)”.
“[0050] A distinct advantage of the methods disclosed herein is that they can be performed in a continuous manner in a hospitalized patient such as an intubated patient. This is particularly advantageous in the early detection of sepsis.”
“[0051] For confined non-human organisms, or populations of such organisms, regular monitoring could be conducted on a continuous basis. Alternatively, similar principles could be applied with respect to monitoring the health of humans in an apartment building on an overall basis.”
“[0061] Healthy fasted humans were instructed to sit quietly at a desk while wearing a sealed mask. The mask consisted of an industrial volatile organic compound mask with all filters removed and a 14 inch polyethylene tube connecting the mask to the iCO2 analyser. Exhaled air from the mask was mixed with CO₂ free air (Zero Air) so that the final CO2 concentration was approximately 1000ppm. Measurements were collected for at least 1 hour each day. ….”
All those passages show that an individual, human or animal according to the description, is sitting in a loop in which the ratios of isotopes are continuously monitored. We are thus far from any in vitro monitoring.
In spite of the apparently harmless wording, when consulting the description as required by G 1/24, leads necessarily to the conclusion that the claimed method is a diagnostic method practiced on the human or animal body.
The board has apparently limited its “consultation” of the description to § [0025] to [0032], but even some of those are clearly indicating that the method is practised on the human or animal body,
In the US this type of claims is clearly allowable. But it is a different story on this side of the Atlantic.
In view of T 125/02 (23.052006), G 1/04 (16.12.2005) and T 1920/21 (16.01.2024), measurements on exhaled air may or may not be performed on the human body in the sense of Art. 53(c).
@ Plu,
As interesting as the decisions you quote might be, they will not change my views on the decision.
For the surplus, I refer to my reply to Extraneous Attorney.
In T 1920/21, EP 3 009 838, and in its predecessor EP 1 685 851, the 13C content in the CO2 is carried out in samples, which are collected from the patient and is therefore not carried out on the body. The measurement can be held to correspond with an in-vitro analysis.
However, Point IV of the headnote of G 1/04 says the following:
“ Article 52(4) EPC [ now Art 53(c) EPC] does not require a specific type and intensity of interaction with the human or animal body; a preceding step of a technical nature thus satisfies the criterion “practised on the human or animal body” if its performance implies any interaction with the human or animal body, necessitating the presence of the latter.”
In the present application, the isotope content is determined continuously for a given length of time by continuous analysis of exhaled breath. During measurement, the individual “sits in the loop” for a certain length of time necessary to come to a conclusion, and the method is therefore carried out on the human or animal body. This aspect has never been considered by the present board when it quoted G 1/04. And yet the description is very clear about it, see my reply to Extraneous Attorney.
Applicants, especially from the US, should not be allowed to hide behind harmless wording in order to get a patent for a diagnostic method.
Proper “consultation” of the description according to G 1/24, and not a partial one, leads necessarily to the conclusion that the claimed method is a diagnostic method practiced on the human or animal body.
To sum it up, you will need more convincing arguments in order for me to consider that my critics of the decision are unjustified. But I am up to the challenge.
Thanks for the insightful discussion. I’m now more up to speed with the case law on this topic than I was before.
Dear Plu,
I am happy to discuss a topic when there is really something to be discussed, and I really appreciated the present discussion. I am pleased to see that it brought matters forward on your side.
I am not Mr Knowitall, but I have a certain experience in patent matters which I am happy to transmit. This is also why, from time to time, I am consulted and give lectures.