EP 3 244 850 A2, published as WO 2016/115418 relates to the estimation of regional metabolic rate and blood flows of a subject’s organ, more specifically the brain, during endovascular interventions.
Brief outline of the case
The application was refused by the ED on the basis that the application did not satisfy the requirements of Art 123(2) and 54.
The board confirmed the refusal, and decided that the subject-matter of claim 1 of the request subject to the ED’s decision was not clear, comprised added matter, was new but lacked IS.
The board’s decision
Lack of clarity
In claim 1 of the MR, it is not clear whether the expression “at least a portion of the subject’s brain” in the phrase “to induce temperature changes of a least a portion of the subject’s brain in a sequence…” refers to the same portion as mentioned before in the claim. The same is true for the same expression in the last paragraph of the claim.
It is also not clear whether the expression “and time as a variable” in the phrase “estimate values for at least one hemodynamic characteristic of at least a portion of the subject’s brain based on the plurality of temperature measurements obtained during the perfusion induced temperature changes and time as a variable” refers to discrete time points of individual measurements or to e.g. the duration of specific phases, e.g. wash-in, equilibrium, wash-out cycles.
If a reference to discrete time points of individual measurements is intended, it is not clear in which sense the expression limits the estimation of the haemodynamic characteristics, given that the temperature measurements will inherently in any case take place at certain times.
Added matter
According to the OD’s decision, there is no clear and unambiguous basis for the amendment “[…] and time as a variable” in the original application documents.
According to the proprietor the original description paragraph [0043] refers to “operating parameters”, i.e. variables, which may include “time”.
The board conceded that said paragraph as well as par. [0074] which is also cited by the appellant disclose “time” as a variable at least in some sense.
However, neither cited paragraph nor any other paragraph provides a basis for “time as a variable” to be used for the estimation of haemodynamic characteristics, as required by the claim.
Novelty
For the board, it can be said that the infusate flow rate is varied to induce temperature changes in at least the portion of the subject’s brain, wherein the controller (22) varies the pump (24) to induce temperature changes of at least a portion of the subject’s brain in a sequence that comprises lowering the temperature of the brain by at least one step in temperature to an equilibrium temperature, cf. par. [0164]: “target temperature”, maintaining the equilibrium temperature for a given time, and raising the temperature of the brain to a temperature above the equilibrium temperature, i.e. when infusion is stopped; see par. [0164], last sentence.
It can also be said that this constitutes a “wash-in” and a “wash-out” cycle. It can further be said that this constitutes a sequence of events, and that these events will occur at certain moments according to a manual or an automatic decision, i.e. “sequence and timing instructions” are provided in the system of D1.
The board held that D1 does not disclose or imply a memory device functionally coupled to the controller, the controller operable to store the plurality of measurements of the temperature of the subject’s brain to the controller taken throughout the at least one of the wash-in and wash-out perfusion induced temperature changes in at least a portion of the subject’s brain.
Further, given that T1, T2 and T4 in D1 do not correspond to measurements of the temperature of the subject’s brain, it cannot be said that par. [0171] discloses that the controller is operable to estimate values for a haemodynamic characteristic based on a plurality of temperature measurements of the subject’s brain, as required by claim 1.
Contrary to the ED, the board held that the subject-matter of claim 1 of the MR is novel.
Lack of inventive step
The board noted that a cooling and heating sequence is also used in the system of D1.
For the board, one may, furthermore, reasonably assume that the skilled person will want to estimate haemodynamic characteristics of a subject’s brain and will to this end use temperature measurements of the subject’s brain acquired during the wash-in, equilibrium, wash-out cycles disclosed in D1, i.e. measurements at different moments, cf. “time as a variable”, which need to be stored at least temporarily in a memory device coupled to the controller in order for the controller to estimate said haemodynamic characteristics.
The skilled person will thus arrive at the subject-matter of claim 1 without the need for an IS.
Comments
The case is interesting in that it shows that, by interpreting the claims in the light of the description, in spite of a lack of clarity and of added matter, the board came to the conclusion that the subject-matter of the claim was novel over D1, but lacked IS over the same.
Although G 1/24 was not mentioned once in the decision, the description was manifestly consulted.
G 1/24 has a really started a new era. It allows a decision on N or IS in spite of problems of clarity and added matter in the claim at stake. The present decision is a confirmation of existing, but not so frequently used practices.
It is interesting to note that the board’s provisional opinion under Art 15(1) RPBA was so compelling that the applicant decided not to appear at the OP scheduled by the board at the applicant’s request.
The applicant did the same with respect of the OP scheduled by the ED, by not appearing.
Comments
4 replies on “T 0268/24-A claim lacking clarity, comprising added matter, does not hinder a decision about N and IS”
I’m old enough to remember when EPO Communications would say (mostly of claims written in the USA) that the claim was so lacking in clarity as to render a meaningful patentability search impossible. Hut ab! I used to think: a great response to what in those days passed as good quality claim drafting in the USA.
Then there are other claims that are so close to being clear as to enable a search and opinion on the basis that the cure for the lack of clarity is readily apparent. With such claims, one can address all patentability issues, even in a Communication that includes an objection under Art 84 EPC.
I doubt that any claim is so “clear” that it defeats all the effort of creative lawyers to find an argument that the claim is less than 100% clear. Therefore, whether they like it or not, as a practical matter, to keep the EPO wheels going round, Examiners have to engage with claims that are less than 100% clear.When it comes to the issue of what is “clear” there is no alternative to being pragmatic and taking each case on its unique matrix of fact.
Daniel, your “not so frequently used” observation leaves me a bit puzzled. Do you perhaps contrast the approach in this Decision with the more usual practice, namely to use Art 84 EPC as a short cut, to get a file off one’s desk without having first to address the time-consuming issues that arise under Art 54 and 56?
Max Drei,
With G 1/24, the cases in it is not possible to carry out a meaningful search pursuant to R 63 should be very low. With a full objection under R 63, no grant can be envisaged. A partial search report under R 63 might end up with a limited grant.
I do agree with you that, when it comes to the issue of what is “clear”, there is no alternative to being pragmatic and taking each case on its unique matrix of fact.
My experience shows that only raising an objection under Art 84 will, in general not bring matters forward, and end up with a series of communications and replies. This is what I meant by not frequently used, as it is not helpful.
What is a pragmatic way out of such a string of communications and replies, is to give the claim a given interpretation based on the description, and then raise an objection of lack of N or IS. This is much more efficient, as faced with such an objection, the applicant has to react and bring some explanations within the framework of the original disclosure. this is what the board has done.
Indeed Art 84 can be used as a short cut, to get a file off one’s desk without having first to address the time-consuming issues that arise under Art 54 and 56. I do not have any figure at hand, but the cases in which an application is refused under Art 84 after appeal are relatively small. In such situations, often the objection can be a combined objection under Art 84 and 83. The latter is the case, if it is necessary to bring matter into the disclosure, and then one ends with a problem of added matter.
In French I would say the applicant has the choice between pest and cholera, but the application will eventually be refused.
For what it’s worth, in my personal experience, cases with only Art 84 objections are few and far between.
In the one I most clearly remember, I had the distinct impression that the examiner had raised the objections because they could not find relevant prior art in time, but tried to force me to amend the claims anyway. As the objections were quite unconvincing, I didn’t amend the claims. The resulting exchanges were not really convincing or helpful on either side.
@ Extraneous Attorney
The cases in which Art 84 is determining in a refusal or a revocation are not so frequent.
One classical case is when the claim defines no more than a result to be achieved.
An example I used during training on clarity: “Container for receiving a video cassette lying on one of its sides”. Can you define the container? I can’t.
At least in the case you quote, the examiner could show that in spite of not having found relevant prior art, he did not simply let the file go though directly.