T 0434/18 (Primary and secondary samples/ROCHE) 12-01-2021
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MANAGEMENT METHOD AND SYSTEM FOR IMPLEMENTATION, EXECUTION, DATA COLLECTION, AND DATA ANALYSIS OF A STRUCTURED COLLECTION PROCEDURE WHICH RUNS ON A COLLECTION DEVICE
Roche Diabetes Care GmbH
F. Hoffmann-La Roche AG
Claims - clarity (no)
Amendment after summons - cogent reasons (no)
Summary of Facts and Submissions
I. The appeal is against the examining division's decision to refuse the application on the grounds that the main request and auxiliary requests I to VI did not meet the requirements of inter alia Article 84 EPC.
II. With their statement setting out the grounds of appeal, the appellants withdrew auxiliary request VI and filed auxiliary request VII. They requested that the decision be set aside and that a patent be granted on the basis of the main request or auxiliary requests I to V or VII. They requested oral proceedings, argued a substantial procedural violation in the examination proceedings, due to the violation of their right to be heard, and requested that the case be remitted to the examining division.
III. In its preliminary opinion issued in preparation for the oral proceedings, the board disagreed with the clarity objections in the contested decision, but raised, inter alia, other clarity objections of its own motion. The board saw no violation of the appellants' right to be heard or a substantial procedural violation in the examination proceedings which would have required the case to be remitted to the examining division.
IV. In response to the summons to oral proceedings, the appellants filed arguments and maintained all their requests.
V. Oral proceedings were held before the board. At the beginning of the oral proceedings, the appellants withdrew their request for the case to be remitted to the examining division. They also filed auxiliary request VIII.
VI. Claim 1 of the main request reads as follows:
"A method of performing a structured collection protocol by utilizing a collection device comprising a processor, wherein the method comprises:
- collecting one or more sampling sets of biomarker data using the collection device, wherein each sampling set comprises a sufficient plurality of sampling instances recorded over a collection period, wherein each sampling instance comprises a biomarker reading;
- determining compliance with adherence criteria for the sampling instances of the sampling set via the processor, wherein noncompliance with adherence criteria is recorded as an adherence event;
- classifying sampling instances as primary samples or secondary samples via the processor, wherein
o primary samples, which do not have corresponding recorded adherence events, are sampling instances utilized in calculations performed by the processor that yield therapy results for a diabetic person, and
o secondary samples are sampling instances not utilized in calculations performed by the processor that yield therapy results for a diabetic person, unless one or more secondary samples, which do not have corresponding recorded adherence events, are promoted to primary samples; and
- performing via the processor at least one additional task if one or more sampling instances is a primary sample with a corresponding recorded adherence event wherein the one at least additional tasks preferably comprises collecting at least one additional primary sample."
VII. Claim 1 of auxiliary request I differs from claim 1 of the main request in that its last paragraph reads as follows:
"- performing via the processor at least one additional task if one or more sampling instances is a primary sample with a corresponding recorded adherence event wherein the at least one additional task comprises replacing via the processor one or more primary samples with corresponding recorded adherence events with one or more secondary samples if the secondary samples have no corresponding recorded adherence events in particular wherein the replacement of the primary samples is performed automatically via the processor."
VIII. Claim 1 of auxiliary request II differs from claim 1 of auxiliary request I in that its last paragraph reads as follows:
"- performing via the processor at least one additional task if one or more sampling instances is a primary sample with a corresponding recorded adherence event wherein the processor includes algorithms that calculate which additional task should be performed based on the contextual information for the sampling instances, the number of sampling instances, the classification of the sampling instances, or the adherence of the sampling instances."
IX. Claim 1 of auxiliary request III differs from claim 1 of the main request in that the following text was added to the end:
"wherein biomarker data are selected from blood glucose values, interstitial glucose values, or HbA1c values."
X. Claim 1 of auxiliary requests IV and V differs from claim 1 of the main request and auxiliary request III, respectively, in that the following text was added to the end:
"wherein when replacing a primary sample with a secondary sample, the processor requires that the secondary sample comprises the same, substantially identical, partially identical or similar contextual information or metric as the primary sample to be replaced."
XI. Claim 1 of auxiliary request VII differs from claim 1 of the main request in that the last paragraph was replaced with the following text:
"performing via the processor at least one additional task if one or more sampling instances is a primary sample with a corresponding recorded adherence event wherein the at least one additional task comprises replacing via the processor one or more primary samples with corresponding recorded adherence events with one or more secondary samples if the secondary samples have no corresponding recorded adherence events,
wherein biomarker data are selected from glucose values."
XII. Claim 1 of auxiliary request VIII differs from claim 1 of auxiliary request VII in that the classifying step reads as follows:
"classifying sampling instances as primary samples or secondary samples via the processor,
wherein primary samples are sampling instances intended to be utilized in calculations performed by the processor that yield therapy results for a diabetic person and are construed as critical events, which should not be missed when conducting the structured testing protocol; however, they can be replaced with secondary samples,
wherein primary samples, which do not have corresponding recorded adherence events, are sampling instances utilized in the calculations performed by the processor that yield therapy results for the diabetic person, and
wherein secondary samples are non-critical sampling instances not intended to be utilized in calculations performed by the processor that yield therapy results for the diabetic person and are not utilized in calculations performed by the processor that yield therapy results for the diabetic person, unless one or more secondary samples, which do not have corresponding recorded adherence events, are promoted to primary samples; and"
Reasons for the Decision
1. Main request and auxiliary requests I to V and VII
1.1 The method in claim 1 of the main request and auxiliary requests I to V and VII classifies sampling instances of biomarker readings collected from a diabetic person as "primary samples" or "secondary samples"; however, it is entirely unclear what distinguishes a so-called "primary sample" from a so-called "secondary sample" and consequently on the basis of which rule the classification step of the claimed method is to be carried out.
1.2 The claim mentions two aspects of "primary samples" and "secondary samples", but fails to define them clearly and hence to distinguish them from each other.
The first aspect is given by the relative clause "which do not have corresponding recorded adherence events" (wherein "adherence event" means noncompliance with adherence criteria), repeated identically for both primary and secondary samples. The appellants confirmed at the oral proceedings that this is not the definition of primary or secondary samples. Indeed, it follows from the next step ("performing ... an additional task") that there might also be one or more primary samples "with a corresponding recorded adherence event".
The other aspect mentioned is the primary samples being "utilized in calculations performed by the processor that yield therapy results", but the secondary samples being "not utilized in calculations performed by the processor that yield therapy results"; however, since the claim also states that a secondary sample can be "promoted" to a primary sample, it follows that a secondary sample can also end up being "utilized in calculations performed by the processor that yield therapy results". Therefore, a so-called primary sample and a so-called secondary sample are indistinguishable by their nature.
1.3 The appellants cited several passages of the description, in particular paragraph [00250], and referred to different figures of the application, both in their written submissions and at the oral proceedings; however, what is in the description and the drawings but not in the claims cannot remedy the lack of clarity of unclear claims. Such submissions are therefore irrelevant to an objection under Article 84 EPC.
1.4 At the oral proceedings, the appellants presented a use case to illustrate how the terms "primary sample", "secondary sample" and "tertiary sample", which is introduced later, in dependent claim 4, should be understood. An example set of rules for classifying sample instances in an example structured collection protocol was given as follows: primary sample "if there are several bG values on one day in the morning, the first one is used", secondary sample "if a first bG value in the morning turns out not to be a fasting value (> 8h fasting), the next measure bG value in the morning may be used that is a fasting value" and tertiary sample if "taken after 10 am"; however, the board cannot see how such a rule set may be derived from the claim wording. Claim 1 itself does not specify any classification rule. The appellants submitted that since there was a classifying step, it was implicit that there should be classification rules in claim 1. The claim was therefore broad, but not unclear. It was unfair to expect the appellants to specify classification rules in the claim at the level of detail given in the example. It is not the appropriate level of generalisation of a clear classification rule that the board objects to, however, but the utter lack of any such rule. When a rule that is implicitly expected to exist is rendered as unclear as the classification rule in the present case, it is indeed no longer a rule.
1.5 Therefore, claim 1 of the main request and auxiliary requests I to V and VII is unclear (Article 84 EPC).
2. Auxiliary request VIII
2.1 The appellants filed auxiliary request VIII during the oral proceedings before the board.
2.2 According to Article 13(2) RPBA 2020, any amendment to a party's appeal case made after notification of a summons to oral proceedings shall, in principle, not be taken into account unless there are exceptional circumstances, which have been justified with cogent reasons by the party concerned. The underlying principle is that amendments filed at an advanced stage of the appeal proceedings are not to be taken into consideration. This principle is even more valid at the latest stage of the appeal proceedings, namely at oral proceedings.
2.3 The appellants submitted that the board had raised new clarity objections in its preliminary opinion other than those on which the contested decision was based. It was during the course of the discussion at the oral proceedings that the appellants became aware that further defining the terms "primary sample" and "secondary sample" in accordance with paragraph [00250] of the description might address the board's objections.
2.4 The board did not raise its objection of lack of clarity to the terms "primary sample" and "secondary sample" at the oral proceedings, however, but rather in its preliminary opinion (see point 4.2.1 of the preliminary opinion). The relevance of paragraph [00250] to the interpretation of these terms did not only become apparent to the appellants at the oral proceedings, either (see the statement setting out the grounds of appeal, page 9, third paragraph; points 4.2.2 and 4.2.3 of the board's preliminary opinion; the appellants' letter of reply of 28 February 2020, page 5, third paragraph). Therefore, filing auxiliary request VIII at the oral proceedings is not justified with any cogent reasons.
2.5 For these reasons, auxiliary request VIII is not admitted into the proceedings.
3. As none of the requests is allowable, the appeal has to be dismissed.
Order
For these reasons it is decided that:
The appeal is dismissed.