T 1630/09 (Medication delivery system/BAXTER) 17-01-2013

I. The present appeal is against the decision of the examining division to refuse the European patent application no. 02 786 891.8, publication no. EP 1 464 023. The decision was announced during oral proceedings on 18 February 2009 and the written reasons were dispatched on 10 March 2009.

II. The decision under appeal was based on a main request comprising claims 1 to 23 filed with the letter of 5 February 2009 and an auxiliary request comprising claims 1 to 24 filed with the letter of 16 January 2009.

III. According to said decision, the main request was not admitted into the proceedings pursuant to Rules 137(3) and 116(1) EPC on the grounds that it was late filed and not clearly allowable due to the introduction of amendments giving rise to new objections under Article 123(2) EPC.

The subject matter of claim 1 of the auxiliary request was found to lack an inventive step over the disclosure of the following document:

D1: WO 01/88828 A.

IV. Notice of appeal was received at the EPO on 22 April 2009 with the appropriate fee being paid on 23 April 2009. A statement setting out the grounds of appeal was received at the EPO on 17 June 2009. With the statement setting out the grounds of appeal, the appellant filed a new main request and five auxiliary requests.

V. In a communication accompanying a summons to oral proceedings to be held on 17 January 2013, the board gave its preliminary opinion that the appellant's requests were not allowable and, inter alia, made the following observations:

(i) With respect to the main request, the board expressed reservations as to whether the invention according to claim 1 of said request had been disclosed with sufficient clarity and completeness to comply with the requirements of Article 83 EPC 1973.

(ii) The board further expressed reservations as to whether claim 1 of the main request defined all of the essential technical features of the invention in a manner compliant with the requirements of Article 84 EPC 1973.

(iii) With respect to the question of inventive step, the board noted that the appellant had essentially argued to the effect that the invention according to the main request was distinguished over D1 in that it addressed the problem of incorrect medication delivery by verifying that the correct delivery channel of a multi-channel medication delivery device was activated. However, the alleged distinctions over the prior art appeared to rely on features in respect of which the board had reservations concerning compliance with the requirements of Articles 83 and 84 EPC 1973. The board was of the preliminary opinion that a meaningful discussion of the question of inventive step would require the question of compliance with the requirements of Articles 83 and Article 84 EPC 1973 to be resolved in the appellant's favour.

VI. With a letter of reply dated 17 December 2012, the appellant filed a new set of requests comprising a main request and four auxiliary requests. A declaration from Mr James Martucci, one of the inventors designated in the present application, was also submitted.

VII. Oral proceedings were held as scheduled on 17 January 2013. During the oral proceedings the appellant submitted an amended main request to replace the main request on file. The appellant also submitted amendments to pages 3, 3A, 4, 5, 6 and 10 of the description.

VIII. Claim 1 of the main request submitted at oral proceedings reads as follows:

"A medication delivery system (20) for communicating and matching prescribed medication data from a first label (28) on a medication container (26) holding the medication (27) and patient data from a second label (29) on a tag (24) adapted to be worn by a patient, the first label also containing instruction on delivering the medication, and the medication data, medication delivery instruction, and patient data are provided in a machine readable format, the medication delivery system comprising:

(a) a medication delivery device (30) which is adapted to deliver the medication from the medication container to the patient said medication delivery device having a data port (38) for receiving information and multiple delivery channels (33); and

(b) a handheld computing device (22) having means (36) for reading the medication delivery instruction, the prescribed medication data and the patient data in the machine readable format and for comparing the prescribed medication data and the patient data to confirm a match between the data, the handheld computing device having a transmitter (32) for transmitting the medication delivery instruction from the handheld computing device to the medical device and wherein the medical device is adapted to deliver the medication to the patient according to the instruction,

wherein each delivery channel (33) of the medication delivery device has a third label (31) with the information to uniquely identify the channel in the machine readable format, the handheld computing device capable of communicating the information read in the machine readable format from the label (31) to the medication delivery device so that the appropriate channel is activated."

Claim 23 of the main request seeks protection for substantially the same subject-matter in the form of an independent method claim.

IX. The appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of the main request submitted at oral proceedings, or the auxiliary requests 1 to 4, all auxiliary requests filed with the letter dated 17 December 2012.

X. Insofar as they are relevant to the present decision, the written and oral submissions made on behalf of the appellant during the present appeal proceedings, may be summarised as follows:

(i) Concerning the question of sufficiency of disclosure, it was submitted that the application complied with the requirements of Article 83 EPC 1973. In this regard, reference was made to the declaration from Mr James Martucci and the description which this declaration provided in respect of how the skilled person would have been able to put the invention into practice.

(ii) With respect to the main request, it was further submitted that, at the claimed priority date, programmable multi-channel infusion pumps were known per se and that the skilled person would have known how to communicate data read from a label on a pump channel to such a pump such that the pump channel identified by the data on the label was activated.

(iii) Concerning the question of inventive step, it was submitted that the claimed invention was clearly distinguished over the disclosure of D1. In particular, it was submitted that the handheld computing device of claim 1 comprised means for reading clinically relevant data (such as medication delivery instructions, prescribed medication data and patient data) in machine readable format and was further adapted to perform a verification check on the data which had been read and to subsequently transmit the medication delivery instruction to the medical device. The claimed invention further prevented incorrect medication delivery by verifying that the correct delivery channel of a multi-channel medication delivery device was activated.

(iv) Although D1 disclosed embodiments which envisaged the use of a handheld computing device capable of transmitting data to a medical device, it was submitted that the disclosure of D1 in this respect was restricted to a handheld computing device whose functionality was limited to receiving and storing data from a stationary computer and transferring such data to a medical device.

(v) The disclosure of D1 did not include a handheld computing device which comprised means for reading and verifying clinically relevant data in machine readable format. Consequently, it was not capable of being used by a caregiver to capture and verify clinically relevant data and patient data prior to transferring a medication delivery instruction to a medical device.

(vi) Moreover, D1 did not contain any teaching aimed at preventing incorrect medication delivery by verifying that the correct delivery channel of a multi-channel medication delivery device was activated.

(vii) Although the skilled person could arguably have modified the system of D1 so as to arrive at the subject-matter of claim 1 of the main request, there was no discernible motivation for the skilled person to modify the teaching of D1 in the required manner. On this basis, it was submitted that, starting from D1, the subject-matter of claim 1 of the main request could only be arrived at using hindsight.

XI. At the end of the oral proceedings the chair announced the board's decision.