T 2227/11 18-02-2016

1. Admissibility of the appeal

With letter of 13 September 2011, the applicant was inter alia informed that:

the first decision refusing the application dated 11 May 2011 had been cancelled,

the second decision refusing the application dated 28 July 2011 was valid, and

the time limits as mentioned on Form 2019 (ie with respect to Artcile 108 EPC) were calculated from the second decision.

The findings in this letter are, however, incorrect as the first decision could only have been "cancelled" by the examining division by way of an interlocutory revision in accordance with Article 109(1) EPC 1973. However, according to the file no interlocutory revision was decided by the examining division (see also Case Law of the Boards of Appeal of the EPO, 7th edition 2013, III.K.4.1.4).

The second decision dated 28 July 2011 is, therefore, null and void.

Accordingly, contrary to what is stated in this letter, the date of notification of the decision for the purposes of Article 108 EPC remains that of the decision posted on 11 May 2011 and is accordingly 21 May 2011 (cf Rule 126(2) EPC).

However, as the first notice of appeal, the first appeal fee and the statement setting out the grounds of appeal were all received within the prescribed time limits as of 21 May 2011, the appeal is admissible.

2. Internet citations

The appellant disputed that D1 and D2 were prior art under article 54(2) EPC. According to T 1134/06, the fact that an internet disclosure was state of the art under article 54(2) EPC should be proved beyond any reasonable doubt. The facts and evidence had to meet the criteria established by the jurisprudence in respect of prior use, ie, they had to answer the questions when the internet disclosure was made available to the public, what was made available and under which circumstances was it made available. Such evidence was not shown by the examining division.

In the board's judgement, however, the examining division was right to comply with the practice followed at the EPO when citing documents retrieved from the Internet provided in the Notice of the EPO concerning internet citations (OJ EPO 8-9/2009, pages 456-462)) which is of a later date than decision T 1134/06 referred to by the appellant. It is noted that the examining division thereby also acted in accordance with the instructions provided in the Guidelines for Examination in the EPO in force at that time (cf C-IV, 6.2; Version April 2010). In particular, the appropriate standard of proof for internet citations is the balance of probabilities.

The EPO standard of proof is generally the balance of probabilities. By way of exception, the standard of proof of the balance of probabilities is shifted to a standard of proof beyond reasonable doubt mainly in opposition where only one party has access to information eg concerning an alleged public prior use. The difficulty of the other party to gain access to information in support of no such public prior use having taken place, allowing it to counter-argue, has caused the case law to tend in this case toward expecting the public prior use to be proved beyond reasonable doubt (see also Case Law of the Boards of Appeal of the EPO, 7th edition 2013, I.C.2.5).

In the specific case of internet citations of prior art, both the EPO and the parties to the proceedings generally have equal access to the relevant information notably concerning the authenticity of its publication date and content. Accordingly, there is no reason to deviate from the standard of proof of the balance of probabilities.

Indeed, while the board agrees with the detailed reasoning in T 1134/06 that internet citations of prior art entail a number of difficulties in assessing the authenticity of notably the publication date and the content, in its judgement there is no reasons to impose a stricter standard of proof.

It is understood that these difficulties may require some far-going investigations in the matter and the provision of supporting evidence. In the board's view, however, it is not because the matter is more complicated that a stricter standard of proof should be adopted.

The burden of proof generally lies with who affirms. In the specific case of internet citations of prior art cited by the EPO, the burden of proof thus lies with the EPO. If the EPO however is satisfied that, on the balance of probabilities, the internet citations constitutes prior art, it is then up to the party to prove otherwise.

3. Documents D1, D1' and D2

Having regard to the above, it is noted that D2 stems from Datalog International (previous name IBG Immucor), which appears to be the former name of the applicant, and that the Safe Track and IBG Immucor Blood Tracking System referred to in D1 are products of these companies. Accordingly, the applicant's access to information concerning these documents should be unproblematic.

In the decision under appeal, the examining division essentially held that document D1 was a presentation that took place at the IBMS Congress 2001 (September 2001) and that therefore the publication date was the date of the congress. Moreover, document D1', a copy of this report dated 21 November 2001 retrieved from the Internet Archive was provided.

Document D2 was retrieved from the Internet Archive and was dated 5 June 2003.

The examining division held that, on the balance of probabilities, both documents D1 and D2 were prior art under Article 54(2) EPC.

Concerning document D1, the appellant argued that the examining division failed to prove beyond any reasonable doubt that D1 was state of the art under Article 54(2) EPC.

As detailed above, however, a proof beyond any reasonable doubt is not required in the present case. A proof on the balance of probabilities suffices.

The content of documents D1 and D1' is identical, apart from an introductory paragraph not present in D1'. Rather than using document D1' as evidence that the publication date of document D1 lies before the priority date of the application, it is considered expedient to refer directly to document D1'.

The board has no reasons to doubt the authenticity of the content and publication date of document D1', so that the document is considered to form part of the state of the art under Article 54(2) EPC 1973.

Having regard to document D2, the appellant argued that in T 1134/06 it was explicitly stated that images of the Internet Archive (archive.org) were not necessarily instantaneous snapshots of a website but could be assembled in the course of successive crawls and that links could connect to different material than at the time of capture (paragraph bridging pages 6 and 7).

However, as is clear from the article referred to in T 1134/06, these successive crawls are completed in any case in two days (cf Howell B.A., "Proving Web History: How to use the Internet Archive", Journal of Internet Law, February 2006, pages 3 to 9, in particular page 8, left-hand column, third paragraph). This point is thus irrelevant in the present case where the crawl dates of the different pages of D2 lie between February and June 2003 and thus several months before the priority date of the application (19 February 2004).

Moreover, the issue of links being inactive or connecting to different sites of the live web does not arise either in the present case, as each page of D2 has been individually crawled on the indicated dates (between 16.02.2011 and 24.06.2011) and archived.

Accordingly, the board has no reasons to doubt the authenticity of the content and publication date of document D2 either, so that also D2 is considered to form part of the state of the art under Article 54(2) EPC 1973.

4. Main request

4.1 Amendments

Claim 1 according the appellant's main request corresponds to claim 1 as originally filed, with the step of collecting the blood sample omitted.

Claim 1 as amended is considered to comply with Article 123(2) EPC.

4.2 Novelty

4.2.1 According to the decision under appeal, the subject-matter of claim 1 of the main request lacks novelty over both document D1 and D2.

The appellant argued that neither D1 nor D2 disclosed the generation of a blood unit request slip for the patient that comprised patient identification information as claimed in step (e) of claim 1 of the main request. Moreover, a comparison of the patient identification information of the blood unit request slip to the patient identification information comprised on the compatibility label on the blood transfusion unit as provided for in step (f) of claim 1 was neither disclosed in D1 nor in D2. In fact, step (f) of claim 1 was performed at the patient's bedside and added to the safety of the system. In document D2, on the other hand, the step of scanning the patient information from the request form was part of the Blood Track system and was performed remote from the patient's bedside at the blood storage location.

Moreover, whereas D1 and D2 disclosed the employment of a compatibility label, it was not described that this compatibility label comprised both patient identification information and the identifying code with which the blood transfusion unit was marked, as claimed in step (d) of claim 1. Moreover D1 and D2 did not disclose the comparison of this information comprised in the compatibility label with the patent identification information stored in the patients wrist band and the identifying code marked on the blood unit, respectively, as claimed in steps (g) and (h) of claim 1 of the main request.

4.2.2 Document D2

Document D2 is a collection of web pages from a website of Datalog International.

- The first page provides an overview of the system.

- Page 2 provides an overview of a first part of the system named "Blood Track". Pages 3 and 4 relate to respective subsections of page 2.

- Page 5 provides an overview of a second part of the system named "Safe Track". Pages 6 to 8 relate to subsections of page 5.

- Page 9 provides an overview of a further part of the system named "AutoPPI" with pages 10 and 11 relating to subsections of page 9.

Incidentally, it is noted that the application as filed refers to both the Safe Track and Blood Track systems from DataLog International Ltd., www.dataloguk.com (cf description page 3, line 33 to page 4, line 22).

Document D2 discloses, in the terminology of claim 1, a method for tracking blood transfusions, the method comprising the steps of:

(a) obtaining identification information for a patient and providing said patient with a wristband comprising an electronically readable indicia comprising said patient identification information (cf AutoPPI system, pages 9 to 11, in particular page 9, second section, "How does it work" and corresponding page 11);

(b) testing a blood sample from said patient to determine the type of blood required by the patient (cf Safe Track system, pages 5 to 8, in particular page 7, first section, "The Phlebotomy Module: Specimen Labels");

(c) allocating from a supply of blood units a blood transfusion unit for the patient, wherein said blood transfusion unit contains the type of blood required by said patient and wherein said blood transfusion unit is marked with an identifying code (cf Blood Track system, pages 2 to 4, in particular page 4).

Moreover, document D2 discloses the step of:

(d) labelling said allocated blood transfusion unit with a compatibility label, wherein said compatibility label comprises an electronically readable indicia comprising said patient identification information and said identifying code (cf page 5, second section; page 6, section "Safe Track Ensures that Patients Receive the Right Blood"; page 7, section "The Transfusion Module: Right Blood for the Right Patient").

In particular, according to D2 "Using a hand-held device, Safe Track scans in the patient ID (on a wristband), the compatibility label, and the blood bag number on the blood units. By cross-matching these information, Safe Track checks for any discrepancy and warns the caregiver accordingly" (cf page 5, supra). Moreover, "Safe Track matches patient information, compatibility label, and blood bag number before starting the transfusion to ensure the blood unit is right for the patient. This is all done by a hand-held device at the patient's bedside" (cf page 6, supra). Furthermore, according to D2 the following steps are performed:

"2. Scan the patient ID. All patient details are captured from the wristband in one scan. Electronic transcription means no errors!

3. Scan the compatibility label on the blood bag.

4. Scan the donation number on the blood bag.

5. Safe Track will warn the caregiver for any discrepancies" (cf page 7, supra).

In the board's judgement the compatibility label in D2 needs to contain both the patient ID and the blood bag number in order to allow a cross-matching as disclosed in D2 of the patient ID scanned from the wristband, the information scanned from the compatibility label and the blood bag number scanned from the blood unit with the aim to ensure that the right blood is given to the right patient. A different possible set-up is not apparent, so that in the board's judgement it is implicit from document D2 that the compatibility label contains both the patient ID and the blood bag number.

The appellant argued in this respect that in the art the term "compatibility" did not refer to patient ID information, but rather incompatible red cell units, RhD mismatch, etc., as exemplified in document D3 (cf section 3.7.1). Moreover, in document D1', although essentially relating to the same system (Safetrack) as document D2, a compatibility label was provided which apparently contained an ISBT bar code for comparison rather than a blood unit identifying code. As the ISBT code was something fundamentally different, no conclusions could be drawn from D2 on what information exactly was provided on the compatibility label.

It is, however, noted that document D3 does not concern a compatibility label of the type at issue, suitable for electronic cross-matching with patient identification information and blood unit number, and is therefore irrelevant to the understanding of the compatibility label of document D2.

According to document D1', which indeed refers to the same Datalog Safe Track system, "Once the laboratory procedures have been carried out and a unit is required for transfusion then the Transfusion module can be used. This module allows for the accurate matching and dispensing of units and allows for process auditing to occur. Once a unit is ready to be transfused, the user scans their own PDF ID and then the PDF ID of the patient. Then the PDF label on the Compatibility label on the unit is scanned and finally the ISBT bar code is scanned. The system then checks all the relevant data and determines if it all matches" (cf page 1, fifth and fourth paragraphs from the bottom). Contrary to the appellant's argument, the ISBT code is a unique donation code and corresponds to the identifying code on the blood transfusion unit as defined in claim 1. Accordingly, document D1' provides matching of the same information and in fact confirms the above understanding of the information provided on the compatibility label of D2.

Finally, reference is made to document D6, which also relates to the same Datalog Safe Track system, according to which the blood unit is provided with a compatibility label with a barcode containing both the patient ID and the blood unit number (cf page 1202, second bullet point).

Accordingly, the appellant's argument that the skilled person would generally understand the compatibility label of D2 not to include patient ID information is not persuasive.

Furthermore, it follows from the above that document D2 also discloses the steps of:

(g) comparing the patient identification information comprised within the electronically readable indicia on the patient's wristband to the patient identification information comprised within electronically readable indicia on the compatibility label on said patient allocated blood transfusion unit; and

(h) comparing the identifying code marked on the patient allocated blood unit with the identifying code comprised within the electronically readable indicia on the compatibility label on said patient allocated blood transfusion unit.

Moreover, document D2 discloses the step of:

(e) generating a blood unit request slip for the patient, the blood unit request slip comprising an electronically readable indicia comprising said patient identification information (cf page 2, second section; page 3, second section; page 4, point 5).

In particular, according to document D2 "Blood Track records the identification of the user, the type of transport mode used (if applicable) and confirms the patient ID if required" (cf page 2, supra), "To further ensure the right unit is taken for the right patient, you can add an extra step in Blood Track to enter or scan the patient information from the request form" (cf page 3, supra) and "You can configure the system to request for patient information at this point, to confirm the blood unit is the correct one. Just scan the patient information from the request form and Blood Track will check it for you" (cf page 4, supra). The request form specified in D2 is, thus, a blood unit request slip for the patient as defined in claim 1.

The appellant argued that the term "patient information" was not explained in D2. From D2, page 4 one merely learned that patient information could be used to ensure the right unit was taken for the right patient. For this purpose, it was not necessary to have information on the patient ID (as stored on the wristband, cf D2, page 7) but rather on group characteristics (blood group etc., cf D2, page 2, last paragraph).

In the board's judgement, however, it is clear from D2 (cf page 2, supra) that the patient ID is confirmed, and that the reference to patient information on the request form (cf pages 3 and 4, supra) in fact refers to patient identification information.

Finally, regarding step (f) of claim 1, document D2 discloses retrieving the blood transfusion unit and confirming that the blood transfusion unit is the correct one by scanning the patient identification information comprised within said electronically readable indicia on the blood unit request slip (cf page 2, second section; page 3, second section; page 4, point 5).

The appellant argued that according to the application, this step was performed at the patient's bedside and added to the safety of the system, whereas in D2 the step of scanning the patient information from the request form was part of the Blood Track system and performed at the blood storage location.

The board notes, however, that claim 1 does not specify that the step is performed at the patient's bedside. In fact, according to the description of the application, the step of retrieving the blood transfusion unit, verifying the blood transfusion unit's identity and scanning the patient identification information comprised within the electronically readable indicia on the blood unit request slip is done at the refrigerator where the blood transfusion units are stored, and thus remote from the patient's bedside, like in document D2 (cf application, page 12, line 9 to page 14, line 9; page 15, line 1 to page 16, line 2; figures 6, 7A, 7C).

Not disclosed in document D2 is, however, verifying the blood transfusion unit's identity by comparing the patient identification information comprised within said electronically readable indicia on the blood unit request slip to the patient identification information comprised within the electronically readable indicia on the compatibility label on the patient allocated blood transfusion unit.

Document D2 in fact merely discloses that after scanning the patient information, ie the patient identification information (see above), from the request form, the system will check that the blood unit is the correct one for the patient.

Accordingly, the subject-matter of claim 1 is new over document D2 in the sense of Article 54(1) EPC 1973.

4.2.3 The subject-matter of claim 1 is also new over the remaining cited documents.

4.3 Inventive step

Document D2 is considered to provide the closest prior art. As discussed above, document D2 discloses that after scanning the patient identification information from the request form, the system checks that the blood unit is the correct one for the patient, but does not provide any detail on how this check is performed.

Accordingly, the objective problem to be solved relative to document D2 is to provide a suitable check step.

In accordance with D2 at the time of performing this check, the user has on the one hand retrieved a blood transfusion unit from the refrigerator and scanned the data thereon, and on the other hand scanned the patient identification information from the request form. Moreover, in accordance with D2 the blood unit is provided with a compatibility label, which contains the patient identification information as discussed above. In the board's judgement, it would be readily apparent to a person skilled in the art that a straightforward check to ensure the right unit is taken for the right patient would consist of comparing the scanned patient identification information from the request form with the patient identification information available from the compatibility label on the blood unit. In particular, it would be obvious to the skilled person to verify the blood transfusion unit's identity by comparing the patient identification information comprised within the electronically readable indicia on the blood unit request slip to the patient identification information comprised within the electronically readable indicia on the compatibility label on the patient allocated blood transfusion unit, as per claim 1, step (f).

Accordingly, the subject-matter of claim 1 according to the main request, having regard to the state of the art, is obvious to a person skilled in the art and, therefore, lacks an inventive step in the sense of Article 56 EPC 1973.

4.4 The appellant's main request is, therefore, not allowable.

5. First auxiliary request

5.1 Amendments

Claim 1 according to the first auxiliary request corresponds to claim 1 of the main request, with the additional feature of

"(i) providing means for a user to provide or record vital signs of the patient".

The additional feature is based on the original description (cf page 5, lines 4 to 13; page 20, line 34 to page 21, line 31; page 22, line 32 to page 23, line 13 and page 23, lines 27 to 37).

Accordingly, claim 1 as amended complies with Article 123(2) EPC.

5.2 Inventive step

According to document D2, Safe Track provides a printed report recording vital signs (temperature, pulse rate and blood pressure) before and after each transfusion episode (cf page 6, section titled "Safe Track Provides an Audit Trail"). Accordingly, it is already known from document D2 to provide means for a user to provide or record vital signs of the patient, as defined in feature (i).

As for the remaining features of claim 1, the same applies as for claim 1 according to the main request as laid down above.

Accordingly, the subject-matter of claim 1 according to the first auxiliary request also lacks an inventive step in the sense of Article 56 EPC 1973.

5.3 The appellant's first auxiliary request is, therefore, also not allowable.

6. Second auxiliary request

6.1 Amendments

Claim 1 according to the second auxiliary request, having regard to claim 1 of the main request, contains the additional feature of reading the patient's wristband and generating the blood unit request slip with the patient identification information read from the wristband.

The additional features are based on the description as originally filed (cf page 11, lines 13 to 35).

Accordingly, claim 1 as amended complies with Article 123(2) EPC.

6.2 Inventive step

Document D2 does not specify how the blood unit request form is generated and in particular, how the patient identification information is provided on the request form. The gist of D2 is, however, to avoid transcription errors and D2 therefore uses barcodes and scanners. In the board's view it would, thus, be obvious to the skilled person charged with the problem of generating the blood unit request form with the patient identification information on it, to scan the patient identification information. An error free and, thus, obvious choice would be to scan it from the patient's wristband.

The appellant argued that document D2 completely failed to disclose any procedure for generating the request form. In D2, the patient identification information need not be scanned from the wristband but could be entered using a keyboard. Reading the patient's wristband and generating the blood unit request slip with the patient identification information read from the wristband avoided any discrepancies between the wristband and the request slip.

In the board's view, however, since D2 explicitly indicates that the Blood Track system "[...] creates a complete audit of the movements of blood units in real time, without the need for manually recording transactions [...]" and that "the Blood Track computers are equipped with touch screen so you do not need keyboards or mouses to use Blood Track", the skilled person is advised against using a keyboard (cf page 2, "What can Blood Track do for me?"; page 3, "Blood Track is Easy to Use"). Document D2 in fact uses scanning to enter data throughout to avoid errors.

Accordingly, the subject-matter of claim 1 according to the second auxiliary request, having regard to the state of the art, is also obvious to a person skilled in the art and, therefore, lacks an inventive step in the sense of Article 56 EPC 1973.

6.3 The appellant's second auxiliary request is, therefore, not allowable either.