T 2247/11 23-06-2015

Summary of Facts and Submissions

I. The applicant lodged an appeal against the decision of the Examining Division refusing European application No. 03 813 604.0. The Examining Division found the various requests then on file not to fulfil the requirements of Article 123(2) EPC and inventive step in view of the following documents:

D1: EP-A-1 168 249

D2: WO-A-02/058 557.

II. Notice of appeal was filed on 20 July 2011 and the fee for appeal was paid the same day. A statement setting out the grounds of appeal was received on 28 September 2011.

III. The Board summoned the appellant to oral proceedings setting out its provisional opinion in an attached communication dated 24 March 2015.

IV. Oral proceedings were held on 23 June 2015.

The appellant requested that the decision under appeal be set aside and that a patent be granted on the basis of one of:

- the first auxiliary request filed with letter dated 22 May 2015;

- the first "bis" and first "ter" auxiliary requests filed during the oral proceedings;

- the second to fifth auxiliary requests filed with letter dated 22 May 2015.

The main request filed with letter dated 22 May 2015 was withdrawn.

V. Claim 1 of the first auxiliary request reads as follows:

"1. Method far radiographic imaging, comprising a step (d) which consists in introducing, into calculation means (17), first digitized radiological data from signals delivered by means (6) of detection of X-rays and corresponding to pixels of a first image of an ananatomical part comprising an osseous body and scanned, in a first incidence, with a beam of X-rays having an energy spectrum distributed about at least two energies, these first data comprising, for each pixel, coordinates of the pixel in the first image and an absorptiometry value for each of said energies, said absorptiometry values being designed to calculate the bone mineral density of the osseous body, referred to a surface area unit, characterized in that it comprises a step (e) which consists in determining the value of a composite index using, on the one hand, first digitized radiological data, and, on the other hand, a three- dimensional actual model of said osseous body,

and in that said composite index is a combination of at least two parameters which comprise the bone mineral density and a parameter chosen from among:

. a specific parameter of the bone geometry, chosen from among the angle, length, surface and volume of an osseous part,

. a mechanical parameter chosen from the section modulus and moments of inertia of an osseous part, and

. a chemical parameter chosen from the water composition, fat composition and bone composition of an anatomical part comprising said osseous body,

and in that a predicted value for a fracture load is deduced from said composite index."

VI. Claim 1 of the first "bis" auxiliary request reads as follows (amendments to claim 1 of the first auxiliary request are highlighted by the Board):

"1. Method far radiographic imaging, comprising a step (d) which consists in introducing, into calculation means (17), first digitized radiological data from signals delivered by means (6) of detection of X-rays and corresponding to pixels of a first image of an ananatomical part comprising an osseous body and scanned, in a first incidence, with a beam of X-rays having an energy spectrum distributed about at least two energies, these first data comprising, for each pixel, coordinates of the pixel in the first image and an absorptiometry value for each of said energies, said absorptiometry values being designed to calculate the bone mineral density of the osseous body, referred to a surface area unit, characterized in that it comprises a step (e) which consists in determining the value of a composite index using, on the one hand, first digitized radiological data, and, on the other hand, a three- dimensional actual model of said osseous body,

and in that said composite index is a combination of at least two parameters which comprise the bone mineral density and a parameter chosen from among:

. a specific parameter of the bone geometry, chosen from among the angle, length, surface and volume of an osseous part,

. a mechanical parameter chosen from the section modulus and moments of inertia of an osseous part, and

. a chemical parameter chosen from the water composition, fat composition and bone composition of an anatomical part comprising said osseous body,

and in that [deleted: a predicted value for] a fracture risk [deleted: load] is evaluated [deleted: deduced] from said composite index."

VII. Independent claims 1, 17, 22 and 23 of the first "ter" auxiliary request read as follows (in claim 1, amendments to claim 1 of the first auxiliary request are highlighted by the Board):

"1. Method far radiographic imaging, comprising a step (d) which consists in introducing, into calculation means (17), first digitized radiological data from signals delivered by means (6) of detection of X-rays and corresponding to pixels of a first image of an ananatomical part comprising an osseous body and scanned, in a first incidence, with a beam of X-rays having an energy spectrum distributed about at least two energies, these first data comprising, for each pixel, coordinates of the pixel in the first image and an absorptiometry value for each of said energies, said absorptiometry values being designed to calculate the bone mineral density of the osseous body, referred to a surface area unit, characterized in that it comprises a step (e) which consists in determining the value of a composite index using, on the one hand, said first digitized radiological data, and, on the other hand, a three-dimensional actual model of said osseous body, and in that said composite index is a combination of at least two parameters which comprise the bone mineral density and at least a parameter chosen from among:

. a specific parameter of the bone geometry, chosen from among the angle, length, surface and volume of an osseous part,

[deleted: . a mechanical parameter chosen from the section modulus and moments of inertia of an osseous part, and]

[deleted: . a chemical parameter chosen from the water composition, fat composition and bone composition of an anatomical part comprising said osseous body,]

and in that [deleted: a predicted value for] a fracture risk [deleted: load] is evaluated [deleted: deduced] from said composite index."

"17. Device for radiographic imaging, comprising:

- calculation means (17) designed to calculate first digitized radiological data from signals delivered by means (6) of detection of X-rays and corresponding to pixels of a first image of an anatomical part comprising an osseous body and scanned, in a first incidence, with a beam of X-rays having an energy spectrum distributed about at least two energies, these first data comprising, for each pixel, coordinates of the pixel in the first image and an absorptiometry value for each of said energies, said absorptiometry values being designed to calculate the bone mineral density of the osseous body, referred to a surface area unit, and

- storage means for storing at least one three- dimensional actual model of said osseous body, characterized in that the calculation means (17) are also designed to determine the value of a composite index using, on the one hand, said first digitized radiological data, and, on the other hand, at least one three-dimensional actual model of said osseous body, stored in the storage means,

and in that said composite index is a combination of at least two parameters which comprise the bone mineral density and at least a parameter chosen from among:

. a specific parameter of the bone geometry, chosen from among the angle, length, surface and volume of an osseous part,

and in that a fracture risk is evaluated from said composite index."

"22. Computer program for digital processing of radiographic images, this program executing an operation which consists in calculating first radiological data, from signals delivered by X-ray detection means (6) and corresponding to pixels of a first image of an anatomical part comprising an osseous body and scanned, in a first incidence, with a beam of X-rays having an energy spectrum distributed about at least two energies, these first data comprising, for each pixel, coordinates of the pixel in the first image and an absorptiometry value for each of said energies, said absorptiometry values being designed to calculate the bone mineral density of the osseous body, referred to a surface area unit, and being

characterized in that it executes an operation which consists in determining the value of a composite index using, on the one hand, said first digitized radiological data, and, on the other hand, a three-dimensional actual model of said osseous body stored in storage means of a computer,

and in that said composite index is a combination of at least two parameters which comprise the bone mineral density and at least a parameter chosen from among:

. a specific parameter of the bone geometry, chosen from among the angle, length, surface and volume of an osseous part,

and in that a fracture risk is evaluated from said composite index."

"23. Computer program product comprising program code means stored on a support readable by a computer, in order to execute the method according to one of Claims 1 to 16, when said program product is operating on a computer."

Claims 2 to 16 and 18 to 21 are dependent claims.

VIII. The arguments by the appellant relevant for the present decision can be summarised as follows:

- Claim 1 of the first and first "bis" auxiliary requests included a definition of the "composite index" defined in original claim 1 which corresponded to some of the alternatives of original claim 17. The supplementary feature of deducing a fracture load found support on original page 22, lines 7 to 9. There was justification for defining the composite index as a combination of the bone mineral density (BMD) with any of the other parameters in original claim 17 due to the prominence of the bone mineral density as a relevant parameter throughout the application as filed. The introduction of the application on pages 1 and 2, in particular page 2, lines 2 to 12, presented the need to calculate BMD in order to evaluate fracture risks. Moreover, page 13, lines 22 to 24 indicated that the composite index included BMD. Page 21, line 8 to page 22, line 9 presented an example of a composite index comprising a combination of various parameters including BMD. It was explained in the paragraph bridging pages 21 and 22 referring to Figures 8 and 9 of the original application that this index correlated better with the fracture load of a bone than BMD alone.

- Claim 1 of the first "ter" auxiliary request no longer defined the composite index in terms of mechanical or chemical parameters, thereby addressing the objections of added subject-matter.

- The invention claimed in the first "ter" auxiliary request was not rendered obvious by D2, neither alone nor in combination with D1, for the following reasons. The "composite index" as claimed was a single-value index combining two or more different parameters from which fracture risk was evaluated, whilst in D2 fracture risk was evaluated separately for different parameters. It was not disclosed or suggested in D2 to combine a plurality of parameters to obtain a relevant single index to directly assess fracture risk. Moreover, D2 did not disclose or suggest to include BMD in this parameter combination. The composite index was shown in Figure 8 to efficiently and precisely assess fracture risk, in particular with a better correlation than that of BMD alone shown in original Figure 9 (which in the original text is referred to as Figure 7). Also D1 did not disclose to determine a composite index defined as a combination of at least two parameters. In fact, D1 disclosed to calculate clinical indices related to the geometry or to the composition or density of the objects examined.