T 2187/10 - Accidental surgical method

T 2187/10

For the decision, click here

• The invention concerns mainly new software to assist with surgery. Applicant had included in a method step the feature "performing the surgical procedure" , which is found to contravene Art.  53(c).
• In addition, the inventive step analysis in this case does not start from a document but from "the prior art acknowledged in the application" (statement in the application of the background of the invention, not referencing an actual prior art document). 
• The decision also provides an example of partial problems, non-technical features and usual design choices.

Summary of Facts and Submissions

I. This is an appeal against the decision, dispatched with reasons on 23 June 2010, to refuse European patent application No. 02 801 707.7 inter alia on the basis that the subject-matter of claim 1 according to the main and first and second auxiliary requests did not involve an inventive step, Article 56 EPC, in view of D1 and that the independent method claim according to the main and first auxiliary requests was not allowable under Article 53(c) EPC, because it set out a method for treatment of the human or animal body by surgery. This document is as follows: D1: EP 0 119 886 A1.

VIII. The claims according to the main request comprise an independent apparatus claim 1 and an independent method claim 15, the latter reading as follows (emphasis by the board):

"A method of implementing a computer-implemented procedure, the method comprising: inserting with a media drive (52) of a computer (10) a one-time-use digital medium (50) containing high level graphics processing software (72) with algorithms for graphics processes that are specific to a selected surgical procedure {p. 8, l. 15-20} wherein the high level graphics processing software interacts with low level graphics processing software (60) to enable the computer (10) to perform image and graphics processing which it may be called on to perform during a surgical procedure {p. 8, l. 21-26}; performing the surgical procedure;
after the procedure, erasing, encrypting or deforming the digital medium against reuse in the computer (10) {p. 3, l. 30-32; p. 9, l. 31-36}."

Reasons for the Decision

3. The main and first auxiliary requests, Article 53 EPC

3.1 According to the reasons for the appealed decision, the independent method claims according to the main and first auxiliary requests were not allowable under Article 53(c) EPC which states that methods for treatment of the human or animal body by surgery were not patentable.

3.2 This has not been disputed by the appellant in the grounds of appeal. For this reason, the board considers that it is not obliged to consider, of its own motion, the substantive merits of the appeal as regards the main request and the auxiliary request on this point. However, it chooses to give its view on the issue nonetheless.

3.3 Under Article 53(c) EPC, European patents shall not be granted in respect of "methods for treatment of the human or animal body by surgery ..., this provision shall not apply to products ... for use in any of these methods". In decision G1/07 (OJ EPO 2011, 134) the Enlarged Board of Appeal upheld the principle confirmed in opinion G1/04 (OJ EPO 2006, 334) that a method claim falls under the prohibition in Article 53(c) EPC inter alia if it comprises at least one feature defining a physical activity or action that constitutes a method step for treatment of a human or animal body by surgery; see Case Law of the BOA of the EPO, 7th edition, I.B.4.3.1.

3.4 In the present case, independent method claims 15 and 16 according to the main and first auxiliary request, respectively, set out the step of "performing the surgical procedure" which, understood in the light of page 1, lines 3 to 5, of the description, which mentions "neurosurgical and orthopedic procedures", is a method step for treatment of a human or animal body by surgery. Hence the board agrees with the finding in the decision that the subject-matter of these claims is unpatentable, Article 53(c) EPC.

4. The second auxiliary request
[Directed to the corresponding apparatus]

4.3 The prior art acknowledged in the application

4.3.1 According to page 1, line 11, to page 3, line 20, it was known in the prior art to use MRI and CT systems to make images of a region of a patient in which surgery was planned and to use software to manipulate these images to yield orthogonal views, slices and perspective renderings which were displayed to provide three-dimensional guidance within the imaged region. The board takes the view that the mention of the use of software implies a computer. The region of the patient was imaged together with anatomical reference markers. At the surgical site, video cameras were used to track the location of surgical tools instrumented with similar markers to determine their location relative to obscured portions of the patient's anatomy. In the board's view, this implies a human-viewable display. As different surgical tools were required for operations on different portions of the human anatomy, the tools were calibrated to the system to establish their dimensions. The surgical tools were reusable. Universal image guided surgery systems were known which were applicable to any portion of the human anatomy and included software for imaging and alignment in virtually any region of the human anatomy. Such systems were prohibitively expensive for most customers.

4.3.2 In terms of claim 1, the acknowledged prior art discloses an apparatus having a human-viewable display and a computer for displaying and manipulating images on the display using high level graphics processing software which interacts with low level graphics processing software to enable the computer to perform image and graphics processing which it may be called on to perform during a surgical procedure, the high level graphics processing software being stored on a digital medium and the computer having an interface which interfaces with cameras of a tracking system.

4.4 Inventive step, Article 56 EPC 1973

4.4.5 In view of these differences, the board considers it more appropriate to start the assessment of inventive step not from D1 but from the prior art acknowledged in the application.

4.4.6 The subject-matter of claim 1 differs from the acknowledged prior art in:

i. the computer including a drive which receives the digital medium;

ii. the high level graphics processing software having algorithms for graphics processes that are specific to a selected surgical procedure;

iii. a means to insure one-time-use of the digital medium, by erasing or encrypting all or part of the digital medium or physically deforming the physical medium, at the end of the surgical procedure;

iv. a disposable kit including the digital medium and

v. the kit also containing tools corresponding to the surgical procedure, the tools being instrumented to be tracked.

4.4.7 The difference features address different problems and their contributions to inventive step will be considered separately.
Regarding difference feature "i", the skilled person would add a drive to a computer as a matter of usual design. In this case, difference features "i" and "iii" limit the graphics processes of the apparatus to one use only. This is an obvious technical solution to a business problem, namely that derivable from page 4, lines 3 to 4, to reduce the capital cost of the apparatus by also charging the user a fee per surgical procedure carried out using the apparatus. This, following the approach in T 641/00 ("COMVIK", OJ EPO 2003, 352), is the aim to be achieved in a non-technical field. The claimed solution to this problem according to difference feature "iii" is known from D1, which discloses the "erasing" approach to ensuring one-time-use of a digital medium. The skilled person, given the above aim to be achieved, would apply the teaching of D1 as a matter of design.

4.4.8 Difference feature "ii" restricts the graphics processes of the apparatus to those which are specific to a selected surgical procedure. This does not solve a technical problem and thus cannot contribute to inventive step.

4.4.9 Difference feature "iv" addresses the packaging of the digital medium, a usual design consideration.

4.4.10 Difference feature "v" is not limited to providing new surgical tools or to the tools being sterilized and thus cannot solve the problems of avoiding the use of blunted tools or assuring the sterility of surgical tools. Moreover the application acknowledges surgical tools which are instrumented to be tracked as per se belonging to the prior art. The bundling of such tools with the software as a kit is seen as solving the business problem of increasing the value of the kit that has to be bought for each surgical procedure, this being an aim to be achieved in a non-technical field (see T 641/00, cited above). As no technical problem is solved by this feature, it cannot contribute to inventive step.

4.4.11 Hence the board finds that the subject-matter of claim 1 does not involve an inventive step, Article 56 EPC 1973, in view of the prior art acknowledged in the application combined with the disclosure of D1.