Control device for examination modalities

Federal Court of Justice

File number	X ZB 22/07
Paragraphs	Section 1, Paragraph 3, No. 3, Paragraph 4 of the Patent Act, Section 1, Paragraph 1 of the Patent Act, Section 4 of the Patent Act, Section 34, Paragraph 4 of the Patent Act, Section 2a, Section 1, No. 2 of the Patent Act (2007), Section 5, paragraph 2, sentence 1 of the Patent Act (1981 )
Keywords	Technicity core theory revelation
cited decisions	BGH logic verification BGH flight cost minimization BGH diving computer BGH search for faulty character strings BGH electronic payment transactions BGH anti-lock braking system EPA T_26 / 86 Koch & Sterzel
Federal Patent Court
File number	17 W (pat) 6/04 (PDF; 61 kB)
Paragraphs	Section 1 Paragraph 3 No. 3, Paragraph 4 PatG
DPMA
File number	DE 101 56 215.2-53
Paragraphs	Section 4 PatG

The decision of the Control Unit for Investigation Modalities of the Federal Court of Justice (BGH) of January 20, 2009 (Az. X ZB 22/07) deals with the patentability of a “method for processing medically relevant data” with the help of an expert system . It discusses the inapplicability of the patent exclusion regulated in Section 1 Paragraph 3 No. 3 and Paragraph 4 of the Patent Act if the claimed method contains instructions which deal with the solution of a specific technical problem with technical means. It confirms the departure from the so-called core theory of patent law. If the specific technical problem solution in this application is the control of the respective examination modality (for example the setting of the image resolution in computer tomographies) compared to the manual setting by the operating personnel, only this technical problem solution is to be taken into account when checking for inventive activity. If this is new and inventive, the patent holder may prohibit any doctor from using the claimed method to diagnose his patient in accordance with Section 9 sentence 2 No. 2 PatG. With regard to the users of the procedure, the Senate asks in the resolution whether the procedure has been sufficiently disclosed.

facts

The German patent application DE 101 56 215.2-53 with the filing date November 15, 2001 relates to a method for processing medically relevant data in the context of an examination to be carried out on a patient, with a program means stored in a data processing device based on inputted symptom-specific and / or diagnosis-specific information using a symptom- and / or diagnosis-based database selects one or more examination modalities to be carried out to examine the patient, which examination modalities are output on a reproduction device.

The examiner of the DPMA rejected the application on October 14, 2003 for lack of inventive step compared to the state of the art

DE 198 09 952 A1 "Method for configuring monitors assigned to medical devices"
US 5,517,405 A "Expert system for providing interactive assistance in solving problems such as health care management"
EP 0 741 361 B1 "Reproduction or display of medical images with configurable text box"

back.

In decision 17 W (pat) 6/04 Expert System of April 17, 2007, the Federal Patent Court introduced the new reason for rejection of the patent exclusion according to Section 1 Paragraph 3 No. 3, Paragraph 4 of the Patent Act, because the claim [instructs] the data processing specialist To create program means that draw conclusions from the information entered according to logical rules using expert knowledge stored in databases (system with artificial intelligence or expert system) and allowed the legal complaint according to Section 100 (2) No. 2 PatG because for Legal evaluation of expert systems, which are designed for an automated making of deliberate intellectual decisions based on stored expert knowledge, there is no case law of the Federal Court of Justice .

The BGH implicitly confirmed the reason for the rejection of the exclusion from patentability for main and auxiliary request 1 - against which the applicant had not lodged a legal complaint - but granted the appeal with regard to auxiliary requests 2 and 3 if, as the Federal Patent Court had confirmed, the claims were procedural contain the solution of a specific technical problem with technical means as the object.

On April 29, 2010, the 17th Senate of the Federal Patent Court rejected the application again.

Summary of the judgment

The BGH again spoke out against the so-called core theory.
The overall consideration of the solution to a specific technical problem beyond data processing is decisive for patenting.
When evaluating this solution, individual technical and non-technical solution features may not be weighted.
The collection, storage, evaluation and use of data are classified as non-technical processes.
For the overall consideration of the solution proposed in the application, in addition to the question of whether finding the solution requires the development of inventive activity, the question of whether this implementation is left to the specialist knowledge of the user (lack of disclosure) must also be addressed.

meaning

With the emphasis on the requirement of solving a specific technical problem and the question of sufficient disclosure, the BGH underlines the principle of protection of solutions (see performance protection ) compared to the protection of entire problem areas .

Claims analysis

The user of the claimed method for processing medically relevant data in the context of an examination to be carried out on a patient is the doctor according to paragraphs 2-4 of the laid-open specification. There were no doubts about the commercial use of the procedure by the doctor in accordance with Section 5 PatG, neither on the part of the Senate nor the examination office. The exclusion from patenting of diagnostic procedures that are carried out on the human body, as stipulated in Section 2a Paragraph 1 No. 2 PatG (at the time of filing, Section 5 Paragraph 2 Sentence 1 PatG), was not discussed.

The explicitly claimed application of the procedure by the doctor according to Section 9 Sentence 2 No. 2 PatG is:

the input of symptom-specific and / or diagnosis-specific information into the program means running on its data processing device.

However, he will also implicitly take note of the information from the reproduction device .

Essential elements for the implementation of the method according to § 10 PatG are the examination modalities and the data processing device with program resources stored therein and a symptom- and / or diagnosis-based database.

Examination modalities and data processing equipment are customary in the trade according to Section 10 (2) PatG.

The program resources stored in the data processing device and the symptom- and / or diagnosis-based database are intended to be used for use in accordance with Section 10 (1) PatG.

As accessories to the examination modalities and the data processing device according to § 97 Paragraph 1 Clause 1 BGB , the components stored in the data processing device are program resources and symptom- and / or diagnosis-based database according to § 93 BGB. The symptom- and / or diagnosis-based database is not viewed by traffic as an accessory to the program ( Section 97 (1) sentence 2 BGB), but as an integral part.

The program resources enjoy protection according to § 69a to § 69g UrhG . The selection of the examination modalities to be carried out for the examination of the patient ("Modality Worklist" in DICOM ) to be carried out with the program means relates to the (already known and yet to be found) medical specialist knowledge ( expert system ) for a according to § 2a Abs. 1 Nr. 2 PatG (to Registration time § 5 Abs. 2 Satz 1 PatG) excluded diagnostic procedure.

The database query and the transmission of the queried information to a data processing and / or control device of a selected examination modality by the program means relates to the data processing, which according to the decision are non-technical processes .

The symptom- and / or diagnosis-based database enjoys protection according to § 87a to § 87e UrhG. It stores examination or measurement protocols ( DICOM Modality Worklist) for the data processing and / or control devices of the examination modalities. According to the Senate's decision, this (standardized) control through the examination or measurement protocols of the Modality Worklist represents the solution to a specific technical problem, which must be checked for inventive activity and sufficient disclosure in combination with all other solution features.

Core theoretical assessment

The assessment under patent law places the understanding of the person skilled in the art who reads the patent application at the time of filing at the center of the assessment. What is revealed to him, based on his specialist knowledge, as a solution to the problem of the application in accordance with Section 34 (4) PatG, is classified as the subject matter of the application according to the International Patent Classification and researched according to Section 43 (1) PatG. Classification and research are based on the single general inventive idea of the application specified in Section 34 (6) PatG, which the skilled person can understand at the time of filing solely from the original application documents. Everything else would be a retrospective consideration that lies outside the original revelation content. During the patent examination, hypothetical areas of protection that would lead to the patent being declared null and void according to Section 22 (1) of the Patent Act are not even examined.

For the examination office of the DPMA, the only general idea was the expert system with a diagnosis-based database, which supports the doctor in the processing of medically relevant data, and this disclosed solution compared to the state of the art according to § 4 PatG was obvious.

The Federal Patent Court, however, did not see this solution as an invention within the meaning of Section 1 (3) No. 3 PatG. The 17th Senate described the technically completely unspecified transfer of the examination and measurement protocols to the data processing and / or control device of the selected examination modalities as a solution to a specific technical problem, although the registration was not classified at all at the time of registration with regard to this point of view , and questioned neither the disclosure of the problem nor the disclosure of the solution, but did not place this problem solution in the foreground of the claimed teaching.

At this point, the BGH took action with regard to this second auxiliary request, called this division of the evaluation of the solution into two separate evaluations as the core theory and demanded that the examination and measurement protocols be transferred to the data processing and / or control device of the selected examination modalities (at the time of registration for the expert) should actually represent a solution to a specific technical problem - and from the user's point of view not just a common technical means such as pen, paper or the computer - this solution must be taken into account and the combination of technical and non-technical or to examine features excluded from patent protection under Section 1 (3) of the Patent Act for sufficient disclosure, novelty and inventive step.

Individual evidence

↑ JurPC web doc. 91/2009

↑ Jürgen Ensthaler: The patent protection of computer programs according to the BGH decision "Control device for examination modalities" . In: GRUR . tape 1 , 2010, p. 1-88 . criticizes: "A core theory ... that its application made criteria for a weighting between technical and non-technical content recognizable ... never existed."

↑ On the question of sufficient disclosure (en: enablement ) see Disclosure_of_the_invention_under_the_European_Patent_Convention .

↑ cf. BGH double axle assembly GRUR. 1980, 166 where the limit to the lack of disclosure has already been reached when the subsequent specialist can only put the teaching into practice with great difficulty and not without previous failures.

↑ cf. BGH BGH Rohrschweißverfahren where a commercially available device that is used to carry out the process is referred to as an essential element of the invention;
Peter Meier-Beck : The case law of the Federal Court of Justice on patent and utility model law in 2007 " . In: GRUR . 2008, p. 1033-1038 ("2nd indirect patent infringement" with further references). Uwe Scharen : The treatment of the (so-called) indirect patent infringement in the case law of the Federal Court of Justice . In: GRUR . 2008, p.
944-948 .
↑ (For the self-creative activity with hardware configuration files see the judgment OLG Hamburg 3 U 120/00 "Faxkarte" , in which the hardware configuration file "EQUILIZE.IN" was denied creative content because the setting parameters are predetermined by the hardware)

↑ on the original disclosure content of an application in detail BGH shopping cart II

↑ different from EPO T_0258 / 03 - 3.5.1 ( memento of the original dated October 2, 2008 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. (PDF; 46 kB) "Hitachi" page 16, with the comparatively broad interpretation of the term invention , that the use of pen and paper already fulfills the necessary technical character @1@ 2

[1] JurPC web doc. 91/2009

[2] Jürgen Ensthaler: The patent protection of computer programs according to the BGH decision "Control device for examination modalities" . In: GRUR . tape 1 , 2010, p. 1-88 . criticizes: "A core theory ... that its application made criteria for a weighting between technical and non-technical content recognizable ... never existed."

[3] On the question of sufficient disclosure (en: enablement ) see Disclosure_of_the_invention_under_the_European_Patent_Convention .

[4] . BGH double axle assembly GRUR. 1980, 166 where the limit to the lack of disclosure has already been reached when the subsequent specialist can only put the teaching into practice with great difficulty and not without previous failures.