G - patentability CH1 and 2 Flashcards

1
Q
  1. Patentability requirements
A

There are four basic requirements for patentability:

(i)
there must be an “invention”, belonging to any field of technology (see G‑II);

(ii)
the invention must be “susceptible of industrial application” (see G‑III);

(iii)
the invention must be “new” (see G‑IV to VI); and

(iv)
the invention must involve an “inventive step” (see G‑VII).

A technical character is an implicit requisite for the presence of an “invention” within the meaning of Art. 52(1) (requirement (i) above, see G‑II, 1 and 2 for further details).

Furthermore,

Art. 52(1)


the invention must be such that it can be carried out by a person skilled in the art (after proper instruction by the application); this follows from Art. 83. Instances where the invention fails to satisfy this requirement are given in F‑III, 3; and

Art. 83


the invention must relate to a technical field (Rule 42(1)(a) – see F‑II, 4.2), must be concerned with a technical problem (Rule 42(1)(c) – see F‑II, 4.5) and must have technical features in terms of which the matter for which protection is sought can be defined in the claim (Rule 43(1) – see F‑IV, 2.1).

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2
Q
  1. Technical progress, advantageous effect
A

The EPC does not require explicitly or implicitly that an invention, to be patentable, must entail some technical progress or even any useful effect. Nevertheless, an advantageous effect, if any, with respect to the state of the art should be stated in the description (Rule 42(1)(c)), as any such effect is often important in determining “inventive step” (see G‑VII, 5).

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3
Q
  1. General remarks
A

The EPC does not define what is meant by “invention”, but Art. 52(2) contains a non-exhaustive list of “non-inventions”, i.e. subject-matter which is not to be regarded as an invention within the meaning of Art. 52(1). The items on this list are all either abstract (e.g. discoveries or scientific theories) and/or non-technical (e.g. aesthetic creations or presentations of information). In contrast to this, an “invention” within the meaning of Art. 52(1) must have a technical character (see G‑I, 1). It may be in any field of technology.

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4
Q
  1. Examination practice
A

The question of whether there is an invention within the meaning of Art. 52(1) is separate and distinct from the questions of whether it is susceptible of industrial application, is new and involves an inventive step.

The exclusions from patentability under Art. 52(2) play a role in assessing both patent eligibility and inventive step because patent protection is reserved for inventions involving a “technical teaching”, i.e. an instruction addressed to a skilled person as to how to solve a particular technical problem using particular technical means. This twofold assessment is referred to as the “two-hurdle approach” (G 1/19).

The first hurdle, also referred to as the patent eligibility hurdle, requires that the claimed subject-matter as a whole must not fall under the “non-inventions” defined in Art. 52(2) and (3). The exclusion from patentability of the subject-matters and activities referred to in Art. 52(2) is limited by Art. 52(3) to such subject-matters or activities that are claimed “as such”. This limitation is a bar to a broad interpretation of the non-inventions. It implies that one technical feature is sufficient for eligibility: If the claimed subject-matter is directed to or uses technical means, it is an invention within the meaning of Art. 52(1). This assessment is made without reference to the prior art.

The second hurdle is where inventive step is assessed. In addition to technical features, claims may also comprise non-technical features. In this context, the term “non-technical features” refers to features which, on their own, would be considered “non-inventions” under Art. 52(2). Inventive step of claims comprising such a mix of technical and non-technical features is assessed using the COMVIK approach (G‑VII, 5.4). This approach is a special application of the problem-solution approach that involves establishing which features of the invention contribute to its technical character (i.e. contribute to the technical solution of a technical problem by providing a technical effect). A feature may support the presence of an inventive step if and to the extent that it contributes to the technical character of the invention. Whether any feature contributes to the technical character of the invention has to be assessed in the context of the invention as a whole.

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5
Q
  1. List of exclusions
A

The items on the list in Art. 52(2) will now be dealt with in turn, and further examples will be given in order better to clarify the distinction between what is patentable in the sense of not being excluded from patentability under Art. 52(2) and (3) and what is not.

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6
Q

3.1 Discoveries

A

If a new property of a known material or article is found, that is mere discovery and unpatentable because discovery as such has no technical effect and is therefore not an invention within the meaning of Art. 52(1). If, however, that property is put to practical use, then this constitutes an invention which may be patentable. For example, the discovery that a particular known material is able to withstand mechanical shock would not be patentable, but a railway sleeper made from that material could well be patentable. To find a previously unrecognised substance occurring in nature is also mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable. An example of such a case is that of a substance occurring in nature which is found to have an antibiotic effect. In addition, if a microorganism is discovered to exist in nature and to produce an antibiotic, the microorganism itself may also be patentable as one aspect of the invention. Similarly, a gene which is discovered to exist in nature may be patentable if a technical effect is revealed, e.g. its use in making a certain polypeptide or in gene therapy.

For further specific issues concerning biotechnological inventions see G‑II, 5, 5.3 to 5.5, and G‑III, 4.

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7
Q

3.2 Scientific theories

A

These are a more generalised form of discoveries, and the same principle as set out in G‑II, 3.1 applies. For example, the physical theory of semiconductivity would not be patentable. However, new semiconductor devices and processes for manufacturing these may be patentable.

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8
Q

3.3 Mathematical methods

A

Mathematical methods play an important role in the solution of technical problems in all fields of technology. However, they are excluded from patentability under Art. 52(2)(a) when claimed as such (Art. 52(3)).

The exclusion applies if a claim is directed to a purely abstract mathematical method and the claim does not require any technical means. For instance, a method for performing a Fast Fourier Transform on abstract data which does not specify the use of any technical means is a mathematical method as such. A purely abstract mathematical object or concept, e.g. a particular type of geometric object or of graph with nodes and edges, is not a method but is nevertheless not an invention within the meaning of Art. 52(1) because it lacks a technical character.

If a claim is directed either to a method involving the use of technical means (e.g. a computer) or to a device, its subject-matter has a technical character as a whole and is thus not excluded from patentability under Art. 52(2) and (3).

Merely specifying the technical nature of the data or parameters of the mathematical method may not be sufficient on its own to define an invention within the meaning of Art. 52(1). Even if the resulting method would not be considered a purely abstract mathematical method as such within the meaning of Art. 52(2)(a) and (3), it may still fall under the excluded category of methods for performing mental acts as such if no use of technical means is implied (Art. 52(2)(c) and (3); see G‑II, 3.5.1).

Once it is established that the claimed subject-matter as a whole is not excluded from patentability under Art. 52(2) and (3) and is thus an invention within the meaning of Art. 52(1), it is examined in respect of the other requirements of patentability, in particular novelty and inventive step (G‑I, 1).

For the assessment of inventive step, all features which contribute to the technical character of the invention must be taken into account (G‑VII, 5.4). When the claimed invention is based on a mathematical method, it is assessed whether the mathematical method contributes to the technical character of the invention.

A mathematical method may contribute to the technical character of an invention, i.e. contribute to producing a technical effect that serves a technical purpose, by its application to a field of technology and/or by being adapted to a specific technical implementation (T 2330/13). The criteria for assessing these two situations are explained below.

Technical applications

When assessing the contribution made by a mathematical method to the technical character of an invention, it must be taken into account whether the method, in the context of the invention, produces a technical effect serving a technical purpose.

Examples of technical contributions of a mathematical method are:


controlling a specific technical system or process, e.g. an X-ray apparatus or a steel cooling process;


determining from measurements a required number of passes of a compaction machine to achieve a desired material density;


digital audio, image or video enhancement or analysis, e.g. de-noising, detecting persons in a digital image, estimating the quality of a transmitted digital audio signal;


separation of sources in speech signals; speech recognition, e.g. mapping a speech input to a text output;


encoding data for reliable and/or efficient transmission or storage (and corresponding decoding), e.g. error-correction coding of data for transmission over a noisy channel, compression of audio, image, video or sensor data;


encrypting/decrypting or signing electronic communications; generating keys in an RSA cryptographic system;


optimising load distribution in a computer network;


determining the energy expenditure of a subject by processing data obtained from physiological sensors; deriving the body temperature of a subject from data obtained from an ear temperature detector;


providing a genotype estimate based on an analysis of DNA samples, as well as providing a confidence interval for this estimate so as to quantify its reliability;


providing a medical diagnosis by an automated system processing physiological measurements.

A generic purpose such as “controlling a technical system” is not sufficient to confer a technical character to the mathematical method. The technical purpose must be a specific one.

Furthermore, the mere fact that a mathematical method may serve a technical purpose is not sufficient, either. The claim is to be functionally limited to the technical purpose, either explicitly or implicitly. This can be achieved by establishing a sufficient link between the technical purpose and the mathematical method steps, for example, by specifying how the input and the output of the sequence of mathematical steps relate to the technical purpose so that the mathematical method is causally linked to a technical effect.

Defining the nature of the data input to a mathematical method does not necessarily imply that the mathematical method contributes to the technical character of the invention (T 2035/11, T 1029/06, T 1161/04).

If steps of a mathematical method are used to derive or predict the physical state of an existing real object from measurements of physical properties, as in the case of indirect measurements, those steps make a technical contribution regardless of what use is made of the results.

Technical implementations

A mathematical method may also contribute to the technical character of the invention independently of any technical application when the claim is directed to a specific technical implementation of the mathematical method and the mathematical method is particularly adapted for that implementation in that its design is motivated by technical considerations of the internal functioning of the computer system or network (T 1358/09, G 1/19). This may happen if the mathematical method is designed to exploit particular technical properties of the technical system on which it is implemented to bring about a technical effect such as efficient use of computer storage capacity or network bandwidth. For instance, the adaptation of a polynomial reduction algorithm to exploit wordsize shifts matched to the word size of the computer hardware is based on such technical considerations and can contribute to producing the technical effect of an efficient hardware implementation of said algorithm. Another example is assigning the execution of data-intensive training steps of a machine-learning algorithm to a graphical processing unit (GPU) and preparatory steps to a standard central processing unit (CPU) to take advantage of the parallel architecture of the computing platform. The claim should be directed to the implementation of the steps on the GPU and CPU for this mathematical method to contribute to the technical character.

Computational efficiency

If the mathematical method does not serve a technical purpose and the claimed technical implementation does not go beyond a generic technical implementation, the mathematical method does not contribute to the technical character of the invention. In such a case, it is not sufficient that the mathematical method is algorithmically more efficient than prior-art mathematical methods to establish a technical effect (see also G‑II, 3.6).

However, if it is established that the mathematical method produces a technical effect due to having been applied to a field of technology and/or adapted to a specific technical implementation, the computational efficiency of the steps affecting that established technical effect is to be taken into account when assessing inventive step. See G‑II, 3.6.4 for examples where an improvement in computational efficiency qualifies as a technical effect.

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9
Q

3.3.1 Artificial intelligence and machine learning

A

Artificial intelligence and machine learning are based on computational models and algorithms for classification, clustering, regression and dimensionality reduction, such as neural networks, genetic algorithms, support vector machines, k-means, kernel regression and discriminant analysis. Such computational models and algorithms are per se of an abstract mathematical nature, irrespective of whether they can be “trained” based on training data. Hence, the guidance provided in G‑II, 3.3 generally applies also to such computational models and algorithms.

Terms such as “support vector machine”, “reasoning engine” or “neural network” may, depending on the context, merely refer to abstract models or algorithms and thus do not, on their own, necessarily imply the use of a technical means. This has to be taken into account when examining whether the claimed subject-matter has a technical character as a whole (Art. 52(1), (2) and (3)).

Artificial intelligence and machine learning find applications in various fields of technology. For example, the use of a neural network in a heart monitoring apparatus for the purpose of identifying irregular heartbeats makes a technical contribution. The classification of digital images, videos, audio or speech signals based on low-level features (e.g. edges or pixel attributes for images) are further typical technical applications of classification algorithms. Further examples of technical purposes for which artificial intelligence and machine learning could be used may be found in the list under G‑II, 3.3.

Classifying text documents solely in respect of their textual content is however not regarded to be per se a technical purpose but a linguistic one (T 1358/09). Classifying abstract data records or even “telecommunication network data records” without any indication of a technical use being made of the resulting classification is also not per se a technical purpose, even if the classification algorithm may be considered to have valuable mathematical properties such as robustness (T 1784/06).

Where a classification method serves a technical purpose, the steps of generating the training set and training the classifier may also contribute to the technical character of the invention if they support achieving that technical purpose.

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10
Q

3.3.2 Simulation, design or modelling

A

Claims directed to methods of simulation, design or modelling typically comprise features which fall under the category of mathematical methods or of methods for performing mental acts. Hence, the claimed subject-matter as a whole may fall under the exclusions from patentability mentioned under Art. 52(2)(a)(c) and (3) (see G‑II, 3.3 and 3.5.1).

The methods considered in this section, however, are at least partially computer-implemented so that the claimed subject-matter as a whole is not excluded from patentability.

Computer-implemented methods of simulating, designing or modelling should be examined according to the same criteria as any other computer-implemented inventions (G‑VII, 5.4, G 1/19).

For establishing the presence of a technical effect, it is not decisive whether the simulated system or process is technical or whether the simulation reflects technical principles underlying the simulated system and how accurately it does so.

Simulations interacting with the external physical reality

Computer-implemented simulations that comprise features representing an interaction with an external physical reality at the level of their input or output may provide a technical effect related to this interaction. A computer-implemented simulation that uses measurements as input may form part of an indirect measurement method that calculates or predicts the physical state of an existing real object and thus make a technical contribution regardless of what use is made of the results.

Purely numerical simulations

A computer-implemented simulation without an input or output having a direct link with physical reality may still solve a technical problem. In such a “purely numerical” simulation, the underlying models and algorithms may contribute to the technical character of the invention by their adaptation to a specific technical implementation or by an intended technical use of the data resulting from the simulation.

Models and algorithms that do not make a contribution to the technical character of the invention form constraints that may be included in the formulation of the objective technical problem when following the COMVIK approach outlined in G‑VII, 5.4.

Specific technical implementation of a numerical simulation

The technical contribution that may be made by a model or algorithm because of their adaptation to the internal functioning of the computer system or network on which they are implemented is assessed in the same manner as adaptations of mathematical methods to specific technical implementations, see G‑II, 3.3.

Intended technical use of the calculated numerical output data of a numerical simulation

Calculated numerical data reflecting the physical state or behaviour of a system or process existing only as a model in a computer usually cannot contribute to the technical character of the invention, even if it reflects the behaviour of the real system or process adequately.

Calculated numerical data may have a “potential technical effect”, which is the technical effect that will be produced when the data is used according to an intended technical use. Such a potential technical effect may only be considered in the assessment of inventive step if the intended technical use is either explicitly or implicitly specified in the claim.

If the data resulting from a numerical simulation is specifically adapted for an intended technical use, e.g. it is control data for a technical device, a potential technical effect of the data can be considered “implied” by the claim. The specific adaptation implies that the claim does not encompass other non-technical uses because the intended technical use is then inherent to the claimed subject-matter over substantially the whole scope of the claim (see also G‑II, 3.6.3). On the other hand, if the claim also encompasses non-technical uses of the simulation results (such as gaining scientific knowledge about a technical or natural system), the potential technical effect is not achieved over substantially the whole scope of the claim and therefore cannot be relied on in the assessment of inventive step.

Accuracy

Whether a simulation contributes to the technical character of the claimed subject-matter does not depend on the quality of the underlying model or the degree to which the simulation represents reality.

However, the accuracy of a simulation is a factor that may have an influence on an already established technical effect going beyond the mere implementation of the simulation on a computer. It may be that an alleged improvement is not achieved if the simulation is not accurate enough for its intended technical use. This may be taken into account in the formulation of the objective technical problem (Art. 56) or in the assessment of sufficiency of disclosure (Art. 83), see F‑III, 12. Conversely, a technical effect may still be achieved by a method where certain simulation parameters are inaccurate but sufficient for its intended technical use.

Design processes

The aforementioned principles apply equally if a computer-implemented simulation is claimed as part of a design process.

If a computer-implemented method results merely in an abstract model of a product, system or process, e.g. a set of equations, this per se is not considered to be a technical effect, even if the modelled product, system or process is technical (T 49/99, T 42/09). For example, a logical data model for a family of product configurations has no inherent technical character, and a method merely specifying how to proceed to arrive at such a logical data model would not make a technical contribution beyond its computer-implementation. Likewise, a method merely specifying how to describe a multi-processor system in a graphical modelling environment does not make a technical contribution beyond its computer-implementation. Reference is made to G‑II, 3.6.2 related to information modelling as an intellectual activity.

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11
Q

3.4 Aesthetic creations

A

Subject-matter relating to aesthetic creations will usually have both technical aspects, e.g. a “substrate” such as a canvas or a cloth, and aesthetic aspects, the appreciation of which is essentially subjective, e.g. the form of the image on the canvas or the pattern on the cloth. If technical aspects are present in such an aesthetic creation, it is not an aesthetic creation “as such” and it is not excluded from patentability.

A feature which might not reveal a technical aspect when taken by itself could have a technical character if it brings about a technical effect. For example, the pattern of a tyre tread may actually be a further technical feature of the tyre if, for example, it provides improved channelling of water. On the contrary, this would not be the case when a particular colour of the sidewall of the tyre serves only an aesthetic purpose.

The aesthetic effect itself is not patentable, neither in a product nor in a process claim.

For example, features relating solely to the aesthetic or artistic effect of the information content of a book, or to its layout or letter font, would not be considered as technical features. Nor would features such as the aesthetic effect of the subject of a painting or the arrangement of its colours or its artistic (e.g. Impressionist) style be technical. Nevertheless, if an aesthetic effect is obtained by a technical structure or other technical means, although the aesthetic effect itself is not of a technical character, the means of obtaining it may be. For example, a fabric may be provided with an attractive appearance by means of a layered structure not previously used for this purpose, in which case a fabric incorporating such structure might be patentable.

Similarly, a book defined by a technical feature of the binding or pasting of the back is not excluded from patentability under Art. 52(2) and (3), even though it has an aesthetic effect too. A painting defined by the kind of cloth, or by the dyes or binders used, is likewise not excluded.

A technical process, even if it is used to produce an aesthetic creation (such as a cut diamond), is nevertheless a technical process which is not excluded from patentability. Similarly, a printing technique for a book resulting in a particular layout with aesthetic effect is not excluded, and nor is the book as a product of that process. Again, a substance or composition defined by technical features serving to produce a special effect with regard to scent or flavour, e.g. to maintain a scent or flavour for a prolonged period or to accentuate it, is not excluded.

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12
Q

3.5 Schemes, rules and methods for performing mental acts, playing games or doing business

A
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13
Q

3.5.1 Schemes, rules and methods for performing mental acts

A

The exclusion from patentability of schemes, rules and methods for performing mental acts under Art. 52(2)(c) concerns instructions to the human mind on how to conduct cognitive, conceptual or intellectual processes, for instance how to learn a language. The exclusion applies only when such schemes, rules and methods are claimed as such (Art. 52(3)).

If a method claim encompasses a purely mental realisation of all method steps, it falls under the category of methods for performing mental acts as such (Art. 52(2)(c) and (3)). This applies regardless of whether the claim encompasses also technical embodiments and of whether the method is based on technical considerations (T 914/02, T 471/05, G 3/08).

An example is a claim defining a method for designing an arrangement for loading nuclear reactor fuel bundles into a reactor core in order to maximise the amount of energy that is generated before the reactor fuel needs to be refreshed. The method involves determining optimal values for specific technical parameters of the arrangement by starting with initial values, performing simulations based on these values, and iteratively changing the values based on simulation results until a stopping criterion is met. Such a method is based on technical considerations related to the technical field of nuclear reactors. However, as long as the claim does not exclude that all method steps may be carried out mentally, the claimed subject-matter is excluded from patentability. This objection also applies when the simulation involves real world values obtained by a technical measurement, if the claim does not include either a step of carrying out the technical measurement or a step of receiving the measured real world values using technical means.

In general, the complexity of a method cannot disqualify it as a method for performing mental acts as such. If technical means (e.g. a computer) are necessary to carry out the method, they are included in the claim as an essential feature (Art. 84, F‑IV, 4.5). See also G‑II, 3.3 for aspects related to algorithmic efficiency.

A claimed method is not a method for performing mental acts as such if it requires the use of technical means (e.g. a computer, a measuring device, etc.) to carry out at least one of its steps or if it provides a physical entity as the resulting product (e.g. if it is a method of manufacturing a product comprising steps of designing the product and a step of manufacturing the product so designed).

Once it is established that the claimed method as a whole is not excluded from patentability under Art. 52(2) and (3), it is examined in respect of the other requirements of patentability, in particular novelty and inventive step (G‑I, 1).

Where a claim defining a method for performing mental acts as such is limited by specifying that the method is carried out by a computer, not only the use of a computer but also the steps carried out by the computer themselves may make a technical contribution if they then contribute to a technical effect. The presence of technical considerations, such as those related to the technical field of nuclear reactors in the example above, is not in itself sufficient to acknowledge the presence of a technical effect (G 1/19).

A method comprising steps which involve the use of technical means may also specify steps which are to be carried out mentally by the user of the method. These mental steps contribute to the technical character of the method only if, in the context of the invention, they contribute to producing a technical effect serving a technical purpose.

For example, a method may specify steps which result in the selection of a product among a family of products based on various criteria, as well as a step of manufacturing the selected product. If said selection steps are carried out mentally, they contribute to the technical character of the method only to the extent that a technical effect can be derived from the features characterising the sub-family of selected products over the generic family of suitable products (T 619/02). If the selection steps rely on purely aesthetic criteria, they result in a non-technical selection and thus do not contribute to the technical character of the method. As another example, in a method of affixing a driver to a Coriolis mass flowmeter, steps specifying how to select the position of the driver so as to maximise the performance of the flowmeter make a technical contribution to the extent that they define that particular position (T 1063/05).

For additional information about methods of simulation, design and modelling, see G‑II, 3.3.2. For methods of information modelling and the activity of programming a computer, see G‑II, 3.6.2.

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14
Q

3.5.2 Schemes, rules and methods for playing games

A

Under Art. 52(2)(c) and (3), schemes, rules and methods for playing games are excluded from patentability, if claimed as such. The exclusion applies to rules for traditional games such as card or board games, as well as to game rules that underlie contemporary forms of gameplay such as in gambling machines or video games.

Game rules define a conceptual framework of conventions and conditions that govern player conduct and how a game evolves in response to decisions and actions by the players. They comprise the setup of the game, options that arise as gameplay unfolds, as well as goals defining progress in the game. They are normally perceived (or even agreed to) by the players as rules serving the explicit purpose of playing the game. Game rules are hence of an abstract, purely mental nature and are meaningful only in the gaming context (T 336/07). For example, a condition requiring two randomly drawn numbers to match for winning is a game rule.

Contemporary games, and in particular video games, are often characterised by complex interactive and narrative elements of a virtual game world. Such game elements govern how the game proceeds of its own accord (e.g. evolving characters and storylines) as well as how it proceeds in interaction with the player(s) (e.g. tapping along with the game soundtrack to make your character dance if rhythms match). Given that these elements are conceptual in nature, they qualify, in a wider sense, as rules for playing games according to Art. 52(2)(c) (T 12/08). This holds true irrespective of the fact that they might be untold or revealed only while playing.

If the claimed subject-matter specifies technical means for implementing game rules, it has a technical character. For example, when implementing the aforementioned condition of matching random numbers, the use of a computer calculating a pseudo-random sequence or of mechanical means such as cubic dice or uniformly sectored reels is sufficient to overcome an objection under Art. 52(2)(c) and (3).

Inventive step of a claim comprising a mix of game rules and technical features is examined in accordance with the problem-solution approach for mixed-type inventions as set out under G‑VII, 5.4. As a principle, inventive step cannot be established by the game rules themselves, irrespective of how original they may be, or by their mere automation. It must rather be based on further technical effects of a technical implementation of the game, i.e. technical effects that go beyond those already inherent to the rules. For example, a networked implementation of a game of chance like bingo, in which numbers physically drawn by an operator undergo a random mapping prior to transmission to remote players, makes a technical contribution since the scrambling of results has the technical effect of securing a data transmission, analogous to encryption, while having no bearing on the actual playing of the game. In contrast, a reduction of memory, network, or computational resources achieved by limiting the complexity of a game does not overcome a technical constraint by a technical solution. Rather than solving the technical problem of improving the efficiency of an implementation, such a limitation would at best circumvent it (G‑VII, 5.4.1). Similarly, the commercial success of a game product resulting from simplified rules is an incidental effect without a direct technical cause.

Inventive step of an implementation is to be assessed from the point of view of the skilled person, typically an engineer or a game programmer, who is tasked with implementing game rules as set by a game designer. Mere claim drafting exercises such as paraphrasing non-technical game elements (“win computation means” for monitoring the number of game tokens) or abstracting them (“objects” instead of “game tokens”) using terms that are technical only on the surface have no bearing on inventive step.

Game rules often are designed to entertain and keep the interest of players by way of psychological effects such as amusement, suspense, or surprise. Such effects do not qualify as technical effects. Similarly, giving rise to a balanced, fair or otherwise rewarding gameplay are psychological effects, not technical ones. Hence, rules and corresponding computations which determine a game score or a skill rating for players, even if computationally complex, are usually considered non-technical.

Highly interactive gameplay such as in video games involves technical means for sensing user input, updating the game state and outputting visual, audio or haptic information. Features defining such presentations of information and user interfaces are assessed according to G‑II, 3.7 and 3.7.1. Cognitive content that informs the player about the current game state at a non-technical level, e.g. about a game score, the arrangement and suits of playing cards, the state and attributes of a game character is regarded as non-technical information. This equally holds for instructions presented on game boards or cards such as “go back to square one”. An example of a technical context in which the manner of presenting information can make a technical contribution is the interactive control of real-time manoeuvres in a game world, the display of which is subject to conflicting technical requirements (T 928/03).

Aside from rules, the state of a game world may also evolve in accordance with numerical data and equations that model physical principles or pseudo-physical behaviour, especially in video games. The systematic calculation of updates to such game states amounts to a computer-implemented simulation based on these models (G 1/19). For the purpose of assessing inventive step in this context, the models are to be understood as defining a given constraint for a corresponding implementation on a computer (G‑VII, 5.4). In contrast to effects that reside within the virtual game world or are otherwise inherent to the model already, a specific implementation of a simulation, if adapted to the internal functioning of a computer system, produces a technical effect. For instance, merely predicting the virtual trajectory of a billiard ball shot by the player, even if highly accurate, fails to solve a technical problem beyond its implementation. In contrast, adjusting the step sizes used in the distributed simulation of bullets fired in a multi-player online game based on current network latencies produces a technical effect.

Features which specify how to provide user input normally make a technical contribution (G‑II, 3.7.1). However, a mapping of parameters obtained from known input mechanisms to parameters of a computer game qualifies as a game rule in a wider sense if it reflects the choice of the game designer, set for the purpose of defining the game or making it more interesting or challenging (e.g. a condition specifying that a slide gesture on a touchscreen determines both the power and the spin of a virtual golf shot).

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3.5.3 Schemes, rules and methods for doing business

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Subject-matter or activities which are of a financial, commercial, administrative or organisational nature fall within the scope of schemes, rules and methods for doing business, which are as such excluded from patentability under Art. 52(2)(c) and (3). In the rest of this section, any such subject-matter or activities will be subsumed under the term “business method”.

Financial activities typically include banking, billing or accounting. Marketing, advertising, licensing, management of rights and contractual agreements, as well as activities involving legal considerations, are of a commercial or administrative nature. Personnel management, designing a workflow for a business process or communicating postings to a target user community based on location information are examples of organisational rules. Other activities typical of doing business concern operational research, planning, forecasting and optimisations in business environments, including logistics and scheduling of tasks. These activities involve collecting information, setting goals, and using mathematical and statistical methods to evaluate the information for the purpose of facilitating managerial decision-making.

If the claimed subject-matter specifies technical means, such as computers, computer networks or other programmable apparatus, for executing at least some steps of a business method, it is not limited to excluded subject-matter as such and thus not excluded from patentability under Art. 52(2)(c) and (3).

However, the mere possibility of using technical means is not sufficient to avoid exclusion, even if the description discloses a technical embodiment (T 388/04, T 306/04, T 619/02). Terms like “system” or “means” are to be looked at carefully, because a “system” might e.g. refer to a financial organisation and “means” to organisational units if it cannot be inferred from the context that these terms refer exclusively to technical entities (T 154/04).

Once it is established that the claimed subject-matter as a whole is not excluded from patentability under Art. 52(2) and (3), it is examined with respect to novelty and inventive step (G‑I, 1). The examination of inventive step requires an assessment of which features contribute to the technical character of the invention (G‑VII, 5.4).

Where the claim specifies a technical implementation of a business method, the features which contribute to the technical character of the claim are in most cases limited to those specifying the particular technical implementation.

Features which are the result of technical implementation choices and not part of the business method contribute to the technical character and thus have to be duly taken into account. This is illustrated with the following example: The claim defines a computerised networked system which allows customers to obtain audio-visual content about selected products using computers installed at each sales outlet of a company, all connected to a central server with a central database storing the audio-visual content as electronic files. The distribution of the electronic files from the central server to the sales outlets could be technically implemented either by enabling download of individual files directly from the central database to the computer on request of a customer or, alternatively, by transferring a plurality of selected electronic files to each sales outlet, storing these files in a local database of the sales outlet and retrieving the corresponding file from the local database when audio-visual content is requested by a customer at the sales outlet. Choosing one implementation among these two options lies within the competence of a technically skilled person, such as a software engineer, as opposed to, for example, specifying that the set of audio-visual contents offered is different for each sales outlet, which would typically be within the competence of a business expert. Features of the claim specifying any of these two possible technical implementations contribute to the technical character of the invention, whereas features specifying the business method do not.

In the case of claims directed to a technical implementation of a business method, a modification to the underlying business method aimed at circumventing a technical problem, rather than addressing this problem in an inherently technical way, is not considered to make a technical contribution over the prior art. In the context of an automation of a business method, effects which are inherent in the business method do not qualify as technical effects (G‑VII, 5.4.1).

For instance, an automated accounting method that avoids redundant bookkeeping may be considered to require fewer computer resources in terms of computer workload and storage requirements. These advantages, in so far as they result from a reduction of the number of operations to be performed and the amount of data to be considered due to the business specification of the accounting method, are inherent to the accounting method itself and hence do not qualify as technical effects.

Another example is based on an electronic auction that is performed by successively lowering the price until the price is fixed by the remote participant who first transmits a message. Since messages may be received out of order due to possible transmission delays, each message contains timestamp information. Changing the auction rules to obviate the need for timestamp information amounts to circumventing the technical problem of transmission delays rather than solving it with technical means (T 258/03). As a further example, in a method for carrying out electronic financial transactions with credit cards at a point of sale, the administrative decision to dispense with the need to obtain the name or address of the buyer to authorise the transaction may result in saving time and reducing data traffic. However, this measure, on its own, is not a technical solution to the technical problem of the bandwidth bottleneck of communication lines and the limited capacity of server computers, but an administrative measure which does not contribute to the technical character of the claimed subject-matter.

The mere fact that the input to a business method is real-world data is not sufficient for the business method to contribute to the technical character of the claimed subject-matter, even if the data relate to physical parameters (e.g. geographic distances between sales outlets) (T 154/04, T 1147/05, T 1029/06). See also G‑II, 3.3.

In a computer-implemented method for facilitating managerial decision-making, automatically selecting from a set of business plans the most cost-effective one which also enables meeting certain technical constraints (e.g. to achieve a targeted reduction in environmental impact) is not considered to make a technical contribution beyond the computer-implementation.

The mere possibility of serving a technical purpose is not enough for a method to contribute to the technical character of the invention. For example, a claim to a “method of resource allocation in an industrial process” encompasses pure business processes and services in finance, administration, or management, without limiting the method to any specific technical process due to the breadth of meaning of the term “industry”.

The result of a business method may be useful, practical or saleable but that does not qualify as a technical effect.

Business method features, e.g. administrative features, can be found in different contexts. For example, a medical support system may be configured to deliver information to the clinician on the basis of data obtained from patient sensors, and only if such data is not available, on the basis of data provided by the patient. The prioritisation of the sensor data over the data provided by the patient is an administrative rule. Establishing it lies within the competence of an administrator, e.g. the head of the clinic, rather than within that of an engineer. As an administrative rule with no technical effect, it does not contribute to the technical character of the claimed subject-matter and may be used in the formulation of the objective technical problem as a constraint that has to be met when assessing inventive step (G‑VII, 5.4). For further examples of applying the problem-solution approach to assess inventive step for subject-matter comprising business-method features, see G‑VII, 5.4.2.1-5.4.2.3.

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16
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3.6 Programs for computers

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Computer programs are excluded from patentability under Art. 52(2)(c) and (3) if claimed as such. However, following the generally applicable criteria for Art. 52(2) and (3) (G‑II, 2), the exclusion does not apply to computer programs having a technical character.

In order to have a technical character, and thus not be excluded from patentability, a computer program must produce a “further technical effect” when run on a computer. A “further technical effect” is a technical effect going beyond the “normal” physical interactions between the program (software) and the computer (hardware) on which it is run. The normal physical effects of the execution of a program, e.g. the circulation of electrical currents in the computer, are not in themselves sufficient to confer technical character to a computer program (T 1173/97 and G 3/08).

Examples of further technical effects which confer technical character to a computer program are the control of a technical process or of the internal functioning of the computer itself or its interfaces (see G‑II, 3.6.1).

The presence of a further technical effect is assessed without reference to the prior art. It follows that the mere fact that a computer program serving a non-technical purpose requires less computing time than a prior-art program serving the same non-technical purpose does not on its own establish the presence of a further technical effect (T 1370/11). Likewise, comparing a computer program with how a human being would perform the same task is not a suitable basis for assessing if the computer program has a technical character (T 1358/09).

If a further technical effect of the computer program has already been established, the computational efficiency of an algorithm affecting the established technical effect contributes to the technical character of the invention and thus to inventive step (e.g. where the design of the algorithm is motivated by technical considerations of the internal functioning of the computer; see also G‑II, 3.3).

A computer program cannot derive a technical character from the mere fact that it has been designed such that it can be automatically performed by a computer. “Further technical considerations”, typically related to the technical considerations of the internal functioning of the computer, going beyond merely finding a computer algorithm to perform a task are needed. They have to be reflected in claimed features that cause a further technical effect (G 3/08).

If a claim is directed to a computer program which does not have a technical character, it is objected to under Art. 52(2)(c) and (3). If it passes the test for having technical character, the examiner then proceeds to the questions of novelty and inventive step (see G‑VI and G‑VII, in particular G‑VII, 5.4).

Computer-implemented inventions

“Computer-implemented invention” is an expression intended to cover claims which involve computers, computer networks or other programmable apparatus wherein at least one feature is realised by means of a computer program. Claims directed to computer-implemented inventions may take the forms described in F‑IV, 3.9 and subsections.

A computer program and a corresponding computer-implemented method are distinct from each other. The former refers to a sequence of computer-executable instructions specifying a method while the latter refers to a method being actually performed on a computer.

Claims directed to a computer-implemented method, a computer-readable storage medium or a device cannot be objected to under Art. 52(2) and (3) as any method involving the use of technical means (e.g. a computer) and any technical means itself (e.g. a computer or a computer-readable storage medium) have technical character and thus represent inventions within the meaning of Art. 52(1) (T 258/03, T 424/03, G 3/08).

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17
Q

3.6.1 Examples of further technical effects

A

If a method has a technical character over and above the mere fact that it is computer-implemented, a corresponding computer program specifying that method produces a further technical effect when run on a computer. For example, a computer program which specifies a method of controlling an anti-lock braking system in a car, determining emissions by an X-ray device, compressing video, restoring a distorted digital image, or encrypting electronic communications brings about a further technical effect when it is run on a computer (see G‑II, 3.3).

Furthermore, if a computer program is designed based on specific technical considerations of the internal functioning of the computer on which it is to be executed, such as by being adapted to the specific architecture of the computer, it may be considered to produce a further technical effect. For example, computer programs implementing security measures for protecting boot integrity or countermeasures against power analysis attacks have a technical character since they rely on a technical understanding of the internal functioning of the computer.

Similarly, computer programs controlling the internal functioning or operation of a computer, such as processor load balancing or memory allocation, normally produce a further technical effect (see, however, G‑VII, 5.4.2.3 for an example of a case where the controlling is based on a non-technical scheme).

Programs for processing code at low level, such as builders or compilers, may well have a technical character. For example, when building runtime objects from development objects, regenerating only those runtime objects resulting from modified development objects contributes to producing the further technical effect of limiting the resources needed for a particular build.

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3.6.2 Information modelling, activity of programming and programming languages

A

Information modelling is an intellectual activity devoid of technical character and typically carried out by a systems analyst in a first stage of software development, to provide a formal description of a real-world system or process. Consequently, specifications of a modelling language, the structure of an information modelling process (e.g. use of a template) or the maintenance of models likewise have no technical character (T 354/07). Similarly, properties inherent to information models, like re-usability, platform-independence or convenience for documentation, are not regarded as technical effects (T 1171/06).

If an information model is purposively used in the context of an invention to solve a specific technical problem by providing a technical effect, it can contribute to the technical character of the invention (see also G‑II, 3.3.2 and 3.5.1).

Features specifying how the model is actually stored (e.g. using relational database technology) can also make a technical contribution.

Conceptual methods describing the process of software development (meta-methods) normally have no technical character. For example, in a computer-implemented method for generating program code for a control task, a feature specifying that a platform-independent model is converted to a platform-dependent model, from which program code adapted to the target platform is derived, makes no technical contribution in so far as the performance of the control task itself is not affected.

The activity of programming, in the sense of writing code, is an intellectual, non-technical activity, to the extent that it is not used in the context of a concrete application or environment to contribute in a causal manner to the production of a technical effect (G 3/08, T 1539/09).

For example, reading a data type parameter from a file as input to a computer program, rather than defining the data type in the program itself, is merely a programming option when writing code, which has per se no technical character. The same applies to naming conventions for object names for facilitating the intelligibility and the management of program code.

Defining and providing a programming language or a programming paradigm such as object-oriented programming does not per se solve a technical problem, even if its particular syntax and semantics enable the programmer to develop a program with greater ease. Easing the intellectual effort of the programmer is per se not a technical effect.

When assessing an invention relating to a programming environment, the features pertaining to the programming language do not normally contribute to its technical character. For example, in a visual programming environment, the provision of specific graphical building blocks is part of the programming language and makes no technical contribution if the only effect is easing the intellectual effort of the programmer. The provision of particular programming constructs may enable a programmer to write shorter programs, but that does not qualify as a technical effect since any resulting reduction of program length ultimately depends on how the programming constructs are used by a human programmer. In contrast, automatically processing machine code by dividing it into an instruction chain and an operand chain and replacing repeating instruction sets by macro-instructions so as to generate optimised code of reduced memory size makes a technical contribution. In this case, the effect does not depend on how a human programmer makes use of the macro-instructions.

Features of a programming environment that relate to its graphical user interface, e.g. visualisations and data input mechanisms, are to be assessed as indicated in G‑II, 3.7 and 3.7.1.

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3.6.3 Data retrieval, formats and structures

A

A computer-implemented data structure or data format embodied on a medium or as an electromagnetic carrier wave has technical character as a whole and thus is an invention within the meaning of Art. 52(1).

A data structure or format contributes to the technical character of the invention if it has an intended technical use and it causes a technical effect when used according to this intended technical use. Such a potential technical effect related to an implied technical use is to be taken into account in assessing inventive step (G 1/19). This may happen if the data structure or format is functional data, i.e. if it has a technical function in a technical system, such as controlling the operation of the device processing the data. Functional data inherently comprise, or map to, the corresponding technical features of the device (T 1194/97). Cognitive data, on the other hand, are those data whose content and meaning are only relevant to human users and do not contribute to producing a technical effect (see however, G‑II, 3.7 for presentation of information to a user in a continued and/or guided human-machine interaction process).

For example, a record carrier for use in a picture retrieval system stores coded pictures together with a data structure defined in terms of line numbers and addresses which instruct the system how to decode and access the picture from the record carrier. This data structure is defined in terms which inherently comprise the technical features of the picture retrieval system, namely the record carrier and a reading device for retrieving pictures therefrom in which the record carrier is operative. It thus contributes to the technical character of the record carrier, whereas the cognitive content of the stored pictures (e.g. photograph of a person or landscape) does not.

Similarly, an index structure used for searching a record in a database produces a technical effect since it controls the way the computer performs the search operation (T 1351/04).

Another example is an electronic message with a header and a content section. Information in the header comprises instructions which are automatically recognised and processed by the receiving message system. This processing in turn determines how the content elements are to be assembled and presented to its final recipient. The provision of such instructions in the header contributes to the technical character of the electronic message, whereas the information in the content section, representing cognitive data, does not (T 858/02).

A data structure or a data format may have features which may not be characterised as cognitive data (i.e. not for conveying information to a user) but which nevertheless do not make a technical contribution. For example, the structure of a computer program may merely aim at facilitating the task of the programmer, which is not a technical effect serving a technical purpose. Furthermore, data models and other information models at an abstract logical level have per se no technical character (see G‑II, 3.6.2).

Digital data is used to control devices in additive manufacturing (AM), which is the general term for technologies manufacturing physical objects by successive addition of material based on a digital representation of the geometry of the object. If the data defines the instructions for operating the AM device, it makes a technical contribution as illustrated in the following example:

Example

A computer-readable medium storing data which defines both a digital representation of the product of claim 1 and operating instructions adapted to control an AM device to fabricate the product using the digital representation of the product when said data is relayed to the AM device.

Remarks

A computer-readable medium is a technical object, so no objection under Art. 52(2) and (3) arises.

Since the data comprises both a digital description of the (physical) product of claim 1 and associated operating instructions adapted to control an AM device, it is intended to be used to control an AM device to fabricate the product. This technical use of the data is implied across substantially the whole scope of the claim. Construing the present claim to encompass a non-technical use of merely visualising the data would be artificial. The technical effect of fabricating the physical product defined in claim 1 that is achieved when the data is used according to its intended use is thus a potential technical effect that is to be taken into account when assessing inventive step. The digital representation of the product makes a technical contribution to the extent that it defines technical features of the fabricated physical product.

However, if such a technical use of the data were not implied by the claim, the potential technical effect of the data of fabricating the physical product could not be taken into account when assessing inventive step as it would not be implied across substantially the whole scope of the claim. This would be the case, for instance, if the data defined only a digital description or 3D model of the product that is not adapted to additive manufacturing of the product and could be used to merely visualise the product in a CAD software tool. Abstract descriptions or models are not considered technical even if the described entities are technical (see G‑II, 3.3.2). In such a case, the stored non-technical data would not make a technical contribution.

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3.6.4 Database management systems and information retrieval

A

Database management systems are technical systems implemented on computers to perform the technical tasks of storing and retrieving data using various data structures for efficient management of data. A method performed in a database management system is thus a method which uses technical means and is therefore not excluded from patentability under Art. 52(2) and Art. 52(3).

Features specifying the internal functioning of a database management system are normally based on technical considerations. Therefore, they contribute to the technical character of the invention and are taken into account for the assessment of inventive step. For instance, technical considerations are involved in improving system throughput and query response times by automatically managing data using various data stores with different technical properties such as different levels of consistency or performance (T 1924/17, T 697/17).

Database management systems execute structured queries, which formally and precisely describe the data to be retrieved. Optimising the execution of such structured queries with respect to the computer resources needed (such as CPU, main memory or hard disk) contributes to the technical character of the invention since it involves technical considerations concerning the efficient exploitation of the computer system.

However, not all features implemented in a database management system necessarily make a technical contribution by virtue of this fact alone. For example, a feature of a database management system for accounting costs related to the use of the system by different users may be regarded as not making a technical contribution.

Data structures, such as an index, hash table or a query tree, used in database management systems to facilitate access to data or for the execution of structured queries contribute to the technical character of the invention. Such data structures are functional since they purposively control the operation of the database management system to perform said technical tasks. Conversely, data structures defined solely by the cognitive information they store are not considered to contribute to the technical character of the invention beyond the mere storage of data (see also G‑II, 3.6.3).

A distinction is made between executing structured queries by a database management system and information retrieval. The latter includes searching for information in a document, searching for documents themselves, and also searching for metadata that describe data such as texts, images or sounds. The query may be formulated by the user in need of information, typically informally using natural language without a precise format: the user may enter search terms as a query in web search engines to find relevant documents or submit an exemplary document to find similar documents. If the method of estimating relevance or similarity relies solely on non-technical considerations, such as the cognitive content of the items to be retrieved, purely linguistic rules or other subjective criteria (e.g. items found relevant by friends in social networks), it does not make a technical contribution.

The translation of linguistic considerations into a mathematical model with the aim of enabling the linguistic analysis to be done automatically by a computer can be seen as involving, at least implicitly, technical considerations. However, this is not enough to guarantee the technical character of the mathematical model. Further technical considerations such as those relating to the internal functioning of the computer system are needed.

For example, a mathematical model for calculating the probability that a given term is similar in meaning to another term by analysing the co-occurrence frequency of the two terms in a collection of documents does not make a technical contribution per se since it is based on considerations of a purely linguistic nature (i.e. based on the assumption that terms which are related are more likely than unrelated terms to occur in the same documents). The search results produced using this method of similarity calculation would differ from prior art that adopts another mathematical model only in that information with different cognitive content would be retrieved. This is a non-technical distinction and does not qualify as a technical effect. In this context of retrieval based on similarity of meaning of terms, the concept of “better search” is subjective (T 598/14). In contrast, optimising the execution time of structured queries in a database management system as discussed above is a technical effect.

See also G‑II, 3.3.1, for artificial intelligence and machine learning algorithms.

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3.7 Presentations of information

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Presentations of information within the meaning of Art. 52(2)(d) are understood as the conveying of information to a user. It concerns both the cognitive content of the information presented and the manner of its presentation (T 1143/06, T 1741/08). It is not limited to visual information, but also covers other presentation modalities, e.g. audio or haptic information. However, it does not extend to the technical means used for generating such presentations of information.

Furthermore, conveying information to a user is to be distinguished from technical representations of information directed to a technical system which will process, store or transmit that information. Features of data encoding schemes, data structures and electronic communication protocols which represent functional data as opposed to cognitive data are not regarded as presentations of information within the meaning of Art. 52(2)(d) (T 1194/97).

When assessing exclusion from patentability under Art. 52(2) and (3), the claimed subject-matter has to be considered as a whole (G‑II, 2). In particular, a claim directed to or specifying the use of any technical means for presenting information (e.g. a computer display) has, as a whole, technical character and is thus not excluded from patentability. As another example, a claim directed to a kit comprising a product (e.g. a bleaching composition) and further features such as instructions for use of the product or reference information for evaluating the results obtained, wherein said further features have no technical effect on the product, is not excluded since the claim has a technical feature: a product comprising a composition of matter.

Once it is established that the claimed subject-matter as a whole is not excluded from patentability under Art. 52(2) and (3), it is examined in respect of the other requirements of patentability, in particular novelty and inventive step (G‑I, 1).

During the assessment of inventive step, features related to the presentation of information are analysed to determine if, in the context of the invention, they contribute to producing a technical effect serving a technical purpose. If not, they make no technical contribution and cannot support the presence of an inventive step (G‑VII, 5.4). To determine whether a technical effect is produced, the examiner assesses the context of the invention, the task the user carries out and the actual purpose served by the particular presentation of information.

A feature defining a presentation of information produces a technical effect if it credibly assists the user in performing a technical task by means of a continued and/or guided human-machine interaction process (T 336/14 and T 1802/13). Such a technical effect is considered credibly achieved if the assistance to the user in performing the technical task is objectively, reliably and causally linked to the feature. This would not be the case if the alleged effect depends on subjective interests or preferences of the user. For example, for some users it is easier to understand data when it is displayed as numerical values, whereas others might prefer a colour-coded display. The choice of the one or other manner of displaying the data is thus not considered to have a technical effect (T 1567/05). Similarly, whether or not it is easier to understand audio information conveyed as a musical scale instead of spoken words is a matter concerned only with the cognitive abilities of the user. As another example, allowing the user to set parameters determining the information to be presented or to select the manner of its presentation does not make a technical contribution if it merely accommodates subjective user preferences.

Determining the extent to which a particular presentation of information may be considered to credibly support the user in performing a technical task may be difficult. It may be simplified during the assessment of inventive step by comparing the invention with the prior art, thus allowing the analysis to be limited to the distinguishing features (G‑VII, 5.4, paragraph 5). This comparison may reveal that the potential support for the performance of the technical task is already achieved in the prior art, with the consequence that the distinguishing features make no technical contribution (e.g. relate only to non-technical subjective user preferences).

A feature relating to the presentation of information may commonly be considered to specify:

(i)
the cognitive content of the information presented, i.e. defining “what” is presented; or

(ii)
the manner in which the information is presented, i.e. defining “how” the information is presented.

This categorisation is adopted to allow for a more detailed discussion of technical effects in the rest of this section. It is noted that these categories are not meant to be exhaustive. Also, there are cases in which a feature falls into both categories. For example, a step of “displaying the surname of a customer in capital letters” in a claimed method defines both the cognitive content of the presented information (surname of a customer) and the manner of its presentation (in capital letters). Such a feature may be considered to consist in fact of two features: the displayed text is the surname of a customer (falling into the first category) and the displayed text is shown in capital letters (falling into the second category). The manner of presentation itself might additionally convey cognitive information. For example, the capitalised part of a name may, as a matter of convention, indicate which part is the surname.

(1)
What (which information) is presented?

If the cognitive content of the information presented to the user relates to an internal state prevailing in a technical system and enables the user to properly operate this technical system, it has a technical effect. An internal state prevailing in a technical system is an operating mode, a technical condition or an event which is related to the internal functioning of the system, may dynamically change and is automatically detected. Its presentation typically prompts the user to interact with the system, for example to avoid technical malfunctions (T 528/07).

Static or predetermined information about technical properties or potential states of a machine, specifications of a device or operating instructions do not qualify as an internal state prevailing in the device. If the presentation of static or predetermined information merely has the effect of helping the user with the non-technical tasks preceding the technical task, it does not make a technical contribution. For example, the effect that the user is not required to know or memorise a sequence of buttons to be operated prior to configuring a device is not a technical effect.

Non-technical information such as the state of a casino game, a business process or an abstract simulation model is exclusively aimed at the user for subjective evaluation or non-technical decision-making. It is not directly linked to a technical task. Therefore, such information does not qualify as an internal state prevailing in a technical system.

(2)
How is the information presented?

A feature in this category typically specifies the form or arrangement in which, or the timing at which, information is conveyed to the user (e.g. on a screen). One example is a diagram designed solely for conveying information. Specific technical features related to, for example, the way audio signals or images are generated are not regarded as a manner in which information is presented.

Features defining a visualisation of information in a particular diagram or layout are normally not considered to make a technical contribution, even if the diagram or layout arguably conveys information in a way which a viewer may intuitively regard as particularly appealing, lucid or logical.

For instance, dealing with limited available screen space is part of designing presentations of information for human viewing and therefore not an indication of technicality per se. The general idea of giving an overview of a plurality of images in a limited display area by displaying a single image and sequentially replacing it with other images is not based on technical considerations, but is a matter of layout design. Similarly, arranging objects within available screen space by eliminating “white space” between window panes follows the same layout principles as would apply to the layout of a magazine cover and does not involve technical considerations.

On the other hand, if the manner of presentation credibly assists the user in performing a technical task by means of a continued and/or guided human-machine interaction process, it produces a technical effect (T 1143/06, T 1741/08, T 1802/13). For example, displaying several images side by side in low resolution and allowing selection and display of an image at higher resolution conveys information to the user in the form of a technical tool that enables the user to perform the technical task of interactively searching and retrieving stored images more efficiently. Storing digital images at different resolutions gives rise to the technical effect of allowing the simultaneous overview display of several images (T 643/00). As another example, in a video soccer game, the particular manner of conveying to the user the location of the nearest teammate by dynamically displaying a guide mark on the edge of the screen when the teammate is off-screen produces the technical effect of facilitating a continued human-machine interaction by resolving conflicting technical requirements: displaying an enlarged portion of an image and maintaining an overview of a zone of interest which is larger than the display area (T 928/03). As a further example, in the context of a visual aid for a surgeon, if, in the course of surgery, the current orientation of a medical ball joint implant is displayed in a manner which credibly assists the surgeon to correct the position of the implant in a more precise manner, this is considered to provide a technical effect.

Effects relying on human physiology

When a manner of presenting information produces in the mind of the user an effect which does not depend on psychological or other subjective factors but on physical parameters which are based on human physiology and can be precisely defined, that effect may qualify as a technical effect. The manner of presenting information then makes a technical contribution to the extent that it contributes to this technical effect. For example, displaying a notification on one of a plurality of computer screens near the user’s current visual focus of attention has the technical effect that it is more or less guaranteed to be seen immediately (compared e.g. with an arbitrary placement on one of the screens). In contrast, the decision to show only urgent notifications (compared e.g. to all notifications) is based only on psychological factors and thus makes no technical contribution. Minimising information overload and distraction is not considered to qualify per se as a technical effect (T 862/10). As another example, displaying a stream of images in which the parameters for delay and change in the content between successive images are computed on the basis of physical properties of human visual perception in order to achieve a smooth transition is considered to make a technical contribution (T 509/07).

If information (e.g. a visual or audio stimulus) is presented to a person for the purpose of producing in that person a physiological reaction (e.g. involuntary eye gaze) which can be measured in the context of assessing a medical condition (e.g. eyesight, hearing impairment or brain damage), that presentation of information may be considered to produce a technical effect.

Effects relying on mental activities of the user

Where the claimed subject-matter comprises a feature of presenting information to a user, be it of category (i) or (ii), an evaluation by the user is involved. Although such an evaluation per se is a mental act (Art. 52(2)(c)), the mere fact that mental activities are involved does not necessarily qualify subject-matter as non-technical. For example, in T 643/00 discussed above, the user makes an evaluation based on an overview of low-resolution images in order to locate and objectively recognise a desired image. This mental evaluation may be considered to be an intermediate step steering the image search and retrieval process and thus forms an integral part of a solution to a technical problem. Such a solution relies neither on facilitating the human tasks of understanding, learning, reading or memorising nor on influencing the user’s decision as to which image is to be searched. It provides a mechanism for inputting a selection which would not be possible if the images were not displayed in that specific arrangement.

On the other hand, if the choice or layout of information presented aims exclusively at the human mind, in particular to help the user to take a non-technical decision (e.g. which product to buy based on a diagram showing properties of products), no technical contribution is made.

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3.7.1 User interfaces

A

User interfaces, in particular graphical user interfaces (GUIs), comprise features of presenting information and receiving input in response as part of human-computer interaction. Features defining user input are more likely to have a technical character than those solely concerning data output and display, because input requires compatibility with the predetermined protocol of a machine, whereas output may be largely dictated by the subjective preferences of a user. Features concerning the graphic design of a menu (such as its look and feel) which are determined by aesthetic considerations, subjective user preferences or administrative rules do not contribute to the technical character of a menu-based user interface. Evaluation of features related to output of data is addressed in G‑II, 3.6.3. The present section focuses on evaluating features relating to how a user can provide input.

Features which specify a mechanism enabling user input, such as entering text, making a selection or submitting a command, are normally considered to make a technical contribution. For example, providing in a GUI an alternative graphical shortcut allowing the user to directly set different processing conditions, such as initiating a printing process and setting the number of copies to be printed by dragging and reciprocated movement of a document icon onto a printer icon, makes a technical contribution. On the other hand, supporting user input by providing information facilitating only the user’s mental decision-making process during this task (e.g. helping the user in deciding what to input) is not considered as making a technical contribution (T 1741/08).

Assisting a user in entering text in a computer system by providing a predictive input mechanism is a technical function. However, generating word variants to be displayed for the predictive input mechanism is, in itself, a non-technical problem. The linguistic model used to solve this non-technical problem does not, on its own, make a technical contribution. If technical considerations are involved to implement the linguistic model on a computer, such as those relating to the internal functioning of a computer, then a technical effect may arise.

Where the actual achievement of effects like simplifying the user’s actions or providing more user-convenient input functions depends exclusively on subjective user abilities or preferences, such effects may not form the basis of an objective technical problem to be solved. For example, a reduction of the number of interactions required to perform the same input is not credibly achieved if it materialises only for some usage patterns that occur depending on the user’s level of expertise or subjective preferences.

Manners of providing input, such as gestures or keystrokes, that merely reflect subjective user preferences, conventions or game rules and from which a physical ergonomic advantage cannot be objectively established, do not make a technical contribution. However, performance-oriented improvements to the detection of input, such as allowing faster or more accurate gesture recognition or reducing the processing load of the device when performing recognition, do make a technical contribution.

23
Q
  1. Exceptions to patentability
A
24
Q

4.1 Matter contrary to “ordre public” or morality

A

Any invention the commercial exploitation of which would be contrary to “ordre public” or morality is specifically excluded from patentability. The purpose of this is to deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour (see also F‑II, 7.2). Antipersonnel mines are an obvious example. Examples in the area of biotechnological inventions as laid down in Rule 28 are listed in G‑II, 5.3. G 1/03 explains that practical examples under Art. 53(a) arise from the fact that not everything can be done to human beings that can be done to other living beings. For example, the avoidance of offspring that are unwanted because of certain properties (sex, colour, health) and for economic reasons may be quite legitimate for domestic animals but when applied to human beings it would be contrary to “ordre public” or morality.

This provision is likely to be invoked only in rare and extreme cases. A fair test to apply is to consider whether it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable. If it is clear that this is the case, an objection is raised under Art. 53(a); otherwise not. The mere possibility of abuse of an invention is not sufficient to deny patent protection pursuant to Art. 53(a) EPC if the invention can also be exploited in a way which does not and would not infringe “ordre public” and morality (see T 866/01). If difficult legal questions arise in this context, then refer to C‑VIII, 7.

Where it is found that the claims relate in part to such excluded subject-matter, this may have led to the issuing of a partial European or supplementary European search report under Rule 63 (see B‑VIII, 1, 3.1 and 3.2). In such cases, in the absence of appropriate amendment and/or convincing arguments provided by the applicant in response to the invitation under Rule 63(1) (see B‑VIII, 3.2) or to the search opinion under Rule 70a (see B‑XI, 8), an objection under Rule 63(3) will also arise (see H‑II, 5).

25
Q

4.1.1 Prohibited matter

A

Exploitation is not to be deemed to be contrary to “ordre public” or morality merely because it is prohibited by law or regulation in some or all of the contracting states. One reason for this is that a product could still be manufactured under a European patent for export to states in which its use is not prohibited.

26
Q

4.1.2 Offensive and non-offensive use

A

Special attention must be paid to applications in which the invention has both an offensive and a non-offensive use, e.g. a process for breaking open locked safes, where use by a burglar is offensive and use by a locksmith in an emergency non-offensive. In such a case, no objection arises under Art. 53(a). Similarly, if a claimed invention defines a copying machine with features resulting in an improved precision of reproduction and an embodiment of this apparatus could comprise further features (not claimed but apparent to the skilled person) the only purpose of which would be that it also allows reproduction of security strips in banknotes strikingly similar to those in genuine banknotes, the claimed apparatus would cover an embodiment for producing counterfeit money which could be considered to fall under Art. 53(a). There is, however, no reason to consider the copying machine as claimed to be excluded from patentability, since its improved properties could be used for many acceptable purposes (see G 1/98, Reasons 3.3.3). However, if the application contains an explicit reference to a use which is contrary to “ordre public” or morality, deletion of this reference is required under the terms of Rule 48(1)(a).

27
Q

4.1.3 Economic effects

A

The EPO has not been vested with the task of taking into account the economic effects of the grant of patents in specific areas of technology and of restricting the field of patentable subject-matter accordingly (see G 1/98 Reasons 3.9, and T 1213/05). The standard to apply for an exception under Art. 53(a) is whether the commercial exploitation of the invention is contrary to “ordre public” or morality.

28
Q

4.2 Surgery, therapy and diagnostic methods

A

European patents are not to be granted in respect of “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.” Hence, patents may be obtained for surgical, therapeutic or diagnostic instruments or apparatuses for use in such methods. The manufacture of prostheses or artificial limbs could be patentable. For instance, a method of manufacturing insoles in order to correct the posture or a method of manufacturing an artificial limb is patentable. In both cases, taking the imprint of the footplate or a moulding of the stump on which an artificial limb is fitted is clearly not of a surgical nature. Furthermore, the insoles as well as the artificial limb are manufactured outside the body. However, a method of manufacturing an endoprosthesis outside the body, but requiring a surgical step to be carried out for taking measurements, would be excluded from patentability under Art. 53(c) (see T 1005/98).

The exception under Art. 53(c) does not extend to products, particularly substances or compositions, for use in these methods of treatment or diagnosis.

Where a substance or composition is already known, (notional) novelty can be derived from a new medical use in accordance with Art. 54(4) and (5).

Art. 53(c)

Pursuant to Art. 54(4), a known substance or composition may still be patented for use in a method referred to in Art. 53(c) if the known substance or composition has not previously been disclosed for use for any such method (“first medical use”). A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods must be in a form such as: “Substance or composition X” followed by the indication of the use, for instance “… for use as a medicament” or “… for use in therapy/in vivo diagnostics/surgery” (see G‑VI, 7.1).

Art. 54(4)

Furthermore, if the known substance or composition was previously disclosed for use in surgery, therapy or diagnostic methods practised on the human or animal body, a patent may still be obtained according to Art. 54(5) for any second or further use of the substance in these methods provided that said use is novel and inventive (“further medical use”). A claim to a further medical use of a known substance must be in the form: “Substance or composition X” followed by the indication of the specific therapeutical/in vivo diagnostic/surgical use, for instance, “… for use in treating disease Y” (see G‑VI, 7.1).

Subject-matter in the description regarded as an exception to patentability needs to be excised, reworded such that it does not fall under the exceptions to patentability or prominently marked as not being according to the claimed invention (see F‑IV, 4.3). For the latter case, in accordance with Art. 53(c), the description may for example be amended by adding an indication as follows: “The references to the methods of treatment by therapy or surgery or in vivo diagnosis methods in examples X, Y and Z of this description are to be interpreted as references to compounds, pharmaceutical compositions and medicaments of the present invention for use in those methods”.

29
Q

4.2.1 Limitations of exception under Art. 53(c)

A

Exceptions under Art. 53(c) are confined to methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body. It follows that other methods of treatment of living human beings or animals (e.g. treatment of a sheep in order to promote growth, to improve the quality of mutton or to increase the yield of wool) or other methods of measuring or recording characteristics of the human or animal body are patentable, provided that such methods are of a technical and not essentially biological character (see G‑II, 5.4.2). For example, an application containing claims directed to the purely cosmetic treatment of a human by administration of a chemical product is considered as being patentable (see T 144/83). A cosmetic treatment involving surgery or therapy would, however, not be patentable (see below).

To be excluded from patentability, a treatment or diagnostic method must actually be carried out on the living human or animal body (G 1/04). A treatment of or diagnostic method practised on a dead human or animal body would therefore not be excluded from patentability by virtue of Art. 53(c). Treatment of body tissues or fluids after they have been removed from the human or animal body, or diagnostic methods applied thereon, are not excluded from patentability as long as these tissues or fluids are not returned to the same body. Thus the treatment of blood for storage in a blood bank or diagnostic testing of blood samples is not excluded, whereas a treatment of blood by dialysis with the blood being returned to the same body would be excluded.

Regarding methods which are carried out on or in relation to the living human or animal body, it must be borne in mind that the intention of Art. 53(c) is only to free from restraint non-commercial and non-industrial medical and veterinary activities. Interpretation of the provision must avoid the exceptions from going beyond their proper limits (see G 5/83, G 1/04, and G 1/07).

Whether or not a method is excluded from patentability under Art. 53(c) cannot depend on the person carrying it out (see G 1/04 and G 1/07, Reasons 3.4.1).

However, in contrast to the subject-matter referred to in Art. 52(2) and (3) which is only excluded from patentability if claimed as such, a method claim is not allowable under Art. 53(c) if it includes at least one feature defining a physical activity or action that constitutes a method step for treatment of the human or animal body by surgery or therapy. In that case, whether or not the claim includes or consists of features directed to a technical operation performed on a technical object is legally irrelevant to the application of Art. 53(c) (see G 1/07, Reasons 3.2.5).

Claims to medical devices, computer programs and storage media which comprise subject-matter corresponding to that of a method for treatment of the human or animal body by surgery or therapy or to that of a diagnostic method practised on the human or animal body are not to be objected to under Art. 53(c), because only method claims may fall under the exception of Art. 53(c).

30
Q

4.2.1.1 Surgery

A

The meaning of the term “treatment by surgery” is not to be interpreted as being confined to surgical methods pursuing a therapeutic purpose (see G 1/07, Reasons 3.3.10). Accordingly, the term “surgery” defines the nature of the treatment rather than its purpose. Thus, for example, a method of treatment by surgery for cosmetic purposes or for embryo transfer is excluded from patentability, as well as surgical treatment for therapeutic purposes. The term “treatments by surgery” further covers interventions performed on the structure of an organism by conservative (“closed, non-invasive”) procedures such as repositioning or by operative (invasive) procedures using instruments.

Whether a claimed method is to be considered as surgical treatment falling under the exception of Art. 53(c) should be assessed on a case-by-case basis, taking the individual merits of each case into account. The reason for the exception is to allow medical and veterinary practitioners to use their skills and knowledge of the best available treatments to achieve the utmost benefit for their patients uninhibited by any worry that some treatment might be covered by a patent (see G 1/07, Reasons 3.3.6).

Thus, any definition of the term “treatment by surgery” must cover the kind of interventions which constitute the core of the medical profession’s activities i.e. the kind of interventions for which their members are specifically trained and for which they assume a particular responsibility (G 1/07, Reasons 3.4.2.3).

The exclusion applies to substantial physical interventions on the body which require professional medical expertise to be carried out and which entail a substantial health risk even when carried out with the required professional care and expertise. The health risk must be associated with the mode of administration and not solely with the agent as such (G 1/07, Reasons 3.4.2.3). Examples of excluded treatments by surgery are the injection of a contrast agent into the heart, catheterisation and endoscopy.

Invasive techniques of a routine character which are performed on uncritical body parts and generally carried out in a non-medical, commercial environment are not excluded from patentability. They include e.g. tattooing, piercing, hair removal by optical radiation and micro-abrasion of the skin.

Similar considerations apply to routine interventions in the medical field. Thus, uncritical methods involving only a minor intervention and no substantial health risks, when carried out with the required care and skill, do not fall under the scope of Art. 53(c). This narrower understanding of the exclusion still protects the medical profession from the concerns indicated above. An example is a method for retraction of the sulcus of a tooth using a paste and a cap to prepare an impression of the tooth to manufacture a dental crown: the possible damage is limited to the superficial epithelium, the only risks are the superficial bleeding and inflammation which rapidly heal and the specific training needed to perform the method is minimal.

The required medical expertise and the health risk involved may however not be the only criteria which may be used to determine that a claimed method actually constitutes “treatment by surgery” within the meaning of Art. 53(c). Other criteria, such as the degree of invasiveness or the complexity of the operation performed, could also determine that a physical intervention on the human or animal body constitutes such treatment (see G 1/07, Reasons 3.4.2.4).

The exclusion under Art. 53(c) applies to multi-step methods which comprise or encompass at least one surgical step, as defined in the previous paragraph. The non-patentable subject-matter must be removed from the scope of the claim. This may be done either by means of a disclaimer or by omitting the surgical step from the wording of the claim (G 1/07, Reasons 4.2.2). For the general principles governing disclaimers, see H‑V, 4. The overall patentability of the amended claim will however depend on its compliance with the other requirements of the EPC, which are assessed on a case-by-case basis.

If a surgical method claim is open to objection under Art. 53(c), this also applies to a corresponding claim directed to a computer-assisted surgical method. In other words, surgical methods for which European patents cannot be granted according to Art. 53(c) do not avoid exclusion merely through computer assistance.

Finally, when interpreting the scope of the exclusion under Art. 53(c), no distinction is to be made between human beings and animals.

31
Q

4.2.1.2 Therapy

A

Therapy implies the curing of a disease or malfunction of the body and covers prophylactic treatment, e.g. immunisation against a certain disease (see T 19/86) or the removal of plaque (see T 290/86). It is concerned with bringing the body from a pathological state back into its normal, healthy state or preventing a pathological state. Where a method is directed to the treatment of a human or animal body that is in a normal, healthy state and, even if subject to some discomfort, not likely to develop a pathological state due to the discomfort, providing relief from the discomfort is not necessarily a therapy. For example, cooling an animal subject to hot weather conditions does not cure or lessen the symptoms of any disorder or malfunction of the animal’s body, nor does it reduce the possibility of contracting any disorder or malfunction, since no such disorder or malfunction would normally occur if the animal were not cooled (T 385/09).

A method for therapeutic purposes concerning the functioning of an apparatus associated with a living human or animal body is not excluded from patentability if no functional relationship exists between the steps related to the apparatus and the therapeutic effect of the apparatus on the body (see T 245/87).

As clinical trials have a therapeutic aspect for the human subjects undergoing them, an objection under Art. 53(c) is raised if a claim includes a step relating to a method of treatment of the human body by therapy (see G‑II, 4.2.2).

The exclusion under Art. 53(c) applies to multi-step methods which comprise or encompass at least one therapeutic step. The non-patentable subject-matter must be removed from the scope of the claim. This may be done either by means of a disclaimer or by omitting the step of treatment by therapy from the wording of the claim (G 1/07). For the general principles governing disclaimers, see H‑V, 4. The overall patentability of the amended claim will however depend on its compliance with the other requirements of the EPC, which are assessed on a case-by-case basis.

If a method claim directed to therapy is open to objection under Art. 53(c), this also applies to a corresponding claim directed to a computer-implemented therapeutic method (T 1680/08). In this respect, the same observations as in G‑II, 4.2.1.1, for computer-implemented surgical methods apply.

32
Q

4.2.1.3 Diagnostic methods

A

Diagnostic methods likewise do not cover all methods related to diagnosis.

To determine whether a claim is directed to a diagnostic method within the meaning of Art. 53(c) and thus excluded from patentability, it must first be established whether all of the necessary phases are included in the claim (G 1/04).

The claim must include method steps relating to all of the following phases:

(i)
the examination phase, involving the collection of data,

(ii)
the comparison of these data with standard values,

(iii)
the finding of any significant deviation, i.e. a symptom, during the comparison,

(iv)
the attribution of the deviation to a particular clinical picture, i.e. the deductive medical or veterinary decision phase (diagnosis for curative purposes stricto sensu).

If features pertaining to any of these phases are missing and are essential for the definition of the invention, those features are to be included in the independent claim (see Example 6 in the Annex to F‑IV). Due account must be taken of steps which may be considered to be implicit: for example, steps relating to the comparison of data with standard values (phase (ii)) may imply the finding of a significant deviation (phase (iii) – see T 1197/02). The deductive medical or veterinary decision phase (iv), i.e. the “diagnosis for curative purposes stricto sensu”, is the determination of the nature of a medical or veterinary medicinal condition intended to identify or uncover a pathology; the identification of the underlying disease is not required (see T 125/02).

Additionally, a method is only regarded as a diagnostic method within the meaning of Art. 53(c), and thus excluded from patentability, if all method steps of a technical nature belonging to the preceding steps which are constitutive for making the diagnosis, i.e. phases (i)-(iii), satisfy the criterion “practised on the human or animal body”. However, the steps of phases (ii) and (iii) which consist in comparing the data collected in the examination phase with standard values and in finding a significant deviation resulting from the comparison are not subject to this criterion, because these activities are predominantly of a non-technical nature and are normally not practised on the human or animal body. Therefore, in most cases only phase (i), which relates to the examination phase and involves the collection of data, can actually be of a technical nature within the meaning of G 1/04 and therefore concerned with the criterion “practised on the human or animal body” (see T 1197/02, T 143/04, T 1016/10).

It is noted that only the steps strictly describing phases (i)-(iv) have to be taken into account in determining the diagnostic character of the claimed method. Additional, preparatory or intermediate steps which may be introduced into the claimed method are irrelevant for this question (see T 1197/02, T 143/04, T 1016/10). For example, preparatory steps which concern the adjustment or preparation of the apparatus with which the collection of data will be performed may be comprised in a method claim. However, these additional features are not part of any of phases (i)-(iii), which are constitutive for making the diagnosis. Likewise, data processing using an automated apparatus is not actually part of the examination phase which involves the collection of data, but it results from a subsequent step, intermediate between data collection and the comparison of the collected data with standard values. The issue of whether or not such additional steps are of a technical nature and practised on the human or animal body is, therefore, irrelevant for the assessment of whether a claimed method is a diagnostic method falling under the exception clause of Art. 53(c).

In order to determine whether a method step of a technical nature fulfils the criterion “practised on the human or animal body” it must be ascertained whether an interaction with the human or animal body takes place. The type or intensity of the interaction is not decisive: this criterion is fulfilled if the performance of the method step in question necessitates the presence of the body. Direct physical contact with the body is not required.

It is noted that a medical or veterinary practitioner does not have to be involved, either by being present or by bearing the overall responsibility, in the procedure.

If all of the above criteria are satisfied, then the claim defines a diagnostic method practised on the human or animal body, and an objection will be raised under Art. 53(c).

Accordingly, methods for merely obtaining information (data, physical quantities) from the living human or animal body (e.g. X-ray investigations, MRI studies, and blood pressure measurements) are not excluded from patentability under Art. 53(c).

33
Q

4.2.2 Methods for screening potential medicaments and clinical trials

A

Although in general a medical claim directed to tests carried out on “animals” must exclude from its scope the use of human beings as “test animals” (e.g. by means of a disclaimer), in some infrequent cases, a claim may, in the light of the description, be interpreted as exclusively relating to a clinical trial of an experimental medicament carried out on human beings. It is assumed that unless there is evidence to the contrary, such trials are performed under strictly controlled conditions and with the informed consent of the patient concerned. In such cases, no objection under Art. 53(a) is raised (see however G‑II, 4.2.1.2).

34
Q
  1. Exclusions and exceptions for biotechnological inventions
A
35
Q

5.1 General remarks and definitions

A

“Biotechnological inventions” are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. “Biological material” means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

36
Q

5.2 Patentable biotechnological inventions

A

In principle, biotechnological inventions are patentable under the EPC. For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the EPC are to be applied and interpreted in accordance with the provisions of Rules 26 to 29. European Union Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions (OJ EPO 1999, 101) is to be used as a supplementary means of interpretation. In particular the recitals (abbreviated as rec.) preceding the provisions of the Directive are also to be taken into account. Judgments of the Court of Justice of the European Union on the interpretation of EU Directive 98/44/EC are not binding on the EPO. Still, they may be considered as being persuasive (T 2221/10 and T 1441/13).

Biotechnological inventions are also patentable if they concern an item on the following non-exhaustive list:

Rule 27
Rule 26(1)

(i)
Biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature

Hence, biological material may be considered patentable even if it already occurs in nature (see also G‑II, 3.1).

Rule 27(a)

Although the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (see G‑II, 5.3), an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Such an element is not a priori excluded from patentability since it is, for example, the result of technical processes used to identify, purify and classify it and to produce it outside the human body, techniques which human beings alone are capable of putting into practice and which nature is incapable of accomplishing itself (EU Dir. 98/44/EC, rec. 21).

Rule 29(1) and (2)

The examination of a patent application or a patent for gene sequences or partial sequences is subject to the same criteria of patentability as in all other areas of technology (EU Dir. 98/44/EC, rec. 22). The industrial application of a sequence or partial sequence must be disclosed in the patent application as filed (see G‑III, 4).

Rule 29(3)

(ii)
Plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety and if said plants or animals are not exclusively obtained by means of an essentially biological process

Inventions which concern plants or animals are patentable provided that the application of the invention is not technically confined to a single plant or animal variety (EU Dir. 98/44/EC, rec. 29). However, said plants or animals must not be exclusively obtained by means of an essentially biological process (see G‑II, 5.4).

The exclusion regarding plants and animals exclusively obtained by means of an essentially biological process applies to patent applications with a filing date and/or a priority date after 1 July 2017. It does not apply to patents granted before that date or to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, can be the result of both a technical intervention (e.g. directed mutagenesis) and an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product (see examples in G‑II, 5.4.2.1 and G‑II, 5.4). Such a disclaimer will only be necessary for patent applications with a filing date and/or a priority date after 1 July 2017. A disclaimer will not be required for patents granted before that date or for pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119). If, on the other hand, the feature in question can be obtained by technical intervention only, e.g. a transgene, no disclaimer is necessary. For the general principles governing disclaimers, see H‑V, 4.

The subject-matter of a claim covering but not identifying plant varieties is not a claim to a variety or varieties (see G 1/98, Reasons 3.8). In the absence of the identification of a specific plant variety in a product claim, the subject-matter of the claimed invention is neither limited nor directed to a variety or varieties within the meaning of Art. 53(b) (G 1/98, Reasons 3.1 and 3.10) and therefore is not excluded from patentability. More detailed instructions on the exclusions on plant varieties can be found in G‑II, 5.4.1.

Rule 27(b)
Rule 28(2)

(iii)
A microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety

Rule 27(c)

“Microbiological process” means any process involving or performed upon or resulting in microbiological material.

37
Q

5.3 List of exceptions (Rule 28)

A

In the area of biotechnological inventions, the following list of exceptions to patentability under Art. 53(a) and Art. 53(b) is laid down in Rule 28. Under Art. 53(a) the list is illustrative and non-exhaustive and is to be seen as giving concrete form to the concept of “ordre public” and “morality” in this technical field. A possible immoral use is only to be taken into account if it is specifically considered or at least suggested in the application and can thus be found to constitute an avowed use (G‑II, 4.1 and T 866/01).

According to Rule 28(2), plants and animals exclusively obtained by means of an essentially biological process are excluded from patentability. This exclusion regarding plants and animals exclusively obtained by means of an essentially biological process applies to patent applications with a filing date and/or a priority date after 1 July 2017. It does not apply to patents granted before that date or to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

Under Art. 53(a), in conjunction with Rule 28(1), European patents are not to be granted in respect of biotechnological inventions which concern:

Rule 28(1)

(i)
Processes for cloning human beings

For the purpose of this exception, a process for the cloning of human beings may be defined as any process, including techniques of embryo splitting, designed to create a human being with the same nuclear genetic information as another living or deceased human being (EU Dir. 98/44/EC, rec. 41).

Rule 28(1)(a)

(ii)
Processes for modifying the germ line genetic identity of human beings

Rule 28(1)(b)

(iii)
Uses of human embryos for industrial or commercial purposes

A claim directed to a product which at the filing date of the application could be exclusively obtained by a method which necessarily involved the destruction of human embryos from which the said product is derived is excluded from patentability under Rule 28(1)(c), even if said method is not part of the claim (see G 2/06). The point in time at which such destruction takes place is irrelevant (T 2221/10).

When examining subject-matter relating to human embryonic stem cells under Art. 53(a) and Rule 28(1)(c), the following has to be taken into account:

(a)
the entire teaching of the application, not only the claim category and wording, and

(b)
the relevant disclosure in the description in order to establish whether products such as stem cell cultures are obtained exclusively by the use, involving the destruction, of a human embryo or not. For this purpose, the disclosure of the description has to be considered in view of the state of the art at the date of filing.

An application pertaining to human pluripotent stem cells, including human embryonic stem cells, uses thereof or products derived therefrom cannot be regarded as excluded from patentability under Art. 53(a) and Rule 28(1)(c) (T 0385/14) if (i) the application has an effective date (i.e. a valid priority date or, if no priority is claimed or the priority is not valid, a filing date) on or after 5 June 2003, and (ii) its technical teaching can be put into practice using human embryonic stem cells derived from parthenogenetically activated human oocytes. In such cases, any disclosure, embodiment, example or similar encompassing the use of human embryonic stem cells excluded from patentability under Art. 53(a) must be excised from the description or prominently marked as not being according to the claimed invention (e.g. by using the term “reference human embryonic stem cell”) (see F‑IV, 4.3).

Foetal and post-natal human cells are in principle not excluded from patentability.

Culture media, supports and apparatuses “suitable for” use with human embryonic cells, or even “specifically designed” for this purpose, are not per se excluded from patentability. Their production normally does not require the use of human embryos as base material.

The exclusion of the use of human embryos for industrial or commercial purposes does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it (EU Dir. 98/44/EC, rec. 42).

Rule 28(1)(c)

(iv)
Processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes

A claim directed to genetically modified animals or to processes for genetically modifying animals needs to meet the requirements of Rule 28(1)(d) and Art. 53(a) (see T 315/03 and T 19/90).

To fulfil the requirements of Rule 28(1)(d), the following needs to be established:

(a)
that the subject-matter in question concerns a process for modifying the genetic identity of animals or animals resulting from that process,

(b)
the likelihood of animal suffering,

(c)
the likelihood of substantial medical benefit and

(d)
the necessary correspondence between suffering and substantial medical benefit in terms of the animals claimed.

The level or standard of proof for establishing animal suffering and substantial medical benefit is likelihood. The correspondence has to be established according to the balance-of-probabilities approach (E‑IV, 4.3).

For Art. 53(a), a careful weighing-up of the suffering of animals and possible risks to the environment, on the one hand, and the invention’s usefulness to mankind, on the other hand, are used to the extent that those two aspects are supported by evidence (see T 19/90 and T 315/03).

The substantial medical benefit referred to above includes any benefit in terms of research, prevention, diagnosis or therapy (EU Dir. 98/44/EC, rec. 45).

The above must be applied to the whole scope of the claim.

For applications relating to non-genetically modified animals, in all cases where animal suffering or possible risks to the environment is involved, the provisions of Art. 53(a) have to be assessed by considering the invention’s usefulness to mankind (T 1553/15).

Rule 28(1)(d)

In addition, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions (see, however, G‑II, 5.2). Such stages in the formation or development of the human body include germ cells (EU Dir. 98/44/EC, rec. 16).

A parthenote is neither a human body at a stage of its formation and development nor one of its elements (i.e. human germ cell); thus a parthenote or cells derived therefrom are in principle not excluded from patentability under Rule 29(1).

Also excluded from patentability under Art. 53(a) are processes to produce chimeras from germ cells or totipotent cells of humans and animals (EU Dir. 98/44/EC, rec. 38).

38
Q

5.4 Plant and animal varieties or essentially biological processes for the production of plants or animals

A

The list of exceptions to patentability under Art. 53(b) also includes “plant or animal varieties or essentially biological processes for the production of plants or animals”.

Art. 53(b)

Rule 28(2) excludes products (plants/animals and plant/animal parts) exclusively obtained by non-technical, i.e. essentially biological, processes. This exclusion regarding plants and animals exclusively obtained by means of an essentially biological process applies to patent applications with a filing date and/or a priority date after 1 July 2017. It does not apply to patents granted before that date or to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

The exclusion extends to plants and animals exclusively obtained by means of an essentially biological process where no direct technical intervention in the genome of the plants or animals takes place, as the relevant parental plants or animals are merely crossed and the desired offspring is selected for. This is the case even if technical means are provided serving to enable or assist the performance of the essentially biological steps. In contrast, plants or animals produced by a technical process which modifies the genetic characteristics of the plant or animal are patentable.

The term exclusively is used here to mean that a plant or animal originating from a technical process or characterised by a technical intervention in the genome is not covered by the exclusion from patentability even if in addition a non-technical method (crossing and selection) is applied in its production.

Determining whether a plant or animal is obtained by exclusively biological means entails examining whether there is a change in a heritable characteristic of the claimed organism which is the result of a technical process exceeding mere crossing and selection, i.e. not merely serving to enable or assist the performance of the essentially biological process steps.

Thus transgenic plants and technically induced mutants are patentable, while the products of conventional breeding are not.

Both targeted mutation, e.g. with CRISPR/Cas, and random mutagenesis such as UV-induced mutation are such technical processes. When looking at the offspring of transgenic organisms or mutants, if the mutation or transgene is present in said offspring it is not produced exclusively by an essentially biological method and is thus patentable.

Furthermore, for living matter to be patentable, it must be possible to reproduce it in a way that has exactly the same technical features. Reproducibility can be assured for example:

(1)
By a deposit of the living matter (seeds, microbiological strains). The deposited material must be publicly available and such that the invention can actually be reproduced starting from it. If, for example, a novel and inventive trait is due to a single transgene, a skilled person can reproduce the invention from a living sample. If, instead, the claimed trait is dependent on a large number of structurally undefined loci in the genome, these will segregate in subsequent generations and it will be an undue burden to reproduce the invention from the deposited sample (T 1957/14).

(2)
By disclosing in the application as filed the gene sequence responsible for the claimed trait together with instructions on how to reproducibly introduce by technical means such an altered sequence in a target organism (e.g. by CRISPR-Cas).

If a technical feature of a claimed plant or animal, e.g. a single nucleotide exchange in the genome, might be the result of either a technical intervention (e.g. directed mutagenesis) or an essentially biological process (a natural allele), a disclaimer is necessary to delimit the claimed subject-matter to the technically produced product in order to comply with the requirements of Art. 53(b) and Rule 28(2). Otherwise the subject-matter is directed to excluded subject-matter and is to be refused on the basis of Art. 53(b) in conjunction with Rule 28(2). A disclaimer is required in all cases and, in particular, even if the description only mentions a technical method of production and is silent on the use of an essentially biological process. If, on the other hand, the feature in question can unambiguously be obtained by technical intervention only, e.g. a transgene, no disclaimer is necessary.

This should apply also if such a disclaimer relates to subject-matter that was not disclosed in the application as filed. In such a case the disclaimer fulfils the requirements laid down in G 1/03, G 2/03 and G 1/16 because it is introduced to exclude subject-matter not eligible for patent protection (for the general principles governing disclaimers see also H‑V, 4).

Such a disclaimer will only be necessary for patent applications with a filing date and/or a priority date after 1 July 2017. A disclaimer will not be required for patents granted before that date or for pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

The technicality of a claimed plant or animal product may lie in a non-heritable physical feature imparted directly to the claimed organism, e.g. a seed coated with a beneficial chemical.

The technical method of production of the plant or animal may be included in the claims, in the form of product-by-process claims (see F‑IV, 4.12).

Plant products that are not propagation material, such as flour, sugars or fatty acids, have to be considered on the basis of their chemical properties only. Thus provided the general patentability requirements are fulfilled, it will not be relevant whether the subject-matter (e.g. a sugar molecule) is isolated from a product (e.g. a living plant) of an essentially biological process or is produced in a laboratory.

Examples are provided below under G‑II, 5.4.2.1.

This exclusion regarding plants and animals exclusively obtained by means of an essentially biological process does not apply to patents granted before 1 July 2017 or to pending patent applications with a filing date and/or a priority date before 1 July 2017 (see G 3/19, OJ EPO 2020, A119).

For these applications and these granted patents, the exclusion from patentability of essentially biological processes for the production of plants does not have a negative effect on the allowability of a product claim directed to plants or plant material such as seeds or other plant propagation material. This applies even if the only method available at the filing date for generating the claimed plants or plant material is an essentially biological process for the production of plants, and also if the claimed product is defined in terms of such a process (product-by-process claim, see F‑IV, 4.12). In this context it is of no relevance that the protection conferred by the product claim encompasses the generation of the claimed product by means of an essentially biological process for the production of plants (see G 2/12 and G 2/13). The same principle applies mutatis mutandis with regard to animals produced by means of essentially biological processes (see also F‑IV, 4.12).

For patent applications with a filing date and/or a priority date on or after 1 July 2017, if the technical characteristics of a claimed plant or animal are due to a technical step, the description must not contain any references to essentially biological methods (such as screening wild populations or conventional breeding) as an alternative method to obtain the claimed plant or animal. If such references are made, they must be deleted because they are not commensurate with the scope of the claim. Adapting the description is necessary – in addition to the disclaimer in the claims – to bring it into line with the claims (see F‑IV, 4.3) but there is no need for an additional disclaimer in the description. In contrast, any mention of essentially biological processes to multiply or transfer a feature obtained with technical means, e.g. mutagenesis, may remain in the description, even though they cannot be claimed.

39
Q

5.4.1 Plant varieties

A

The term “plant variety” is defined in Rule 26(4). A patent is not to be granted if the claimed subject-matter is directed to a specific plant variety or specific plant varieties. The method for the plant’s production, be it by recombinant gene technology or by a classical plant breeding process, is irrelevant for considering this issue (see T 1854/07). Therefore, plant varieties containing genes introduced into an ancestral plant by recombinant gene technology are excluded from patentability (G 1/98). However, if the invention concerns plants or animals, which are not exclusively obtained by means of an essentially biological process (see G‑II, 5.4, above and G 3/19), and if the technical feasibility of the invention is not confined to a particular plant or animal variety, the invention is patentable (see G‑II, 5.2).

A claimed plant grouping is not excluded from patentability under Art. 53(b) if it does not meet the definition of a plant variety set out in Rule 26(4).

When a claim to a process for the production of a plant variety is examined, Art. 64(2) is not to be taken into consideration (see G 1/98). Hence, a process claim for the production of a plant variety (or plant varieties), which is not exclusively essentially biological, is not a priori excluded from patentability merely because the resulting product constitutes or may constitute a plant variety.

Controlled hybrids with inbred parents are excluded from patentability under Art. 53(b), as they define either a seed or a plant which necessarily belongs to a particular plant grouping within the meaning of plant variety pursuant to Rule 26(4).

A claim cannot escape the exclusion of plant varieties under Art. 53(b) by consisting of a large number of varieties, not even if there are hundreds of them. Only if the subject-matter of the claim comprises at least one embodiment which does not constitute a variety is the claim allowable under Art. 53(b) (see T 1208/12). For instance, a claim directed to a hybrid of a specific deposited Brassica variety with any high-yielding Brassica variety results in a Brassica hybrid variety, which is not patentable.

40
Q

5.4.2 Essentially biological processes for the production of plants or animals

A

A process for the production of plants or animals which is based on the sexual crossing of whole genomes and on the subsequent selection of plants or animals is excluded from patentability as being essentially biological. This applies even if the process comprises human intervention, including the provision of technical means, serving to enable or assist the performance of the process steps or if other technical steps relating to the preparation of the plant or animal or its further treatment are present in the claim before or after the crossing and selection steps (see G 1/08 and G 2/07).

To take some examples, a method of crossing, interbreeding, or selectively breeding, say, horses involving merely selecting for breeding and bringing together those animals (or their gametes) having certain characteristics would be essentially biological and therefore excluded from patentability. Also selfing of a transgenic plant is excluded from patentability, as selfing, like crossing, is the mixing of entire genomes. These methods remain essentially biological and thus excluded from patentability even if they contain an additional feature of a technical nature, for example the use of genetic molecular markers to select either parent or progeny. Patent protection is available for any such additional technical steps per se which are performed either before or after the process of crossing and selection. However, such steps are ignored when determining whether or not the process as a whole is excluded from patentability under Art. 53(b) EPC (see G 1/08, G 2/07).

However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then such a process is not excluded from patentability under Art. 53(b) but qualifies as a potentially patentable technical teaching (see G 1/08, G 2/07).

Genetic engineering techniques applied to plants which techniques differ profoundly from conventional breeding techniques as they work primarily through the purposeful insertion and/or modification of one or more genes in a plant are patentable (see T 356/93). However, in such cases the claims must not, explicitly or implicitly, include the sexual crossing and selection process.

Processes for selecting plants or animals using genetic molecular markers without crossing the plants or animals are not excluded from patentability. Technical means, such as genetic molecular markers, used in such processes are not excluded, either.

A process for producing triploid seedless melon fruit which involves the pollination of sterile female flowers of a triploid plant, unable to carry out successful meiosis, with pollen of the diploid polliniser plant and which therefore does not concern sexually crossing two whole genomes of plants (implying meiosis and fertilisation) and the subsequent selection of plants is not an essentially biological process and is hence not excluded from patentability (T 1729/06).

A process of treating a plant or animal to improve its properties or yield or to promote or suppress its growth, e.g. a method of pruning a tree, would not be an essentially biological process for the production of plants or animals since it is not based on the sexual crossing of whole genomes and subsequent selection of plants or animals; the same applies to a method of treating a plant characterised by the application of a growth-stimulating substance or radiation. The treatment of soil by technical means to suppress or promote the growth of plants is also not excluded from patentability (see also G‑II, 4.2.1).

Claims to breeding methods leaving out an explicit reference to either a crossing or selection step, but where such a step is an essential feature, lack clarity and support (Art. 84).

The abbreviation NBT stands for “new breeding techniques”. This is not a technical term, but a general one which is used for a variety of methods, some clearly technical but others either comprising or consisting of essentially biological processes. Therefore it is not suitable to differentiate whether claimed subject-matter is allowable under Art. 53(b) and has no relevance in terms of patentability.