G - patentability CH6 Flashcards
- State of the art pursuant to Art. 54(2)
An invention is considered to be new if it does not form part of the state of the art. For a definition of “state of the art”, see G‑IV, 1. It is to be noted that in considering novelty (as distinct from inventive step; see G‑VII, 6), it is not permissible to combine separate items of prior art together. It is also not permissible to combine separate items belonging to different embodiments described in one and the same document unless such combination has specifically been suggested (see T 305/87). For the specific case of selection inventions see G‑VI, 8.
Furthermore, any matter explicitly disclaimed (with the exception of disclaimers which exclude unworkable embodiments) and prior art acknowledged in a document, in so far as explicitly described therein, are to be regarded as incorporated in the document.
It is further permissible to use a dictionary or similar document of reference in order to interpret a special term used in a document.
An unclear term cannot be used to distinguish the invention from the prior art and is not allowable under Art. 84 (see F‑IV, 4.6.1).
- Implicit features or well-known equivalents
A document takes away the novelty of any claimed subject-matter derivable directly and unambiguously from that document including any features implicit to a person skilled in the art in what is expressly mentioned in the document, e.g. a disclosure of the use of rubber in circumstances where clearly its elastic properties are used even if this is not explicitly stated takes away the novelty of the use of an elastic material. The limitation to subject-matter “derivable directly and unambiguously” from the document is important. Thus, when considering novelty, it is not correct to interpret the teaching of a document as embracing well-known equivalents which are not disclosed in the documents; this is a matter of obviousness.
- Relevant date of a prior-art document
In determining novelty, a prior-art document is to be read as it would have been read by a person skilled in the art on its relevant date. By “relevant” date is meant the publication date of the prior-art document in the case of a previously published document and the date of filing (or priority date, where applicable) in the case of a document according to Art. 54(3) (see G‑IV, 5.1).
- Enabling disclosure of a prior-art document
Subject-matter described in a document can only be regarded as having been made available to the public, and therefore as comprised in the state of the art pursuant to Art. 54(1), if the information given therein is sufficient to enable the skilled person, at the relevant date of the document (see G‑VI, 3), to practise the technical teaching which is the subject of the document, taking into account also the general knowledge at that time in the field (see T 26/85, T 206/83 and T 491/99).
Similarly, it is to be noted that a chemical compound, the name or formula of which is mentioned in a prior-art document, is not thereby considered as known unless the information in the document, together, where appropriate, with knowledge generally available on the relevant date of the document, enables it to be prepared and separated or, for instance in the case of a product of nature, only to be separated.
- Generic disclosure and specific examples
In considering novelty, it is to be borne in mind that a generic disclosure does not usually take away the novelty of any specific example falling within the terms of that disclosure, but that a specific disclosure does take away the novelty of a generic claim embracing that disclosure, e.g. a disclosure of copper takes away the novelty of metal as a generic concept, but not the novelty of any metal other than copper, and one of rivets takes away the novelty of fastening means as a generic concept, but not the novelty of any fastening other than rivets.
- Implicit disclosure and parameters
In the case of a prior-art document, the lack of novelty may be apparent from what is explicitly stated in the document itself. Alternatively, it may be implicit in the sense that, in carrying out the teaching of the prior-art document, the skilled person would inevitably arrive at a result falling within the terms of the claim. An objection of lack of novelty of this kind is raised by the examiner only where there can be no reasonable doubt as to the practical effect of the prior teaching (for a second non-medical use, however, see G‑VI, 7).
Situations of this kind may also occur when the claims define the invention, or a feature thereof, by parameters (see F‑IV, 4.11). It may happen that in the relevant prior art a different parameter, or no parameter at all, is mentioned. If the known and the claimed products are identical in all other respects (which is to be expected if, for example, the starting products and the manufacturing processes are identical), then in the first place an objection of lack of novelty arises. The burden of proof for an alleged distinguishing feature lies with the applicant. No benefit of doubt can be accorded if the applicant does not provide evidence in support of the allegations (see T 1764/06). If, on the other hand, the applicant is able to show, e.g. by appropriate comparison tests, that differences do exist with respect to the parameters, it is questionable whether the application discloses all the features essential to manufacture products having the parameters specified in the claims (Art. 83).
- Examination of novelty
In determining novelty of the subject-matter of claims, the examiner must have regard to the guidance given in F‑IV, 4.5 to 4.21. Particularly for claims directed to a physical entity, non-distinctive characteristics of a particular intended use are to be disregarded (see F‑IV, 4.13.1). For example, a claim to a substance X for use as a catalyst would not be considered to be novel over the same substance known as a dye unless the use referred to implies a particular form of the substance (e.g. the presence of certain additives) which distinguishes it from the known form of the substance. That is to say, characteristics not explicitly stated, but implied by the particular use, are to be taken into account (see the example of a “mold for molten steel” in F‑IV, 4.13.1). For claims to a first medical use, see G‑II, 4.2.
A claim defining a compound as having a certain purity lacks novelty over a prior-art disclosure describing the same compound only if the prior art discloses the claimed purity at least implicitly, for example by way of a method for preparing said compound, the method inevitably resulting in the purity as claimed. Such a claim, however, does not lack novelty if the disclosure of the prior art needs to be supplemented, for example by suitable (further) purification methods allowing the skilled person to arrive at the claimed purity.
7.1 First or further medical use of known products
Where a substance or composition is already known, it may still be patentable under Art. 54(4) if the known substance or composition was not previously disclosed for use in a method referred to in Art. 53(c).
Where a substance or composition is already known to have been used in a “first medical use”, it may still be patentable under Art. 54(5) for any second or further use in a method according to Art. 53(c), provided that said use is novel and inventive.
Art. 54(4) and (5) thus provide for an exception from the general principle that product claims can only be obtained for novel products. However, this does not mean that product claims for the first and further medical uses need not fulfil all other requirements of patentability, especially that of inventive step (see T 128/82).
A claim in the form “Use of substance or composition X for the treatment of disease Y…” will be regarded as relating to a method for treatment explicitly excluded from patentability under Art. 53(c) and therefore will not be accepted. A claim in the form “Substance X for use as a medicament” is acceptable, even if X is a known substance, but its use in medicine is not known. Likewise, it is acceptable to have a claim in the form “Substance X for use in the treatment of disease Y”, provided that such a claim involves an inventive step over any prior art disclosing the use of X as a medicament.
If an application discloses for the first time a number of distinct surgical, therapeutic or diagnostic uses for a known substance or composition, normally independent claims each directed to the substance or composition for one of the various uses are allowed; i.e. an a priori objection of lack of unity of invention is not, as a general rule, raised (see F‑V, 7).
Where the subject-matter of a claim is rendered novel only by a new therapeutic use of a medicament, the claim may no longer have the format of a so-called “Swiss-type” claim as instituted by decision G 5/83 (“Use of a substance or composition X for the manufacture of a medicament for therapeutic application Z”) if the application has a filing or earliest priority date of 29 January 2011 or later (see the notice from the EPO dated 20 September 2010, OJ EPO 2010, 514).
The effect of the different claim formulations on patentability is summarised in the table below:
- Note: The corresponding Swiss-type claims for cases C and D (required under EPC 1973) would be “The use of Product X for the manufacture of a medicament for the treatment of cancer/leukaemia”.
In cases where an applicant simultaneously discloses more than one “subsequent” therapeutic use, claims of the above type directed to these different uses are allowable in the one application, but only if they form a single general inventive concept (Art. 82). Regarding use claims of the above type, it is also to be noted that a mere pharmaceutical effect does not necessarily imply a therapeutic application. For instance, the selective occupation of a specific receptor by a given substance cannot be considered in itself as a therapeutic application; indeed, the discovery that a substance selectively binds a receptor, even if representing an important piece of scientific knowledge, still needs to find an application in the form of a defined, real treatment of a pathological condition in order to make a technical contribution to the art and to be considered as an invention eligible for patent protection (see T 241/95). See also F‑IV, 4.22 for the functional definition of a pathological condition.
A claim in the format of a Swiss-type claim is a purpose-related process claim, whereas a claim drafted in accordance with Art. 54(5) is a purpose-related product claim. Therefore, such claims have different categories. This has the following consequences:
(i)
If a parent application has been granted with a Swiss-type claim, granting a patent on the basis of the purpose-related product claim in its divisional application would not lead to double patenting (T 13/14; see also G‑IV, 5.4).
(ii)
Since a claim to a particular physical activity (e.g. method, process, use) confers less protection than a claim to the physical entity per se (G 2/88, Reasons 5.1), a Swiss-type claim confers less protection than a claim formulated according to Art. 54(5). Therefore a change from a Swiss-type claim to a claim drafted in accordance with Art. 54(5) contravenes Art. 123(3) (T 1673/11; see also H‑IV, 3.4).
7.1.1 Products that may be claimed for a further medical use
The scope of protection of use-related product claims under Art. 54(5) is limited to the substance or composition in the context of its medical use which confers novelty and non-obviousness, if any, on the claimed product.
This principle applies only to substances and compositions and cannot be extended to other products. A claim directed to a device for an intended medical use (e.g. pacemaker or implantable chemical sensor for use in …) must be construed as claiming a device which is suitable for that medical use (F‑IV, 4.13).
A product qualifies as a “substance or composition” in the sense of Art. 54(5) if it is the active agent or ingredient in the specific medical use and if the therapeutic effect can be ascribed to its chemical properties (see G 5/83 and T 1758/15). For example, consider a filler material which is injected between a first tissue targeted for radiation treatment and a second sensitive tissue which is desired to be protected from radiation. If the shielding effect of the filler material is achieved by a mere mechanical displacement of the sensitive tissue relative to the target tissue, due to the volume it occupies between the two tissues, the filler material qualifies as a device rather than a substance or composition. On the other hand, if the filler material produced a radiation-reducing effect on the sensitive tissue which could be attributed to its chemical properties, it would be considered as a “substance or composition” in the sense of Art. 54(5).
7.1.2 Therapeutic uses pursuant to Art. 54(5)
The treatment of a disease with a substance or composition which is already known to be used for treating said disease, where the only difference from the known treatment is in the dosage regime, is a specific further medical use within the meaning of Art. 54(5) (see G 2/08). Thus, therapeutic uses of a substance/composition may be based not only on the treatment of a different disease but also on the treatment of the same disease by a different therapeutic method differing for example in the dosage, administration regime, group of subjects or route of administration (G 2/08).
A claim directed to the further therapeutic use of a substance/composition must indicate the illness/disease to be treated, the nature of the therapeutic compound used for that purpose and, if relevant for establishing novelty and inventive step, the subject to be treated. If the further therapeutic use relates to a different therapy of the same disease using the same substance/composition, the claim must also define all technical features of the therapy giving rise to the desired technical effect (G 2/08).
An independent claim directed to a further therapeutic use of a substance/composition which is based on the use of said product in the treatment of a different disease must be formulated as follows:
Substance X
or
Composition comprising X
for use
in a method for the treatment of Y, or
in the therapy of Y, or
in a method of treating Y, or
in a method of therapy of Y, or
as a medicament defined by its function, (e.g. as an anti-inflammatory medicament)
The presence of the term “for use” is mandatory, to closely adhere to the wording of Art. 54(5).
If the independent claim is directed to a composition, the definition of the composition may be inserted before or after the term “for use”. For example: “Composition comprising X for use in the therapy of Y” or “Composition for use in the therapy of Y comprising X”.
If the further therapeutic use is based on the use of the same product in a different treatment of the same disease, the independent claim must be formulated as follows:
Substance X for use
or
Composition comprising X for use
in a method for the treatment of Y, or
in the therapy of Y, or
in a method of treating Y, or
in a method of therapy of Y, or
as a medicament defined by its function (e.g. as an anti-inflammatory medicament)
characterised in that/ wherein
other features (e.g. the substance/ composition is administered topically, three times daily…)
Purpose-related product claims which do not define exclusively (see claim 4 in the table below) a medical use excluded from patentability under Art. 53(c) are construed as claims directed to a product per se which is suitable for the claimed use.
The table below shows some examples of claims which do not define a further medical use within the meaning of Art. 53(c).
… because …
- Substance X or Composition comprising X in/for
a method for the treatment of Y, or
the therapy of Y, or
a method of treating Y, or
a method of therapy of Y, or the (topical) treatment of Y, or
the (topical) therapy of Y
without the term “for use” it is not evident if the claim is directed to the product suitable for the specified use or if the claim is limited by the medical use
- (Anti-inflammatory) medicament, or Pharmaceutical comprising substance X, or Composition comprising X
for topical treatment
the claim indicates neither a therapeutic role nor a therapeutic application of the claimed product. Moreover, without the term “for use” it is not evident if the claim is directed to the product suitable for the specified use or if the claim is limited by the medical use
- Substance X or Composition comprising X
as an anti-inflammatory
agent
without the term “for use” it is not evident if the claim is directed to the product suitable for the specified use or if the claim is limited by the medical use
- Substance X or
Composition comprising X
for use as an antifungal /antibacterial agent
the claim does not define a specific medical use of the claimed product. It encompasses non-medical uses, because antifungal/ antibacterial agents are also used in e.g. agriculture for treating plants
If the prior art discloses either the product per se in a form which could be considered suitable for the claimed use, or its first medical application, claims 1 to 4 would lack novelty. The novelty objection could be overcome by reformulating the claim as described above (first table of G‑VI, 7.1.2).
These amendments may be proposed by the examining division in the Rule 71(3) communication without the need to consult the applicant beforehand (see C‑V, 1.1, point (f)).
The following are examples of claims which would not be considered novel:
Example 1
Composition comprising X for use by topical treatment/application
It is assumed that a composition comprising X is already known in the prior art.
Reasons for objection: Since the claim fails to identify the specific therapeutic indication for X, the feature “for topical treatment/application” remains de facto purely illustrative and does not limit the scope of the claim to that specific application.
Furthermore, the term “topical treatment/application” does not necessarily relate to use in a method referred to in Art. 53(c) since it could refer to a cosmetic treatment. Consequently, the subject-matter of the claimed composition would be anticipated if said composition comprising X is already known in the prior art.
Example 2
Composition comprising X for use in therapy by topical administration
It is assumed that a composition comprising X is already known in the prior art for a medical use.
Reasons for objection: The mode of administration may be a critical factor in a medical treatment and has been considered as a limiting feature, but only in relation to a further (specific) medical indication (T 51/93). “Topical administration” specifies only the mode of delivery, but does not relate to any therapeutic effect obtained thereby. Consequently, since the claim fails to identify the specific therapeutic indication, the feature “by topical administration” is merely illustrative and not a restrictive technical feature capable of establishing novelty. The subject-matter of the claimed composition would thus be anticipated if said composition comprising X is already known in the prior art for any medical use.
Example 3
Product X for use in a method of contraception
Reasons for objection: Such a claim would not be considered novel over the disclosure of product X per se because pregnancy is not a disease. This claim can usually be reformulated as a method of contraception using product X. Reformulation may not be possible in so far as the contraception method involves the personal and private sphere, i.e. it does not fulfil the requirement of industrial application (T 74/93).
7.1.3 Diagnostic uses pursuant to Art. 54(5)
A suitable formulation of a diagnostic claim according to Art. 54(5) may read:
Substance X
or
Composition comprising X
for use in a method of diagnosis
“in vivo”
of disease Y
The wording “in vivo” limits the scope of the claim to diagnostic methods which are excluded from patentability pursuant to Art. 53(c).
If the independent claim is directed to a composition, the definition of the composition may be inserted before or after the term “for use”.
Purpose-related product claims which do not define a diagnostic use excluded from patentability under Art. 53(c) are construed as claims directed to a product per se which is suitable for the claimed use.
The following table shows some examples of claims which do not define a diagnostic use within the meaning of Art. 53(c):
- Substance X or Composition comprising X
for use in the diagnosis of disease Y,
or for use in the “in vitro”/”ex vivo” diagnosis of disease Y
- Substance X or Composition comprising X
for use as a contrast agent for imaging blood flow
Claims 1 and 2 would lack novelty over prior art disclosing either the product per se in a form which could be considered suitable for the claimed use, or its first medical application.
Claim 1 could be reformulated as “Use of […] in the “in vitro/ex vivo” diagnosis of disease Y”. If the application as filed discloses, either explicitly or implicitly, that the claimed diagnostic methods are to be carried out “in vivo”, the wording of claim 1 could also be limited to encompass only “in vivo” methods, as described above.
Claim 2 could be reformulated as “Use of […] as contrast agent for imaging blood flow”.
Claims 1 and 2 could also be reformulated as method claims, e.g. “A method for in vitro/ex vivo diagnosing disease Y using substance X […]” or “ A method for diagnosing disease Y in a sample by using substance X […]” or “A method of imaging blood flow using substance X […]”.
These amendments may be proposed by the examining division in the Rule 71(3) communication without the need to consult the applicant beforehand (see C‑V, 1.1, point (f)).
7.1.4 Surgical uses pursuant to Art. 54(5)
A claim defining a second surgical use may read “Substance X/ Composition comprising X for use in a method of intracardiac catheterisation as a protector of blood vessel walls”.
If the independent claim is directed to a composition, the definition of the composition may be inserted before or after the term “for use”.
Purpose-related product claims which do not define a surgical use excluded from patentability under Art. 53(c) are construed as claims directed to a product per se which is suitable for the claimed use.
The following table shows an example of a claim which does not define a surgical use within the meaning of Art. 53(c):
- Substance X or
Composition comprising X
for use in a method for hair removal by laser radiation
The claim would lack novelty over prior art disclosing either the product per se in a form which could be considered suitable for the claimed use, or its first medical application.
The claim could be reformulated as “Use of […] for hair removal by laser radiation” or as “Method for removing hair by laser radiation by using substance X […]”.
This amendment may be proposed by the examining division in the Rule 71(3) communication without the need to consult the applicant beforehand (see C‑V, 1.1, point (f)).
7.1.5 Dependent claims pursuant to Art. 54(5)
The wording of the dependent claims must clearly reflect their dependency on the independent claim (T 2106/10). A suitable formulation may read:
Substance (X) or
Composition (comprising X) (according to claim #)
for use in the therapy of disease Y according to claim # or
for use according to claim #
wherein
other features (e.g. it is provided as water-soluble granulates)
In the following example, the dependent claim is not correctly formulated according to Art. 54(5).
Claim 1: Composition comprising X for use in the treatment of Y.
Claim 2: Composition according to claim 1, comprising 5 mg X.
The category of claim 2 is unclear and the dependency is doubtful. The claim appears to depend on a claim directed to a product per se.
The claim would also lack novelty over prior art disclosing a composition comprising 5 mg X, or a first medical application thereof.
The claim must be reformulated as indicated above by inserting “for use” between “Composition” and “according”. This amendment may be proposed by the examining division in the Rule 71(3) communication without the need to consult the applicant beforehand (see C‑V, 1.1, point (f)).
7.2 Second non-medical use
A claim to the use of a known compound for a particular purpose (second non-medical use) which is based on a technical effect is interpreted as including that technical effect as a functional technical feature. Accordingly, said claim is not open to objection under Art. 54(1), provided that such technical feature has not previously been made available to the public (G 2/88, and G 6/88). The novelty of the use of the known compound for the known production of a known product cannot be deduced from a new property of the produced product. In such a case, the use of a compound for the production of a product has to be interpreted as a process for production of the product with the compound. It can be regarded as novel only if the process of production as such is novel (see T 1855/06). For claims to a second or further medical use, see G‑II, 4.2.
However, a feature of a step in a chemical process which merely serves to explain the technical effect obtained is not a functional technical feature which could render a claim novel over prior art which discloses the same process with the same step which provides the same effect, even if it does not comprise a corresponding indication of technical effect. It is rather considered to be a discovery (T 151/13).
- Selection inventions
Selection inventions deal with the selection of individual elements, subsets, or sub-ranges, which have not been explicitly mentioned, within or overlapping with a known set or range.
For determining novelty, it has to be decided which subject-matter has been made available to the public by a prior-art disclosure and thus forms part of the state of the art. In this context, it is not only examples, but the whole content of the prior-art document which has to be taken into consideration. Matter that is “hidden” in a prior-art document, in the sense of being reconditely submerged rather than deliberately concealed, is not considered to have been made available to the public (see T 666/89).
(i)
In determining the novelty of a selection, it has to be decided whether the selected elements are disclosed in an individualised (concrete) form in the prior art. A selection from a single list of specifically disclosed elements does not confer novelty. However, if a selection from two or more lists of a certain length has to be made in order to arrive at a specific combination of features then the resulting combination of features, not specifically disclosed in the prior art, confers novelty (the “two-lists principle”). Examples of such selections from two or more lists are the selection of:
(a)
individual chemical compounds from a known generic formula whereby the compound selected results from the selection of specific substituents from two or more “lists” of substituents given in the known generic formula. The same applies to specific mixtures resulting from the selection of individual components from lists of components making up the prior art mixture;
(b)
starting materials for the manufacture of a final product;
(c)
sub-ranges of several parameters from corresponding known ranges.
(ii)
A sub-range selected from a broader numerical range of the prior art is considered novel if both of the following two criteria are satisfied (see T 261/15):
(a)
the selected sub-range is narrow compared to the known range;
(b)
the selected sub-range is sufficiently far removed from any specific examples disclosed in the prior art.
The meaning of “narrow” and “sufficiently far removed” has to be decided on a case by case basis.
In this context, it must be assessed whether the skilled person, in the light of the teaching of the prior art, would seriously contemplate working in the selected sub-range. If it can be fairly assumed that the skilled person would do so, the selected sub-range is not novel. Novelty is also destroyed by explicitly mentioned intermediate values or a specific example of the prior art in the selected sub-range. Further, it is not sufficient to exclude specific novelty-destroying values known from the prior-art range to establish novelty.
The concept of “seriously contemplating” is fundamentally different from the concept used for assessing inventive step, namely whether the skilled person “would have tried, with reasonable expectation of success”, to bridge the technical gap between a particular piece of prior art and a claim whose inventiveness is in question (see G‑VII, 5.3), because in order to establish anticipation, there cannot be such a gap.
For example, in T 1571/15, regarding an alloy defined by its composition, it was held that the skilled person would not seriously contemplate working in the selected sub-range, despite it falling in the centre region of a range disclosed in the prior-art document, since said prior-art document contained a pointer to another region.
(iii)
In the case of overlapping numerical ranges between claimed subject-matter and the prior art, the same principles apply for the assessment of novelty as in the cases discussed in (i) and (ii) above.
Novelty is destroyed by an explicitly mentioned end-point of the known range, explicitly mentioned intermediate values or a specific example of the prior art in the overlap. As with the selection of a sub-range, it is not sufficient to exclude specific novelty-destroying values known from the prior-art range, it must also be considered whether the skilled person, in the light of the technical facts and taking into account the general knowledge in the field, would seriously contemplate applying the technical teaching of the prior-art document in the range of overlap.
(iv)
These principles also apply to overlapping chemical formulae. Novelty is acknowledged if the claimed subject-matter is distinguished from the prior art in the range of overlap by a new technical teaching, see T 12/90, point 2.6 of the Reasons. There is a new technical teaching if certain technical elements are new in comparison to the prior-art disclosure. An example of a new technical element is a specifically selected chemical residue which is covered in general terms by the prior art in the overlapping area, but which is not individualised in the prior art document. If this is not the case, then it must be considered whether the skilled person would seriously contemplate working in the range of overlap and/or would accept that the area of overlap is directly and unambiguously disclosed in an implicit manner in the prior art (see for example T 536/95). If the answer is yes, then novelty is lacking.
Analogous considerations apply if the claimed chemical formula defines a sub-range of a chemical formula known from the prior art.
