F-II Content of application other than claims

Question 1

1. General
   The requirements for a European patent application are set out in Art. 78. The application must contain:

Answer 1

(i)
a request for the grant of a European patent;

Art. 78(1)(a)

(ii)
a description of the invention;

Art. 78(1)(b)

(iii)
one or more claims;

Art. 78(1)(c)

(iv)
any drawings referred to in the description or the claims; and

Art. 78(1)(d)

(v)
an abstract.

This Chapter deals with all these requirements, in so far as they are the concern of the search or examining division, with the exception of item (iii) which is the subject of Chapter F‑IV. Item (v) is dealt with first.

Question 2

2.1 Purpose of the abstract (not for paper A)

Answer 2

The application must contain an abstract. The purpose of the abstract is to give brief technical information about the disclosure as contained in the description, claims and any drawings. The abstract is merely for use as technical information and in particular cannot be used for the purpose of interpreting the scope of the protection sought. The abstract needs to be drafted so that it constitutes an efficient instrument for searching in the particular technical field and for evaluating if it is worth considering the whole content of the application.

Question 3

2.2 Definitive content (not for paper A)

Answer 3

The abstract is initially supplied by the applicant. The search division has the task of determining its definitive content, which will normally be published with the application. In doing this, it considers the abstract in relation to the application as filed (see B‑X, 7(i)). If the search report is published later than the application, the abstract, published with the application will be the one resulting from the examination referred to in B‑X, 7(i), third sentence.

In determining the definitive content, the search division takes into consideration the purpose of the abstract (see F‑II, 2.1).

Question 4

2.3 Content of the abstract (not for paper A)

Answer 4

The abstract must:

(i)
indicate the title of the invention

Rule 47(1)

(ii)
indicate the technical field to which the invention pertains;

Rule 47(2)

(iii)
contain a concise summary of the disclosure as contained in the description, the claims and any drawings, which must be so drafted as to allow a clear understanding of the technical problem, the gist of the solution of that problem through the invention and the principal use or uses of the invention and, where applicable, it should contain the chemical formula which, among those contained in the application, best characterises the invention;

Rule 47(2)

(iv)
not contain statements on the alleged merits or value of the invention or its speculative application;

Rule 47(2)

(v)
preferably not contain more than one hundred and fifty words; and

Rule 47(3)

(vi)
if the application contains drawings, be accompanied by an indication of the figure or exceptionally more than one figure of the drawings which should accompany the abstract. Each main feature mentioned in the abstract and illustrated by a drawing needs to be followed by a reference sign in parenthesis.

Question 5

2.4 Figure accompanying the abstract (not for paper A)

Answer 5

The search division considers not only the text of the abstract but also the selection of the figures for publication with it. It alters the text to the extent that this may be necessary in order to meet the requirements set out in F‑II, 2.3. The search division will select a different figure, or figures, of the drawings if it considers that they better characterise the invention.

The search division may prevent the publication of any drawing with the abstract, where none of the drawings present in the application is useful for the understanding of the abstract. This can be done even when the applicant has requested that a particular drawing or drawings be published with the abstract according to Rule 47(4).

In determining the content of the abstract, the search division concentrates on conciseness and clarity, and refrains from introducing alterations merely for the purpose of embellishing the language (see B‑X, 7).

Question 6

2.5 Checklist (not for paper A)

Answer 6

In considering the abstract, the search division checks it against the General Guidelines for the Preparation of Abstracts of Patent Documents, using the checklist contained in WIPO Standard ST.12, the relevant parts of which are annexed to this Chapter (F‑II, Annex 1).

Question 7

2.6 Transmittal of the abstract to the applicant (not for paper A)

Answer 7

The content of the abstract is transmitted to the applicant together with the search report (see B‑X, 7(i)).

Question 8

2.7 Abstract in examination (not for paper A)

Answer 8

The general considerations relating to the abstract are set out in F‑II, 2.1 to F‑II, 2.6. The abstract relates to the application as filed and published and its final form for publication is determined by the search division. It is not necessary to bring it into conformity with the content of the published patent even if this should differ in substance from that of the application, since the patent specification does not contain an abstract. The examining division therefore does not seek any amendment of the abstract.

The abstract has no legal effect on the application containing it; for instance, it cannot be used to interpret the scope of protection or to justify the addition to the description of new subject-matter.

Question 9

3. Request for grant – the title

Answer 9

The items making up this request are dealt with in A‑III, 4. They do not normally concern the search division or the examining division, with the exception of the title.

The title should clearly and concisely state the technical designation of the invention and should exclude all fancy names (see A‑III, 7.1). While any obvious failures to meet these requirements are likely to be noted during the formalities examination (and possibly during the search, see B‑X, 7(ii)), the search division or the examining division reviews the title in the light of its reading of the description and claims and any amendments thereto, to make sure that the title is concise and gives a clear and adequate indication of the subject of the invention. Thus, if amendments are made which change the categories of claims, the examining division checks whether a corresponding amendment is needed in the title.

Question 10

4. Description (formal requirements)

Question 11

4.1 General remarks

Answer 11

The application must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art.

The “person skilled in the art” for this purpose is considered to be the skilled practitioner in the relevant field aware not only of the teaching of the application itself and the references therein, but also of what was common general knowledge in the art at the date of filing (date of priority) of the application. They are assumed to have at their disposal the means and the capacity for routine work and experimentation, which are normal for the technical field in question. As “common general knowledge” can generally be considered the information contained in basic handbooks, monographs and textbooks on the subject in question (see T 171/84). As an exception, it can also be the information contained in patent specifications or scientific publications, if the invention lies in a field of research which is so new that the relevant technical knowledge is not yet available from textbooks (see T 51/87). Sufficiency of disclosure must be assessed on the basis of the application as a whole, including the description, claims and drawings, if any. The provisions relating to the content of the description are set out in Rule 42. The purpose of the provisions of Art. 83 and Rule 42 is:

(i)
to ensure that the application contains sufficient technical information to enable a skilled person to put the invention as claimed into practice; and

(ii)
to enable the skilled person to understand the contribution to the art which the invention as claimed has made.

Question 12

4.2 Technical field

Answer 12

The invention should be placed in its setting by specifying the technical field to which it relates, for example by reproducing the first (“prior art”) portion of the independent claims in full or in substance or by simply referring to it.

If claims are amended, the “field of the invention” and “summary of the invention” may also need to be amended to correspond to the claims. If appropriate, it is possible to use statements like “the invention is set out in the appended set of claims” instead of repeating the claims verbatim.

Question 13

4.3 Background art

Answer 13

The description should also mention any background art of which the applicant is aware, and which can be regarded as useful for understanding the invention and its relationship to the prior art; identification of documents reflecting such art, especially patent specifications, should preferably be included. This applies in particular to the background art corresponding to the first (“prior art”) portion of the independent claim or claims (see F‑IV, 2.2).

In principle, when filing an application the applicant should cite in the description the closest prior art known to them. It may happen that the prior art cited by the applicant is not the closest existing for the claimed invention. Therefore, the documents cited in the application as filed do not necessarily describe the known innovations closest to the claimed invention, but may in fact constitute more distantly related prior art.

The insertion into the statement of prior art of references to documents identified during examination may be necessary to put the invention into proper perspective (see T 11/82). For instance, while the originally filed description of prior art may give the impression that the inventor has developed the invention from a certain point, the cited documents may show that certain stages in, or aspects of, this alleged development were already known. In such a case the examining division requires a reference to these documents and a brief summary of the relevant contents. The subsequent inclusion of such a summary in the description does not contravene Art. 123(2). The latter merely lays down that, if the application is amended, for example by limiting it in the light of additional information on the background art, its subject-matter must not extend beyond the content of the application as filed. But the subject-matter of the European patent application within the meaning of Art. 123(2) is to be understood – starting off from the prior art – as comprising those features which, in the framework of the disclosure required by Art. 83, relate to the invention (see also H‑IV, 2.1). In addition, relevant prior-art documents not cited in the original application may be subsequently acknowledged in the description even if these were known to the applicant at the time of filing (T 2321/08 and H‑IV, 2.2.7).

References to the prior art introduced after filing must be purely factual. Any alleged advantages of the invention must be adjusted if necessary, in the light of the prior art.

New statements of advantage are permissible provided that they do not introduce into the description matter which extends beyond the content of the application as filed (see H‑V, 2.2).

The applicant may cite documents in the application which relate to standard technical knowledge (background art neither addressing the same technical problem nor necessary to complete the disclosure of the claimed invention). Such citations typically relate to well-known tests for measuring certain parameters mentioned in the description or to the definitions of terms of established meaning that are used in the application. Usually they are not relevant for assessing the patentability of the claimed invention, unless for example they contain relevant information which the applicant does not mention in the description.

Acknowledgment of prior art relevant to the dependent claims only is generally not required. If the applicant indicates that subject-matter initially cited as prior art is only “in-house state of the art”, such prior art may not be used in the assessment of novelty and inventive step (see T 654/92, Reasons 4, and T 1001/98, Reasons 3). However, it may be allowed to remain in the description, provided the fact that it is only “in-house state of the art” is made clear.

Rule 42(1)(b)
Art. 123(2)

If the relevant prior art consists of another European patent application falling within the terms of Art. 54(3), this relevant prior document belongs to the state of the art for all contracting states. This is the case even if the two applications do not share any commonly designated state, or the designation of commonly designated states has been dropped (see G‑IV, 6). The fact that this document falls under Art. 54(3) must be explicitly acknowledged. Thus the public is informed that the document is not relevant to the question of inventive step (see G‑VII, 2). According to Rule 165, the above also applies to international applications designating EP, for which the filing fee pursuant to Rule 159(1)(c) has been validly paid and, where applicable, the translation into one of the official languages has been filed (Art. 153(3) and (4)) (see G‑IV, 5.2).

Art. 54(3)

For transitional provisions concerning the applicability of Art. 54(4) EPC 1973, see H‑III, 4.2.

Question 14

4.3.1 Format of background art citations

Answer 14

In citing documents or inserting references, applicants and examining divisions alike must use codes that allow the references to be retrieved without difficulty. This can be best achieved through consistent use of the WIPO standards format:

(i)
for non-patent literature, WIPO Standard ST.14 (Recommendation for the Inclusion of References Cited in Patent Documents);

(ii)
for patent literature (applications, granted patents and utility models): for the two-letter country code, WIPO Standard ST.3 (Recommended Standard on Two-Letter Codes for the Representation of States, Other Entities and Intergovernmental Organizations); for symbols indicating the type of document, WIPO Standard ST.16 (Recommended Standard Code for the Identification of Different Kinds of Patent Documents).

WIPO standards:

ST.14 (http://www.wipo.int/export/sites/www/standards/en/pdf/03-14-01.pdf)
ST.3 (http://www.wipo.int/export/sites/www/standards/en/pdf/03-03-01.pdf)
ST.16 (http://www.wipo.int/export/sites/www/standards/en/pdf/03-16-01.pdf)

These can be found on the WIPO website.

However, in the case of deviation from these standards there is no need to correct the codes used, as long as straightforward retrieval of the citation(s) is possible.

Question 15

4.3.1.1 Examples of quotation for non-patent literature

Answer 15

(i)
For a monograph:

WALTON Herrmann, Microwave Quantum Theory. London: Sweet and Maxwell, 1973, Vol. 2, pages 138 to 192.

(ii)
For an article in a periodical:

DROP, J.G. Integrated Circuit Personalization at the Module Level. IBM tech. dis. bull. October 1974, Vol. 17, No. 5, pages 1344 and 1345.

(iii)
For a separately published abstract:

Chem. abstr., Vol. 75, No. 20, 15 November 1971 (Columbus, Ohio, USA), page 16, column 1, abstract No. 120718k, SHETULOV, D.I. “Surface Effects During Metal Fatigue,” Fiz.-Him. Meh. Mater. 1971, 7(29), 7-11 (Russ.).

Patent Abstracts of Japan, Vol. 15, No. 105 (M-1092), 13 March 1991, JP 30 02404 A (FUDO).

Question 16

4.3.1.2 Examples of quotation for patent literature

Answer 16

(i)
JP 50-14535 B (NCR CORP.) 28 May 1975 (28.05.75), column 4, lines 3 to 27.

(ii)
DE 3744403 A1 (A. JOSEK) 29.08.1991, page 1, abstract.

Question 17

4.4 Irrelevant matter

Answer 17

Since the skilled person is presumed to have the general technical background knowledge appropriate to the art, the examining division does not require the applicant to insert anything in the nature of a treatise or research report or explanatory matter which is obtainable from textbooks or is otherwise well-known. Likewise the examining division does not require a detailed description of the content of cited prior documents. It is sufficient that the reason for the inclusion of the reference is indicated, unless in a particular case a more detailed description is necessary for a full understanding of the invention of the application (see also F‑III, 8 and F‑IV, 2.3.1).

A list of several reference documents relating to the same feature or aspect of the prior art is not required; only the most appropriate need be referred to. On the other hand, the examining division does not insist upon the excision of any such unnecessary matter, except when it is very extensive (see F‑II, 7.4).

Question 18

4.5 Technical problem and its solution

Answer 18

The invention as claimed should be disclosed in such a way that the technical problem, or problems, with which it deals can be appreciated and the solution can be understood. To meet this requirement, only such details should be included as are necessary for elucidating the invention.

As an example, to elucidate the nature of the solution according to the independent claims, either the characterising portion of the independent claims could be repeated or referred to, or the substance of the features of the solution according to the relevant claims could be reproduced (see F‑II, 4.2).

In cases where the subject-matter of a dependent claim can be understood either by the wording of the claim itself or by the description of a way of performing the invention, no additional explanation of this subject-matter will be necessary. A mention in the description that a particular embodiment of the invention is set out in the dependent claim will then be sufficient.

When there is doubt, however, as to whether certain details are necessary, the examining division does not insist on their excision. It is not necessary, moreover, that the invention be presented explicitly in problem-solution form. Any advantageous effects which the applicant considers the invention to have in relation to the prior art should be stated, but this should not be done in such a way as to disparage any particular prior product or process. Furthermore, neither the prior art nor the applicant’s invention should be referred to in a manner likely to mislead. This might be done e.g. by an ambiguous presentation which gives the impression that the prior art had solved less of the problem than was actually the case. Fair comment as referred to in F‑II, 7.3 is, however, permitted. Regarding amendment to, or addition of, a statement of problem, see H‑V, 2.4.

Question 19

4.6 Rule 42(1)(c) vs. Art. 52(1)

Answer 19

If it is decided that an independent claim defines a patentable invention within the meaning of Art. 52(1), it must be possible to derive a technical problem from the application. In this case the requirement of Rule 42(1)(c) is fulfilled (see T 26/81).

Question 20

4.7 Reference in the description to drawings

Answer 20

If drawings are included they should first be briefly described, in a manner such as: “Figure 1 is a plan view of the transformer housing; Figure 2 is a side elevation of the housing; Figure 3 is an end elevation looking in the direction of the arrow X of Figure 2; Figure 4 is a cross-section taken through AA of Figure 1.” When it is necessary to refer in the description to elements of the drawings, the name of the element should be referred to as well as its number, i.e. the reference should not be in the form: “3 is connected to 5 via 4” but, “resistor 3 is connected to capacitor 5 via switch 4”.

Question 21

4.8 Reference signs

Answer 21

The description and drawings need to be consistent with one another, especially in the matter of reference numbers and other signs, and each number or sign must be explained. However, where as a result of amendments to the description whole passages are deleted, it may be tedious to delete all superfluous references from the drawings and in such a case the examining division does not pursue an objection under Art. 1(2)(i) of the decision of the President of the EPO dated 25 November 2022 (OJ EPO 2022, A113) as to consistency too rigorously. The reverse situation should never occur, i.e. all reference numbers or signs used in the description or claims must also appear on the drawings.

Question 22

4.9 Industrial application

Answer 22

The description should indicate explicitly the way in which the invention is capable of exploitation in industry, if this is not obvious from the description or from the nature of the invention. The expression “capable of exploitation in industry” means the same as “susceptible of industrial application”, and indeed identical expressions are used in the French and German texts of the EPC. In view of the broad meaning given to the latter expression by Art. 57 (see G‑III, 1), it is to be expected that, in most cases, the way in which the invention can be exploited in industry will be self-evident, so that no more explicit description on this point will be required; but there may be a few instances, e.g. in relation to methods of testing, where the manner of industrial exploitation is not apparent and must therefore be explicitly indicated.

Also, in relation to certain biotechnological inventions, i.e. sequences and partial sequences of genes, the industrial application is not self-evident. The industrial application of such sequences must be disclosed in the patent application (see G‑III, 4).

Question 23

4.10 Manner and order of presentation

Answer 23

The manner and order of presentation of the description should be that specified in Rule 42(1), i.e. as set out above, unless, because of the nature of the invention, a different manner or a different order would afford a better understanding. Since the responsibility for clearly and completely describing the invention lies with the applicant, the examining division does not object to the presentation unless satisfied that such an objection would be a proper exercise of its discretion.

Some departure from the requirements of Rule 42(1) is acceptable, provided the description is clear and orderly and all the requisite information is present. For example, the requirements of Rule 42(1)(c) may be waived where the invention is based on a fortuitous discovery, the practical application of which is recognised as being useful, or where the invention breaks entirely new ground. Also, certain technically simple inventions may be fully comprehensible with the minimum of description and only slight reference to prior art.

Question 24

4.11 Terminology

Answer 24

Although the description needs to be clear and straightforward with avoidance of unnecessary technical jargon, the use of recognised terms of art is acceptable, and will often be desirable. Little-known or specially-formulated technical terms may be allowed provided that they are adequately defined and that there is no generally recognised equivalent. This discretion may be extended to foreign terms when there is no equivalent in the language of the proceedings. Terms already having an established meaning are not allowed to be used to mean something different if this is likely to cause confusion. There may, however, be circumstances where a term may legitimately be borrowed from an analogous art. Terminology and signs must be consistent throughout the application.

Question 25

4.12 Computer programs

Answer 25

In the particular case of inventions in the computer field, program listings in programming languages cannot be relied on as the sole disclosure of the invention. The description, as in other technical fields, should be written substantially in normal language, possibly accompanied by flow diagrams or other aids to understanding, so that the invention may be understood by a person skilled in the art who is deemed not to be a specialist in any specific programming language, but does have general programming skills. Short excerpts from programs written in commonly used programming languages can be accepted if they serve to illustrate an embodiment of the invention.

Question 26

4.13 Physical values, units

Answer 26

When the properties of a material are referred to, the relevant units need to be specified if quantitative considerations are involved. If this is done by reference to a published standard (e.g. a standard of sieve sizes) and such standard is referred to by a set of initials or similar abbreviation, it needs to be adequately identified in the description.

Physical values must be expressed in the units recognised in international practice, which is generally in the metric system, using SI units and the other units referred to in Chapter I of the Annex to EEC Directive 80/181/EEC of 20 December 1979, as amended by EEC Directives 85/1/EEC of 18 December 1984, 89/617/EEC of 27 November 1989, 1999/103/EC of 24 January 2000, 2009/3/EC of 11 March 2009 and Commission Directive (EU) 2019/1258 of 23 July 2019 (see F‑II, Annex 2). Any values not meeting this requirement must also be expressed in the units recognised in international practice. Values expressed in the system of imperial units (e.g. inches/pounds) or in units having local character (e.g. pint), in general, do not meet the criterion “recognised in international practice”.

As determined by the President under Rule 49(2), for mathematical formulae the symbols in general use must be employed. For chemical formulae, the symbols, atomic weights and molecular formulae in general use must be employed.

In general, use should be made of the technical terms, signs and symbols generally accepted in the field in question.

Question 27

4.14 Registered trade marks

Answer 27

It is the applicant’s responsibility to ensure that registered trade marks are acknowledged as such in the description. For the assessment of the clarity of claims referring to a trade mark (Art. 84), see F‑IV, 4.8. With regard to the effect of references to trade marks on sufficiency of disclosure (Art. 83), see F‑III, 7.

Question 28

5. Drawings (not for paper A)

Question 29

5.1 Form and content (not for paper A)

Answer 29

Most of the requirements relating to the form and content of drawings are formal (see A‑IX), but the examining division may sometimes need to consider the requirements as determined by the President under Rule 49(2). Of these, the only question likely to cause difficulty is whether the textual matter included on the drawings is absolutely indispensable. In the case of circuit diagrams, block schematics and flow sheets, identifying catchwords for functional integers of complex systems (e.g. “magnetic core store”, “speed integrator”) may be regarded as indispensable from a practical point of view if they are necessary to enable a diagram to be interpreted rapidly and clearly.

Question 30

5.2 Printing quality (not for paper A)

Answer 30

The examining division has also to check whether the drawings in the printing copy (“Druckexemplar”) are suitable for printing. If necessary, a copy of the original drawings must be prepared as the printing copy. If, however, the quality of the original drawings is also insufficient, then the examining division must request the applicant to present drawings of sufficient quality for printing. It needs to, however, beware of any extension of subject-matter (Art. 123(2)).

Question 31

5.3 Photographs (not for paper A)

Answer 31

For the presentation of photographs, see A‑IX, 1.2. In the case of photographs of insufficient original quality for printing, the examining division does not request filing of better photographs, as the risk of infringing Art. 123(2) is obvious. In that case, the insufficient quality is accepted for reproduction.

Question 32

6.1 Reference to sequences disclosed in a database (not for paper A)

Answer 32

The application may refer to a biological sequence belonging to the state of the art by merely providing the sequence’s accession number and its version or release number in a publicly available database, without presenting the sequence itself either in a sequence listing complying with the applicable WIPO standard or in any other format.

Since in this case the sequence is already publicly available, the applicant does not need to supply a sequence listing. This applies even if reference is made to these sequences in one or more claims or if the sequences are essential features of the invention or necessary for the prior-art search (see J 8/11). If the European patent application discloses nucleotide or amino acid sequences that are fragments or variants of a prior-art sequence, a sequence listing complying with the applicable WIPO standard has to be filed for these sequence fragments or variants (see the notice from the EPO dated 9 December 2021, OJ EPO 2021, A97, p. 7). If the database and/or the sequences in question is/are not completely and unambiguously identified, the sequences are not sufficiently disclosed according to Art. 83 and cannot be added to the application to complete the disclosure without contravening Art. 123(2) (see F‑III, 2).

If such insufficiently disclosed sequences are not essential features of the claimed invention, normally no objection is raised. On the other hand, where these sequences are essential features of at least a part of the claimed subject-matter, this results in problems relating to the sufficiency of the original disclosure according to Art. 83, because the nature of the sequences cannot be unambiguously derived from the incomplete or ambiguous reference to the database.

Examples where a biological sequence is considered an essential feature of the invention would be a diagnostic method using a particular nucleic acid sequence or a product made by a biochemical process using an enzyme with a particular amino acid sequence. An example of ambiguous identification would be the citation of an accession number of a certain protein in the database of the European Molecular Biology Laboratory EMBL with no indication of which version number or database release number is meant when there are several such numbers referring to different sequences of the protein.

Question 33

6.2.1 Requirements relating to sequence length and enumeration of residues (not for paper A)

Answer 33

As defined in paragraph 7 of the WIPO Standard ST.26, a sequence must be included in the sequence listing if:

1.
it is disclosed anywhere in the application by enumeration of its residues, i.e. by listing, in order, each residue of the sequence as defined in paragraph 3(c) of WIPO Standard ST.26 (e.g. aagtgttcctagtg), and

2.
it contains 10 or more specifically defined nucleotides or four or more specifically defined amino acids.

According to ST.26, “specifically defined” residues are any nucleotide other than those represented by the symbol “n” and any amino acid other than those represented by the symbol “X”, listed in Annex I (see paragraph 3(k) of WIPO Standard ST.26).

Degenerate symbols representing a subgroup of residues are considered as specifically defined. For example, the degenerate nucleotide symbol “s” (used to represent “c” or “g” as defined in Annex I, Table 1 of ST.26) is specifically defined.

Sequences containing fewer than ten specifically defined nucleotides, or fewer than four specifically defined amino acids must not be included in the sequence listing (WIPO Standard ST.26, paragraph 8).

If a sequence is only disclosed in prose, i.e. a text describing the sequence, but the sequence is not enumerated, then the sequence does not have to be included, but may be included if the applicant wishes so.

For instance, if the application refers to a partial sequence as follows: “nucleotides 90-179 of SEQ ID NO. 1”, the partial sequence is described in prose only and, therefore, does not have to be entered as a separate SEQ ID in the sequence listing.

However, if the partial sequence was described by enumerating only the residues between positions 90 and 179, then paragraph 7 of WIPO Standard ST.26 would apply and the partial sequence would have to be included in the sequence listing.

Question 34

6.2.2 Sequences comprising residues that are not specifically defined (n or X) (not for paper A)

Answer 34

If an enumerated sequence comprises regions of specifically defined residues separated by one or more gaps of n or X, i.e. residues that are not specifically defined, the representation of this sequence in the sequence listing depends on whether the exact number of n or X residues is known (see WIPO Standard ST.26, paragraph 36) or unknown (see WIPO Standard ST.26, paragraph 37).

For example, considering that the following sequence is enumerated in the application:

a10nxt12

if the number of “n” residues is known, e.g. x=2, the sequence should be represented as a single SEQ ID (if it also meets the minimal length requirement as defined in paragraph 7 or ST.26 and in F‑II, 6.2.1) as follows:

aaaaaaaaaanntttttttttttt

If the number of “n” residues is unknown, each region of specifically defined residues that meets the minimal length requirement in paragraph 7 of WIPO Standard ST.26 must be included in the sequence listing as a separate SEQ ID.

For example, for the sequence: a10nxt12

the sequence listing must have two entries

SEQ ID No. 1: aaaaaaaaaa

SEQ ID No. 2: tttttttttttt

The sequences should be annotated to indicate that they are part of the same molecule and separated by an undefined number of “n” residues (see example 37-2 of Annex VI of WIPO Standard ST.26).

If a range is disclosed, e.g. x= 5-10 nucleotides, the sequence should be represented as a single SEQ ID comprising 5 n or 10 n (see example 36-3 of Annex VI of WIPO Standard ST.26).

In the above example, the sequence must either comprise 5 n or 10 n. In both cases, the SEQ ID must be annotated with a “note” qualifier. In cases where the sequence comprises 5 n, the note should indicate that up to 5 n can be added. In cases where the sequence comprises 10 n, the note should indicate that up to 5 n can be deleted. The appropriate feature key must be associated with the “note” qualifier describing the variant. See paragraph 96 of WIPO Standard ST.26 and F‑II, 6.2.3 for information on selecting the correct feature key.

Alternatively, if a range is disclosed, e.g. x= 5-10 nucleotides, all possible variants may be represented independently, i.e. as separate SEQ IDs.

Question 35

6.2.3 Variants (not for paper A)

Answer 35

If the application describes variants of a sequence, e.g. “nucleotides 90-179 of SEQ ID No. 1 are deleted or substituted by another sequence”, then paragraph 95 of WIPO Standard ST.26 applies. This paragraph defines that these variants should be described by annotation of the primary sequence. It is a recommendation but it is not compulsory as long as the specific variant sequence is not enumerated as such in the application.

If the applicant chooses to enter this information in the sequence listing, the following rules as defined in paragraph 95 of ST.26 should be followed:

(a)
the variant may be represented by annotation of the primary sequence, where it contains variation(s) at a single location or multiple distinct locations and the occurrences of those variations are independent,

(b)
the variant should be represented as a separate sequence and assigned its own sequence identification number, where it contains variations at multiple distinct locations and the occurrences of those variations are interdependent, and

(c)
must be represented as a separate sequence and assigned its own sequence identification number, where it contains an inserted or substituted sequence that contains in excess of 1 000 residues.

The following table indicates which feature key and qualifier should be used to annotate the variants according to the type of sequence and the type of variation (see paragraph 96 of WIPO Standard ST.26).

Question 36

6.2.4 The qualifier “mol_type” (not for paper A)

Question 37

7.1 Categories

Answer 37

There are three categories of specifically prohibited matter, these being defined in sub-paragraphs (a) to (c) of Rule 48(1) (see also G‑II, 4).

Question 38

7.2 Matter contrary to “ordre public” or morality

Answer 38

The omission, from the publication of the application, is mandatory for the first category (Rule 48(1)(a)). Examples of the kind of matter coming within this category are: incitement to riot or to acts of disorder; incitement to criminal acts; racial, religious or similar discriminatory propaganda; and grossly obscene matter.

With regard to patentability issues with such matter, see G‑II, 4.1 and subsections.

Question 39

7.3 Disparaging statements

Answer 39

It is necessary to discriminate in the second category between libellous or similarly disparaging statements, which are not allowed, and fair comment, e.g. in relation to obvious or generally recognised disadvantages, or disadvantages stated to have been found and substantiated by the applicant, which, if relevant, is permitted.

Question 40

7.4 Irrelevant or unnecessary matter

Answer 40

The third category is irrelevant or unnecessary matter: such matter is specifically prohibited under Rule 48(1)(c) only if it is “obviously irrelevant or unnecessary”, for instance, if it has no bearing on the subject-matter of the invention or its background of relevant prior art (see also F‑II, 4.4). The matter to be removed may already be obviously irrelevant or unnecessary in the original description. It may, however, be matter which has become obviously irrelevant or unnecessary only in the course of the examination proceedings, e.g. owing to a limitation of the claims of the patent to one of originally several alternatives. When matter is removed from the description, it must not be incorporated into the patent specification by reference to the corresponding matter in the published application or in any other document (see also F‑III, 8).

Question 41

7.5 Omission of matter from publication

Answer 41

Generally, the Receiving Section will deal with matter falling under category 1(a) and may have dealt with matter obviously falling within category 1(b), but if any such matter has not been so recognised and has therefore not been omitted from the publication of the application, it is required to be removed during examination of the application together with any other prohibited matter. The applicant is informed of the category under which matter is required to be removed.