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Manual for Substantive Examination Procedure

Sec.21
R.200

1.1    There are four basic requirements for patentability: 

(i)      There must be an "invention" that can be considered as a “technical
solution of a problem in any field of human activity”. 

(ii)              The invention must be "industrially applicable".  

(iii)             The invention must be "new".  

(iv)            The invention must involve an "inventive step".  

These requirements will be dealt with in turn in the following sections  IV, 2 and 3, 4, 5 to 8, and 9, respectively.  

1.2    In addition to these four basic requirements, the examiner should be aware of the following two requirements that are implicitly contained in the IP-code and the Implementing Rules and Regulations:

Sec.35.1
R.909(c)

R.407(1)(a)
R.407(1)(c)
R.416

(i)       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 Sec.35.1. Instances where the invention fails to satisfy this requirement are given in C-II, 4.11.  

(ii)      The invention must be a “technical solution to a problem”, hence of a "technical” character", to the extent that it must relate to a technical field (R.407(1)(a)), must be concerned with a technical problem (R.407(1)(c)), and must have technical features in terms of which the matter for which protection is sought can be defined in the claim (R.416(a)(b)), See also C-III, 2.1).

1.3     Sec. 21 of the IP-Code Convention does not require explicitly or implicitly that an invention to be patentable must entail some technical progress or even any useful effect. Nevertheless, advantageous effects, if any, with respect to the prior art should be stated in the description (R.407(1)(c)), and any such effects are often important in determining "inventive step" (See IV, 9 here below).

Sec.21
Sec.22

2. Inventions 

2.1 Sec.21 gives a definition of what is meant by "invention", but Sec.22 contains a non-exhaustive list of things which shall not be regarded as patentable inventions. It will be noted that the exclusions in Sec.22.1 and  

Sec.22.2 are abstract (e.g. discoveries, scientific theories etc.) and the exclusions in Sec.2.5 are non-technical (e.g. aesthetic creations). In contrast to this, an "invention" within the meaning of Sec.21 must be of both a concrete and a technical character (See IV, 1.2 (ii) here above). 

The exclusions under Sec.22.1, 22.2 and 22.5 are dealt with under IV, 2.2 and 2.3 here below. The exclusions under Sec.22.4 (inventions in the biological field) and 22.6 (public order and morality) are dealt with under IV, 3 here below. The exclusions under Sec.22.3 (inventions in the medical field) and under Sec.27 (industrial applicability) are dealt with under IV, 4 here below.

2.1a     Examples of what an invention may be are given in Sec.21, R.201 and R.415, i.e. 

a)      a useful machine;

b)      a product;

c)      or process or an improvement of any of the foregoing;

d)      microorganism; and

e)      non-biological and microbiological processes, or the use of an item in a specific process and/or for a specific purpose.

2.2    In considering whether the subject-matter of an application is an invention within the meaning of Sec.21, there are two general points the examiner must bear in mind.  

Firstly, any exclusion from patentability under Sec.22.1 or Sec.22.2 will in general apply only to the extent to which the application relates to the excluded subject-matter as such. Secondly, the examiner should disregard the form or kind of claim and concentrate on its content in order to identify the real contribution which the subject-matter claimed, considered as a whole, adds to the known art. If this contribution is not of a technical character, there is no invention within the meaning of Sec.21. Thus, for example, if the claim is for a known manufactured article having a painted design or certain written information on its surface, the contribution to the art is as a general rule merely an aesthetic creation or presentation of information. Similarly, if a computer program is claimed in the form of a physical record, e.g. on a conventional tape or disc, the contribution to the art is still no more than a computer program. In these instances the claim relates to excluded subject-matter as such and is therefore not allowable. If, on the other hand, a computer program in combination with a computer causes the computer to operate in a different way from a technical point of view, the combination might be patentable.  

It must also be borne in mind that the basic test of whether there is an invention within the meaning of Sec.22, is separate and distinct from the questions whether the subject-matter is susceptible of industrial application, is new and involves an inventive step.  

2.3      The items of Sec.22.1, 22.2 and 22.5 will now be dealt with in turn,and further examples will be given in order better to clarify the distinction between what is patentable and what is not.

Sec.22.1
R.202(a)

Discoveries  

If a person finds out a new property of a known material or article, that is a mere discovery and therefore not patentable. If however a person puts that property to practical use, an invention has been made 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 substance freely occurring in nature is also mere discovery and therefore not patentable. However, if a substance found in nature has first to be isolated from its surroundings and a process for obtaining it is developed, that process is patentable. Moreover, if the substance can be properly characterized either by its structure, by the process by which it is obtained or by other parameters (See III, 4.7a) and it is "new" in the absolute sense of having no previously recognized existence, then the substance per se may be patentable (See also IV, 7.3 here below). An example of such a case is that of a new substance which is discovered as being produced by a micro-organism.

Scientific theories  

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

Mathematical methods  

These are a particular example of the principle that purely abstract or intellectual methods are not patentable. For example, a shortcut method of division would not be patentable but a calculating machine constructed to operate accordingly may well be patentable. A mathematical method for designing electrical filters is not patentable; nevertheless filters designed according to this method could be patentable provided they have a novel technical feature to which a product claim can be directed.

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

These are further examples of items of an abstract or intellectual character. In particular, a scheme for learning a language, a method of solving cross-word puzzles, a game (as an abstract entity defined by its rules) or a scheme for organising a commercial operation would not be patentable. However, novel apparatus for playing a game or carrying out a scheme might be patentable.

Programs for computers

The basic patentability considerations here are exactly the same as for the other exclusions listed in Sec.22. However a data-processing operation can be implemented either by means of a computer program or by means of special circuits, and the choice may have nothing to do with the inventive concept but be determined purely by factors of economy or practicality. With this point in mind, examination in this area should be guided by the following approach:

A computer program claimed by itself or as a record on a carrier, is not patentable irrespective of its content. The situation is not normally changed when the computer program is loaded into a known computer. If however the subject-matter as claimed makes a technical contribution to the known art, patentability should not be denied merely on the ground that a computer program is involved in its implementation. This means, for example, that program-controlled machines and program-controlled manufacturing and control processes should normally be regarded as patentable subject-matter. It follows also that, where the claimed subject-matter is concerned only with the program-controlled internal working of a known computer, the subject-matter could be patentable if it provides a technical effect. As an example consider the case of a known data-processing system with a small fast working memory and a larger but slower further memory. Suppose that the two memories are organised under program control, in such a way that a process which needs more address space than the capacity of the fast working memory can be executed at substantially the same speed as if the process data were loaded entirely in that fast memory.

The effect of the program in virtually extending the working memory is of a technical character and might therefore support patentability.

Aesthetic creations  

An aesthetic creation relates to an article (e.g. a painting or sculpture) having aspects which are other than technical and the appreciation of which is essentially subjective. If, however, the article happens also to have technical features, it might be patentable, a tyre tread being an example of this. The aesthetic effect itself is not patentable, neither in a product nor in a process claim. For example a book characterized by the aesthetic or artistic effect of its information contents, of its layout or of its letterfont, would not be patentable, and neither would a painting characterized by the aesthetic effect of its subject or by the arrangement of colours, or by the artistic (e.g. Impressionist) style. Nevertheless, if an aesthetic effect is obtained by a technical structure or other technical means, although the aesthetic effect itself is not patentable, 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 mightbe patentable. Similarly, a book characterized by a technical feature of the binding or pasting of the back, may be patentable, even though the effect thereof is solely aesthetic, similarly also a painting characterized by the kind of cloth, or by the dyes or binders used. Also a process of producing an aesthetic creation may comprise a technical innovation and thus be patentable. For example, a diamond may have a particularly beautiful shape (not of itself patentable) produced by a new technical process. In this case, the process may be patentable. Similarly, a new printing technique for a book resulting in a particular layout with aesthetic effect, may well be patentable, together with the book as a product of that process. Again a substance or composition characterized 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, may well be patentable.

Presentations of information  

Although there is no corresponding, explicit provision in the IP-code and the IRR, mere representation of information characterized solely by the content of the information will not usually be patentable since it cannot be considered as a technical solution to a problem. This applies whether the claim is directed to the presentation of the information per se (e.g. by acoustical signals, spoken words, visual displays), to information recorded on a carrier (e.g. books characterized by their subject), gramophone records characterized by the musical piece recorded, traffic signs characterized by the warning thereon, magnetic computer tapes characterized by the data or programs recorded), or to processes and apparatus for presenting information (e.g. indicators or recorders characterized solely by the information indicated or recorded). If, however, the presentation of information has new technical features there could be patentable subject-matter in the information carrier or in the process or apparatus for presenting the information. The arrangement or manner of representation, as distinguished from the information content, may well constitute a patentable technical feature. Examples in which such a technical  feature may be present are: a telegraph apparatus or communication system characterized by the use of a particular code to represent the characters (e.g. pulse code modulation); a measuring instrument designed to produce a particular form of graph for representing the measured information; a gramophone record characterized by a particular groove form to allow stereo recordings; or a diapositive with a soundtrack arranged at the side of it.  

2.4    Under certain circumstances, protection for non-patentable items may be sought for by means of a utility model application or an industrial design application (aesthetic aspects of an article of manufacture) or by means of the law relating to copyright (computer software as such).

Reference is made to the corresponding provisions in the IP-code and the IRR.

Sec.22.6

3. Further exclusions from patent protection – Sec.22.6 and 22.4

3.1    Any invention, the publication or exploitation of which would be contrary to "public order or morality” is specifically excluded from patentability. The purpose of this is to exclude from protection inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour (See also II, 7.1); one obvious example of subject-matter which should be excluded under this provision is a letter-bomb. 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, objection should be raised under Sec.22.6; otherwise not.  

R.412

3.2     Exploitation is not to be deemed to be contrary to "public order" or morality merely because it is prohibited by law or regulation in the Philippines. For example, a product could still be manufactured under a Philippine patent for export to states in which its use is not prohibited.

3.3     In some cases refusal of a patent may not be necessary. This may result when the invention has both an offensive and a non-offensive use: e.g. a process for breaking open locked safes, the use by a burglar being offensive but the use by a locksmith in the case of emergency inoffensive. In such a case no objection arises under Sec.22.6, but if the application contains an explicit reference to a use which is contrary to "public order or morality”, deletion of this reference should be required under the terms of R.412.

3.4    Also excluded from patentability are "plant or animal breeds varieties or essentially biological processes for the production of plants or animals". One reason for this exclusion is that, at least for plant varieties, other means of obtaining legal protection are available in most countries. The question whether a process is "essentially biological" or “non-biological” (Sec.22.4, 2^nd sentence) is one of degree depending on the extent to which there is technical intervention by man in the process; if such intervention plays a significant part in determining or controlling the result it is desired to achieve, the process would not be excluded. To take some examples, a method of crossing, inter-breeding, or selectively breeding, say, horses involving merely selecting for breeding and bringing together those animals having certain characteristics would be essentially biological and therefore not patentable. On the other hand, 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 essentially biological since although a biological process is involved, the essence of the invention is technical; the same could apply to a method of treating a plant characterized 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 IV, 4.3).

Sec.27
R.208

3.5     As expressly stated in Sec.22.4, 2^nd sentence, the exclusion from patentability referred to in the preceding paragraph does not apply to microorganisms and non-biological and microbiological processes. The term "microbiological process" is to be interpreted as covering not only industrial processes using micro-organisms but also processes for producing new micro-organisms, e.g. by genetic engineering. The product of a microbiological process may also be patentable per se (product claim). A micro-organism can also be protected per se (Sec.22.4, 2^nd sentence). The term micro-organism in general includes not only bacteria and yeasts, but also fungi, algae, protozoa and human, and possibly animal and plant cells, i.e. all generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory, including plasmids and viruses.

3.6      In the case of microbiological processes, particular regard should be had to the requirement of repeatability referred to in II, 4.11. As for biological material to be deposited under the terms of R.408 and R.409, repeatability is assured by the possibility of taking samples, and there is thus no need to indicate another process for the production of the biological material.

4. Industrial application Sec.27 - Medical inventions Sec.22.3

4.1     An invention shall be considered “industrially applicable” if it can be produced and used in any kind of industry. Agriculture is in general considered as an industry as well. "Industry" should be understood in its broad sense as including any physical activity of "technical character" (See IV, 1.2 here above), i.e. an activity which belongs to the useful or practical arts as distinct from the aesthetic arts; it does not necessarily imply the use of a machine or the manufacture of an article and could cover e.g. a process for dispersing fog, or a process for converting energy from one form to another. Thus, Sec.27 excludes from patentability very few "inventions" which are not already excluded by the list in Sec.22 (See IV, 2.1 here above). One further class of "invention" which would be excluded, however, would be articles or processes alleged to operate in a manner clearly contrary to well-established physical laws, e.g. a perpetual motion machine. Objection could arise under Sec.27 only in so far as the claim specifies the intended function or purpose of the invention, but if, say, a perpetual motion machine is claimed merely as an article having a particular specified construction then objection should be made under Sec.35.1 (See II, 4.11).

4.2    "Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body” are excluded from patent protection. Moreover, they will not in general be  regarded as inventions which are industrially applicable. “Products and composition for use in any of these methods” are not excluded from patent protection.

Patents may, however, also be obtained for surgical, therapeutic or diagnostic instruments or apparatus for use in such methods. Also the manufacture of prostheses or artificial limbs, as well as taking measurements therefor on the human body, would be patentable, so that a method of manufacturing a prosthetic tooth which involves making a model of a patient's teeth in the mouth would not be excluded from patentability either, provided the prosthetic tooth is fabricated outside of the body.

Patents may also be obtained for new products for use in these methods of treatment or diagnosis, particularly substances or compositions. However in the case of a known substance or composition, this may only be patented for use in these methods if the known substance or composition was not previously disclosed for use in surgery, therapy or diagnostic methods practised on the human or animal body ("first medical use"). The same substance or composition cannot subsequently be patented for any other use of that kind. A claim to a known substance or composition for the first use in surgical, therapeutic and/or diagnostic methods should be in a form such as: "substance or composition X" followed by the indication of the use, for instance" for use as a medicament", " as an antibacterial agent " or " for curing disease Y". In contrast to what is stated in III, 4.8 these types of claims will be regarded as restricted to the substance or composition when presented or packaged for the specified use. This constitutes an exception from the general principle that product claims can only be obtained for (absolutely) novel products. However this does not mean that product claims for the first medical use need not fulfil all other requirements of patentability, especially that of inventive step. 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 by Sec.22.3 and therefore will not be accepted.

If an application discloses for the first time a number of distinct surgical, therapeutic or diagnostic uses for a known substance or composition, normally in the one application independent claims each directed to the substance or composition for one of the various uses may be allowed; i.e. objection should not, as a general rule, be raised that there is lack of unity of invention.

A claim in the form "Use of a substance or composition X for the manufacture of a medicament for therapeutic application Z" is allowable for either a first or "subsequent" (second or further) such application, if this application is new and inventive. The same applies to claims in the form "Method for manufacturing a medicament intended for therapeutic application Z, characterized in that the substance X is used" or the substantive equivalents thereof. 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 (Sec.38).

4.3     It should be noted that Sec.22.3 excludes only methods of treatment by surgery or therapy and diagnostic methods. It follows that other methods of treatment of live 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 (as would probably be the case) such methods are of a technical, and not essentially biological character (See IV, 3.4 here above) and provided that the methods are industrially applicable. The latter proviso is particularly important in the case of human beings.

For example an application with a claim for a method of contraception, which is to be applied in the private and personal sphere of a human being, may not be considered “industrial applicable”. However, an application containing claims directed to the purely cosmetic treatment of a human by administration of a chemical product could be considered as “industrially applicable”. A cosmetic treatment involving surgery or therapy would not however be patentable (See below).

A treatment or diagnostic method, to be excluded, would generally have to be carried out on the living human or animal body. A treatment of or diagnostic method practised on a dead human or animal body would therefore not be excluded from patentability by virtue of Sec.. 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 in so far 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 should be borne in mind that the intention of Sec.22.3 is to free from restraint non-commercial and non-industrial medical and veterinary activities. Interpretation of the provision should avoid the exclusions from going beyond their proper limits.

However, in contrast to the subject-matter referred to e.g. Sec.22.1 and Sec.22.2, which are in general only excluded from patentability if claimed as such, a claim is not allowable under Sec.22.3 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 or a diagnostic method step to be exercised on the human or animal body. 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.

Taking the three exclusions in turn:

Surgery defines the nature of the treatment rather than its purpose. Thus, e.g. a method of treatment by surgery for cosmetic purposes is excluded, as well as surgical treatment for therapeutic purposes.

Therapy implies the curing of a disease or malfunction of the body and covers prophylactic treatment, e.g. immunisation against a certain disease or the removal of plaque.

Diagnostic methods likewise do not cover all methods related to diagnosis. Methods for obtaining information only (data, physical quantities) from the living human or animal body may not necessarily excluded by Sec.22.3, if the information obtained merely provides intermediate results which on their own do not enable a decision to be made on the treatment necessary. Examples of such methods include X-ray investigations, NMR studies, and blood pressure measurements.

4.4    Methods of testing generally should be regarded as inventions susceptible of industrial application and therefore patentable if the test is applicable to the improvement or control of a product, apparatus or process which is itself susceptible of industrial application. In particular, the utilisation of test animals for test purposes in industry, e.g. for testing industrial products (for example for ascertaining the absence of pyrogenetic or allergic effects) or phenomena (for example for determining water or air pollution) would be patentable.

4.5     It should be noted that "susceptibility of industrial application" is not a requirement that overrides the restriction of Sec.22, e.g. an administrative method of stock control is not patentable, having regard to Sec.22.2 , even though it could be applied to the store of spare parts of a factory. On the other hand, although an invention must be industrially applicable and the description must indicate, where this is not obvious, the way in which the invention is so industrially applicable (See II, 4.12), the claims need not necessarily be restricted to the indicated industrial application(s).

Sec.21
Sec.23
Sec.24.1

5. Novelty; prior art 

5.1     Sec.21 requires an invention to be new in order to be patentable. Sec.23 gives a negative definition of novelty, i.e. that “an invention shall not be considered new if it forms part of a prior art”. The "prior art" is defined in Sec.24.1  as consisting of "everything which has been made available to the public anywhere in the world, before the filing date or the priority date of the Philippine application claiming the invention”.  

R.204(a),
1^st sentence

R.204(a),
2^nd sentence

R.204(a),
2^nd sentence

The width of this definition should be noted. R.204(a), 1^st sentence indicates that there are no restrictions whatever as to the geographicallocation where, or the language or manner (e.g. by means of a written or oral description, by use, or in any other way) in which the relevant information was made available to the public; also no age limit is stipulated for the documents or other sources of the information. There are however certain specific exclusions (See IV, 8 here below). A prior use in a foreign country must however by disclosed in printed documents or in a tangible form. However, since the "prior art" available to the examiner will mainly consist of the documents listed in the search report, the following  section IV, 5.2 deals with the question of public availability only in relation to written description (either alone or in combination with an earlier oral description or use). Other kinds of prior art are discussed in section IV, 5.4 here below.

5.2     A written description, i.e. a document, should be regarded as made available to the public if, at the relevant date, it was possible for members of the public to gain knowledge of the content of the document and there was no bar of confidentiality restricting the use or dissemination of such knowledge. For instance, German utility models ("Gebrauchsmuster") are already publicly available as of their date of entry in the Register of utility models ("Eintragungstag"), which precedes the date of announcement in the Patent Bulletin ("Bekanntmachung im Patentblatt"). The search report also may cite documents in which doubts with regard to the fact of public availability and doubts concerning the precise date of publication of a document have not, or not fully, been removed.  If the applicant contests the public availability or assumed date of publication of the document the examiner should consider whether to investigate the matter further. If the applicant shows sound reasons for doubting whether the document forms part of the "prior art" in relation to his application and any further investigation does not produce evidence sufficient to remove that doubt the examiner should not pursue the matter further. The only other problem likely to arise for the examiner is where:

(i)        a document reproduces an oral description (e.g. a public lecture) or gives an account of a prior use (e.g. display at a public exhibition); and

(ii)      only the oral description or lecture was publicly available before the "date of filing" of the European application, the document itself being published on or after this date.

In such cases, the examiner should start with the assumption that the document gives a true account of the earlier lecture, display or other event and should therefore regard the earlier event as forming part of the "prior art". If, however, the applicant gives sound reasons for contesting the truth of the account given in the document then again the examiner should not pursue the matter further.

5.3     It should be noted that the relevant date for establishing whether a piece of prior art belongs to the state of the art is the date of filing, or where a priority date has been validly claimed, the priority date (Sec.24). If a priority date has not been validly claimed (subject-matter claimed not disclosed in priority document), the filing date will become the relevant date for this purpose. For details, See V.

It should be remembered that different claims, or different alternatives claimed in one claim, may have different relevant dates, depending on the validity of the priority for the subject-matter concernedThe question of novelty must be considered against each claim (or part of a claim where a claim specifies a number of alternatives) and the prior art in relation to one claim or one part of a claim may include matter which cannot be cited against another claim or part of a claim because the latter has an earlier relevant date.

Of course if all the matter in the prior art was made available to the public before the date of the earliest priority document, the examiner need not (and should not) concern himself with the allocation of priority dates.

5.4   In determining whether other kinds of prior art (which could be introduced into the proceedings e.g. by a third party under Sec.47) have been made available to the public, the following issues will need to be considered, depending on the circumstances and the type of prior art:

Prior use which is not present in the Philippines, even if widespread in a foreign country, cannot form part of the prior art if such prior use is not disclosed in printed documents or in any tangible form.

5.4a    Prior art made available to the public by use or in any other way

Types of use and instances of prior art made available in any other way

Use may be constituted by producing, offering, marketing or otherwise exploiting a product, or by offering or marketing a process or its application or by applying the process. Marketing may be effected, for example, by sale or exchange. The prior art may also be made available to the public in other ways, as for example by demonstrating an object or process in specialist training courses or on television. Availability to the public in any other way also includes all possibilities which technological progress may subsequently offer of making available the aspect of the prior art concerned.

Matters to be determined as regards use:

When dealing with an allegation that an object or process has been used in such a way that it is comprised in the prior art, the following details will need to be checked:

Is the alleged use relevant at all?

The date on which the alleged use occurred, i.e. whether there was any instance of use before the relevant date (prior use).

What has been used, in order to determine the degree of similarity between the object used and the subject-matter claimed.

All the circumstances relating to the use, in order to determine whether and to what extent it was made available to the public, as for example the place of use and the form of use. These factors are important in that, for example, the details of a demonstration of a manufacturing process in a factory or of the delivery and sale of a product may well provide information as regards the possibility of the subject-matter having become available to the public.

5.4b     Ways in which subject-matter may be made available

General principles

Subject-matter should be regarded as made available to the public by use or in any other way if, at the relevant date, it was possible for members of the public to gain knowledge of the subject-matter and there was no bar of confidentiality restricting the use or dissemination of such knowledge (See also IV, 5.2 with reference to written descriptions). This may, for example, arise if an object is unconditionally sold to a member of the public, since the buyer thereby acquires unlimited possession of any knowledge which may be obtained from the object. Even where in such cases the specific features of the object may not be ascertained from an external examination, but only by further analysis, those features may nevertheless to be considered as having been made available to the public.

If, on the other hand, an object could be Seen in a given place (a factory, for example) to which members of the public not bound to secrecy, including persons with sufficient technical knowledge to ascertain the specific features of the object, had access, all knowledge which an expert was able to gain from a purely external examination is to be regarded as having been made available to the public. In such cases, however, all concealed features which could be ascertained only by dismantling or destroying the object will not be deemed to have been made available to the public.

Agreement on secrecy

The basic principle to be adopted is that subject-matter has not been made available to the public by use or in any other way if there is an express or tacit agreement on secrecy which has not been broken (concerning the particular case of a non-prejudicial disclosure arising from an evident abuse in relation to the applicant, See IV, 8 below), or if the circumstances of the case are such that such secrecy derives from a relationship of good faith or trust. Good faith or trust are factors which may occur in contractual or commercial relationships.

Use on non-public property

As a general rule, use on non-public property, for example in factories and barracks, is not considered as use made available to the public, because company employees and soldiers are usually bound to secrecy, save in cases where the objects or processes used are exhibited, explained or shown to the public in such places, or where specialists not bound to secrecy are able to recognize their essential features from the outside. Clearly the above-mentioned "non-public property" does not refer to the premises of a third party to whom the object in question was unconditionally sold or the place where the public could See the object in question or ascertain features of it.

Example of the accessibility of objects used

A press for producing light building (hard fibre) boards was installed in a factory shed. Although the door bore the notice "Unauthorised persons not admitted", customers (in particular dealers in building materials and clients who were interested in purchasing light building boards), were given the opportunity of Seeing the press although no form of demonstration or explanation was given. An obligation to secrecy was not imposed as, according to witnesses, the company did not consider such visitors as a possible source of competition. These visitors were not genuine specialists, i.e. they did not manufacture such boards or presses, but were not entirely laymen either. In view of the simple construction of the press, the essential features of the invention concerned were bound to be evident to anyone observing it. There was therefore a possibility that these customers, and in particular the dealers in building materials, would recognize these essential features of the press and, as they were not bound to secrecy, they would be free to communicate this information to others.

Example of the inaccessibility of a process

The subject of the patent concerns a process for the manufacture of a product. As proof that this process had been made available to the public by use, a similar already known product was asserted to have been produced by the process claimed. However, it could not be clearly ascertained, even after an exhaustive examination, by which process it had been produced.

5.4c   Prior art made available by means of oral description

Cases of oral description

The prior art is made available to the public by oral description when facts are unconditionally brought to the knowledge of members of the public in the course of a conversation, a lecture, a conference, or by means of radio, television or sound reproduction equipment (tapes and records).

Non-prejudicial oral description

The prior art will not be affected by oral descriptions under the circumstances referred to in Sec.25 and in IV, 8 here below.

Matters to be determined in cases of oral description

Once again, in such cases the following details will have to be determined:

When the oral description took place, what was described orally, whether the oral description was made available to the public ; this will also depend on the type of oral description (conversation, lecture) and on the place at which the description was given (public meeting, factory hall.  

5.4d    Prior art made available to the public in writing or by any othermeans

For this prior art, the details such as those referred to above might have to be determined, if they are not clear from the written or otherwise made available disclosure itself.

Sec.24.2

6. Conflict with other Philippine applications

6.1   The prior art in addition comprises the whole content of other applications for a patent, utility model or industrial design published under Republic Act No. 8293 (Sec.44 for patents), filed or effective in the Philippines, with a filing date or a validly claimed priority date that is earlier than the filing or priority date of the application under examination, even if the earlier patent, utility model or industrial design publication is published on or after the date of filing or the priority date of the application being examined. This does not apply when the applicant or the inventor identified in both applications is one and the same. Concerning this case, See however IV, 6.4 here below.

Hence, where two or more applications are independently filed with respect to the same invention, and the later applications are filed before the first application or earlier application is published, the whole contents of the first or earliest filed application  published in accordance with Sec. 44 on or after the filing date or priority date of the later filed application shall be  novelty destroying with respect to the later filed application. 

Whether a piece of prior art has to be taken into consideration or not may depend on whether the priority dates of the application under examination and of the earlier application have been validly claimed (See Chapter V).

According to R.206(b) such earlier applications are part of the prior art only when considering novelty and not when considering inventive step.  

By the whole content of a Philippines application is meant the whole  

disclosure, i.e. the description, drawings and claims, including:  

(i)        any matter explicitly disclaimed (with the exception of disclaimers for unworkable embodiments), 

(ii)          any matter for which an allowable reference (See II, 4.18, penultimate paragraph) to other documents is made or  

(iii)      prior art insofar as explicitly described.  

However, the "content" does not include any priority document (the purpose of such document being merely to determine to what extent the priority date is valid for the disclosure of the Philippines application (See V, 1.2)) nor, in view of  Sec.37, last sentence, the abstract.  

6.1a    Whether a published Philippine application can be a conflicting application under Sec.24.2 is determined firstly by its filing date and the date of its publication, which have to be before, respectively on or after the filing date of the application under examination. If such an application validly claims priority (See first proviso in Sec.24.2) , the priority date replaces the filing date for that subject-matter in the application which corresponds to the priority application. If a priority claim was abandoned or otherwise lost with effect from a date prior to the publication, the filing date and not the priority date of such an application is relevant, irrespective of whether or not the priority claim might have conferred a valid priority right.  

Further it is required that the conflicting application was still pending at its publication date. If the application has been withdrawn or otherwise lost before the date of publication, but published because the Office could not stop its publication, the publication has no effect under Sec.24.2 pursuant to Sec.25(b)(a). 

6.2      Earlier application(s) not yet published 

In cases where the application under examination is ready for grant before the search for conflicting applications could be finalised (e.g. because some of the potentially interferring applications have not yet been published), See C-VI, 8.4.

Sec.24.2 R.204(b)
2^nd proviso

6.3   The second proviso in Sec.24.2 specifies that an application otherwise meeting the definitions given in Sec.24.2 does not  belong to the prior art to be taken into consideration if in this application and in the application under examination one and the same. Further, the IP-code does not deal explicitly with the case of co-pending Philippines applications of the same effective date.

However, it is an accepted principle in most patent systems that two patents shall not be granted to the same applicant for one invention. This principle is e.g. reflected in R.915. It is permissible to allow an applicant to proceed with two applications having the same description where the claims are quite distinct in scope and directed to different inventions. However, in the rare case in which there are two or more Philippines applications of the type referred to here above, from the same applicant, and the claims of those applications relate to the same invention (the claims conflicting in the manner explained in VI, 9.6), the applicant should be told that he must either amend one or more of the applications in such a manner that they no longer claim the same invention, or choose which one of those applications he wishes to proceed to grant.

6.4    Concerning applications of the same effective date and received from two different applicants, See R.304, 2^nd paragraph. 

7. Test for Novelty 

7.1    It should be noted that in considering novelty (as distinct from inventive step), it is not permissible to combine separate items of prior art together (See IV, 9.7). However, if a document (the "primary" document) refers explicitly to another document as providing more detailed information on certain features, the teaching of the latter may be regarded as incorporated into the document containing the reference, if the document referred to was available to the public on the publication date of the document containing the reference. For conflicting applications, See III, 6.1 here above and II, 4.18.  

The same principle applies to any matter explicitly disclaimed (except disclaimers which exclude unworkable embodiments) and to prior art insofar as explicitly described. It is further permissible to use a dictionary or similar document of reference in order to interpret a special term used in the primary document. The effective date for novelty purposes (See IV, 7.3 here below) is always the date of the primary document.  

7.2     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.  

7.3     In determining novelty a prior document should be read as it would have been read by a person skilled in the art on the effective date of the document. By "effective" date is meant the publication date in the case of  a previously published document and the date of filing (or priority date, where appropriate) in the case of a document according to Sec.24.2.

However, it should be noted that a chemical compound, the name or formula of which was mentioned in a document, is not considered as known unless the information in the document, together, where appropriate, with knowledge generally available on the effective date of the document, enable it to be prepared and separated or, for instance in the case of a product of nature, only to be separated.  

7.4     In considering novelty it should 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.  

7.5     In the case of a prior 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 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 should be 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 IV, 7.6 here below). Situations of this kind may also occur when the claims define the invention, or a feature thereof, by parameters (See III, 4.7a). 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. If 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 (Sec.35.1).  

7.6     In determining novelty of the subject-matter of claims the examiner should have regard to the guidance given in III, 4.4 to 4.13. He should remember that, particularly for claims directed to a physical entity, non-distinctive characteristics of a particular intended use, should be disregarded (See III, 4.8 to 4.9). 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,should be taken into account (See the example of a "mold for molten steel" in III, 4.8).

It should further be borne in mind that a claim to the use of a known compound for a particular purpose (second non-medical use), which is based on a technical effect, should be interpreted as including that technical effect as a functional technical feature, and is accordingly not open to objection under Sec.23 and 24.1, provided that such technical feature has not previously been made available to the public. For claims to a second or further medical use, See IV, 4.2, here above.

Sec.25.1

8. Non-prejudicial disclosures 

8.1      There are three specified instances in which a prior disclosure of the information contained in the application during the twelve months preceding the filing date or the priority date of the application shall not prejudice the applicant on the ground of lack of novelty, viz. if such disclosure was made by:

Sec.25.1(b)

Sec.25.1(c)

Sec.25.2
Sec.28

Sec.67

(a)   The inventor; 

(b)   A foreign patent office, the Bureau or the Office, and the information was contained (a) in another application filed by the inventor and should not have been disclosed by the office, or (b) in an application filed without the knowledge or consent of the inventor by a third party which obtained the information directly or indirectly from the inventor; or  

(c)   A third party which obtained the information directly or indirectly from the inventor. 

For the purposes of Sec.25.1,  “inventor” also means any person who, at the filing date of application, had the right to the patent according to Sec.28.   

 (i)   an evident abuse in relation to the applicant or his legal predecessor - e.g. the invention was derived from the applicant and disclosed against his wish; or  

8.2     An essential condition in all instances is that the disclosure in point must have taken place not earlier than twelve months preceding the filing date or the priority date of the application.  

  8.3  Regarding the cases addressed in Sec.25.1(a) and (c) , the disclosure might be made in a published document or at a conference or in any other way.  

8.4   Regarding the cases addressed in Sec.25.1(b), they might occur whenever a patent office publishes an application by mistake (e.g. after the application has been explicitly been withdrawn, or publication before the date foreSeen by the law), or for example, when a person B who has been told of A's invention in confidence, applies for a patent for this invention. If so, the disclosure resulting from the publication of B's application will not prejudice A's rights provided that A has already made an application, or applies within six months of such publication. In any event, having regard to Sec.67, B may not be entitled to proceed with his application (See VI, 9.7 to 9.11).

Sec.26

Sec.24
R.204(a)(b)
R.206(b)

Sec.24
2^nd
Sentence

Sec.21
1^st
Sentence

9. Inventive step 

9.1     "An invention involves an inventive step if, having regard to the prior art, it is not obvious to a person skilled in the art at the time of the filing date or priority date of the application claiming the invention”. Novelty and inventive step are different criteria. Novelty exists if there is any difference between the claimed invention and the known art. The question - Is there inventive step? - only arises if there is novelty.  

9.2     The "prior art" for the purposes of considering inventive step is as defined in Sec.24.1 (See IV, 5 here above); it does not include later published Philippine patent, utility model or industrial design applications as referred to in Sec.24.2.  

9.3     Thus the question to consider, in relation to any claim defining the invention, is whether at the priority date of that claim, having regard to the art known at the time, it would have been obvious to the person skilled in the art to arrive at something falling within the terms of the claim. If so, the claim is bad for lack of inventive step. The term "obvious" means that which does not go beyond the normal progress of technology but merely follows plainly or logically from the prior art, i.e. something which does not involve the exercise of any skill or ability beyond that to be expected of the person skilled in the art. In considering inventive step, as distinct from novelty (See IV, 7.3 here above), it is fair to construe any published document in the light of subsequent knowledge and to have regard to all the knowledge generally available to the person skilled in the art at the filing or priority date of the claim.  

9.3a   The invention claimed must normally be considered as a whole. Thus it is not correct as a general rule, in the case of a combination claim, to argue that the separate features of the combination taken by themselves are known or obvious and that "therefore" the whole subject-matter claimed is obvious. The only exception to this rule is where there is no functional relationship between the features of the combination i.e.  

where the claim is merely for a juxtaposition of features and not a true combination (See the example at 2.1 of the Annex 1 to this Chapter).  

9.4     While the claim should in each case be directed to technical features (and not, for example, merely to an idea), in order to assess whether an inventive step is present it is important for the examiner to bear in mind that there are various ways in which the skilled person may arrive at an invention. An invention may, for example, be based on the following:  

(i)     The formulation of an idea or of a problem to be solved (the solutionbeing obvious once the problem is clearly stated).  

Example: the problem of indicating to the driver of a motor vehicle at night the line of the road ahead by using the light from the vehicle itself. As soon as the problem is stated in this form the technical solution, viz. the provision of reflective markings along the road surface, appears simple and obvious.  

(ii)          The devising of a solution to a known problem.

Example: the problem of permanently marking farm animals such as cows without causing pain to the animals or damage to the hide has existed since farming began. The solution ("freeze-branding") consists in applying the discovery that the hide can be permanently de-pigmented by freezing.

(iii)         The arrival at an insight into the cause of an observed phenomenon (the practical use of this phenomenon then being obvious).

Example: the agreeable flavour of butter is found to be caused by minute quantities of a particular compound. As soon as this insight has been arrived at, the technical application comprising adding this compound to margarine is immediately obvious.

Many inventions are of course based on a combination of the above possibilities - e.g. the arrival at an insight and the technical application of that insight may both involve the use of the inventive faculty.

9.5     In identifying the contribution any particular invention makes to the art in order to determine whether there is an inventive step, account should be taken first of what the applicant himself acknowledges in his description and claims to be known. Any such acknowledgment of known art should be regarded by the examiner as being correct unless the applicant states he has made a mistake. However, the further prior art contained in the search report may put the invention in an entirely different perspective from that apparent from reading the applicant's specification by itself (and indeed this cited prior art may cause the applicant voluntarilyto amend his claims to redefine his invention before his application comes up for examination). In order to reach a final conclusion as to whether the subject-matter of any claim includes an inventive step it is necessary to determine the difference between the subject-matter of that claim and the prior art and, in considering this matter, the examiner should not proceed solely from the point of view suggested by the form of claim (prior art plus characterising portion - See III, 2).

Considering the definition of an invention as given in Sec.21, when assessing inventive step the examiner will normally apply the following “problem and solution approach”:

In the problem and solution approach there are three main stages:  

           1.      determining the closest prior art,  

           2.      establishing the technical problem to be solved, and  

           3.         considering whether or not the claimed invention, starting from the closest prior art and the technical problem, would have been obvious to the skilled person. 

In the first stage, the closest prior art must be determined. The closest prior art is that combination of features derivable from one single reference that provides the best basis for considering the question of obviousness. The closest prior art may be, for example:  

(i)     a known combination in the technical field concerned that discloses technical effects, purpose or intended use, most similar to the claimed invention or  

(ii)             that combination which has the greatest number of technical features in common with the invention and capable of performing the function of the invention.  

In the second stage, one establishes in an objective way the technical problem to be solved. To do this, one studies the application (or the patent), the closest prior art and the difference in terms of technical features (either structural or functional) between the claimed invention and the closest prior art and then formulates the technical problem. In this context  the technical problem means the aim and task of modifying or adapting the closest prior art to provide the technical effects that the invention provides over the closest prior art.  

The technical problem derived in this way may not be what the application presents as "the problem". The latter may require to be reformulated, since the objective technical problem is based on objectively established facts, in particular appearing in the prior art revealed in the course of the proceedings, which may be different from the prior art of which the applicant was actually aware at the time the application was filed.  

The extent to which such reformulation of the technical problem is possible has to be assessed on the merits of each particular case. For instance, any effect provided by the invention may be used as a basis for the reformulation of the technical problem, as long as said effect is derivable from the application as filed. It may also be possible to rely on new effects submitted subsequently during the proceedings by the applicant, provided that the skilled person would recognize these effects as implied by or related to the technical problem initially suggested.

The expression “technical problem” should be interpreted broadly; it does not necessarily imply that the solution is a technical improvement over the prior art. Thus the problem could be simply to Seek an alternative to a known device or process providing the same or similar effects or which is more cost-effective.  

Sometimes the technical features of a claim provide more than one technical effect, so one can speak of the technical problem as having more than one part or aspect, each corresponding to one of the technical effects. In such cases, each part or aspect generally has to be considered in turn.  

In the third stage, the question to be answered is whether there is any teaching in the prior art as a whole that would (not simply could, but would) prompt the skilled person, faced with the technical problem, to modify or adapt the closest prior art while taking account of that teaching, thus arriving at something falling within the terms of the claims, and thus achieving what the invention achieves (See IV, 9.3 here above).  

9.5a If an independent claim is new and non-obvious, there is no need to investigate the obviousness or non-obviousness of any claims dependent thereon, except in situations where the priority claim for the subject-matter of the dependent claim has to be checked because of intermediate documents (See e.g. V, 2.6.3). Similarly, if a claim to a product is new and non-obvious there is no need to investigate the obviousness of any claims for a process which inevitably results in the manufacture of that product or any claims for a use of that product. In particular, analogy processes are patentable insofar as they provide a novel and inventive product. 

9.6     The “person skilled in the art” should be presumed to be an ordinary practitioner aware of what was common general knowledge in the art at the relevant date. He should also be presumed to have had access to everything belonging to the "prior art", in particular the documents cited in the search report, and to have had at his disposal the normal means and capacity for routine work and experimentation.  

If the problem prompts the person skilled in the art to Seek its solution in another technical field, the specialist in that field is the person qualified to solve the problem. The assessment of whether the solution involves an inventive step should  therefore be based on that specialist's knowledge and ability. There may be instances where it is more appropriate to think in terms of a group of persons, e.g. a research or production team, than a single person. This may apply e.g. in certain advanced technologies such as computers or telephone systems and in highly specialised processes such as the commercial production of integrated circuits or of complex chemical substances.  

9.7    In considering whether there is inventive step (as distinct from novelty (See IV, 7 here above), it is permissible to combine together the disclosures of two or more documents or parts of documents, different parts of the same document or other pieces of prior art, but only where such combination would have been obvious to the person skilled in the art at the filing or priority date of the claim under examination. In determining whether it would be obvious to combine two or more distinct disclosures, the examiner should have regard to the following:  

(i)        Whether the content of the documents is such as to make it likely or unlikely that the person skilled in the art, when concerned with the problem solved by the invention, would combine them – for example, if two disclosures considered as a whole could not in practice be readily combined because of inherent incompatibility in disclosed features essential to the invention, the combining of these disclosures should not normally be regarded as obvious.  

(ii)        Whether the documents come from similar, neighbouring or remote technical fields.  

(iii)     The combining of two or more parts of the same document would be obvious if there is a reasonable basis for the skilled person to associate these parts with one another. It would normally be obvious to combine with a prior art document a well-known textbook or standard dictionary; this is only a special case of the general proposition that it is obvious to combine the teaching of one or more documents with the common general knowledge in the art. It would, generally speaking, also be obvious to combine two documents one of which contains a clear and unmistakable reference to the other (for references which are considered an integral part of the disclosure, See 6.1 and 7.1 here above. In determining whether it is permissible to combine a document with an item of prior art made public in some other way, e.g. by use, similar considerations apply.  

9.8     To this chapter ("Guidance for the assessment of inventive step"), as well as Chapter VII (parts VII, 1 and VII, 5.4) give examples of circumstances where an invention should be regarded as obvious or where it involves an inventive step. It is to be stressed that these examples are only guides and that the applicable principle in each case is "was it obvious to a person skilled in the art?" Examiners should avoid attempts to fit a particular case into one of these examples where the latter is not clearly applicable. Also, the list is not exhaustive.  

9.9    It should be remembered that an invention which at first sight appears obvious might in fact involve an inventive step. Once a new idea has been formulated it can often be shown theoretically how it might be arrived at, starting from something known, by a series of apparently easy steps. The examiner should be wary of “ex post facto” analysis of this kind. He should always bear in mind that the documents produced in the search have, of necessity, been obtained with foreknowledge of what matter constitutes the alleged invention. In all cases he should attempt to visualise the overall prior art confronting the skilled man before the applicant's contribution and he should Seek to make a "real life" assessment of this and other relevant factors. He should take into account all that is known concerning the background of the invention and give fair weight to relevant  arguments or evidence submitted by the applicant. If, for example, an invention is shown to be of considerable technical value, and particularly if it provides a technical advantage which is new and surprising, and this can convincingly be related to one or more of the features included in the claim defining the invention, the examiner should be hesitant in pursuing an objection that such a claim lacks inventive step. The same applies where the invention solves a technical problem which workers in the art have been attempting to solve for a long time, or otherwise fulfils a long-felt need. Commercial success alone is not to be regarded as indicative of inventive step, but evidence of immediate commercial success when coupled with evidence of a long-felt want is of relevance provided the examiner is satisfied that the success derives from the technical features of the invention and not from other influences (e.g. selling techniques or advertising).

9.10     The relevant arguments and evidence to be considered by the examiner for assessing inventive step may be taken either from the originally filed patent application, or be submitted by the applicant during the subsequent substantive examination proceedings (See IV-9.5 here above and VI, 5.7, 5.7a, 5.7c and 5.7d. 

Care must be taken, however, whenever new effects in support of inventive step are referred to. Such new effects may only be taken into account if they are implied by or at least related to the technical problem initially suggested in the originally filed application. Otherwise they have to be considered as corresponding to another invention that was not originally disclosed. 

Example of such a new effect:  

The invention as filed relates to a pharmaceutical composition having a specific activity. At first sight, having regard to the relevant prior art, it would appear that there is a lack of inventive step. Subsequently the applicant submits new evidence which shows that the claimed composition exhibits an unexpected advantage in terms of low toxicity. In this case it is allowable to reformulate the technical problem by including the aspect of toxicity, since pharmaceutical activity and toxicity are related in the sense that the skilled person would always contemplate the two aspects together.  

The reformulation of the technical problem may or may not give rise to an amendment, and subsequent insertion, of the statement of the technical problem in the description. Any such amendment is only allowable if it satisfies the conditions listed in VI, 5.7c. In the above example of a pharmaceutical composition, neither the reformulated problem nor the information on toxicity could be introduced into the description without infringing the proviso of Sec.49.

ANNEX 1 to CHAPTER IV, 9  
Guidance for the assessment of inventive step