PCT International Search and Preliminary Examination Guidelines
PART III EXAMINER CONSIDERATIONS COMMON TO BOTH THE INTERNATIONAL SEARCHING AUTHORITY AND THE INTERNATIONAL PRELIMINARY EXAMINING AUTHORITY
Chapter 9 Exclusions from, and Limitations of, International Search and International Preliminary Examination
9.02 Rule 39 specifies certain subject matter which an International Searching Authority is not required to search. Rule 67 sets out an identical list of subject matter, on which an International Preliminary Examining Authority is not required to perform an international preliminary examination (and also, in accordance with Rule 43bis.1(b), for which the International Searching Authority is not required to establish a written opinion concerning novelty, inventive step and industrial applicability). While the subject matter in these Rules may be excluded from search or examination, there is no requirement that it be excluded. Depending on the policy of the Authority, such subject matter may be searched or examined, for example, where it is searched or examined under the national law of the Office acting as the International Searching Authority or the International Preliminary Examining Authority. This may also be the case even though the subject matter is not considered patentable under the respective national law. Any such subject matter which a particular Authority is prepared to search or examine is set forth in an Annex to the Agreement between that Authority and the International Bureau. Accordingly, the subject matter excluded from the international search or international preliminary examination may vary between the various Authorities.
9.03 Any such restriction to the search, or to the international preliminary examination should be accompanied by a reasoned explanation in the written opinion or international preliminary examination report issued by the Authority. If no search is to be carried out the search examiner will complete Form PCT/ISA/203 (Declaration of Non-Establishment of International Search Report). As a general principle, a search or examination is to be carried out wherever practicable, including in the case where the relevant Authority has decided to search or examine any subject matter listed in Rule 39 or 67 although it is not considered patentable under the national law of the Office acting as the Authority.
9.04 The following paragraphs relate to subjects that may be excluded from international search or preliminary examination according to Rules 39 and 67. Practices differ among the Authorities regarding the exclusions issue. Some Authorities use an approach involving a “practical application” while others use an approach involving a “technical character.” Each Authority may use the approach that is consistent with its own practice. Paragraphs 9.05, 9.07 and 9.11 to 9.15 use both terms to accommodate these alternative practices. For the purposes of these paragraphs, the term “practical application” should be understood to mean a characteristic that the claimed invention, when viewed as a whole, has a practical application providing a useful, concrete and tangible result. “Technical character” should be understood to mean that the claimed invention must relate to a technical field, must be concerned with a technical problem and must have technical features in terms of which the matter for which protection is sought can be defined in the claim. However, it is noted that paragraphs 9.06 and 9.08 to 9.10, below, relate to exclusions that are not affected by these alternative practices.
9.05 The mere presence of scientific or mathematical theories in claims does not immediately exclude the claims from search or preliminary examination. When viewing the claims as a whole, if the theories are applied or implemented to produce a practical application or to have technical character, search and preliminary examination is required since the result is not purely abstract or intellectual. Scientific theories are a more generalized form of discoveries. For example, the physical theory of semi-conductivity would be excluded, whereas new semiconductor devices and processes for manufacturing would require search and preliminary examination. Mathematical theories are a particular example of the principle that purely abstract or intellectual methods are excluded. For example, a shortcut method of division would be excluded but a calculating machine designed to operate accordingly would require search and preliminary examination.
9.06 While plant and animal varieties may be excluded from search, transgenic plants and genetically modified non-human animals, as well as methods of making these types of inventions would be searched and examined. The question whether a process is “essentially biological” 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. For example, a method of selectively breeding horses involving merely selecting for breeding and bringing together those animals having certain characteristics would be essentially biological. However, a method of treating a plant characterized by the application of a growth-stimulating substance or radiation would not be essentially biological since, although a biological process is involved, the essence of the claimed invention is technical. Similarly, methods of cloning or genetically manipulating non-human animals are not essentially biological processes and would be searched and examined. The treatment of soil by technical means to suppress or promote the growth of plants is also not excluded. The exclusion referred to above does not apply to microbiological processes or the products thereof. The term “microbiological process” is to be interpreted as covering not only industrial processes using microorganisms but also processes for producing microorganisms, for example, by genetic engineering. The product of a microbiological process may also be subject to search and preliminary examination (product claim). Propagation of the product of a microbiological process itself is to be construed as a microbiological process for the purposes of Rules 39 and 67; consequently, the product can be protected per se as it is a product obtained by a microbiological process. The term “product of a microbiological process” covers plasmids and viruses also.
9.07 Schemes, rules or methods of doing business, performing purely mental acts or playing games are further examples of items of an abstract or intellectual character. Note that it is not the particular art involved or classification of claimed invention that is determinative of exclusion, but rather whether the claimed invention is of an abstract character. Specific guidance where divergent practices exist is set forth in the appendix to this chapter.
9.08 Methods for treatment of the human or animal body by surgery or therapy as well as diagnostic methods practiced on the human or animal body are further subject matter on which an Authority is not required to carry out international search or preliminary examination. Search and preliminary examination should, however, be conducted for surgical, therapeutic or diagnostic instruments or apparatus for use in such methods. Search and preliminary examination should also be conducted for new products, particularly substances or compositions for use in these methods of treatment or diagnosis.
9.09 It should be noted that Rules 39.1(iv) and 67.1(iv) exclude only certain treatment by surgery or therapy or certain diagnostic methods. It follows that other methods of treatment of live human beings or animals (for example, 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 appropriate for international search and preliminary examination, provided that (as would probably be the case) such methods are not of essentially biological character (see paragraph 9.06). For example, an application containing claims directed to the cosmetic treatment of a human by administration of a chemical product should be searched and examined. A search or preliminary examination on a cosmetic treatment involving surgery need not, however, be carried out (see the last sentence of paragraph 9.10).
9.10 A treatment or diagnostic method, to be excluded, must actually be limited to being carried out on the living human or animal body. A treatment of or diagnostic method practiced on a dead human or animal body would therefore not be excluded from international search and preliminary examination by virtue of Rules 39(1)(iv) and 67.1(iv). Treatment of body tissues or fluids after they have been removed from the human or animal body, or diagnostic methods applied thereon would not be excluded from the search or preliminary examination insofar 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 could be excluded. Diagnostic methods comprise the carrying out of an investigation for medical purposes into the state of a human or animal body, so that a method of measuring the blood pressure of a body or a method of obtaining information regarding the internal state of a body by passing X-rays through the body could be excluded from international search or preliminary examination. A treatment by therapy implies the curing of a disease or malfunction of the body; prophylactic methods, for example, immunization, are considered to be therapeutic treatments and thus may be excluded. Surgery is not limited to healing treatments, being more indicative of the nature of the treatment; methods of cosmetic surgery may thus be excluded from search or preliminary examination.
9.11 Any presentation of information characterized solely by the content of the information would be excluded under Rules 39 and 67. This applies, whether the claim is directed to the presentation of the information per se (for example, by acoustical signals, spoken words, visual displays), to information recorded on a carrier (for example, 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 program recorded), or to processes and apparatus for presenting information (for example, indicators or recorders characterized solely by the information indicated or recorded). If, however, the presentation of encoded information has a technical character or both a structural and functional relationship to the information carrier, process or apparatus, these should be examined as the subject matter relates to the information carrier or to the process or apparatus for presenting the information. Such examples would include a measuring device with volumetric markings having both a structural and functional relationship with a measuring receptacle providing for recalibration of the device depending on the quantities desired; a gramophone record characterized by a particular groove form to allow stereo recordings; or a diapositive with a sound track arranged at the side of it.
9.12 Mere arrangements or compilations of data are generally excluded subject matter unless the arrangement or manner of presentation has technical character or a practical application. For example, a mere program listing itself is not capable of execution and represents merely the expression of the underlying idea rather than the application of that idea, and would thereby fall within this exclusion. A disembodied data structure that has no interaction with an underlying program would not require international search and examination, while a data structure embodied in a tangible medium that has a technical character or has a practical application should be subject to international search and examination. Further examples in which such a technical character or practical application may be present are: a telegraph apparatus or communication system characterized by the use of a particular code to present the characters (for example, pulse code modulation) and a measuring instrument designed to produce a particular form of graph for presenting the measured information. A computer system for searching gene sequences within a particular library of genetic data (the searching function goes beyond mere presentation of information) would have a technical character or a practical application as would a computer program capable of directing the display of three dimensional coordinates of a polypeptide and the atomic coordinates of a polypeptide Q. A computer readable media having the atomic coordinates of a polypeptide encoded thereon, however, would not have a technical character or practical application even though the data structure is embodied in a tangible medium. The examples below illustrate both excluded and non-excluded subject matter for arrangements or compilations of data in the field of bioinformatics.
Claim 1. A computer model of protein P generated with the atomic coordinates listed in Fig. 1.
Claim 2. A data array comprising the atomic coordinates of protein P as set forth in Fig. 1 which, when acted upon by a protein modeling algorithm, yields a representation of the 3-D structure of protein P.
International search and examination are not required for claims 1 and 2. Both claims are directed to a disembodied data structure that has no interaction with an underlying program.
Claim 1. A method of identifying compounds that can bind to protein P, comprising the steps of: applying a 3-dimensional molecular modeling algorithm to the atomic coordinates of protein P shown in Fig. 1 to determine the spatial coordinates of the binding pocket of protein P; andelectronically screening the stored spatial coordinates of a set of candidate compounds against the spatial coordinates of the protein P binding pocket to identify compounds that can bind to protein P.
Claim 2. A database encoded with data comprising names and structures of compounds identified by the method of claim 1.
Claim 1 is directed to a method that has a technical character or practical application. Accordingly, international search and examination is required.
Claim 2 is directed to a disembodied data structure that has no interaction with an underlying program. Thus, international search and examination is not required.
9.15 Computer programs are excluded subject matter to the extent that the Authority is not equipped to carry out search or preliminary examination on such programs. It should be noted at the outset that programs for computers can be expressed in many forms. Normally, claims that merely recite program code are excluded subject matter. However, to the extent that a natural language description of any computer-executable program, or a self-documented code, is included in the description and the claims, the Authority should be considered “equipped” to carry out a search and preliminary examination based on such a description subject to the relevant guidelines regarding the conditions as to exclusion. The Authorities have diverging practices with respect to determinations of exclusions as to computer programs. Specific guidance where divergent practices exist is set forth in the appendix to this chapter.