PCT International Search and Preliminary Examination Guidelines
PART III EXAMINER CONSIDERATIONS COMMON TO BOTH THE INTERNATIONAL SEARCHING AUTHORITY AND THE INTERNATIONAL PRELIMINARY EXAMINING AUTHORITY
Appendix to Chapter 14
A14.01 Not all International Authorities have the same requirements for industrial applicability. An International Authority may rely upon either of the alternative guidelines below as appropriate.
Utility
A14.01[1] The term “industrially applicable” may be deemed by an International Authority to be synonymous with the term “utility.” Accordingly, a claimed invention is considered industrially applicable if it has a utility that is: (a) specific, (b) substantial, and (c) credible.
Specific, or Particular, Utility
(a) It is necessary to distinguish between situations where an applicant has disclosed a specific use or application of the invention, and situations where the applicant merely indicates that the invention may prove useful without identifying with specificity why it is considered useful. For example, indicating that a compound may be useful in treating unspecified disorders, or that the compound has “useful biological” properties, would not be sufficient to define a specific utility for the compound. Similarly, a claim to a polynucleotide whose use is disclosed simply as a “gene probe” or “chromosome marker” would not be considered to be specific in the absence of a disclosure of specific DNA target. A general statement that a compound could be used to diagnose a disease would ordinarily be insufficient absent a disclosure of what condition can be diagnosed. Contrast the situation where an applicant discloses a specific biological activity of a compound and reasonably correlates that activity to a disease condition. Assertions falling within the latter category are sufficient to identify a specific utility for the invention. Assertions that fall in the former category are insufficient to define a specific utility for the invention, especially if the assertion takes the form of a general statement that makes it clear that a “useful” invention may arise from what has been disclosed by the applicant.
Substantial, or Practical “Real World” Utility
(b) Utilities that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use are not substantial utilities. For example, both a compound for treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a “substantial utility” define a “real world” context of use. An assay that measures the presence of a material which has a stated correlation to a predisposition to the onset of a particular disease condition would also define a “real world” context of use in identifying potential candidates for preventive measures or further monitoring. It is necessary to distinguish between inventions that have a specifically identified substantial utility and inventions whose asserted utility requires further research to identify or reasonably confirm. Labels such as “research tool,” “intermediate” or “for research purposes” are not helpful in determining whether an applicant has identified a specific and substantial utility for the invention. The following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a “real world” context of use and, therefore, do not define “substantial utilities:”
(i) basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved;
(ii) a method of assaying for or identifying a material that itself has no specific and/or substantial utility;
(iii) a method of making a material that itself has no specific, substantial, and credible utility; and
(iv) a claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility.
(c) An assertion is credible unless (i) the logic underlying the assertion is seriously flawed, or (ii) the facts upon which the assertion is based are inconsistent with the logic underlying the assertion. Credibility, as used in this context, refers to the reliability of the statement based on the logic and facts that are offered by the applicant to support the assertion of utility. One situation where an assertion of utility would not be considered credible is where a person skilled in the art would consider the assertion to be “incredible in view of contemporary knowledge” and where nothing offered by the applicant would counter what contemporary knowledge might otherwise suggest. Claims directed to a compound for curing a disease or vaccinating against a disease for which there have been no previously successful cures or vaccines warrant careful review for compliance with the industrial applicability requirement. The credibility of an asserted utility of a compound for treating a human disorder may be more difficult to establish where current scientific understanding suggests that such a task would be impossible. Such a determination has always required a good understanding of the state of the art as of the time that the invention was made. The fact that there is no known cure for a disease, however, cannot serve as the basis for a conclusion that such an invention lacks industrial applicability. Rather, it is necessary to determine whether the asserted utility for the invention is credible, based on the information disclosed in the application.
A14.01[2].1 Some International Authorities consider claimed subject matter to have industrial applicability only when all of the following requirements have been met; otherwise industrial applicability is lacking:
(1) The international application must indicate the way in which the invention is capable of exploitation in industry (its intended function, special purpose or specific use).
(2) The international application must disclose the invention in a manner sufficiently clear and complete (defining means and ways) for the invention to be carried out by a person skilled in the art. In the absence of such information it is permissible that the manner for carrying out the invention is disclosed in a source that was available to the public before the date of priority of the invention.
(3) It must actually be possible while carrying out any claim (or claims) by a person skilled in the art to realize the indicated special purpose (specific use) of the invention.
A14.01[2].2 It should be noted that as a rule the special purpose is readily apparent from the subject matter as defined in a claim (or claims) or from the nature of the invention. For example, when defining the subject matter of the invention as “computer” no question would arise of whether it is possible to use it in industry, that is, that requirement (1) would be considered to be complied with. On the other hand, if the subject matter of the invention refers to a novel chemical compound or a process for producing a novel compound, the invention would not be considered as complying with requirement (1) if the indication of its specific use is lacking in the international application.
A14.01[2].3 The application is deemed to describe the invention in a manner complying with requirement (2) if the information contained in the international application, together with information available from a source that was available to the public before the priority date of the invention, is sufficient for the claimed subject matter to be carried out by a person skilled in the art. The information provided by the application is appreciated not only from the point of view of its use for carrying out the invention but also from the point of view of its use for finding the required information in the prior art. For example, suppose an independent claim defines a purported technical feature as follows: “heat expansion ratio for material from which a unit Q of a mechanism is made is in the range from A to B.” Where the material having a heat expansion ratio in the range is known from the prior art, the application shall be deemed to disclose the invention in a manner complying with requirement (2) regardless of whether the material is identified in the application or not. Where such material is not known from the prior art, but the application contains information that is sufficient to manufacture the material, requirement (2) is deemed to be satisfied.
A14.01[2].4 On the other hand, requirement (2) in the example given above would not be deemed to have been complied with where a material having a heat expansion ratio in said range is neither known from the prior art nor can be manufactured because the international application as filed does not contain any information relating to its composition or its method of manufacture.
Possibility of Realizing the Special Purpose
A14.01[2].5 Verification of compliance with requirement (3) is, in fact, a verification of the technical correctness of the invention as defined in each claim. A positive result of such verification means that the implementation of the invention in accordance with the purported technical features as set forth in the claim will result in an embodiment capable of being used for the indicated special purpose.
A14.01[2].6 As an example, when the subject matter of the claim is “perpetuum mobile” it would not be recognized as complying with requirement (3) even where the international application complies with requirement (2), since it operates contrary to the well-established physical laws. Requirement (3) is also deemed not to have been complied with in cases of technical errors which are not necessarily linked with basic laws of nature but nevertheless result in a failure of the claimed subject matter to be usable for the special purpose indicated by the applicant.
A14.01[2].7 As another example, when a motor is claimed, requirement (3) would be deemed to have been complied with if the functioning of the motor results in, say, mechanical movement. If at the same time it is found that certain characteristics, for example, the specified efficiency ratio of a motor, described in the international application cannot be achieved, this finding is of no relevance in the context of the industrial applicability requirement, but is to be treated under the sufficiency of description requirement.
Date at Which Requirements Must Be Met
A14.01[2].8 Verification of the compliance with requirements (1) to (3) is carried out as of the priority date of the invention. Accordingly, if no prior disclosure made before the priority date provided the information required to carry out the claimed invention and the earlier application on the basis of which priority of the application concerned was claimed did not contain such information, incorporation of the information into the application under review would not be sufficient to establish the invention as having industrial applicability as of the priority date and would be considered as adding new matter in contravention of Articles 19(2) and 34(2)(b).