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

Extent of Search and Preliminary Examination in Certain Situations

9.19 There may be exceptional situations where the description, the claims or the drawings fail to comply with the prescribed requirements to such an extent that a meaningful search cannot be carried out, that is, no search at all is possible for a particular claim (see paragraph 9.01). However, in certain situations where the description, the claims, or the drawings can be sufficiently understood, even though a part or parts of the application are not in compliance with the prescribed requirements, a search is performed taking into consideration the non-compliance in determining the extent of the search. In such cases, the international search report and the written opinion then indicate how the description, claims, or drawings fail to comply with the prescribed requirements (see paragraphs 16.28, 16.29 and 17.34). In this indication, it is also noted by the International Searching Authority to what degree that non-compliance with the particular prescribed requirements has been taken into account for the purposes of determining the extent of the search, and this extent is indicated as precisely as possible. In general, a search should be carried out to the maximum extent practical.

Examples Where Search or Preliminary Examination Possible, with an Indication in the Written Opinion

9.20 Example 1

Claim 1. "Distillate fuel oil boiling in the range 120oC to 500oC which has a wax content of at least 0.3 weight% at a temperature of 10oC below the Wax Appearance Temperature, the wax crystals at that temperature having an average particle size less than 4000 nanometers."

The description does not disclose any other method of obtaining the desired crystal size than the addition of certain additives to the fuel oil and there is no common general knowledge of making fuel oils of this kind available to the person skilled in the art.

A search would first be made for the additive and fuel oils having defined amounts of the additive disclosed. The field of search would then be extended to all probable areas relevant to the claimed subject matter, that is, the broad concept of fuel oil compositions having the desired property. However, the search need not be extended to areas in which it could reasonably have been determined that there was a low probability of finding the best reference. If the broad concept of having crystals as small as possible was known in the art, the written opinion should indicate the claim as not complying with the requirements of novelty and/or inventive step. The written opinion should also include any observations on non-prior art grounds (that is, requirements under Articles 5 and 6 such as sufficiency and support as well as industrial applicability). In this example, the claim would be objected to in the written opinion on the following non-prior art grounds: (1) it is not supported by the description and drawings "in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art" (see paragraph 5.45); and/or (2) it is not fully supported in the description and drawings thereby showing that the applicant only claims subject matter which he recognized and described on the filing date (see paragraphs 5.54 and 5.58). The international search report would cite the fields of search, the most relevant references for prior art purposes, and, where possible, the most relevant references for non-prior art purposes (see paragraph 16.72 (which indicates that the symbol "T" should be used for designating documents which are cited to show that the reasoning or the facts underlying the invention are incorrect), and paragraph 15.66 (directed to the category symbol to be used for subject matter which may be excluded from the international search)), which in this example involve a lack of support by the description. The International Searching Authority should also include in the objection on non-prior art grounds an indication as to what degree the objection has been taken into account for purposes of determining the extent of the search, and this extent should be indicated as precisely as possible, for example, the additive and fuel oils having defined amounts of the additive disclosed and/or the broad concept of fuel oil compositions having the desired property.

9.21 Example 2: Claim Characterized Solely by the Result to be Achieved

Claim 1: "A process of reacting starting materials in such a way that a sustained release tablet with improved properties is obtained."

The description discloses an example of reacting particular materials in a particular manner to obtain a sustained release tablet having a particular release rate of a particular bioactive material.

A search would first be made for the particular materials reacting in the particular manner. If the particular example disclosed could not be found, the search would then be extended. For instance, the search could be extended to sustained release tablets having the particular bioactive material. However, the search does not need to be extended to areas in which it could reasonably have been determined that there was a low probability of finding the best reference. Aside from any opinion on novelty or inventive step, the written opinion should indicate any observations on non-prior art grounds (that is, requirements under Articles 5 and 6 such as sufficiency and support, as well as industrial applicability). In this example, the claim would be objected to in the written opinion on the following non-prior art grounds: (1) the claim lacks clarity since (a) the claim fails to recite any steps of a process such that the scope of the invention is not set forth with a reasonable degree of clarity and particularity (paragraph 5.32), and (b) the phrase "improved properties" is a relative term (paragraph 5.34); and (2) the claim attempts to define the invention solely by the result to be achieved (paragraph 5.35). Again, the international search report would cite the fields of search, the most relevant references for prior art purposes, and the most relevant references for non-prior art purposes. The International Searching Authority should also include in the objection on non-prior art grounds an indication as to what degree the objection has been taken into account for purposes of determining the extent of the search, and this extent should be indicated as precisely as possible, for example, the particular materials reacted in the particular manner.

9.22 Example 3: Claim Characterized Solely by Unusual Parameters

Claim 1: "A fat having a nausea index of less than or about 1.0."

The description discloses a number of fats that purportedly have a nausea index of less than 1.0 and a number of fats which have a nausea index greater than 1.0. Examples of fats having a nausea index of less than 1.0 include different mixtures of saturated and unsaturated fats. Examples of fats having a nausea index greater than 1.0 also include different mixtures of saturated and unsaturated fats. No other properties, for example, melting point, of these mixtures of fats are disclosed. The description discloses determining the nausea index by whipping the fat at a particular speed and temperature and measuring the viscosity of the whipped mixture at room temperature.

A search should first be made for the examples disclosed in the description as having a nausea index less than or about 1.0. If one of these examples is found in the prior art, an indication that the claim lacks novelty over the prior art would be made since the same material would be expected to have the same properties. Aside from any opinion on novelty and inventive step, the written opinion should indicate any observations on non-prior art grounds (that is, requirements under Articles 5 and 6 such as sufficiency and support, as well as industrial applicability). In this example, the claim would be objected to on the following non-prior art grounds: (1) the claimed subject matter is not supported by the description and drawings "in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art" over the entire scope of the claim (paragraph 5.45); and/or (2) the claimed invention is not fully supported in the description and drawings thereby showing that the applicant only claims subject matter which he had recognized and described on the filing date (paragraphs 5.54 and 5.58); and (3) the claimed invention lacks clarity because the parameters cannot be clearly and reliably determined by indications in the description or by objective procedures which are recognized in the art (paragraph 5.36). If one of these examples is not found, the search need not be limited to only the examples simply because a newly described/discovered parameter is used by the applicant to explain the invention. A search can usually be performed using other known parameters or chemical or physical properties that may lead to a conclusion that the newly described/discovered parameter is necessarily present, that is, inherent. For instance, in this example, perhaps a search using a parameter such as the extent of saturation could be made. The International Searching Authority should also include in the objection on non-prior art grounds an indication as to what degree the objection has been taken into account for purposes of determining the extent of the search, and this extent should be indicated as precisely as possible, for example, the examples disclosed in the description and/or other known parameters or chemical or physical properties that imply the presence of the new parameter.

9.23 Example 4: Chemical Markush-Type Claim Encompassing Many Embodiments

In this example the claims encompass a very large number of possible embodiments while the description discloses, and provides support for, only a relatively small proportion of those embodiments (see paragraph 5.48).

In such cases, the search may be directed only towards claimed embodiments that relate to specifically disclosed compounds, or prepared or tested compositions and a structural generalization of these. The written opinion should also include observations on Articles 5 and 6 (sufficiency and support) describing specifically how the description provides support for only a relatively small proportion of the embodiments claimed. The International Searching Authority should also include in the objection on non-prior art grounds an indication as to what degree the objection has been taken into account for purposes of determining the extent of the search, and this extent should be indicated as precisely as possible, for example the specifically disclosed compounds, or prepared or tested compositions, and a structural generalization of these.

9.24 Example 5: Chemical Markush-Type Claim with Many Options, Variables, Etc.

In this example, the claim contains so many options, variables, possible permutations and/or provisos, that the claim is rendered unclear and/or inconcise to the extent that it is not in compliance with Article 6 and Rule 6 (see paragraph 5.42).

In such cases, the search should be carried out for those parts of the claim that are clear and concise or to the extent that the claimed invention can be understood. For example, the search may be directed only towards claimed embodiments that relate to clearly disclosed compounds, or clearly prepared or tested compositions, and a structural generalization of these. The written opinion should also include observations on Article 6 (clarity and/or conciseness) describing specifically how the claims lack clarity and/or conciseness. The International Searching Authority should also include in the objection on non-prior art grounds an indication as to what degree the objection has been taken into account for the purposes of determining the extent of the search, and this extent should be indicated as precisely as possible, for example the clearly disclosed compounds, or clearly prepared or tested compositions, and a structural generalization of these.

9.25 Example 6: Multitudinous Claims

An application contains 480 claims, of which 38 are independent. There is no clear distinction between the independent claims because of overlapping scope. There are so many claims, and they are drafted in such a way that they are not in compliance with Article 6 and Rule 6. However, there is a reasonable basis in the description, for example from a particular passage, that clearly indicates which subject matter might be expected to be claimed.

The search should be based on the subject matter that would be expected to be claimed. In the written opinion, the claims should be objected to on the non-prior art grounds of lack of compliance with Article 6 and Rule 6. The International Searching Authority should also include in the objection on non-compliance with Article 6 and Rule 6 an indication to what degree the objection has been taken into account for the purposes of determining the extent of the search, and this extent should be indicated as precisely as possible, for example by a brief written description of the searched subject matter, where possible citing a particular passage.

Examples of Exceptional Situations Where No Search at All is Possible for All or Some of the Claims

9.26 These examples relate to exceptional situations where, due to non-compliance of the application with the prescribed requirements, all or some of the claims cannot be meaningfully searched at all. This means that for cases where a meaningful search of all or some of the claims is possible, for example by taking into account a likely amendment to overcome the non-compliance, then such a search is carried out along the procedural lines set out in paragraph 9.19 and the examples in paragraphs 9.20 to 9.25.

9.27 When none of the claims can be meaningfully searched at all, since no likely amendment can be determined to overcome the non-compliance, the International Searching Authority makes a declaration in accordance with Article 17(2)(a)(ii). When only some of the claims cannot be meaningfully searched at all, however, an indication is made in the international search report in accordance with Article 17(2)(b) to this effect whereas the other claims will be searched as usual.

9.28 Example 1

Claim 1: "My invention is worth a million dollars."

Claim 1 is the only claim in the application. The description does not provide sufficient information about the invention to determine the subject matter to which the claim might reasonably be expected to be directed after it had been amended.

No search at all is possible. A declaration will be made in accordance with Article 17(2)(a)(ii). In the written opinion, the claim should be objected to on the non-prior art grounds of lack of compliance with Article 6 and Rule 6. The International Searching Authority should also include in the objection on non-compliance with Article 6 and Rule 6 an indication to what degree the objection has been taken into account for the purposes of determining that no search at all is possible.

9.29 Example 2

Claim 1: "A composition of matter comprising kryptonite."
The description recites the term "kryptonite". However, the description fails to define the purported material in terms of any of the elements of the periodic table. The description also fails to set forth any of the physical properties of the purported material such as density, melting point, etc.

No search at all is possible for claim 1.

9.30 Example 3: Multitudinous Claims

An application contains 480 claims, of which 38 are independent. There is no clear distinction between the independent claims because of overlapping scope. There are so many claims, and they are drafted in such a way, that they are not in compliance with Article 6 and Rule 6. There is no reasonable basis in the description or elsewhere, for example from a particular passage, that indicates which subject matter would be expected to be claimed.

No search at all is possible.

Non Prior-Art Issues

9.31 More detailed discussions regarding the extent of the search can be found in Chapter 5. For searches regarding non-prior art issues, see paragraphs 15.02 and 15.53.

9.32 More detailed discussions of non-prior art concerns including clarity of the claims, conciseness and number of claims, support in the description, clear and complete disclosure of the claimed invention, sufficiency commensurate with the claims, and the relationship of claims to the disclosure can be found in paragraphs 5.31 to 5.58. A more detailed discussion of new matter can be found in paragraphs 20.20 and 20.21.

Industrial Applicability

9.33 If the opinion regarding industrial applicability is negative, then any prior art used to establish this should be cited in the search report and the reasoning set forth in the written opinion. In addition, if applicable, an indication with respect to novelty and inventive step is appropriate (see paragraph 17.42).

Informal Clarification

Articles 17(2)(a)(ii), (b), 34(4)(a)(ii), (b)

9.34 In the event that the description, claims, or drawings fail to comply with a requirement, such as clarity or support of the claims by the description, to such an extent that no meaningful search can be made, the International Searching Authority may, where appropriate, ask the applicant informally for clarification before declaring that no international search report will be established. The examiner should keep in mind that without a search and written opinion of the International Searching Authority for all or part of the claimed subject matter, the international preliminary examination may be limited accordingly, and that the international search and written opinion of the International Searching Authority should be as useful as possible in the event that there is no demand for international preliminary examination. Similarly, if at the time of the first written opinion of the International Searching Authority or a written opinion of the International Preliminary Examining Authority, no opinion is possible on the question of novelty, inventive step (non-obviousness) or industrial applicability for all or part of the claimed subject matter, the examiner may ask the applicant informally for clarification. However, this does not mean that the applicant can be invited or allowed to file amendments before the International Searching Authority. An opinion may not be possible on the question of novelty, inventive step (non-obviousness) or industrial applicability for all or part of the claimed subject matter because the description or claims of the international application fail to meet the requirements of Articles 5 and 6 to such an extent that it is impossible to examine the claimed subject matter as to novelty, inventive step or industrial applicability. In such a case, the examiner examines the claimed subject matter to the extent possible and establishes a written opinion that reflects the inadequate support or other deficiencies for all or part of the claimed subject matter (see paragraph 17.35). The examiner still makes any objections on non-prior art grounds in the written opinion even after informal clarification by the applicant, since the claimed subject matter was, and remains, unclear absent such clarification.

9.35 A need for clarification as referred to in paragraph 9.34 may arise where there are any kinds of defects in the claims which cause difficulty in determining the scope of the claims, for example, obscure, inconsistent, vague or ambiguous expressions. These kinds of defects include cases where the language used in the claims is not clear even after taking the description and drawings (if any) into account.

Unclear Claims

9.36 When the claimed subject matter taken as a whole includes alternatives, some of which are clear realizations of the invention, as well as other alternatives, which are unclear realizations of the invention, the search examiner searches the clear realization of the invention. With regard to the other, unclear realizations, the examiner determines the subject of search based on the subject matter which might reasonably be expected to be claimed by amendment taking into account the contents of the description and drawings and the common general knowledge in the relevant technical field and conduct the search based on the determined subject. The written opinion and international preliminary examination report establish opinions on the novelty, inventive step and industrial applicability of the claims to the extent that this is possible and explain the reasons why the remainder could not be properly assessed.

9.37 For example: if the invention relates to a combination of A + B + C + D in which B is unclear, a search would be performed insofar as the examiner can determine the subject matter to be searched as indicated in paragraph 9.36. However, if B is totally unclear such that it is impossible to determine the subject matter that may be reasonably expected to be claimed, no search would be performed. As another example, if the invention relates to a combination of (A1 or A2) + (B1 or B2), in which A2 is unclear but can be determined by the examiner as indicated in paragraph 9.36, then the entirety of the claim would be searched, including all alternative combinations. However, if A2 is totally unclear such that it is impossible to determine the subject matter that may reasonably be expected to be claimed, the alternative combinations (A1 + B1) and (A1 + B2) would still be searched, while the alternative combinations (A2 +B1) and (A2 + B2) need not be searched.

Perpetual Motion

Article 17(2)(a)

9.38 Where an international application pertains to perpetual motion (perpetuum mobile), it is not necessarily excluded from searching. The International Searching Authority should endeavor to search such an application unless it is so unclear that the application of the principle of Article 17(2)(a) is required.

Sequence Listings

Rule 13ter.1(a); Section 208; AI Annex C

9.39 Another situation where a meaningful search or preliminary examination is not possible may arise where the international application contains disclosure of nucleotide and/or amino acid sequences required to be included in a sequence listing but the International Searching Authority does not have available to it a copy of the sequence listing complying with the standard provided for in Annex C of the Administrative Instructions and in an accepted language. The International Searching Authority requests the provision of such a sequence listing as soon as possible, before the search report and written opinion are established (see paragraphs 15.12 and 15.14A). However if the listing is not provided or is not provided in the form required by the standard or in an accepted language, the Authority makes a meaningful search or preliminary examination to the extent that this is possible. For example, if a named protein is claimed, such a protein could be searched by its name rather than by its sequence. Note that sequences having fewer than ten specifically defined nucleotides or fewer than four specifically defined amino acids are not required to be included in a sequence listing (see paragraph 4.15).