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Assessment of unity of invention

Claims that are unduly complex

6.43 Occasionally an application may contain a large number of claims with overlapping scope, which may relate to separate inventions. In some cases the claims may be unduly complex or broad in scope. In approaching such cases there may be different strategies that may be employed. Some of the key considerations are as follows.

1. Is there a lack of unity?

6.44 This is likely to be a consideration in combination claims (including methods) where each feature may itself comprise a large number of alternatives such as where the individual features are defined in generic terms.

6.45 The considerations set out in previous sections should be taken into account in the unity determination. Moreover the objection should clearly identify the different inventions. Admittedly this may be difficult if the claim is relatively broad, but must be done in order for the applicant to determine the nature of the amendments that they need to make. Following the guidance of the PCT, the consideration may take into account the description and figures to identify groups of inventions.

2. Is inventive step or novelty the key issue?

6.46 In many cases concerning a posteriori lack of unity, the key issue may instead relate to novelty and/or inventive step. In this regard the nature of the citation should be taken into account before raising a lack of unity.

6.47 As discussed in previous sections, whether the common matter is well known is a consideration. Furthermore, whether the broad inventive concept or merely a specific embodiment within the scope of the claim is disclosed in the prior art should be taken into account.

3. Are the claims supported?

6.48 Another consideration is whether the claims are in fact supported by the disclosure. The usual considerations of support should be taken into account, such as whether, for example, the inventive concept is a principle of general application which is supported by the description.

6.49 It should be noted that a divisional application filed for any additional invention(s) which were not supported by the description would be invalid. Accordingly unity is clearly not the only issue here. An objection to lack of unity may be raised together with a support objection, with a warning to the applicant against filing a divisional application.

6.50 Example 1:

A method for the diagnosis of prostate cancer comprising the measurement of one or more of the 2000 markers shown in Table 1.

In this case, the markers have no significant structural or functional feature in common. The description describes the analysis, identification (using commercial Affymetrix microarrays) and comparison of markers in cancerous and non cancerous cells. The description states that the up- or down-regulation of a group of 20 markers may be used to determine the presence of prostate cancer.

A literal approach to the claim would be to identify each of the 2000 individual markers, and each and every combination of such as a single invention. This would result in an indeterminate number of inventions. However, a consideration of the specification as a whole indicates that the invention relates to the particular group of markers that can be used to diagnose cancer. In this case, a lack of support could be considered if the specification provides no support for the claim to each and every combination of the named markers being used for this purpose.

Furthermore, a search of the broad inventive concept of fingerprinting the genetic markers produced in prostate cancer cells could be carried out. Any document found by such a search could be used as a novelty and/or inventive step objection (even if the specific markers are not identified since it would be a matter of routine to determine the identity of such markers).

Nevertheless, in case a lack of unity objection is not raised in the first instance, it may still be necessary to raise such an objection once the claims are amended to overcome the other objections such as inventive step/support. In such cases the applicant should be warned in the first instance that there is a potential for lack of unity, but that full consideration is being deferred pending amendment of the claims.

6.51 Example 2:

A method for the diagnosis of prostate cancer comprising the measurement of one or more of the (2000) markers shown in Table 1.

As in the above example, the markers have no significant structural or functional feature in common. The description describes the analysis, identification (using commercial Affymetrix microarrays) and comparison of markers in cancerous and non-cancerous cells.

The description states that a group of 20 markers may be used to diagnose lethal prostate cancer. A second group of different markers may be used to diagnose benign prostate disease. A third set of markers may be used to determine the likelihood that chemotherapy will be successful.

In this case a similar approach as taken in Example 1 may be taken to the broad claim on the ground of lack of support. Furthermore a lack of unity may be appropriate, identifying the three inventions as noted above.