New examination guidelines: overlapping subject matter

Recently published guidelines for examiners with regard to overlapping subject matter (see www.justice.gov.il/NR/rdonlyres/8EA9E6D9-F779-485C-8FA0-AFF66C3DE5FB/34339/AppendixE.doc) have clarified the definition of "overlapping subject matter" and provide an insight into the strategy for drafting and prosecuting divisional and continuation applications before the Israeli Patent and Trademark Office (ILPTO).

Sections 4 and 5 of the Patent Law provide general guidelines for determining patentability according to the novelty and inventiveness of the claimed subject matter. Section 19 of the Patent Law requires the examiner or the patent registrar to suspend examination of any application, including claims relating to subject matter that overlaps subject matter claimed in an earlier application that is still pending before the ILPTO. Section 23 of the new guidelines sets down the criteria for determining such overlap – such criteria substantially broaden the examiner's ability to refuse to consider applications based on incremental differences over previously claimed subject matter. 

Like European patent law, the Israeli Patent Law does not provide a solution to overlap (also known as "double patenting") similar to that afforded by the terminal disclaimer under US patent law.

According to the guidelines, overlap results from a "substantial identity" between the claims being examined and those of a pending application or an issued patent. According to the guidelines, overlap must be asserted regarding individual claims of the current application, but with regard to the entire specification, not just to the claims of the earlier application.

Overlap occurs when subject matter claimed in both applications is "substantially identical". "Substantially identical" is further defined as comprising all of the features essential to make or use the later invention as claimed.

"Overlap", as defined in the guidelines, extends to the (direct) product(s) of any process claimed in the earlier application. Overlap also extends to the specific application or use of a composition, where an earlier application claiming the composition or a process for making the composition also discloses, but does not claim, the same specific application or use of the composition.

Additional grounds for suspending examination due to overlap include where there are incremental changes lacking inventive step or "failing to alter the essence" of the earlier disclosed invention, or if a specific (eg, narrow) claim of the later application falls within the scope of a broad claim of an earlier application. According to the guidelines, the examiner need not present detailed reasoning for suspension of examination, and the responsibility for demonstrating evidence of inventive step or advantageous features lies with the applicant.

Overlap also extends to the obverse situation, wherein a broad claim of the later application includes a narrower aspect of an earlier application. In the latter case, the guidelines provide for resolution of such "overlap" by a proviso to the broad claim to exclude the earlier disclosure's subject matter specifically.

By way of illustration, the guidelines describe the case of an earlier claim directed to compound A described in a Markush group, while claims of a latter application are directed to one or more individual components of the group with identical activity. The examiner must demand evidence of an advantage of the narrower compound or group of compounds, even where the earlier application lacks specific disclosure of the latter subject matter, or the latter claim is amended to exclude subject matter specifically disclosed in the earlier application. If the earlier application has been published, the differences should be considered in the context of novelty and obviousness of the latter claims.

The guidelines set forth criteria according to which suspension of examination due to overlap is invoked if the earlier application has not yet been published, and rejection of claims on the basis of anticipation and obviousness is appropriate where the earlier applications have already been published. Thus, the search for earlier overlapping applications extends to applications dated no more than 20 months before the date of the latter application, assuming the probability that any published applications which might have been candidates for overlap had already been cited in the search report and written opinion for novelty and/or inventive step.

Stricter enforcement of the suspension of examination due to overlap is effectively limiting the number of divisionals and continuations filed in the ILPTO. Coupled with greater attention to the unity of invention requirements, the suspension of examination due to overlap may reflect the tightening of ILPTO policy regarding the scope of protection available for inventions in fields such as pharmaceuticals and biologics, where the filing of a patent application often precedes identification of the final product by many years.