Unity of Invention

Biotechnology examples

6.74 Biosequences can generally be considered using the same principles as used for chemical inventions (for examples point mutations in a protein can be viewed as being analogous to Markush structures), or using the general principles (different categories relating to the same underlying inventive concept). However, there are some circumstances that require further detail.

6.75 One of the issues most often encountered in this technology is how to deal with claims to sequences. There are a number of different circumstances that can arise, and while some guidance may be provided there is still a need to consider the entire circumstances and avoid too technical an approach:

(1) If a claim is directed to peptides or proteins having a significant structural similarity and the same activity, then there will be a single inventive concept. This can include sequences where there may be mutations at different and remote parts of a molecule. Note that both structure and function are required. If the claims relate to different mutations (such as SNPs) on the same nucleotide and a common function is stated, then the claim will have unity. However, if no function is stated then there prima facie will be no unity.

(2) Nucleotides/Peptides having different sequences will generally not be considered a single invention. This type of situation might arise where screening of a library may identify certain members having desirable activities. Consistent with the principles relating to a Markush grouping, the sequences would need to possess a significant structural homology and a common activity. In practice, the sequences would be grouped according to any homology members of the group may possess (including conservative substitution and the like) and an objection of lack of unity taken on the basis of these groupings following the form objection given under Markush groupings.

(3) Applications may claim different structurally distinct epitopes from a single receptor. If the parent protein is novel, then it may be appropriate toconsider these as a single invention since they relate to the same activity and the same protein. However if the search identifies that epitopes from the same protein having this activity are already known, then the invention may lie in identification of further epitopes and each different sequence would constitute a different invention (a posteriori).

(4) If the only common structural feature of a claim is known then an a posteriori lack of unity may be a consideration. However this will only be appropriate where the structural element is known for the same purpose. For example a claim to various sequences having a common catalytic domain may not constitute a single invention if the catalytic domain was previously known for that purpose.