2.9.2.16.4 Tips on Claim Construction

Date Published

In some cases, it may not be readily apparent that a claim defines or includes a non-patentable collocation or kit of known integers, or whether the claim defines a patentable combination. Care should be taken to construe the claims and determine whether there is a patentable combination.

In general, the following will be considered patentable combinations, provided there is no indication in the specification that any terms are intended to be interpreted differently:

  • A composition comprising A and B.
  • A formulation comprising A and B.
  • A mixture comprising A and B.
  • A cell culture comprising cell A and cell B.
  • A cell population comprising cell A and cell B, provided the cells are derived from different sources or tissues and are unlikely to be naturally occurring in this form (see 2.9.2.14 Micro-Organisms and Other Life Forms).

However, claims such as the following define non-patentable “kits” or collocations:

  • A pharmaceutical which includes combinations of known integers A and B for separate, sequential or simultaneous use. This reference may be provided as an explicit definition in the claim or as a ‘dictionary’ in the description.

    In this case, the definition of separate or sequential use clearly requires that the dosage forms are separate integers and, as a consequence, the pharmaceutical is a kit. Such kits may be referred to as a “composition”, “combination’ or ‘formulation”, however this does not change their nature and a manner of manufacture objection should be taken.

  • A pharmaceutical composition comprising a solution of component A and a solution of component B.

    In this case, the definition of a “composition” suggests a single admixture, however the definition of separate solutions is indicative of a kit or collocation of separate integers.

  • Similarly, wording such as an “article of manufacture”, a “package”, a “system”, a “kit of parts” and a “free combination”, indicates that the individual integers are merely collocated.