This is the fourth installment in our discussion of the first of two recent draft circulars, “Draft Circular 34/2016”.
Part E concerns “Claims that refer to drawings and examples to define properties or technical aspects of the invention”, i.e. omnibus claims. Until sometime during the tenure of the Commissioner who served from 2003-2011, the ILPTO allowed omnibus claims, e.g. “A composition/device/process substantially as hereinbefore described with reference to any of the drawings.” Then the Commissioner issued a circular saying such claims wouldn’t be accepted, as they were indefinite. The proposed circular seeks to bring back omnibus claims in a limited fashion, by requiring such claims to explicitly recite the specific properties or aspects of the claimed invention. Having said this, the circular then needs to clarify the confusion it has sown:
“25. The following references shall not be considered omnibus claims: a claim on genetic sequences that refers to a sequence that appears in the specification; a claim on a crystalline structure of material that is characterized by physical properties that the result of their measurement appears in the drawings, to which the claim refers [i.e. you can claim a crystalline polymorph by referring to an XRD shown in the drawings]; a claim on a product or apparatus characterized by a functional form that cannot be described in words and the form appears clearly in a drawing to which the claim refers.
“26. The examples listed above [viz. in par. 25 – DJF] are not exhaustive and are intended to ease the understanding of this circular.”
Inasmuch as I don’t think anyone ever included an omnibus claim thinking they would actually seek to enforce it, I don’t think anyone cared when the ILPTO did away with omnibus claims (even if it may have – surprise! – exceeded its authority in doing so), and I wonder why the ILPTO is bothering to bring them back in a way that seems likely to be more confusing than helpful.
Part F concerns claims on sequences and portions thereof.
“27. Sequences per se will be allowed on condition that the specification describes the activity of the biological sequence [this should probably read, “the biological activity of the sequence” – DJF], as required by section 3 of the statute. If the examiner requires it, applicant will refer to the place where the activity of the sequence is specified.
“28. Claims on sections, derivatives and homologues of the claimed sequence will not be accepted unless the structure is defined. Such claims shall be considered unclear since the number of possible combinations in such claims is extremely large, and it is not possible to conduct a prior art search concerning every one of the possibilities within such claims. Furthermore, in order to ascertain the boundaries of the invention, many experiments are required.
“29. To the extent a claim on a sequence recites it as part of a larger sequence by use of the word “comprising”, “containing” and the like, if the activity of the sequence is not recited in the claim, the search will be conducted according to the broad claim.”
I’ll leave it to the true biologists to comment on the (un)reasonableness of these proposed rules as they affect claims on DNA and RNA sequences, but with respect to proteins section 28 is both ambiguous and, at first glance, seems overly harsh, if not – again – going beyond what the statute empowers the ILPTO to do.
Section 28 is ambiguous because it’s unclear what’s meant by “structure”: the sequence itself is sometimes called the primary structure. So what’s meant by “structure” in section 28? If what’s meant is three-dimensional structure, requiring that is ridiculous, as the 3D structure of many proteins is never elucidated, and even when it has been determined, the particular conformation may be condition-dependent, e.g. dependent on the solvent used in the crystallization process. Moreover, requiring 3D protein structure as part of a claim will make it difficult if not impossible to enforce the claim, as in many cases it won’t be possible to determine the 3D structure of an allegedly infringing protein.
If, on the other hand, what is meant is that the sequence of every section, derivative or homologue to be claimed must be recited, then section 28 should clearly state that. Assuming that that’s what was intended, such a requirement seems overly harsh. If, for example, a claim recites a protein having a molecular weight within a given range, a particular sequence for at least a portion thereof, and a particular activity, claiming homologues having X percent homology and retaining the activity is long-standing way of claiming proteins. Why deviate from that practice now?
This is particularly clear with respect to antibodies, where most of the molecule is merely a scaffold, and what is critical are the six “complementarity determining regions” (CDRs), three on the light chain, three on the heavy chain. Once the sequence of the CDRs has been elucidated, it’s not too much work for competitors – or the patent office – to figure out a priori which variations might plausibly be made that share the activity. One is unlikely, for example, to substitute an amino acid with a hydrophilic side chain for one having a hydrophobic side chain. More practically, it’s not difficult for a competitor to determine if an antibody having the recited activity falls within the scope of the claims – after screening an antibody library for the recited activity, determining the amino acid sequences of the CDRs is routine. Of course, those antibody variants lacking the activity won’t fall within the scope of the claim.
In this respect, section 28 seems to attempt to restrict applicants’ rights in a way that contravenes section 13(b) of the statute, which says that the claims can define an invention functionally. Here, where both the activity and sequence of the CDRs is recited, if the specification defines “homologues” in a clear way (and the ILPTO itself says in section 18.104.22.168 of Appendix K of its Examination Guidelines exactly how to define homology clearly), that meets the requirements of Section 13(b) of the statute. The ILPTO is not empowered to deny applicants their rights under 13(b).