IP SPOTLIGHT MAY 18

INTERNAL VALIDITY REQUIREMENTS FOR PATENTS UNDER THE RAISING THE BAR ACT

GROUNDS OF OPPOS I T ION AND OUTCOME Clarity The Delegate found the claims to be clear in the face of two arguments from the Opponent. The structure of the primer was defined by reference to its ability to hybridise with an unfixed target sequence, so for any given primer, it was not possible to assess whether it fell within the scope of the claim without reference to the target sequence. The Delegate held that this did not render the claims unclear because the primers could only be designed once the relevant target sequences (and variants) were identified. The Applicant also argued that different “corresponding conventional primers” may yield different results leading to a different comparative baseline. However, the Delegate found that the opponent failed to provide sufficient evidence to establish this argument. Clear Enough and Complete Enough: Previous cases established that the relevant questions for this ground were (a) whether it was plausible that the invention could be worked across the full scope of the claim and; (b) whether it could be performed across the full scope without undue burden. The specification provided a universally applicable theory as to why primers with the claimed structure would preferentially amplify any rare target sequence. The Delegate held that it was not necessary to show that every possible primer with the claimed structure would meet the functional requirements - it was sufficient that it was plausible that additional primers having the claimed structural features would meet the functional requirements of the claim, in light of the theory set out in the specification. The Opponent had not shown otherwise. The experiments that a skilled person would undertake to design further primers falling within the scope of the claims were explained in the specification. The specification also explained variations to the primer which enhanced selectivity. The Delegate found that these experiments were routine and not a research programme, and that the Opponent had failed to satisfy its burden of proof. Undue Burden Plausibility

Support

The Applicant’s technical contribution to the art was not so narrow as to only cover the particular primers exemplified in the specification. The Delegate found that the technical contribution was much broader, and in line with the breadth of the claims. Therefore, the Delegate found the claims to be supported across their breadth. Manner of Manufacture: The opponent argued that the kit claims were not a manner of manufacture because they included only a combination of known integers. However, the kits comprised the multi-part primers of the invention, which were not known. Therefore the opponent also failed on this ground. KEY TAKEAWAYS – – The opponent bears the onus of proof in oppositions, and it is not for the applicant to disprove the grounds of opposition. The Opponent here failed to adduce sufficient evidence to satisfy its burden. – – Explanations in the specification of how and why the theory underlying the invention provides a principle of general application can be helpful for establishing the “plausibility” requirement for the clear enough and complete enough ground. – – Examples in the specification of how the skilled person can design and test additional embodiments, including the relevant experiments they would use, can be useful for refuting that there would be an “undue burden” for the clear enough and complete enough ground.

The recent Patent Office decision of SpeeDx Pty Ltd v Rutgers, The State University of New Jersey [2020] APO 20 is the latest opposition case to consider the internal validity requirements under the Raising the Bar Act, which applies to all patent applications for which a request for examination was filed on or after 15 April 2013.

The application was opposed on the grounds of clarity, clear and complete enough disclosure for the invention, support and manner of manufacture. However, the opponent failed to satisfy its burden in establishing any of the grounds, and the applicant was successful. THE I NVENT ION AND CLA IMS The patent application related to “multi-part primers” for primer dependent nucleic acid amplification methods (such as PCR), which were able to selectively amplify a rare sequence in a large population of an abundant common sequence. The primers comprised three parts – an anchor sequence, a bridge sequence and a foot sequence. The claims defined the primer by reference to the three part structure, as well as two functional requirements, being that the primer could distinguish between the rare target sequence and the abundant variant, and a comparison to PCR using a corresponding conventional primer.

BINDHU HOLAVANAHALLI Associate

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