In the latest Australian Patent Office decision to consider the allowability of post-acceptance amendments, the patent applicant, Asahi Kasei Medical Co., Ltd. (Asahi), prevailed over the opponent EMD Millipore Corporation (EMD) in defending its amended claims.
EMD opposed the grant of Asahi’s patent application for a porous membrane that is useful for removing, by filtration, viruses and other pathogens from fractionated plasma products and other biopharmaceuticals.
In the course of the opposition proceedings, Asahi filed amendments to its claims. These amendments were opposed by EMD. This decision of the Australian Patent Office considers the allowability of the amendments.
Relevant Law
Under the Patents Act Cth (1990) (incorporating the Raising the Bar amendments which apply to all patent applications for which examination was requested after 15 April 2013), post-acceptance amendments are not allowable if, as a result of the amendment:
- the specification would claim or disclose matter that extends beyond that disclosed in the complete specification as filed (section 102(1)(a))
- a claim would not in substance fall within the scope of the claims of the specification before amendment (section 102(2)(a))
- the specification would not comply with s40(2), (3) or (3A) (section 102(2)(b)) – meaning that the specification would not comply with the requirements (amongst others):
- to disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art
- to disclose the best method
- for the claims to be clear, succinct, and supported by the matter disclosed in the specification (i.e. the requirements of clarity and support).
The delegate provided that the correct approach in considering whether an amendment would result in the specification claiming or disclosing new matter, is to ask whether the skilled person would learn anything about the invention which they could not learn from the specification as filed. The delegate stated that:
“This comparison is a strict one in the sense that subject matter will be added unless it is clearly and unambiguously disclosed in the relevant documents…”
The Claims
The specification provided that the object of the invention was to provide a “porous membrane by which a useful component such as protein can be recovered in a highly efficient manner while suppressing clogging during filtration of a protein solution and from which only a small amount of an eluate is eluted even when an aqueous solution is filtered.”
The claims specified the particular features of the porous membrane such as the characteristics of the polymers from which the membrane was constructed, the layers present, the upstream and downstream portions, and the gradient index of the average pore diameter in the layers.
The claims were amended to include additional features such as the specific location of the layers, specific pore diameters in the layers, how the gradient index was to be calculated and how the pore diameters were to be calculated.
EMD’S Arguments
EMD argued that the amended claims were not allowable because:
- the amended claims extended beyond the matter disclosed in the specification as filed, as the additional features in the amended claim were not clearly and unambiguously disclosed in the specification as filed. The delegate however found that the amendments did not introduce any inconsistency or disclose matter that extended beyond the disclosure of the specification as filed
- the amended claims extended beyond the scope of the claims of the specification before the amendment because something that was not an infringement prior to the amendment would be an infringement as a result of the amendment, particularly in view of the lack of clarity of the scope of the claims. However, the Delegate found that the amendment only added features to claim 1, and the terms in the claim were clear, so the amended claims fell within the scope of the claims before amendment
- as a result of the amendment, the specification does not disclose the invention in a manner which was clear enough and complete enough, and that the amended claims were not supported by the specification. As the delegate found that the relevant terms were clear, and did not go beyond the disclosure in the specification as filed, the delegate found that the specification was clear enough and complete enough, and the claims were supported by the disclosure in the specification.
Key Takeaways
In undertaking the above analysis, the delegate considered the whole disclosure of the patent, rather than formalistically looking at whether the precise terms used in the amended claims appeared in the specification as filed. Therefore, this case serves as a reminder that the assessment of the allowability of post-acceptance amendments will be based on a holistic review of the disclosure of the patent and a consideration of the context in which the original disclosure was made.
Further information can be found in the reported patent office decision of EMD Millipore Corporation v Asahi Kasei Medical Co., Ltd. [2020] APO 39 (21 August 2020).