The Australian provisions outlining whether an amendment to a patent specification is allowable or not were revised with the IP Laws Amendment (Raising the Bar) Act 2012 which came into effect on 15 April 2013. However, we have only recently had a Court decision to interpret these provisions. In formulating an approach, the Court has looked particularly to Europe and the UK.
A key outcome of this decision is that a proposed amendment by way of intermediate generalisation is not likely to be allowable as this will generally constitute matter extending beyond the disclosure of the complete application as filed.
The Law
Prior to Raising the Bar, s102(1) of the Patents Act (1990) recited:
An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
This contrasts with s102(1) of the Patents Act (1990) post Raising the Bar Act, which now recites:
An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim or disclose matter that extends beyond that disclosed in the following documents taken together:
- the complete specification as filed;
- other prescribed documents (if any).
There are two key differences:
- Pre-raising the bar, new information could be added to a complete specification provided that this new information did not result in the claims covering subject matter that was ‘not in substance disclosed in the specification as filed’. Post-raising the bar, the addition of new information to the specification is not allowable since this would result in the specification disclosing matter extending beyond that disclosed in the complete specification as filed.
- Pre-raising the bar, the test for whether an amendment is allowable was if the subject matter of that amendment (as it pertained to the claims) was “in substance disclosed in the specification as filed” whereas, post raising the bar, the test is whether the subject matter of the amendment “extends beyond” that disclosed in the complete specification as filed.
Recent case law highlights the Australian Courts approach to interpreting the ambit of “extends beyond” in the context of an intermediate generalisation.
The CSIRO v BASF case
Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2020] FCA 328 (12 March 2020) (“CSIRO vs BASF) was the first Australian Court case to consider the post-raising the bar amendment allowability criteria. This case concerned Australian patent application 2013273704 to BASF, which is directed to a process for production of polyunsaturated fatty acids in transgenic organisms.
At issue were proposed amendments by BASF to insert new dependent claims and a corresponding consistory clause. CSIRO filed a notice of opposition to the allowance of the proposed amendments. However, the Patent Office allowed the proposed amendments. CSIRO appealed the allowance of the proposed amendments to the Federal Court.
The key issue considered by the trial Judge was whether the proposed amendments constituted subject matter that extended beyond that disclosed in the complete application as filed, in which case, the proposed amendments would not be allowable. In approaching this task, the trial Judge summarised the disclosure of the original application and proposed amendments as follows:
- The complete specification as filed disclosed three relevant features, Feature A, Feature B, and Feature C.
- Feature A related to a particular range of polypeptides exhibiting a “substrate specificity of the delta-6 desaturase shown in SEQ ID NO: 14”.
- Feature B specified a “preference for conversion of alpha linolenic acid compared to linoleic acid”.
- Feature C related to a particular range of polypeptides with the feature of “at least 75% identity to a nucleotide sequence which codes for a polypeptide as shown in SEQ ID NO: 14”.
- Feature A was a subset of Feature C [at 130].
- The complete specification as filed discloses Feature A with Feature B.
- The complete specification does not disclose Feature C with Feature B.
The proposed amendments sought by BASF related to the introduction of dependent claims and corresponding statements of invention to cover the combination of Feature C with Feature B.
CSIRO argued that the amendment should not be allowable since this would constitute added subject matter by way of intermediate generalisation. The term “intermediate generalisation” refers to an amendment where a feature is added to a broad statement of invention or claim in the absence of the context within which that feature was disclosed. CSIRO’s position was that the complete specification as filed only disclosed Feature A (being a subset of Feature C) with Feature B; that the complete specification does not disclose Feature C (a class of polypeptides covering Feature A and variants that do not have Feature A) [at 130] with Feature B; and thus, the proposed amendments sought by BASF take the specific disclosure of Feature A with Feature B, extract Feature B from the context of that disclosure, and seek to generalise that disclosure through combination of Feature C with Feature B.
In approaching this issue, the trial Judge relied on UK case law, ultimately forming the view that:
“An amendment is not allowable if it takes a feature which is only disclosed in a particular context and seeks to introduce it into a claim deprived of that context. In the United Kingdom, this is described as an “intermediate generalisation” and is an established aspect of “added matter”.” [at 205]
The trial Judge agreed with CSIRO that the proposed amendments to combine Feature C with Feature B took Feature B from the narrow context in which it was disclosed with Feature A. Thus, the trial Judge concluded that the proposed amendment was not allowable since it amounted to added subject matter by way of an intermediate generalisation.
The Decision indicates that Courts have adopted a strict approach in considering the allowability of an amendment to a complete specification, and that generally, intermediate generalisations – where features are taken from a specific context and introduced into the claim in generalised form are likely to constitute added subject matter and thus are unlikely to be allowed. The decision also highlights that the Courts continue to be guided by European – and in particular UK – patent law.
The Patent Office Decision
EMD Millipore Corporation v Asahi Kasei Medical Co., Ltd. [2020] APO 39 (21 August 2020) (“EMD Millipore v Asahi”) is a recent Patent Office decision concerning the allowability of claim and specification amendments to Australian patent application 2015309939 (“the ‘939 patent application”).
The ‘939 patent application is directed to a porous filtration membrane having a dense layer and a coarse layer possessing pores, and further defining that the membrane has a gradient asymmetric structure wherein the average pore diameter increased from the downstream portion of filtration to the upstream portion of filtration.
EMD Millipore filed a Notice of Opposition to oppose the grant of the application. During opposition proceedings, Asahi filed claim amendments which EMD Millipore further opposed.
One of the key amendments was to further define the arrangement of the coarse layer and dense layer relative to each other, and in particular to specify the arrangement of the “coarse layer adjacent to the dense layer at an upstream surface side of filtration in the membrane, said coarse layer having an average pore diameter of larger than 50 nm”.
EMD Millipore took issue with the language that the coarse layer was adjacent to the dense layer “at an upstream surface side of filtration”, arguing that the complete specification as filed disclosed the coarse layer as being provided in an upstream portion of the membrane and not on the upstream surface side of filtration, and that the meanings of “upstream surface side” and “upstream portion of filtration” were not the same since the term “surface side” implies an external surface whereas “portion” implies a part of the membrane which can include external and internal regions.
In considering the allowability of the amendments, the Hearings Officer noted the recent CSIRO vs BASF decision, and commented that:
- the specification disclosed the general arrangement that the upstream portion of filtration in the membrane has a coarse structure and the downstream portion of filtration in the membrane has a dense structure, and [at 25]
- the specification disclosed that in the case where the porous membrane is a porous hollow fiber membrane in the present embodiments, there is a case where the porous hollow fiber membrane has a coarse layer in the inner surface portion and has a dense layer in the outer surface portion, or there is a case where the porous hollow fiber membrane has a coarse layer in the outer surface portion and has a dense layer in the inner surface portion. [at 25]
Based on these disclosures, the Hearings officer allowed the amendment concluding that the amendment did not extend beyond the matter disclosed in the complete specification as filed since it “is clear from these passages, that not only does the CSAF [complete specification as filed] describe the dense layer and coarse layer as being adjacent and being provided in the downstream portion and the upstream portion respectively, it also discloses that the dense and coarse layers can be adjacent and be provided on the inner surface portion and the outer surface portion of the membrane. The critical requirement is that the coarse layer should be adjacent to and upstream of the dense layer. In my view, the disclosure of the CSAF is wide enough for the coarse layer to be anywhere in the upstream portion including the upstream surface portion.” [at 26]
Ultimately, the Hearing Officer allowed the amendment on the basis that the amendment did not extend beyond the matter disclosed in the complete specification as filed, consistent with the CSIRO vs BASF decision.
This decision is interesting because from a strict reading of the cited passages relied upon by the Hearing Officer, this amendment appears to constitute an “intermediate generalisation” since the above passage relied upon by the Hearing Officer makes it clear that the disclosure of the coarse layer being the inner surface portion of the membrane is only in relation to hollow fiber membranes and not the broader class of porous membranes as recited in the claims. However, this was not a point of contention in the opposition and the Hearing Officer did not provide any commentary on whether this amendment constituted an “intermediate generalisation”. Presumably the Hearing Officer formed the view that this passage, when taken in the overall context of the disclosure of the complete specification as filed, supported the proposed amendment.
Comparison between the ‘pre-Raising the Bar law’ and the ‘post-Raising the Bar law’
As an interesting aside, in the CSIRO v BASF case the trial Judge stated, “I do not propose to indulge in any disquisition concerning the differences, if any, between the scope of the old s 102(1) and the new s 102(1).” [at 222] Thus, this judgement should not be taken to provide commentary on the interpretation of the ambit of “in substance disclosed” under the pre-Raising the Bar law. Notwithstanding this, the Patent Office provides an interpretation of “in substance disclosed” based on their interpretation of case law:
Where the specification as filed includes a term which is very broad and not exemplified, that term may be regarded as disclosing “in substance” the meaning that the skilled addressee would have understood it to mean at the priority date, based on the common general knowledge in the art (Herchel Smith’s Applications (1968) AOJP 774). For example, the term “mechanical fastening means” would in substance disclose nuts and bolts if these were known in the art at the priority date. [see Examiner’s manual section 2.23.8.1]
This approach appears significantly broader than the test for whether a proposed amendment extends beyond the disclosure of the complete specification as filed, as advocated by the trial Judge in the CSIRO v BASF case at [203]:
…this comparison is a strict one. Subject matter will be added “unless it is clearly and unambiguously disclosed in the application as filed.” Moreover, it is appropriate to consider what has been disclosed both explicitly and implicitly… what I am considering and applying is not an obviousness test… a patentee “is not permitted to add matter by amendment which would have been obvious to the skilled person from the application.”
Given this, it appears that the post-Raising the Bar law is applied in a more stringent manner than the pre-Raising the Bar law.
Concluding remarks
One thing is clear from these cases; Applicants should take care to consider the possible combinations of elements that make up an invention. It is not unusual for claims to be narrowed during the course of the patent examination process, so care must be taken to write the patent specification in such a way to make all possible combinations available. As noted above, if optional Feature C is only every described in combination with optional Feature A, it is unlikely to be allowable to amend the claims to add only C without A and potentially A without C.