An amendment of a complete specification is not allowable at any time if the amendment would result in the specification claiming or disclosing matter that "extends beyond" that disclosed the specification as originally filed (together with other prescribed documents).1Matter "extends beyond" if the person skilled in the art (PSA) could not directly derive the matter from what is explicitly or implicitly disclosed in the "complete specification as filed".2The primary test for whether the matter is directly derivable is whether the amendment causes the PSA to learn something new about the invention that they could not learn from the originally filed specification.

There are a number of "specific circumstances" that are highlighted by the Examiner's Manual3 that Examiners are to consider relating to allowability of amendments, such as: whether an amendment removes or introduces ambiguity; whether adding further embodiments is inconsistent with the specific disclosed examples; whether the amendment is an "intermediate generalisation" (discussed below); or the effect of insertion of, or amendment to, a proviso.

One of the more common reasons for filing an amendment during prosecution is to include a proviso (also referred to as a disclaimer, or a negative claim limitation), which is typically for distinguishing a generic invention from the prior publication of a particular entity that falls within the scope of the generic invention. The Examiner's Manual provides a convenient example of a specification and its claims concerning the use of a specific pharmaceutical compound to treat cancer, where the applicant proposes to amend the claims by adding the proviso that the compound is used to treat cancer, but not breast cancer. The Examiner's Manual notes that a broad disclosure of the treatment of 'cancer' implicitly discloses treatment of any cancer, including breast cancer, and in this situation the amendment would be allowable since the proviso simply narrows the scope of the claims to a subset of the cancers originally disclosed. Accordingly, no new matter is added under these circumstances. Under Australian practice, adding a proviso that simply limits the scope of a claim is allowable even where the subject matter dealt with in the proviso was not itself disclosed in the specification as filed, but providing that the proviso is not added in a manner that adds to the disclosure. However, an amendment is not allowable if different embodiments of a specification disclose different features, and it would not have been apparent to the PSA that the features of the different embodiments could be interchanged and were more generally applicable (referred to as an intermediate generalisation4 – see our previous article here). The main test is whether the PSA is being presented with any new information about the invention which is not directly and unambiguously apparent from the original disclosure.

The recent case BioNTech RNA Pharmaceuticals GmbH v CureVac SE5 related to an opposition to an amendment filed during opposition proceedings. In particular, the opposition was focused on whether amendments proposed under subsections 102(1) and 102(2)(b) were allowable, or if they would extend beyond the specification as filed. The substantive amendments to the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) applied to this case.

The invention related to RNA-containing compositions for use in the treatment or prophylaxis of tumour and/or cancer diseases, and the claims as accepted were directed to a method of using compositions containing mRNA encoding interleukin-12 (a cytokine). The Applicant sought the amendments to narrow the issues in dispute in the main (s59) opposition, whereby amended claim 1 clarified that the at least one coding RNA is "not a replicon RNA", and added claims 36 and 40 clarified that the at least one coding RNA is "not a viral RNA or a retroviral RNA".

The Opponent argued that there was no basis in the specification as filed for the "negative limitations" introduced by the amendments, and as a consequence the proposed amendment resulted in the specification claiming and disclosing matter that extended beyond that disclosed in the specification as filed, and lacked clarity and support. 6

The Hearing Officer noted that the concept of "intermediate generalisation" was at the heart of the opposition, and went on to summarise some of the principles set out in several UK decisions. In brief, those principles are:

  • an amendment utilising a feature may amount to added subject matter, even where there is a literal reference to such a feature in the specification as filed. An example of where this may occur is where by reason of the amendment, a feature that was not suggested to be significant is, for the first time, suggested to have a technical significance. For example, where a feature is taken from a specific embodiment, and introduced into a claim in a manner that is stripped from relevant context provided by that embodiment.
  • Even if a feature was suggested to be technically significant, if by the amendment the feature is used in a manner significantly different from its original context, or where a new combination of features is sought to be created by the proposed amendment which was not apparent in the application as filed, there will be an impermissible intermediate generalisation.
  • However, an "intermediate generalisation" is to be distinguished from an amendment that claims a subclass of an inventive concept, whether or not it is presented as inventively distinct in the specification as filed.7

The Opponent referred to passages in the specification that indicate that the coding RNA can be selected from the group of mRNA, viral RNA, retroviral RNA and replicon RNA, which makes it clear that the coding RNA of the claims can be replicon RNA. The Opponent went on to assert that there is no basis in the application for the "negative limitations" in the proposed amendments, and that a replicon RNA is to be avoided. The Opponent's expert noted that the specification taught that the different coding RNA are interchangeable, and therefore it made no sense to him to exclude replicon RNA from the claimed composition. On this basis, the Opponent asserted that a feature that was not suggested to be significant was, for the first time, suggested to have a technical significance, and this resulted in the specification claiming and disclosing matter that extends beyond that disclosed in the specification as filed.

The Applicant acknowledged that the specification as filed made it clear that the coding RNA can be replicon RNA, but it does not state that the coding RNA should or must be a replicon RNA, and thus the amendment was directed to clarifying the scope of the invention, rather than being a situation where for the first time a defined feature is suggested to have a technical significance; a feature that has always had technical significance is merely being defined more narrowly.

The Applicant also referred to Boehringer Ingelheim Animal Health USA Inc v Elanco New Zealand,8 where an amendment was made to a claim defining a class of antiseptics to include a proviso "wherein the antiseptic is not an acridine". In that case, the amendment was found to be allowable because the specification did not indicate a preference for acridine antiseptics. As there was no positive recommendation to use acridines there was no fundamental inconsistency between the body of the specification and the amended claims. Following this line of reasoning, the Applicant in this matter asserted that there was no positive recommendation in the specification to use a replicon RNA or a viral RNA or retroviral RNA, and therefore the amendment was allowable. They also noted that it was not unusual for a patent to disclose various possibilities but claim only certain features.

The Hearing Officer ultimately disagreed with the Opponent's submissions. Whilst it was acknowledged that the specification does clearly define the coding RNA to include replicon RNA, it is only the at least one coding RNA of the composition. In other words, there would be other coding RNAs in the composition, which does not change the broader definition of the term "coding RNA" as presented in the specification as filed. The coding RNAs mentioned, being large in size and molecularly complex was considered to form the "essence" of the invention, which focused on mRNA encoding IL-12. The amendment therefore did not constitute an impermissible intermediate generalisation as the claim as proposed to be amended did not teach anything that the PSA would not have gleaned from the specification as filed, even though there was no explicit disclosure in the specification that corresponded to the wording of the proposed amendment. The same considerations were also given to the Applicant's other proposed amendments, whereby in the other claims there was recitation of "wherein the at least one coding RNA is not a viral RNA or retroviral RNA". In sum, the Opponent was unsuccessful on all grounds, and the proposed amendments made by the Applicant were subsequently allowed.

Closing comments

Adding a proviso that simply limits the scope of a claim is allowable even where the subject matter dealt with in the proviso was not itself disclosed in the specification as filed, but providing that the proviso is not added in a manner that adds to the disclosure. However, an amendment is not allowable if it is an intermediate generalisation. The main test is whether the PSA is being presented with any new information about the invention which is not directly and unambiguously apparent from the original disclosure.

When prosecuting patent applications obtaining advice from an experienced practitioner is critical. At Spruson & Ferguson, we have a number of highly experienced attorneys who can assist in prosecuting your patent applications.

Footnotes

1s102(1) of the Patents Act 1990 (Cth) (the Act), as applicable to standard and innovation patents for which examination was or is requested after 15 April 2013 (when the "Raising the Bar" amendments took effect).
2 The other prescribed documents comprises: (a) an abstract that was filed with the complete specification (Reg. 10.2A(a)); (b) a missing part or element of a complete specification that was incorporated into the specification, in accordance with regulation 3.5A or Rule 20.5 or 20.6 of the PCT (Reg. 10.2A(b)); or (c) an amendment that has been made to the complete specification after filing, for the purpose of: (i) correcting a clerical error or obvious mistake; or (ii) complying with paragraph 6(c) of the Act (Reg. 10.2A(c)).
3 Examiner's manual at 5.7.4.2 Allowability of amendments before acceptance.
4 as discussed in CSIRO v BASF Plant Science GmbH (2020) FCA 328 (CSIRO v BASF).
5 [2023] APO 36.
6 subsections 40(2) or (3)
7 CSIRO v BASF at [211]-[215]
8 [2021] FCA 1457 at [112]

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