As we come to the end of 2023, we can reflect on some of the decisions that have passed through the Australian Patent Office for technologies in the Life Sciences space. Whilst not all cases will be discussed in the present article, we present case summaries for a selection of these that may be of interest and significance to both applicants and attorneys. In Australia, decisions made by the Hearing Officer can be appealed before the Federal Court of Australia, within 21 days of the delegate’s decision. However, none of the cases discussed here have proceeded down this avenue.
Marlow Foods Limited v The Fynder Group, Inc.  APO 18 (4 April 2023)
The technology in the case of Marlow Foods related to isolated filamentous fungi strains within several species, methods of conducting surface fermentation to produce filamentous fungi biomats from the fungal strains, and use of filamentous fungi to produce useful products including food. The patent application, AU2017227612 was filed by The Fynder Group Inc (The Applicant) and opposed by the opponent, Marlow Foods Limited, on 13 August 2021.
The grounds of opposition were based on the following:
- That the claimed invention is not a manner of manufacture
- There is a lack of novelty
- There is a lack of inventive step
- Lack of utility
- Lack of a clear enough and complete enough disclosure in the specification
- No disclosure of the best method
- Lack of support and
- Lack of clarity
It was further alleged that the claims of the application were not entitled to claim priority from any of the three US provisional applications that were listed on the specification, since none of those US provisional applications were considered to disclose the claimed invention in a manner that is clear enough and complete enough.
During the evidentiary stage, the Applicant filed a request to make voluntary amendments to the description and claims of the application, to which excess claim fees were applicable. Leave to amend the specification was granted and details of the request to amend were advertised for opposition purposes. Whilst no opposition was filed to the Applicant’s amendments, such that the amendments were allowed on 7 September 2022, the Applicant failed to pay the excess claim fee prior to the due date. This meant that the request for leave to amend the specification was taken to not have been filed. Allowance of the amendments on 7 September 2022 was therefore ultra vires.
Once the Commissioner had identified this error in January 2023, both parties were notified, and the Applicant filed a request for an extension of time shortly afterwards under s223(2)(a), alongside a declaration that it was always the intention of the applicant to pay the excess claim fees. The extension of time request was allowed and in the absence of comments from the opponent, the opposition proceeded in respect of the amended claims.
For the remainder of the opposition process, the opponent chose not to make any further submissions and thus the opposition was decided on the submissions filed in the statement of grounds and particulars, which had not only been compiled prior to the Applicant’s amendments, but the amendments of which altered the claim scope quite significantly such that much of the opponent’s submissions in the statement of grounds and particulars were not directed to the amended specification. The opposition therefore proceeded only of those allegations that remained relevant to those in the statement of grounds and particulars.
With respect to sufficiency of disclosure, the question of whether or not the application provided a clear enough and complete enough disclosure for a skilled person to obtain a filamentous fungal biomat according to amended claim 1, was analysed. It was determined that in light of the amendments that provided structural and production features that were required to define a biomat, the amended specification did provide a principle of general application, based on the growth characteristics of filamentous fungi under the defined conditions to produce a biomat with the defined structure. From this, it was considered that the skilled person would be able to apply the general principles broadly to any species or strains of filamentous fungi.
The amendments to the claims also introduced an “inactivation of viability” step, a post-fermentation treatment step that helps to prevent any instances of biomats having unsuitably high levels of toxins, which would otherwise affect use of the filamentous fungal biomat as a food product.
All amendments to the specification were found to provide a clear enough and complete enough disclosure for the invention in the specification. Advantageously, the amendments also assisted with overcoming a potential finding of lack of support, in that the amendments introduced one or more features that corresponded to the technical contribution to the art, which was determined to include a general principle of using filamentous fungi and surface fermentation methodology under a set of defined conditions to produce a filamentous fungi biomat with a defined structure. Specifically, the defined conditions enabled the production of a filamentous fungi biomat having a high cell density with at least two structurally different layers and sufficient tensile strength and structural integrity to allow for ease of handling without potentially tearing the biomat.
The case further discussed whether or not the opposed application was entitled to its earlier claimed priority date of 1 March 2016, the determination of which affected whether D1 was considered as a relevant document for the purposes of novelty and inventive step. Regardless, it was held that even if D1 were considered to qualify as relevant prior art, the amended claims do not lack novelty and/or an inventive step in light of D1.
The arguments that were ultimately successful in addressing novelty and inventive step relied on the fact that D1 did not disclose the generation of a mat or biomat, but instead referred to a “mycelial mass”. The context in which this was used was in the process of filtering the mycelial mass away from liquid. D1 was noticeably silent as to the properties of the mycelial mass, and whether this could be used as a mat or biomat. Nevertheless, given that the mycelial mass underwent a filtering step to be separated from liquid, it was considered that most likely it cannot be lifted off from the liquid as a coherent biomat. D1 was therefore not a relevant document for the purposes of novelty and inventive step.
As mentioned above, the amendments to the claims also introduced an “inactivation of viability” step, which advantageously was a feature that was not suggested or taught by any of the other cited prior art documents. The prior art documents generally all related to “surface fermentation processes with a goal to produce a metabolite with the consequences that the fermentation conditions will be less favourable for biomass production”, which contrasted with the production of fungal biomass, as per the opposed application.
The opponent’s allegations that the originally claimed invention (prior to amendment) was not a manner of new manufacture, was also not successful, given that the originally filed specification was considered to clearly explain the advantages of the claimed biomat over the prior art. Consequently, it was found that the originally claimed invention was not a “mere working direction” or “a mere collocation of known components”.
BioNTech RNA Pharmaceuticals GmbH v CureVac SE  APO 36 (16 June 2023)
The technology in the case of BioNTech RNA Pharmaceutical related to RNA containing compositions for use in the treatment or prophylaxis of tumour and/or cancer diseases.
The opposition considered a number of issues including whether amendments proposed under subsections 102(1) and 102(2)(b) were allowable or if it would extend beyond the specification as filed. Further considerations were also given to whether the claims would lack clarity and support as a result of the amendments.
The Applicant, CureVac SE filed a patent application AU 2016251687, acceptance of which was opposed by BioNTech RNA Pharmaceuticals GmbH (“the Opponent”) on 11 September 2020 (the S59 opposition). In response to the notice of opposition, the Applicant filed a request to amend the specification on 20 July 2021, which was granted and the amendments were subsequently advertised for opposition on 2 September 2021. The Opponent filed a notice of opposition to the amendments on 1 November 2021, under Section 104 of the Patents Act, which was the subject of the present case.
The claims as accepted were directed to a method of using compositions containing mRNA encoding interleukin-12 (a cytokine). However, the description of the specification disclosed that the invention comprises composition containing at least one RNA, preferentially administered intratumorally. The RNA of which may be selected from a range of RNA types, including from the coding or non-coding regions, the coding RNA of which may be mRNA, viral RNA, retroviral RNA and replicon RNA.
The amendments filed by the Applicant post-acceptance can be summarised as follows:
- Amended claim 1 removed use of the RNA composition for prophylaxis of cancer to specify that the invention is used for the purposes of treatment. Claim 1 was also amended to clarify that at least one coding RNA “is not a replicon RNA”
- Amended claim 5 clarified that the coding RNA is the “at least one further RNA” recited in claim 4.
- Amended claims 36 and 40 clarified that the at least one coding RNA is “not a viral RNA or a retroviral RNA”
- New claims 37 and 41 specified that the at least one coding RNA is a “purified mRNA”
- New claims 38 and 42 specified that the at least one coding RNA is complexed with one or more lipids to form liposomes, lipid nanoparticles or lipoplexes.
- Amended claim 39 was amended to reflect the amendments to claim 1.
In light of the amendments, the Opponent submitted that there was no basis in the specification for the disclaimers introduced by the amendments.
The Hearing Officer emphasized that the concept of “intermediate generalisation” is central to the present opposition, which was previously discussed by Beach J in the context of subsection 102(1) in the case of Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH  FCA 328 at : “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 other words, an impermissible intermediate generalisation may take place if by the amendment the feature is used in a manner significantly different from its original context. There may also be impermissible generalisation if a new combination of features is created by the proposed amendment which was not apparent in the specification as filed (at paragraphs -). In assessing whether “intermediate generalisation” has occurred, Beach J indicated that this would rely on whether a skilled person would, looking at the specification as proposed to be amended, “learn anything about the invention which they could not learn or directly derive from the complete specification as filed” (at paragraph ).
In the present opposition, the proposed amendment reciting, ”wherein the at least one coding RNA is not a replicon RNA” was discussed on whether this amendment to further characterize the coding RNA to exclude replicon RNA constituted the addition of new subject matter. The relevant paragraphs in the specification as filed disclosed that the coding RNA “can be selected from the group of mRNA, viral RNA, retroviral RNA and replicon RNA”, to which the Applicant argued makes clear that the coding RNA of the claims could be replicon RNA.
The Opponent argued that there was no basis in the specification for the “negative limitations”. For example, there is nothing in the specification as filed that states the replicon RNA is to be avoided, especially since a replicon RNA can be used in the invention as one of the interchangeable options. There is therefore no disclosure in the specification that would direct a skilled person to preferentially choose a non-replicon RNA.
In turn, the Applicant argued that whilst the specification does disclose that the coding RNA can be replicon RNA, it does not state anywhere that it should or must be a replicon RNA and it was further contended that the amendment proposed sought to clarify the scope of the invention, not to introduce a defined feature to have a technical significance.
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 Hearing Officer further considered that replicon RNA is not typically considered to be an mRNA in the art. Specifically, in contrast to mRNA, the other coding RNA disclosed in the specification are understood to be much larger pieces of RNA, being fragments of viruses either joined together or are entirely viral RNA. Viral RNA, retroviral RNA and replicon RNA will contain coding RNA, but they are more complex pieces of RNA in comparison to an mRNA, which simply expresses a protein and not a whole host of genes as would be found in a virus. 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, 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”.
The Opponent further contended that a proposed amendment to use the term “purified RNA” was impermissible due to the addition of added subject matter. However, this argument failed on the grounds that the Hearing Officer considered the term to refer to the synthetic manufacture of mRNA, defining the mRNA to be separate from all other reaction components.
Other grounds of opposition include lack of support, to which the Hearing Officer referred to the case of CSR Building Products Limited v United States Gypsum Company 2015 APO 72 at , whereby the approach to determine whether or not there is support relied on the following:
- Construing the claims to determine the scope of the invention claimed;
- Construing the description and the technical contribution to the art, that is how far the concept has carried forward the state of the art;
- Deciding whether the claims are supported by the technical contribution to the art.
It was ultimately determined that the Applicant’s proposed amendments did not lead to a lack of support under subsection 102(2)(b), for the reason that prior to the amendment, the claims defined a method of treating tumours or cancer using a composition that comprises at least one coding RNA wherein the at least one coding RNA is an mRNA encoding IL-12. The proposed amendments only sought to further characterize the at least one coding RNA, which is defined to be an mRNA, as not being a replicon RNA, or a viral RNA, or retroviral RNA. The further characterisation of the first RNA was considered to be somewhat unnecessary. Thus, the scope of the claims before and after the amendments were the same.
Rozenberg & Co Pty Ltd v Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute; Fred Hutchinson Cancer Center  APO 55 (1 November 2023)
In this case, the opposed application concerned cellular immunotherapy. Specifically, methods and compositions for carrying out cellular immunotherapy comprising T cells modified with tumor targeting receptors.
The patent application in question was a divisional application (AU 2018204209) filed by the Applicant, Seattle Children’s Hospital d/b/a/ Seattle Children’s Research Institute and Fred Hutchinson Cancer Center (“the Applicant”), which was advertised for acceptance on 15 October 2020.
Rozenberg & Co Pty Ltd (“the Opponent”) filed a notice of opposition on the grounds of manner of manufacture, novelty, inventive step, utility, sufficiency, best method, claims defining the invention, clarity and succinctness of claims, as well as on support, some grounds of which will be discussed in the present article.
On the issue of inventive step, the Opponent submitted that there was a lack of inventiveness for the reason that the components of the chimeric antigen receptor (CAR) construct and also the technique of customizing spacer lengths for different targets are known in the art. Thus, the combination of these known components does not yield inventiveness. It was considered by the Hearing Officer that whilst each of the components were known and were used for their known purposes, where their known properties make them suitable, collectively the parts resulted in an invention of a unique CAR with improved in vivo therapeutic activity. In other words, the claimed CAR construct was novel, due to the previously unknown combination and the manner in which the known components interact to form the claimed invention, which has different biological activity to other combinations. Thus, the Opponent’s arguments on the grounds of inventive step were not successful.
The Opponent further contended that there was a lack of support and lack of an enabling disclosure, given the unpredictable nature of CAR development. Specifically, it was argued that “the Applicants should not be relying on providing a principle of general application, of for example, customizing a spacer length for a particular target, because each CAR is unpredictable”, especially since there is absence of general design rules that would hold true across all CARs. A skilled person would therefore require significant effort to make and identify a CAR that provides tumor efficacy when expressed in T cells, particularly as the description did not provide sufficient information on any permitted deviations within the specific embodiments.
Whilst the Applicant acknowledged that there is a lack of general design rules and reliability across designing CAR constructs, it was contended that any unpredictability that may arise would normally relate to major modifications, such as replacing a component with a completely different structure. Specifically, this may include substituting for example, the single-chain variable fragment from one that binds to CD19 to another that binds to CD20, which would require the rest of the construct to be modified accordingly. It was emphasized by the Applicant that the contribution to the art made by the opposed application is in selecting the short IgG4 hinge spacer for the single-chain variable fragment of a given sequence ID number.
The Hearing Officer agreed with the Applicant in that the spacer selection ensured that the CD19-specific single-chain variable fragment of the given sequence ID number is held in a specific spatial orientation relative to the transmembrane domain, which promoted better binding of the target CD19 on tumour cells. With respect to the Opponent’s submission that the principle of general application does not provide enough information for a skilled person to perform the claimed invention, the Hearing Officer considered that a 12-mer short IgG4 hinge spacer would be reasonably representative of other short IgG4 hinge spacers of up to 15 amino acids, which must also share the 12 amino acid sequence of the claimed construct. The grounds for lack of support and lack of enablement therefore failed.
On the issue of best method, the Opponent contended that that nature of the invention included everything from the design of the CAR construct to the engineering steps to have T cells expressing the CAR and the effective deployment of the CAR-T cell therapy using the construct, irrespective of the scope of the claimed invention. Thus, the best method of performing of the invention was not disclosed by the Applicant at the time of filing the patent application. In turn, the Applicant submitted that the nature of the invention is the CAR itself, to which the Hearing Officer agreed. Thus, the best method for using new expression systems, new engineering techniques for CAR-T cells and the use of the constructs in clinical CAR-T cell therapy was not required.
Lack of utility was also raised as a ground of opposition. However, this ground failed as the Hearing Officer considered it unnecessary for the claims to include a functional definition to satisfy the utility requirements where the claims otherwise adequately define a construct that would be useful. The Hearing Officer also considered that the grounds were based merely on speculation, given the lack of evidence provided by the Opponent to support their submissions, with respect to any embodiments that may fall within the scope of the claims that would not be useful or would not be able to achieve at least some aspect of the benefits as promised in the specification.
Some of the key take away points to note from the Patent Office decisions discussed above: firstly, in terms of sufficiency of disclosure, the use of general principles in a patent application does not always lead to a lack of a clear enough and complete enough disclosure, particularly if the general principles disclosed may be broadly applicable to what is disclosed in the claims.
It is also apparent that disclaimers imposing a negative limitation to claims are permissible, even if such disclaimers are not explicitly provided in the description, provided that the introduction of such disclaimers does not lead to the skilled person learning something that could otherwise not be learnt or directly derived from the complete specification as filed. In other words, disclaimers are permissible as long as they provide further clarification about a feature, which can be understood and derived from the accompanying description.
We are also further reminded that disclosure of a combination of known components, used for their known purposes, can still result in a finding of inventive step if the result of the combination yields an invention having improved properties or improved biological activities.
In light of the increased filings of patent applications in the Life Sciences space, we anticipate that even more cases will be heard before the Australian Patent Office in the year ahead. We will keep you updated on these as new cases arise in 2024.