Trisco ICAP Pty Ltd - [2023] APO 49

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Trisco ICAP Pty Ltd [2023] APO 49

Patent Application: 2017325108

Title:Storage and delivery system

Patent Applicant: Trisco ICAP Pty Ltd

Delegate: Leslie. F. McCaffery

Decision Date: 26 September 2023

Hearing Date: 9 August 2023, by videoconference

Catchwords: PATENTS – examiner objection – clear enough and enough complete disclosure (section 40(2)(a)) – inventive step – the specification is sufficient – the claims are inventive – application accepted.

Representation: Patent attorneys for the applicant: Mr Steve Gledhill and Dr David Loch of FB Rice Pty Ltd

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2017325108

Title:Storage and delivery system

Patent Applicant: Trisco ICAP Pty Ltd

Date of Decision: 26 September 2023

DECISION

The specification is sufficient to work the invention across the scope of the claims.

The claims are inventive in view of the evidence provided.

I direct that the application proceeds to acceptance.

REASONS FOR DECISION

Background

Australian application 2017325108 (the application) was filed by Trisco ICAP Pty Ltd (the applicant) under the provisions of the PCT on 6 September 2017. The application has an earliest priority date of 6 September 2016 based on Australian provisional application 2016903574. The application entered the national phase on 5 April 2019. The applicant was directed to request examination on 4 August 2020, and a request for examination was filed on 2 October 2020. Nothing in the present decision turns on these facts.
A first examination report issued on 10 September 2021. The report referred to the novelty and inventive step objections taken under the PCT. The applicant filed a response on 29 August 2022. In addition to amendments, the response included declarations by John Holahan (Holahan) and Michael Tristram (Tristram), as well as screen captures of a video showing a comparison of some prior art compositions with a composition of the present invention. These are further discussed below.
A second examination report issued on 1 September 2022. The report raised a new objection under section 40(2)(a) (clear enough and complete enough disclosure, referred to hereinafter as sufficiency). The previous objection of lack of inventive step was also maintained.
The applicant filed a further response and statement of proposed amendments on 6 September 2022. However, the following day the examiner called the attorney to inform them that there was insufficient time to consider the response before the final date for acceptance (10 September 2022). On 9 September 2022 the applicant requested a hearing.
The matter was set for hearing on 9 August 2023. On 13 March 2023, I contacted the attorneys for the applicant to clarify a potential issue with the definition given in Claim 1 (the ratio of thickener to polysaccharide defined in the claims appeared to be incorrect). On 3 July 2023 the applicant proposed amendments to replace the claims on file. A further amendment was filed on 25 August 2023 (after the hearing) to replace the description on file. This amendment brought the description into line with the amended claims. Another amendment was made on 5 September 2023 to correct the page numbering. No changes were made to the substance of the claims by this amendment. I have not gone into detail on the point in the following considerations, but I consider the proposed amendments meet the requirements of section 102(1).
The specification under consideration therefore comprises Claims pages 45 to 49 dated 5 September 2023 (comprising Claims numbered 1 to 19), description pages 1 to 44 dated 25 August 2023, and the figures as originally filed. I will refer to this document in this decision unless otherwise indicated.

Onus

The examination of the present application is governed by the Patents Act 1990 (the Act) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act). The standard of proof that applies to the examination of the present application is the balance of probabilities – I must accept the present application if satisfied on the balance of probabilities that the application complies with the Act. If I am not so satisfied, then I can refuse the application.

The specification

The field of the invention relates to a storage and delivery system for a stable liquid composition comprising a thickening agent and a polysaccharide suitable for increasing the viscosity of a liquid or semi-liquid foodstuff.[1] These are particularly useful in the preparation of foodstuffs for patients suffering from dysphagia.
[1] Specification at page 1, lines 4 to 8.
Dysphagia is a condition often observed in older adults or patients with diseases of the nervous system such as cerebral palsy, where the patient has trouble in swallowing. The specification states that it is often desirable, particularly in the geriatric and convalescent markets, to provide viscous thickened liquids. These can slow down the patient’s swallow and prevent comorbidities associated with dysphagia such as aspiration pneumonia.[2]
[2] Specification at page 1, lines 15 to 18.

10. The viscosity of thickened liquids has been categorised as mildly thick (nectar consistency), moderately thick (honey consistency) and thick (pudding consistency). The three levels in the framework correlate to measured viscosities of 150, 400 and 900 mPa.s[3] respectively.[4] These viscosity levels have been included in an international framework (the International Dysphagia Diet Standardisation Initiative Framework or IDDSI) which also sets out an objective test to ensure strict compliance with the consistency to be achieved. Foodstuffs that are not at an appropriate viscosity can increase the risk of an unsafe swallow by the patient.[5]

[3] Viscosity is a measure of a fluid’s resistance to flow, which is essentially the amount of force necessary to move a layer of liquid in relation to another liquid. It can be expressed in mPa.s (millipascal-second) or in centipoise (cP). One cP is the equivalent of 1 mPa.s. The specification uses the two units interchangeably.

[4] Specification at page 1, line 19 to page 2, line 11.

[5] Specification at page 1, line 24 to page 2, line 10.

11. The specification states that thickening of beverages for the management of dysphagia is typically achieved using powdered thickeners. These are said to have limitations. Specialised mixing equipment is typically required to achieve sufficient shear forces to ensure adequate dispersion. High shear mixers or staged process homogenizers are ideal, but in institutions and homes mixing is often done using a hand-held whisk or hand stirring using a fork. This can result in air being incorporated, resulting in a beverage having a whipped consistency. Powdered thickeners may take up to several minutes to bring a foodstuff up to the desired consistency. Powdered thickeners are also measured volumetrically using a scoop, but the delivered volume can be inaccurate due to the degree of packing or compression that can occur in powders. Uptake of moisture can also occur once the powder is exposed to the atmosphere. The specification estimates that the inaccuracies introduced in powdered thickeners by such factors can be as much as 20%.[6]

[6] Page 2, line 15 to page 3, line 22.

12. Claim 1 (as filed on 5 September 2023) provides a convenient summary of the present invention:[7]

[7] I have formatted the claim to highlight some of the features that are important in the present determination.

1. A storage and delivery system for a stable liquid composition, comprising:

(a) a container containing the stable liquid composition, said composition for increasing the viscosity of an aqueous liquid or aqueous liquid solid mixture foodstuff,
wherein the composition is stable for at least six months at room temperature
and wherein the composition comprises a viscosity of less than 3000 cP
and a water activity of greater than 95%,
wherein the composition comprises:
(i) one or a plurality of thickening agents selected from the group consisting of agar, alginic acid, carrageenan, guar gum, gum tragacanth, gum ghatti, microcrystalline cellulose, methyl cellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, methylethylcellulose, gum karaya, locust bean gum, tara gum, psyllium seed gum, quince seed gum, a pectin, furcellaran, gellan gum, konjac, sodium alginate, xanthan gum and any combination thereof,
wherein the concentration of said thickening agents is 3% to 15% by weight;
(ii) one or a plurality of polysaccharides or extracts thereof selected from the group consisting of an Acacia gum,[8] a Larix occidentalis polysaccharide extract, a Larix laricina polysaccharide extract, a Larix decidua polysaccharide extract, a Larix sibirica polysaccharide extract and any combination thereof,
[8] Acacia gum is also referred to as gum arabic.
wherein said polysaccharides or extracts thereof comprises 10 to over 100,000 saccharide units
and the concentration of said polysaccharides or extracts thereof is 15% to 25% by weight; and
(iii) water and/or a food grade aqueous solution;

and

(b) a pump dispenser sealingly attached to the container,
said dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.

13. The issues of dispute in examination were largely focussed on the ingredients and properties of the compositions rather than the combination as a whole, and, as a consequence, this is also the main focus of the present determination. This is perhaps unavoidable on the issue of sufficiency since it involves a consideration of whether the invention or a feature of the invention, and in this case the composition, represents a principle of general application. In relation to the obviousness of the present invention, there is a question of whether it would have been obvious to select the present compositions from the prior art. However, it is important to bear in mind that the invention relates to a combination of particular compositions with particular pump dispensers, and it is the combination as a whole that must be shown to be obvious, rather than the individual features within the combination.

14. Claim 4 defines a method of delivering a stable liquid composition to an aqueous liquid or aqueous liquid solid mixture using the storage and delivery system of claim 1 including the step of applying a force to the pump dispenser to thereby deliver one or more doses of a predetermined volume of the composition to the foodstuff.

15. The specification acknowledges that gel compositions for thickening or increasing the viscosity of a foodstuff are known in the art. For example, US2004/0197456 (later referred to as D4 in this decision) describes a gel thickener, but the thickening agent in this composition is concentrated to several times its intended usage level. The thickening agent is also fully hydrated before addition to the foodstuff.[9] The specification states that it is clear from the embodiments described that the thickening agent in the present composition is not fully hydrated prior to its addition to the foodstuff.[10]

[9] Specification at page 16, lines 2 to 12.

[10] Specification at page 32, lines 17 to 19.

16. As an aside I note that the claims do not explicitly define that the thickening agent is not fully hydrated. It also appears that the viscosity-inhibiting interaction between the polysaccharide and the thickening agent is achieved by the addition of the gum thickener to a solution of the polysaccharide, as opposed to the addition of the polysaccharide to a solution of the (fully hydrated) thickener. However, I am satisfied that the definitions of the viscosity and water activity implicitly derive from the interaction between the polysaccharide and thickener components. Furthermore, there is no evidentiary basis to argue that the method of making the compositions, and in particular the order in which the ingredients are added, is an essential feature of the invention.

17. The present invention is said to be predicated on the finding that the water binding ability of particular thickening agents can be modulated and/or controlled by the addition of one or more polysaccharides. This essentially inhibits the ability of the thickeners to form a viscous solution. Once the liquid composition is added to the foodstuff (and diluted), the viscosity inhibiting action of the polysaccharides is reduced, and the thickening agents can then act to increase the viscosity of the foodstuff.[11]

[11] Specification at page 16, lines 13 to 19.

18. The polysaccharides may be from 10 to over 100,000 saccharide units.[12] In the second report the examiner suggested that this definition covered “most, if not all possibilities”, but I do not agree with this assertion. The definition characterises the chain length of the polysaccharides and, more specifically, excludes oligosaccharides from the scope of the claims. These presumably have a greater potential than long chain polysaccharides to adversely affect the flavour of foodstuffs, as well as having different solution properties.

[12] Specification at page 16, line 20 to page 17, line 7.

19. Water activity is defined as the ratio of the partial vapour pressure of water in a material to the standard state partial vapour pressure of water at the same temperature. Additionally, water generally migrates from areas of high water activity to areas of low water activity. Foodstuffs having high water activity generally require protection from atmospheres or environments with a relative humidity of lower than 95% to protect the liquid composition from drying out.[13] The present invention comprises a pump dispenser that is able to protect the liquid composition from the drying effect of such conditions whilst contained or stored.[14] The specification indicates that other sealed delivery systems “as are known in the art” may be used, but these are not claimed so I have not considered these further.

[13] Specification at page 17 lines 8 to 18.

[14] Specification at page 17, line 19 to page 18, line 3.

20. The delivery system of the invention is said to provide a relatively precise and/or accurate dose or volume of the liquid composition to the foodstuff to within at least +/- 7.5% of the desired or predetermined viscosity of the foodstuff). More preferably the viscosity is within +/- 3.5% of the desired or pre-determined viscosity of the foodstuff.[15] Such accuracy is required to meet the consistency requirements of the IDDSI Framework. Commercially available pump dispensers typically do not have the accuracy to be used with the present compositions.[16]

[15] Specification at page 18, lines 4 to 14.

[16] Specification at page 18, lines 15 to 24.

21. Furthermore, some types of pump arrangement, though potentially providing more accurate delivery, may be more prone to leakage or drainage over time.[17] The valve mechanism of the present invention is preferably self-sealing, and in particular embodiments is selected from a cross-slit valve, a ball valve, a flapper valve, an umbrella valve, a duck bill valve or a reed valve.[18] The pumps used in the present invention are also preferably configured to deliver predetermined quantities to provide the standard first, second and third IDDSI viscosity levels in consecutive doses.[19]

[17] Specification at page 22, lines 4 to 6.

[18] Specification at page 10, lines 11 to 14.

[19] Specification at page 9, line 24 to page 10, line 3.

22. The specification states that the composition and foodstuff may be combined using low-shear mixing, such as gentle mixing or stirring with a spoon or the like. Such mixing is sufficient to promote separation of the polysaccharide from the thickening agent so as to allow it to increase the viscosity of the foodstuff.[20] The liquid composition preferably makes little flavour and/or colour contribution when added to the foodstuff. The specification notes that the prior art gel compositions require significantly higher volumes than that of the present liquid composition to be added to achieve the requisite thickening. This can dilute the flavour and colour characteristics of the foodstuff.[21]

[20] Specification at page 14, lines 15 to 20.

[21] Specification at page 30, lines 2 to 16.

23. The liquid composition have a viscosity of less than 3000 cP, and more preferably less than 2000 cP. This level of viscosity allows the composition to be dispensed using a pump dispenser, as well as being able to be dispersed with little or no agitation when added to the foodstuff. The composition can accommodate a higher concentration of thickener without losing flowability.[22] On addition of the composition, the viscosity of the foodstuff is raised to at least 95 cP by the controlled release of the viscosity inhibitory effect of the polysaccharide on the thickening agent.[23]

[22] Specification at page 30, line 17 to page 31, line 4.

[23] Specification at page 32, lines 1 to 16.

24. The specification states that the thickening agent may be present in an amount from about 3% to about 30%. The polysaccharide is used at a high enough concentration that it does not significantly contribute to the viscosity of the liquid composition, and preferably in an amount from about 3% to about 30% by weight.[24] However as noted above the claims are limited to thickener and polysaccharide concentrations of 3% to 15% and 15% to 25% respectively.

[24] Specification at page 33, lines 3 to 22.

25. The compositions are said to be stable for at least 6 months, and up to 2 years at room temperature.[25] Stability is indicated by retention of colour, flavour, separation, microbiological spoilage, viscosity and/or clarity of the liquid.[26] The compositions optionally contain preservatives and have a pH of between 3 and 7.5.[27]

[25] Specification at page 35, lines 3 to 13.

[26] Specification at page 35, line 22 to page 36, line 10.

[27] Specification at page 36, line 11 to page 37, line 3.

26. The specification contains three examples. Example 1 describes the preparation of a composition having the following ingredients.

Larix occidentalis polysaccharide extract    20% by weight
Xanthan gum   7% by weight
Citric acid   0.3% by weight
Potassium sorbate   0.07% by weight
Water   72.63% by weight
Gellan gum   0.08% by weight

27. The liquid composition is made by dissolving the polysaccharide in water, followed by citric acid and potassium sorbate. Xanthan gum is then added. The mixture is heated to 80°C with agitation and then the gellan gum added. Addition of 7g of the liquid composition to 100 mL of water with gentle stirring for 30 seconds produced thickened water with a viscosity of 160 cP.

28. Example 2 describes a comparative study of the microbiological stability and physical stability of the composition of Example 1 with a prior art composition described at column 4, line 26 of US 6455090 (hereinafter D1). The prior art composition contains 10% by weight gum arabic and 5% by weight xanthan gum.[28] I note the amount of polysaccharide used in the prior art composition falls outside of the range now defined in the present claims (15 to 25%). This is discussed in detail below.

[28] D1 also describes compositions comprising several other compositions using 20, 30 and 40% by weight gum arabic together with 5% xanthan gum.

29. The microbiological study measures the time to develop evidence of microbiological growth. This is indicated by the appearance of gas being produced and the development of off odours. The composition used in the present invention showed stability of greater than 52 weeks, while D1 was less than 1 week.

30. Physical stability is measured by separation of the thickening agent from the polysaccharide. The test involved measuring the viscosity of a 20g sample taken from the bottom of the container and mixed with 100 mL of water. Measurements were taken over 6 weeks. The composition of the present invention showed consistent stability over the 6-week comparison and is said to have been stable for greater than 52 weeks. In comparison the composition of D1 showed thinning after a week, and by week 4 had the consistency of a thin fluid. After 8 weeks, a separation layer formed at the bottom of the container that contained only polysaccharide and no thickening agent.

31. Example 3 compares the time taken to achieve maximum viscosity when 5 g of liquid or powder thickener is added to 100 mL of water at different mixing rates. The results are shown in the following table. As indicated in the table, the composition used in the present invention shows significantly shorter times to achieve maximum viscosity than the composition of D1 and a powder thickener.

Description of thickener	Mixing Rate
Description of thickener	Gentle (10-40rpm)	Moderate (40-180rpm)	Brisk (Greater than 180rpm)
Example 1	31	19	12
D1 composition	123	67	33
Agglomerated powder thickener (Resource ThickenUp Clear)	241	186	121

The examiner objections

32. The following citations are referred to in the examination reports:

D1 US6455090

D2 WO2011/140598

D3 WO2004/069179

D4 US2004/0197456

33. The first examination report referred to the novelty and inventive step objections raised in the PCT examination report during the international phase of the application. The PCT examination report stated that Claims 1 to 10 were novel but claims 11 to 18, which were directed to a method for increasing the viscosity of an aqueous liquid or aqueous liquid solid mixture foodstuff, lacked novelty in view of D1 as these did not include the feature of a pump container. A copy of original Claim 1 is given in Attachment A. Amendments were also made to Claim 11 and dependent claims, but these have been deleted in the latest proposed amendments, so I have not discussed them further.

34. The applicant amended Claim 1 as indicated in Attachment B. The key changes to the claim included the addition of the following features:

Viscosity less than 3000 cP.
Stable for at least 6 months.
Concentration of thickening agents is 15% to 25% by weight.
Polysaccharide is Acacia gum or one of several Larix polysaccharide extracts.
Polysaccharide extracts comprise 10 to over 100,000 saccharide units.
Concentration of polysaccharide is 3% to 15% by weight.

35. The applicant submitted that although D1 discloses a liquid thickener concentrate, the compositions are not stable for 6 months. They referred to the comparative results given in Example 2, and provided further evidence that the D1 composition is not stable (referred to as Appendices 1 and 2). D1 is silent as to the source of the Acacia gum used, so a comparison was made using both Acacia Senegal (Appendix 1) and Acacia seyal (Appendix 2). The composition shown in Appendix 1 did not thicken the water at all and physical separation of the composition results in a clear layer formed at the bottom of the container. The composition shown in Appendix 2 produced some thickening, but it was not homogenous. This example also showed distinct mould formation at the top of the composition.

36. The applicant also submitted that the present invention overcomes the problem of instability at least in part by the use of a pump dispenser sealingly attached to a container that ensures that the container is at least partly hermetically sealed. This inhibits the liquid from becoming physically and microbially unstable by minimising physical separation and microbial ingress, as well as preventing the composition from drying out and maintaining a water activity of at least 95%. Furthermore, the system defined in the present claims advantageously provides precise and accurate doses of the liquid composition. Prior art pumps typically rely on the resistance of a viscous product to function correctly. As the claimed liquid composition is not viscous, it would not be dispensed accurately using such prior art pumps.

37. In the case of D2, the applicant submitted that viscosity was inhibited using a concentrated sugar solution, sugar derivative, ethyl alcohol, glycerol, or sorbitol. In contrast, the polysaccharides of the present invention provide improved stability and do not alter the flavour and/or colour characteristics of the foodstuff. The applicant noted that in D3 and D4, the thickening agent is fully hydrated. Specifically, D3 relates to pre-thickened liquid food compositions, while D4 comprises a concentrate prepared from thickener and water.

38. The applicant also provided the Holahan and Tristram declarations, which they said provided secondary indications of inventiveness. These declarations had been filed in support of a corresponding US Patent Application No. 16/330,664. The declarations relate to a commercial viscosity-inhibited liquid thickener called “Precise Thick-N-INSTANT liquid thickener” (the Precise product) marketed by the applicant. The Precise product falls within the scope of the present claims. Tristram was said to illustrate the significant commercial success of the Precise product since its introduction into the marketplace in 2018/2019. Holahan is said to support the superiority of the Precise product over competitor products based on, for example, the ease and rapidity of thickening and the long shelf life thereof.

39. The examiner did not find the applicant’s submissions persuasive. A new objection was raised under sufficiency and the inventive step objection was maintained with respect to the claims as a whole. The gist of the examiner’s sufficiency objection was that the specification does not provide sufficient information to perform the invention across the whole width of the claims, without undue burden or the need for further invention:

The evidence (that is the comparative studies provided by the applicant) suggests that not all Acacia gums are able to produce the “contemplated result/performance”, and particularly stability.
The evidence and the guidance in the specification does not establish that the other features (water activity, ratio of components, dispenser pump, saccharide units) correlate with stability. Therefore, these do not constitute a principle of general application that can be practically applied to “enable” all embodiments falling within the scope of the claims.
In the alternative, these features are inherent or disclosed by the prior art compositions.

40. Documents D1 and D2 appear to be relied on for the inventive step objection, but D3 and D4 are briefly referred to in the concluding paragraph as indicating that the ranges of ingredients are “commonly used in the art”.

41. D1 was said to disclose thickener compositions of xanthan and arabic gum having the weight ratios, and to inherently possess the water activity and number of saccharide units defined in the present claims. The objection acknowledges that D1 does not disclose the use of a pump dispenser or the 6-month stability but noted that claim 11 was not limited to include a pump dispenser. There is no specific discussion of Claim 1 so it is not entirely clear from the objection whether the objection was intended to apply to Claim 1 in respect of D1.

42. D2 was said to provide a clear disclosure of the stability of at least 6 months for a variety of thickeners, and the accurate dispensing by precision volumetric pumps. The objection states that D2 highlights “thickeners such as guar, xanthan, arabic (i.e. acacia) and larch (i.e. larix)”. The examiner appears to have erred here, as the Acacia gum and Larch extracts in the present application act as the polysaccharide viscosity regulating agent rather than the thickening agent. The objection states that it is plausible to expect the contemplated stability for liquid compositions below 7500 cP (which is the most general level of viscosity referred to in D2).

43. The objection concludes that in the absence of evidence to the contrary, the features such as water activity and number of saccharide units were inherent in the prior art disclosures and have no technical significance that correlates with stability. The specific range of thickener and polysaccharide were said to be normal levels in the art, and it would be obvious to the skilled person to tailor the quantities to achieve the desired level of thickening.

44. The applicant filed a further response and proposed amendments on 6 September 2022. However, they were advised in a telephone conversation on 7 September 2022 that there was insufficient time to give their response a detailed consideration before the final date for acceptance. A case note by the examiner indicates that they considered the objections still applied, but little detail was provided in the case note and I therefore have not considered it any further.

45. I note that the claims under consideration by the examiner at second report, dated 29 August 2022, defined the polysaccharide in a range of 3% to 15% and the thickener in a range of 15% to 25%. That is, the claims defined that thickener to be present in an amount greater than the polysaccharide. This range also did not encompass Example 1, which comprises polysaccharide in an amount of 20% by weight and thickener in an amount of 7%.

46. The second examination report also indicated that D1 discloses compositions falling within the range defined by the claims dated 29 August 2022. However, there appears to a broad disclosure of the use of polysaccharides in the range of 3 to 50%, which overlaps with the present range, but no general range of thickener is given. The embodiments corresponding to the present invention use thickener at 5% by weight, together with gum arabic in a range of 10% to 40% by weight. A table also shows viscosities for formulations using 15 to 30% by weight of polysaccharide and 5% gum arabic.[29] Notably, all examples use the thickener in a lesser amount than the polysaccharide. Contrary to the statements in the examiner’s objection, I was unable to find any compositions in D1 that fall within the ranges defined in the claims under consideration by the examiner at second report, and particularly any in which the thickener is used in an amount greater than the polysaccharide.

[29] D1, Figure 3.

47. These inconsistencies raised a couple of concerns. Firstly, it seemed unusual that the claims would not cover the preferred embodiments. Furthermore, the general teaching in the specification, and indeed the approach taken in the prior art, was towards the use of an excess of viscosity inhibiting agent (in this case the polysaccharide) to thickener. To ensure that all relevant issues were covered in the hearing and, if possible, avoid any further delays in the prosecution of the case, I queried the ranges defined in the claims with the applicant. The applicant subsequently proposed amendment of the claims, which now define the use of compositions comprising thickener in a range of 3% to 15%, and polysaccharide in a range of 15% to 25% (Claim 1 as amended is given above and also shown in Attachment C).

48. Given the significant differences between the prior art and the claims under consideration at second report, I consider it unlikely that the objections raised in the second report could have been sustained to that claim set. But that is not to say that I am satisfied that the application may now proceed to acceptance. The issues raised in the examination report are at least still relevant to the present claims, if not more so, as a result of the amendment. I will therefore consider these with respect to the claims as amended. I note that it is open to me to raise new grounds of objection, but I do not consider that any other objections apply.

49. Two grounds of objection are outstanding: sufficiency and inventive step. I will deal with each of these in turn.

Sufficiency

50. Section 40(2)(a) of the Act requires that the complete specification must 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 (referred to as sufficiency). The Explanatory Memorandum to the Raising the Bar Act stated that the changes to section 40(2)(a) were:

“… intended to align the disclosure requirement with that applying in other jurisdictions with the effect that sufficient information must be provided to enable the whole width of the claimed invention to be performed by the skilled person without undue burden, or the need for further invention…”

51. The Explanatory Memorandum noted that the similarity of the wording of section 40(2)(a) with section 14(3) of the UK Patents legislation, and Art 83 of the European Patent Convention, and went on to state that:

“The intention is that paragraph 40(2)(a) be given, as closely as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention.”

52. A growing body of judicial decisions is providing guidance on the application of section 40(2)(a) and the related ground of support under section 40(3).[30] Consistent with the guidance provided in the Explanatory Memorandum, these have drawn on UK and European Patent Office decisions. Several Federal Court decisions have referred to the summary of the key elements of sufficiency provided by Kitchin J in Eli Lilly v HGS:

(i) the first step is to identify the invention and that is to be done by reading and construing the claims;
(ii) in the case of a product claim that means making or otherwise obtaining the product;
(iii) in the case of a process claim, it means working the process;
(iv) sufficiency of the disclosure must be assessed on the basis of the specification as a whole including the description and the claims;
(v) the disclosure is aimed at the skilled person who may use his common general knowledge to supplement the information contained in the specification;
(vi) the specification must be sufficient to allow the invention to be performed over the whole scope of the claim;
[30] Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477; Cytec Industries Inc. v Nalco Company [2021] FCA 970; Rakman International Pty Limited v Boss Fire & Safety Pty Ltd [2022] FCA 464; Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540; TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493; Calix Limited v Grenof Pty Ltd [2023] FCA 378; ToolGen Incorporated v Fisher (No 2) [2023] FCA 794.
[31] Eli Lilly & Co v Human Genome Sciences Inc [2008] EWHC 1903; [2008] RPC 29.
(vii) the specification must be sufficient to allow the invention to be so performed without undue burden.[31]

53. Decisions have also referred to the Supreme Court decision in Regeneron v Kymab, where Lord Briggs considered Article 83 of the EPC, as well as the UK law, and concluded that:

“Reflection upon those European and UK authorities yields the following principles:
(i) The requirement of sufficiency imposed by article 83 of the EPC exists to ensure that the extent of the monopoly conferred by the patent corresponds with the extent of the contribution which it makes to the art.
(ii) In the case of a product claim, the contribution to the art is the ability of the skilled person to make the product itself, rather than (if different) the invention.
(iii) Patentees are free to choose how widely to frame the range of products for which they claim protection. But they need to ensure that they make no broader claim than is enabled by their disclosure.
(iv) The disclosure required of the patentee is such as will, coupled with the common general knowledge existing as at the priority date, be sufficient to enable the skilled person to make substantially all the types or embodiments of products within the scope of the claim. That is what, in the context of a product claim, enablement means.
(v) A claim which seeks to protect products which cannot be made by the skilled person using the disclosure in the patent will, subject to de minimis or wholly irrelevant exceptions, be bound to exceed the contribution to the art made by the patent, measured as it must be at the priority date.
(vi) This does not mean that the patentee has to demonstrate in the disclosure that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made. Patentees may rely, if they can, upon a principle of general application if it would appear reasonably likely to enable the whole range of products within the scope of the claim to be made. But they take the risk, if challenged, that the supposed general principle will be proved at trial not in fact to enable a significant, relevant, part of the claimed range to be made, as at the priority date.
(vii) Nor will a claim which in substance passes the sufficiency test be defeated by dividing the product claim into a range denominated by some wholly irrelevant factor ... The requirement to show enablement across the whole scope of the claim applies only across a relevant range. Put broadly, the range will be relevant if it is denominated by reference to a variable which significantly affects the value or utility of the product in achieving the purpose for which it is to be made.
(viii) Enablement across the scope of a product claim is not established merely by showing that all products within the relevant range will, if and when they can be made, deliver the same general benefit intended to be generated by the invention, regardless how valuable and ground-breaking that invention may prove to be.”[32]
[32] Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27.

54. While the wording of the respective section 40 provisions (support and sufficiency) was intended to align Australian law with the corresponding UK and EP laws, there is a notable difference in the application of the Australian legislation. In particular, sufficiency is a ground of revocation and refusal in the UK and EP, while support is a ground of refusal only. In contrast, pursuant to the changes made by the RTB Act, support is a ground of both refusal and revocation in Australia.

55. The lack of any post-grant provision to address a failure of a patent to satisfy the claim support requirements apparently led to the development of Biogen sufficiency in the UK.[33] Given its origin, the underlying approach of Biogen insufficiency, and the need that the invention be enabled across the full scope of the claim, appears to align more closely with the claim support requirements under section 40(3) rather than 40(2)(a).[34] However I do not understand this to mean that the precedent with Biogen insufficiency applies only to the ground of support under Australian law – classical and Biogen insufficiency both serve to “prevent a patentee laying claim to products or processes which the teaching of the patent does not enable in the relevant sense”.[35] As noted by Nicholas J, after considering Eli Lilly v HGS and Kymab v Regeneron noted that:

“Both Eli Lilly and Regeneron were revocation actions. The question was therefore whether the specification as a whole made a disclosure sufficient to enable the notional skilled addressee to perform the invention (leaving aside de minimis or irrelevant exceptions) across the scope of the relevant claims. What the invention is depends on the proper construction of the claim. Once the claim is construed it is then necessary to determine whether performance of the invention as claimed is enabled.
In the case of the patent application the same question must be addressed. The claims must be construed for the purpose of identifying the invention. It is then necessary to consider whether performance of the invention by the person skilled in the relevant art is sufficiently enabled by the complete specification. Although s 40(2)(a) of the Act does not expressly refer to the invention as the invention defined by the claim, or the invention in the claim (cf. s 43(2A)(b) of the Act), there is no reason to doubt that the sufficiency of the disclosure is to be assessed against the invention as claimed. This is confirmed by those parts of the Explanatory Memorandum to which I have referred which describe the requirement that the skilled person reading the specification be able to perform the invention across the whole width of the claims.”[36]
[33] Merck Sharp & Dohme v Wyeth LLC (No 3), supra at [527].

[34] Ibid at [544].
[35] Zipher Ltd v Markem Systems [2008] EWHC 1379 (Pat); [2009] FSR 1 at [362].
[36] Toolgen v Fisher, supra at [174]-[175].

56. The general approach taken by the Patent Office to determine sufficiency of disclosure is as set out in CSR:

(i) Construe the claims to determine the scope of the invention as claimed
(ii) Construe the description to determine what it discloses to the person skilled in the art, and
(iii) Decide whether the specification provides an enabling disclosure of all the things that fall within the scope of the claims.[37]
[37] CSR Building Products Limited v United States Gypsum Company [2015] APO 72.

57. A key consideration is whether the claimed invention as a whole, or an individual feature of the invention, represents a principle of general application. As set out in the Explanatory Memorandum, an enquiry is also made as to whether the invention can be performed across the full scope of the claim without an undue burden of experimentation or need for further invention. To that end, an expanded approach was taken in Evolva to the third of the CSR enquiries:

(1) Is it plausible that the invention can be worked across the full scope of the invention?
(2) Can the invention be performed across the full scope of the claims without undue burden?[38]
[38] Evolva SA [2017] APO 57.

58. The approaches used in CSR and Evolva were based on the principles set out, inter alia, in Eli Lilly v HGS and Kymab v Regeneron. These approaches appear to have found approval with the Federal Court in, for example, Cytec v Nalco,[39] though the concept of plausibility, and the requirement as it developed under European and UK law “that the patent should disclose not just what the invention is and how to replicate it, but some reason for expecting that it will work”,[40] perhaps sits with the concept of “speculative claiming” and support more generally.[41] Nevertheless as noted by Nicholas J in Toolgen:

409. The respondents submitted that the support requirement in s 40(3) in combination with the requirement of disclosure in s 40(2)(a), operates to ensure that there is an enabling disclosure, and if the disclosure does not enable the invention to be performed to the full extent of the claim, the claim will lack the support required by s 40(3).
410. The facts in Warner-Lambert UK show how a claim might meet the requirement of s 40(2)(a) by providing an enabling disclosure, but not meet the support requirement of s 40(3). However, it is difficult to see how a claim to an invention for which there was no enabling disclosure could meet the support requirement. In such circumstances, the scope of the monopoly defined by the claim could not be justified by the technical contribution to the art. The two requirements are closely interrelated and not wholly distinct in their fields of operation.
[39] Cytec v Nalco, supra at [143]-[149].
[40] Warner-Lambert LLC v Generics (UK) Ltd t/a Mylan [2018] UKSC 56
[41] Toolgen v Fisher, supra at [397] to [402].

59. The examiner’s objection in the present case referred to a principle of general application, which is consistent with a consideration of Biogen sufficiency. In the following considerations, I have touched on plausibility, and it is therefore arguable whether the issues raised sit better under the ground of support rather than sufficiency. However, as noted above, the two grounds are closely related, and in any case an assertion that is implausible would most likely require an undue burden to work the invention. For convenience I have only considered the present issues under the ground of sufficiency.

60. The examiner’s concerns relate mainly to the comparative studies provided by the applicant, and in particular the fact that a composition made using Acacia gum did not provide the desired stability. It was therefore not reasonable to expect that all embodiments falling within the scope of the claim would be successful in achieving the desired stability. The examiner went on to state that, in the alternative, the thickeners used by the applicant in the comparative prior art compositions, which were selected because the prior art did not provide clear details as to the specific type of Acacia gum used, may be a “poor selection to represent the lack of stability”. The record of conversation dated 7 September 2022 also indicates that the examiner also considered that the stability may be due to other factors such as the use of Larix rather than Acacia gum, or the inclusion of citric acid to prevent microbial spoilage.

61. The comparative study was carried out on a prior art composition that falls outside the range of polysaccharide defined for the present invention (that is, both the claims under consideration at second report and the present claims). The applicant submitted in their response of 29 August 2022, that the comparative studies were intended to demonstrate the inherent instability of an embodiment of a liquid composition amongst the many alternatives described in D1. Their submissions at hearing stated that in order to show that the invention could not be worked across the scope of the invention, evidence would need to be available to the examiner to show that something inside the scope of the claims does not work. No such evidence was available. To the contrary, the evidence that something outside the scope of the claims does not work in the manner that the claimed invention does, supports the proposition that the claim scope is suitable.[42]

[42] Applicant submissions (AS) at [30].

62. The key point of contention in the examination report related to the stability of the compositions, and the assertion that there was no principle of general application that correlates to achieving stability. The applicant noted that the thickening agents and polysaccharides defined in the claims are common food additives, and independently well-known at the priority date.[43] The concentration ranges defined for these components are also relatively narrow and provide specific guidance as to the concentrations of thickening agent and polysaccharide that may be used to achieve a stable composition. Notably, the claims also encompass only two types of polysaccharides – an Acacia gum and a Larch gum. These types of gums are predominantly made up of arabinogalactan units. Larch is a well-known substitute for Acacia gum, and it would be understood that the defined polysaccharides could be used interchangeably in the viscosity-inhibited compositions defined by the claims.[44]

[43] AS at [14], appendices A-C.

[44] AS at [16] to [17], appendix B at page 192-193.

63. The viscosity-inhibiting interaction between the polysaccharide and the thickening agent is an important factor in achieving the desired level of stability in the present invention. At the hearing the applicant noted that most gums form highly viscous solutions at low concentrations of about 1-5%, while Acacia gum is extremely soluble and not very viscous at low concentrations. High viscosities are not obtained with Acacia gum solutions until concentrations of 40-50% are reached.[45] Larch gum has similar properties to Acacia gum, being highly soluble at low concentrations and not forming viscous solutions until concentrations of around 60% are reached.[46] The applicant acknowledged that there would be some variation in the viscosity and water activity of a liquid composition that results from changing the precise concentrations and ratios of the different thickeners and polysaccharides. However, given the known physicochemical properties of the individual thickeners and polysaccharides, the person skilled in the art would have a reasonable understanding of the likely changes to viscosity that might result from applying significantly varied concentrations of each component to a liquid composition. The claims limit the concentrations of the components to a relatively narrow range, and the claims further include the limitations that the compositions have a viscosity of less than 3000 cP and a water activity of greater than 95%. These provide further guidance as to how any variation should be tempered so as to ensure that these overarching physicochemical properties of the resulting composition achieves the technical effect of stability.[47]

[45] AS, Appendix B, page 100.

[46] AS, Appendix B, page 193.

[47] AS at [20].

64. I find the applicant’s submissions on this point to be persuasive. Given the nature of the interaction between the polysaccharide and the thickener, sufficient polysaccharide is presumably required to inhibit interaction of the thickener with water and provide a stable solution. I consider that is reflected by the instability shown in the comparative tests with the prior art compositions containing a concentration of polysaccharide lower than the defined range (10%). The examples given in the specification show that a composition within the defined concentration range has a suitable level of stability. At higher concentrations, the solutions will presumably become unstable (or at least too viscous) due to the polysaccharide reaching a concentration at which it forms viscous solutions. On balance I consider it plausible that compositions containing the specific thickeners and polysaccharides in the defined ratios provide the desired level of stability.

65. Moreover, as noted by the applicant water activity and viscosity are well-known in the art, as are methods for their measurement.[48] I do not consider it would require an undue burden of experimentation to undertake such routine tests on the relatively narrow range of combinations defined by the present claims to arrive at a particular combination that falls within the scope of the claims.

[48] AS at [22] to [25]

66. In summary, I consider that the specification is clear enough and complete enough to enable the person skilled in the art to work the invention across the full scope of the claims without an undue burden of experimentation or the need for further invention.

Inventive step

67. Section 7(2) of the Act sets out that an invention is taken to involve an inventive step unless it would have been obvious to the person skilled in the art in the light of the common general knowledge, either considered alone or together with information of the kind set out in section 7(3) of the Act. The information set out in section 7(3) consists of any single piece of prior art information, or a combination of 2 or more pieces of prior art information that the skilled person could, before the priority date of the claim, be reasonably expected to have combined.

68. In Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd, Aickin J formulated the test for whether an invention is obvious as whether it would have been a matter of routine to proceed to the claimed invention.[49] In Aktiebolaget Hassle v Alphapharm Pty Ltd,[50] the High Court accepted the approach taken by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd, where he posed the reformulated Cripps question:

“Would the notional research group at the relevant date, in all the circumstances, ... directly be led as a matter of course to try [the claimed combination] in the expectation that it might well produce a [useful or better result]?”[51]
[49] [1981] HCA 12; 148 CLR 262 at 286.
[50] [2002] HCA 59 at [53]; (2002) 212 CLR 411 at [53].
[51] Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at [187].

69. The present claims are directed to a combination of features. In such cases, obviousness is not established merely by identifying each of those features in the prior art or the common general knowledge – the question is whether the combination of those features is obvious.[52] As noted in Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd:

“An allegation of want of inventive step is not made out by saying you may take one or two, or twenty-one or twenty-two, prior publications and then select from them appropriate extracts or pieces of information, which will add up to the invention claimed and so demonstrate that it was obvious. So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness. The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent. If this were not so, there could never be a valid patent for a new combination of old integers. The proper question is not whether it would have been obvious to the hypothetical addressee who was presented with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process. It is rather whether it would have been obvious to a non-inventive skilled worker in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination of integers from those selected publications. In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious.
It is in relation to this process that the misuse of hindsight is most common. When once an idea or an object or a process or a combination, admittedly novel, has been published, it is very easy to say after perhaps months of search and study in the Patent Office and the public libraries that the integers into which the patent might be dissected could be found scattered amongst the prior documents by a person who already knew the solution to the problem and therefore knew what to look for and what to discard. But that process does not demonstrate lack of an inventive step. The opening of a safe is easy when the combination has been already provided.” [53]

The problem

[52] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; 144 CLR 253 at 293, Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at 429, [41].

[53] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; 144 CLR 253 at 293.

70. The examiner’s objection did not specifically set out the problem to be solved. This of course is not essential, but it can provide a framework and context for the inventive step consideration and help avoid hindsight. The applicant submitted that the “objective technical problem” could be formulated as the provision of a storage and delivery system for a viscosity-inhibited liquid thickener that offers improved stability of said liquid thickener and provides accuracy of delivery volumes, allowing consistency of thickening. I note the reference to an objective technical problem appears to import a European approach to the consideration, where the problem is formulated from a consideration of the application and the closest prior art to identify the difference between the invention and the prior art, which is then used to identify the technical effect resulting from the distinguishing features and formulate the technical problem. Such an approach would, in my view, risk formulating a “starting point” based on information given in the present specification. As noted by the expanded Full Court of the Federal Court in AstraZeneca v Apotex:

“If the problem addressed by a patent specification is itself common general knowledge, or if knowledge of the problem is s 7(3) information, then such knowledge or information will be attributed to the hypothetical person skilled in the art for the purpose of assessing obviousness. But if the problem cannot be attributed to the hypothetical person skilled in the art in either of these ways then it is not permissible to attribute a knowledge of the problem on the basis of the inventor’s “starting point” such as might be gleaned from a reading of the complete specification as a whole.”[54]
[54] AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [203].

71. The applicant submitted that during the development of the present invention, they discovered that the use of polysaccharides to inhibit liquid thickener compositions tended to result in phase separation between the thickening agent and the polysaccharide (this is demonstrated in Example 2). In addition to the physical instability, the high water activity of the present invention, which is advantageous in terms of the flowability of the composition and the advantages it provides in terms of dosage accuracy, makes it highly prone to microbial spoilage and drying out over time. There is no evidence that such issues were common general knowledge in the art relating to viscosity inhibited thickening agents.

72. Turning to whether the knowledge of the present problem would have been available through information under section 7(3), I consider D2 represents the most relevant document in this regard. D2 discloses different viscosity inhibiting formulations, and the problem associated with that disclosure relates to the provision of compositions providing storage stability, accuracy of delivery volumes and consistency of thickening. Furthermore, the viscosity inhibiting compositions described in D2 are unable to reach a water activity of greater than 95%,[55] so they would presumably not be subject to the same issues of microbial growth as the present invention. I therefore consider the problems associated with the present formulations could not have been gleaned from D2. For completeness, D1 similarly does not provide any disclosure of the problems identified in the present case.

[55] AS at [71] and Appendix H.

73. There is no evidence before me that otherwise establishes that the problems encountered in the development of the present invention were common general knowledge or section 7(3) information. It follows, in my view, that the problem is not so limited as the provision of a storage and delivery system for a viscosity-inhibited liquid thickener. It seems to me that this would incorporate knowledge that, as discussed above, could not be attributed to the person skilled in the art from the common general knowledge or documents under section 7(3). I therefore consider the present problem can be formulated more broadly as the provision of an improved (or alternative) liquid thickener and system that provides for storage stability, accuracy of delivery volumes and consistency of thickening.

The person skilled in the art

74. It probably does not impact significantly on my determination, but neither the examiner nor the applicant provided a definition for the person skilled in the art. Given the nature of the invention, I consider the skilled person would constitute a team comprising a food technologist and a food packaging engineer. I would expect such a team to have a broad working knowledge of thickening agents and packaging for dispensing liquid compositions.

The common general knowledge

75. The inventive step objection stated the following:

The level of thickening suited to the need for patients suffering from dysphagia (i.e. nectar, honey, pudding) is a known and desirable goal in the art.
Dispensing pumps are commonplace as suitable packaging known to inhibit drying analogous to any other kind of packaging designed to do so like foil backed pouches, well known for shelf stability.
The claims as amended are considered parametric claims suffering parameteritis as per the Patent Manual of Practice and Procedure at 2.11.2.3.12, specifically water activity greater than 95%, stability for at least 6 months, and the polysaccharides of group (ii) comprise 10 to over 100,000 units.

76. The first two dot points go to the issue of the common general knowledge in the art. Before considering these, I will address the third dot point that the claims suffer from parameteritis.

77. Parameteritis, at least in the manner described by Laddie J in Raychem,[56] refers to situations where an arbitrary or technically meaningless parameter is used to characterise an invention and avoid anticipation by prior art that does not explicitly disclose such a parameter. In Raychem this involved the measurement of a parameter using equipment that was not available at the time of the prior art. In contrast, in Austal Ships v Stena, claims directed to a hull that was defined by particular parameters were found to be novel on the basis that:

“… there is reference in the patent specification and evidence which supports the fact that the parameters have been carefully chosen, are part of the invention and are related to a claimed advantage as part of the combination of the design.”
[56] Raychem Corp.’s Patents [1998] RPC 31.

78. Thus, it seems to me that the determination of whether a claim suffers parameteritis involves a consideration of whether the defined feature makes a “technical” contribution to the invention (and therefore is not technically meaningless), or whether the additional feature is merely further knowledge about an existing invention.[57] In the present case, the invention lies in the provision of a viscosity-inhibited composition for use as a food thickener. The properties of the polysaccharides enable relatively concentrated amounts of thickener to be accommodated in a “controlled-release” manner while providing for long-term stability. The resulting solutions also have lower viscosity and higher water activity than the prior art pre-thickened and pre-hydrated compositions. These properties, and particularly the relatively low viscosity, enables the formulation to be stored and dispensed by precision volumetric pumps and contributes to the advantages of the claimed combination. The definitions of these properties are therefore not arbitrary or technically meaningless, but rather are intrinsic (or at least essential) to the working of the invention – noting that the invention is a combination of a pump dispenser and a composition, and not merely the composition itself. I therefore do not agree with the assertion that these features are technically meaningless or arbitrary features that can be disregarded for the assessment of obviousness.

[57] Otsuka Pharmaceutical Co Ltd v Generic Health Pty Ltd (No 2) (2016) 120 IPR 431 at [115].

79. Turning to the common general knowledge, I am satisfied that it is common general knowledge in the art that the viscosity of liquid foodstuffs for dysphagia patients should be within certain levels, as set out in the IDDSI framework. I am also satisfied that various types of packaging are common general knowledge in the art, including the foil-backed pouches and pumps referred to by the examiner. However, I note that the examiner did not only state that pumps were known, but that they were known to inhibit drying analogous to any other packaging designed to do so like foil-backed pouches. The examiner did not refer to any specific source for this assertion, but the specification states that pumps used with the viscous prior art liquid thickeners are not suitable for use with the present invention. This suggests that the key consideration is not so much whether pumps were generally known, but whether pumps that are capable of dispensing low viscosity and moisture sensitive liquids (and, more particularly, liquids having a water activity of greater than 95%) were common general knowledge at the relevant time. The objection did not specifically address these points, perhaps because viscosity and water activity were regarded as arbitrary or meaningless parameters. However verbal submissions at the hearing concerning the relatively generic definition of the pump in the claims suggested that such pumps were well-known in the art and the skilled person would choose one that was fit for purpose in view of the parameters defined. I therefore consider that pumps which are suitable for delivery of low-viscosity and moisture sensitive liquids, including high precision delivery systems, were common general knowledge in the art at the relevant time.

80. I also consider that powder and fully hydrated liquid thickeners can be considered common general knowledge in the art. On the other hand, based on the material before me I am not satisfied that viscosity inhibited liquid thickeners, including those described in D1 and D2, form part of the common general knowledge in the art. While it is not in dispute here, it follows that this would preclude a finding of obviousness based on the common general knowledge alone.

81. The remaining consideration is whether the claimed invention would have been obvious in view of the common general knowledge combined with prior art information as set out in section 7(3). D1 and D2 are the most relevant documents for this purpose. I will deal with these documents in turn. The examiner objection also mentions D3 and D4, and while I consider they have little relevance in the present matter, I have considered them briefly below.

Determination in relation to document D1

82. D1 discloses viscosity inhibited liquid thickening compositions that are suitable for use with dysphagia patients. Three broad forms or types of thickener are disclosed. These differ based on the viscosity inhibiting agent used in combination with the thickening agent.

83. The first form uses a solution of a thickening agent in combination with a poor solvent such as ethyl alcohol, acetone or isopropyl alcohol. The third form uses a solution of a thickening agent together with a metal ion such as potassium, calcium or magnesium. Neither of these two forms is relevant to the present claims.

84. The second form described in D1 corresponds to the thickening agents used in the present invention. These use a thickening agent in combination with a polysaccharide such as gum arabic, pullulan, soybean polysaccharide and arabinogalactan (which is another name for larch gum).[58] The polysaccharides are said to work particularly well at high concentrations, and preferably 8-30% in the case of gum Arabic.

[58] D1, column 4, lines 26 to 32.

85. An embodiment comprising xanthan gum (5% by weight) and gum arabic (10% by weight) is prepared and tested as a thickener in water, consommé soup and salad dressing. The thickening agent has a viscosity of 648 cP.[59] When 20 parts by weight of the thickening agent was added to 100 parts by weight of water, a viscous solution was immediately formed which had a viscosity of 412 cP.

[59] Figure 3 of D1 shows a composition comprising 10% gum arabic has viscosity of about 5000 cP. This composition appears to be the same one as referred to in column 4, lines 26 to 32, which is said to have a viscosity of 648 cP. It is not readily apparent why the viscosities are different.

86. D1 also discloses the preparation of several other compositions comprising 5% xanthan gum together with 15, 20, 30 and 40% gum arabic. The viscosity of these solutions is shown in Table 3.[60] The solutions comprising 15 and 20% gum arabic fall within the ranges defined in the present claims. D1 states that:

A plurality of liquid thickening agents of xanthan gum were prepared at the same concentration as above using solutions of arabic gum at different concentrations. FIG. 3 shows a measured result with respect to viscosity of these liquid thickening agents. It can be confirmed from this figure that the liquid thickening agent of xanthan gum with the solution of arabic gum has a lower viscosity than that of the liquid thickening agent of xanthan gum only with water and that arabic gum obviously imparts fluidity on the liquid thickening agent.
[60] D1, Figure 3.

87. This is the only specific disclosure in relation to the compositions comprising 15, 20, 30 and 40% gum arabic. The study is said to confirm that solutions of gum arabic and xanthan gum have lower viscosity than xanthan gum alone. There is no actual disclosure of the use of these solutions as thickening agents, and in particular the viscosity of liquid foods after addition of the thickening agents. It seems to me that on one hand the polysaccharide might simply inhibit the action of the thickening agent. Thus, dilution of the polysaccharide by addition of the composition to a liquid food releases the thickening agent to gel. This being the case, the thickening properties of the compositions might be largely independent of the polysaccharide concentration (that is, a 5% solution of xanthan would give substantially the same viscosity irrespective of the concentration of the polysaccharide). However, on the other hand, gum arabic is itself a thickener, and therefore could potentially contribute to the final viscosity of the foodstuff. D1 is silent as to the thickening properties of compositions using different concentrations of polysaccharide.

88. The applicant also highlighted some other considerations in relation to D1. They noted that Example 2 of the present application demonstrates that the liquid thickener described at column 4 of D1 is both physically and microbially unstable. D1 is silent as to the stability of the liquid thickeners, providing no teaching or experimental data relating to their shelf-stability.

89. There is also no suggestion that the stability of liquid thickeners could be improved using the storage and delivery system of the present invention. There is no disclosure or suggestion of the use of pump dispensers. While D1 is silent on the topic of stability, the implication is forwarded that particular combinations may be best prepared and delivered as separate liquids. In such cases it is preferable to use a container such as “Dispenpax”[61] that contains two liquids in separate packages which can be taken out at the same time for use. Even where the thickening agent and polysaccharide are stored as a combination, D1 discloses that “it is preferable that the liquid additive thickener is separated little by little and contained individually either in a portion container or a small bag”. The applicant argued therefore that D1 teaches away from the combined storage of a thickening gum and a viscosity inhibiting polysaccharide in a container as defined by the present claims. The applicant concluded that as such, D1 does not provide any motivation for the skilled person to combine any of the various viscosity inhibited liquid thickeners described therein with a pump dispenser having a valve. To the contrary, the teaching is towards separate storage of the components, or storage in portion containers or small bags.

[61] I have been unable to find this specific product in a Google search. However, there are products having similar names, e.g. Dispen Pak, that refer to containers that are used to dispense separate liquids. These are similar to single serve, foil topped plastic sauce packets that comprise two separate sections, such as “squeeze-mate” sauce packaging. The packaging is bent in the middle to press the two separate sections together and force their contents through the foil top.

90. On balance I find the applicant’s submissions persuasive.

91. Prima facie the facts of the present case are relatively straightforward. The polysaccharides used in the present invention certainly fall within one of several broad classes of viscosity inhibiting agents described in D1 (“poor solvents”, polysaccharides and reactive ions). Acacia and larch gums are a sub-class of the polysaccharides described in D1, and two compositions are described in Figure 3 that appear to fall within the scope of the compositions defined for use in the present claims (namely compositions comprising 15 and 20% gum arabic).[62] Pump dispensers are known in the art, and the invention lies in the use of a pump to store and dispense such compositions. However, as cautioned by the High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No. 2), the question of whether it would be obvious to add one integer to a combination of other integers:

“…will turn on what a person skilled in the relevant art, possessed with that person’s knowledge would have regarded, at the time, as technically possible in terms of mechanics, and also as practical. … Even if an idea of combining integers, which individually may be considered mere design choices, is simple, its simplicity does not necessarily make it obvious.”[63]
[62] I note that these two compositions have viscosities lower than 3000 cP. Their water activity is not provided, I consider it reasonable to assume that they have the water activity defined in the present claims.
[63] [2007] HCA 21; 235 CLR 173 at [111].

92. In this regard I am not satisfied that the skilled person would be motivated to combine the features of the present claims in the expectation that they would provide the stated advantages. As discussed above, the present problem can be formulated as the provision of an improved (or alternative) liquid thickener and system that provides for storage stability, accuracy of delivery volumes and consistency of thickening. The key question is whether the skilled person would be directly be led as a matter of course to try the claimed combination, and specifically the combination of the defined compositions and a container with a sealed pump dispenser comprising a valve for preventing and inhibiting drying of the composition in the container, in the expectation that it might well provide the advantages of storage stability, accuracy of delivery volumes and consistency of thickening. Notably the determination is not whether each of the individual features are known or obvious, but whether the combination as a whole is obvious.

93. D1 is entirely silent as to the chemical and microbial stability of compositions comprising acacia gum and xanthan gum, or indeed any of the compositions disclosed in the document. Admittedly, Figure 3 of D1 appears to provide a disclosure of two compositions that fall within the present claims and that these compositions have a viscosity below 3000 cP, but the purpose of this experiment appears to be to confirm that solutions of gum acacia and xanthan gum have lower viscosity than a solution of xanthan gum alone. There is no suggestion that any particular range of concentrations or any level of viscosity has any advantage over any other, and certainly not any advantages in the way of stability. I also note that the only composition which is specifically used as a thickener in liquid foodstuffs falls outside the scope of the compositions defined in the present claims. This composition comprises gum acacia in a concentration of only 10%, and Figure 3 indicates that this composition has a viscosity of around 5000 cP. The teaching provided by D1 is arguably towards the use of this composition as a thickening agent.

94. There is also no disclosure or even a suggestion in D1 of the use of pump dispensers for the storage and delivery of the liquid thickeners. Indeed, as submitted by the applicant, most of the discussion in D1 relates to single serve pouches or bags. I acknowledge that pump dispensers suitable for use with low-viscosity and moisture sensitive liquids may be common general knowledge, but the evidence suggests that the prior art liquid thickeners were generally fully hydrated and more viscous than the compositions used in the present invention. The present specification indicates that such pump dispensers are not suitable for use with the compositions of the present invention. In this regard, the unsuitability of the prior art pumps relates to problems with leakage and issues with drying out in circumstances where the composition comes into contact with the surrounding air. Given that D1 is silent as to the water activity of the compositions, including the specific compositions given in Figure 3, there is no evidence before me that would establish that the skilled person would be motivated to employ the specific sealed pump dispensers defined in the present claims in view of D1.

95. On balance I am not satisfied that the skilled person would be led to the specific combination of the defined compositions with the storage and pump dispensing system, to achieve the present advantages of storage stability, accuracy of delivery volumes and consistency of thickening. To arrive at the specific features of the combination as set out in the present claims and achieve the stated advantages would appear to require a degree of hindsight. I therefore consider the claims are inventive in view of D1 in light of the common general knowledge in the art.

Determination in relation to D2

96. D2 is in the name of the present applicant. It apparently describes an earlier version or generation of a viscosity inhibited thickener comprising an edible gum and a viscosity inhibiting carrier.[64] The invention is said to have a viscosity of less 7500 cP, which, on addition to a foodstuff, increases the viscosity of the foodstuff to greater than 400 cP.

[64] AS at [67].

97. The edible gum may be selected from a large of known thickening agents including gum arabic and larch gum. The viscosity inhibiting carrier or agent is a concentrated sugar solution, concentrated polydextrose solution, ethanol, glycerol, sorbitol, vegetable oil, propylene glycol, triacetin and alcohols. The concentrated sugar solution is said to include any practicable sugar, mixture of sugars, or sugar derivative such as sucrose, fructose, glucose, maltose, or any other mono-, di-, tri- or polysaccharide. No specific illustration or exemplification of the term polysaccharide is provided, but a distinction appears to be drawn between the viscosity inhibiting component and the polysaccharide gums that are used as thickeners. Concentrations of the sugar component are said to range from 50% to 90% by weight. The thickening agents can be used in a range of 0.1 to 60% by weight. The general method of manufacture involves dissolving the sugar component in water, substantially to saturation, heating, and addition of the edible gum.

98. Example 4 is perhaps the most relevant example. It describes the preparation of a thickening agent comprising polydextrose (44%) and maltodextrin (6.8%) as the viscosity inhibiting agent, together with guar gum (10%) and xanthan gum (0.06%) as thickening agents. I note that none of the examples use larch gum or gum arabic.

99. The applicant submitted that the present claims are distinguished from D2 by the water activity, pump dispenser and the specific compositions. They noted that the compositions disclosed by D2 do not reach a water activity of greater than 95% because they contain high concentrations of sugar or sugar derivatives. For example, D2 discloses that the concentration of the sugar solution is in a range of 50 to 90%. The water activity of sugar solutions at this concentration is well below 95%.[65] Similarly polydextrose solutions have only slightly higher water activity than sucrose solutions.[66] The compositions in D2 using polydextrose would therefore be expected to have a water activity of less than 95%.

[65] AS, Appendix H, Figures 2 and 3.

[66] AS, Appendix I, page 238.

In the case of the pump dispenser, the applicant submitted that there is no disclosure in D2 of a pump dispenser being used to improve the stability of the liquid thickener compositions therein. They also noted that there is no indication in D2 that the compositions experience any stability issues. In this regard D2 states that:
“Because the composition of the invention is stable, and the viscosity remains constant for a commercially reasonable period of time, the formulation can be provided as a packaged product perse [sic] to the end user.”

The applicant submitted that this stability may be related to the lower water activity of the compositions and/or the low molecular weight carriers. Furthermore, while D2 mentions the use of precision volumetric pumps, there is no disclosure of the use of a valve to prevent the composition from drying out. To the contrary, the relatively low water activity of such compositions means they are not prone to drying out. The skilled person would therefore appreciate that they do not require the storage and delivery systems defined in the present claims.
The key distinguishing feature between D2 and the present invention lies in the ingredients used in the compositions. In particular the viscosity inhibiting carriers are all low molecular weight materials, and their mode of action differs from that of the polysaccharides of the present invention. Notably, due to their low molecular weight, the viscosity inhibiting agents are used in high concentrations. It is simply not possible to use concentrated amounts of polysaccharides without thickening of the solution as these would not be suitable for use with a pump dispenser.
Furthermore, guar gum, gum acacia, xanthan gum and larch gum are used as thickeners in D2. There is no disclosure of the use of gum acacia or larch gum as the viscosity inhibiting carrier. The applicant argued that there is no motivation in D2 to use any of these thickening agents as a viscosity inhibiting carrier, much less at the range defined by the present claims. The use of polysaccharides in this manner provides for controlled release of the thickener, while not adversely altering the desirable attributes of the foodstuff, such as flavour and colour, which is a disadvantage of the use of concentrated sugar solutions.
On balance I find these submissions persuasive. There is nothing in D2, when read in light of the common general knowledge, that would lead the skilled person to the invention defined by the present claims. I therefore consider the claims to be inventive in view of D2.

Determination in relation to documents D3 and D4

The examination report did not refer to D3 and D4 alone as impacting on the validity of the present claims, but instead referred to these as providing support for the assertion that certain features were well-known in the art. D3 discloses a process of providing thickened food compositions using a dispenser and in-line mixer. D4 describes xanthan gum concentrate solutions. These comprise mixtures of xanthan gum in water and are fully hydrated. Neither of these documents relates to viscosity inhibited compositions, or to the storage of such compositions. There is no evidence before me to establish that the skilled person would arrive at the present invention as a matter of routine in view of these disclosures. I therefore consider the present claims are inventive in view of both D3 and D4.

Conclusion on Inventive Step

In summary, the claims are not obvious in view of each of D1 to D4. The invention lies in the combination of a specific class of viscosity inhibited food thickening compositions and a pump dispenser which comprises a valve for inhibiting or preventing drying of the composition. The composition, and particularly the choice and concentration of the polysaccharide viscosity inhibiting agent in the composition, is selected to provide for higher water activities, improved dispersibility, and improved flowability, while achieving advantageous physical and chemical stability. These features enable the compositions to be stored for extended periods in pump dispensers that provide for additional stability and the ability to dispense the solutions in an accurate and portion-controlled manner. The specific choice of pump dispenser further improves the stability of the compositions, which due to their high water activity are susceptible to drying out. None of the prior art documents teaches or suggests this combination of features, nor the advantages provided by such.
I therefore am satisfied that the claims are inventive in view of D1 to D4.

Conclusion

In view of the material before me, I do not consider that the objections under section 40(2)(a) and inventive step can be maintained. There are no other relevant grounds of objection that I consider would prevent acceptance of the application.
I therefore direct that the application proceeds to acceptance. For the avoidance of doubt, the specification comprises Claims pages 45 to 49 dated 5 September 2023 (comprising Claims numbered 1 to 19), description pages 1 to 44 dated 25 August 2023 and drawing pages 1/2 and 2/2 as originally filed.

Dr Leslie F. McCaffery
Delegate of the Commissioner of Patents

Attachment A: Claims 1 as originally filed

1. A storage and delivery system for a stable liquid composition, comprising:

(a) a container containing the stable liquid composition, said composition for increasing the viscosity of an aqueous liquid or aqueous liquid solid mixture foodstuff and having a viscosity of less than 2000 cP and a water activity of greater than 95%, wherein the composition comprises:

(i) one or a plurality of thickening agents selected from the group consisting of agar, alginic acid, carrageenan, guar gum, gum tragacanth, gum ghatti, microcrystalline cellulose, methyl cellulose, hydroxypropylmethylcellulose, hydroxyproylcellulose, methylethylcellulose, gum karaya, locust bean gum, tara gum, psyllium seed gum, quince seed gum, a pectin, furcellaran, gellan gum, konjac, sodium alginate, xanthan gum and any combination thereof; and

(ii) one or a plurality of polysaccharides or extracts thereof selected from the group consisting of scleroglucan, dextran, elsinan, soy bean polysaccharide, levan, an arabinogalactan, alternan, inulin, a gluco-oligosaccharide, pullulan, an arabinoxylan, curdlan, low viscosity carboxymethylcellulose (CMC), an Acacia gum, a Larix occidentalis polysaccharide extract, a Larix laricina polysaccharide extract, a Larix decidua polysaccharide extract, a Larix sibirica polysaccharide extract and any combination thereof; and

(b) a pump dispenser sealingly attached to the container, said dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.

Attachment B: Claim 1 filed 29 August 2022

A storage and delivery system for a stable liquid composition, comprising:

(a) a container containing the stable liquid composition, said composition for increasing the viscosity of an aqueous liquid or aqueous liquid solid mixture foodstuff,

wherein the composition is stable for at least six months at room temperature and

wherein the composition comprises a viscosity of less than 3000 cP and a water activity of greater than 95%,

wherein the composition comprises:

(i) one or a plurality of thickening agents selected from the group consisting of agar, alginic acid, carrageenan, guar gum, gum tragacanth, gum ghatti, microcrystalline cellulose, methyl cellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, methylethylcellulose, gum karaya, locust bean gum, tara gum, psyllium seed gum, quince seed gum, a pectin, furcellaran, gellan gum, konjac, sodium alginate, xanthan gum and any combination thereof,

wherein the concentration of said thickening agents is 15% to 25% by weight;

(ii) one or a plurality of polysaccharides or extracts thereof selected from the group consisting of an Acacia gum, a Larix occidentalis polysaccharide extract, a Larix laricina polysaccharide extract, a Larix decidua polysaccharide extract, a Larix sibirica polysaccharide extract and any combination thereof,

wherein said polysaccharides or extracts thereof comprises 10 to over 100,000 saccharide units and
the concentration of said polysaccharides or extracts thereof is 3% to 15% by weight; and

(iii) water and/or a food grade aqueous solution; and

(b) a pump dispenser sealingly attached to the container, said dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.

Attachment C: Claim 1 filed 5 September 2023

A storage and delivery system for a stable liquid composition, comprising:

(a) a container containing the stable liquid composition, said composition for increasing the viscosity of an aqueous liquid or aqueous liquid solid mixture foodstuff,

wherein the composition is stable for at least six months at room temperature and

wherein the composition comprises a viscosity of less than 3000 cP and a water activity of greater than 95%,

wherein the composition comprises:

(i) one or a plurality of thickening agents selected from the group consisting of agar, alginic acid, carrageenan, guar gum, gum tragacanth, gum ghatti, microcrystalline cellulose, methyl cellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, methylethylcellulose, gum karaya, locust bean gum, tara gum, psyllium seed gum, quince seed gum, a pectin, furcellaran, gellan gum, konjac, sodium alginate, xanthan gum and any combination thereof,

wherein the concentration of said thickening agents is 3% to 15% by weight;

wherein said polysaccharides or extracts thereof comprises 10 to over 100,000 saccharide units and

the concentration of said polysaccharides or extracts thereof is 15% to 25% by weight; and

(iii) water and/or a food grade aqueous solution; and

(b) a pump dispenser sealingly attached to the container, said dispenser comprising a valve for inhibiting or preventing drying of the composition in the container.