Fonterra’s Opposition Brings Perfect Day’s Accepted Application Down To (and below) Ground

In Fonterra Co-operative Group Ltd v Perfect Day Inc [2022] APO 59 an application relating to dairy substitutes was successfully opposed in a case where more careful drafting could have avoided that outcome.

Perfect Day’s patent application relates to dairy substitutes, methods of manufacturing them, compositions comprising animal-free milk fats and proteins for food applications such as milk, butter, cheese, yoghurt, and cream. The Australian patent office accepted the application in September 2019 and Fonterra opposed it on the grounds of lack of inventive step, inutility, insufficiency and lack of support.

The specification states that the current plant and nut based substitutes for dairy milk fall short in terms of flavour and almost universally fail to form derivative products such as cheese, yoghurt, cream or butter when subjected to the same processes used on dairy milk. The specification claims to disclose compositions having a similar taste, mouth feel, aroma, and nutritional value to a mammal-based milk, but which lack one or more undesirable components of a mammal-produced milk (e.g., allergens, lactose, antibiotics, stress hormones and/or growth hormones, heavy metals, bacteria such as  E. coli , viruses, and prions). It also claims that the disclosed compositions have an improved shelf-life and aroma profile compared to mammal-produced milk. Claim 1 is as follows:

A food composition comprising:
(i) a recombinant β-lactoglobulin and a recombinant α-lactalbumin, wherein one or both of the recombinant β-lactoglobulin protein and the recombinant α-lactalbumin protein comprises a sequence that is at least 90% identical to the bovine protein amino acid sequence and has been produced by a fungal cell;
(ii) one or more sweetening agents;
(iii) ash; and
(iv) optionally, one or more lipids,
wherein:
the food composition has one or more characteristics of a dairy food product selected from the group consisting of: taste, aroma, appearance, handling, mouthfeel, density, structure, texture, elasticity, springiness, coagulation, binding, leavening, aeration, foaming, creaminess, and emulsification; and
the food composition does not comprise any other milk proteins than those in (i).

Construction: Noting that “food composition” is not defined in the specification Fonterra argued that the claim is over-broad as it could include compositions that would not be considered foods on account of qualities such as not being sufficiently palatable. The Delegate accepted Perfect Day’s submission that the phrase should be given its ordinary meaning of being a substance that is eaten or taken into the body for nourishment. The Delegate went on to construe claim 1 as defining dairy substitute products that possess one or more characteristic properties of a corresponding dairy product.

Obviousness: Regarding lack of inventive step Fonterra argued that it would be routine for the skilled person to arrive at the claimed compositions for use as dairy food substitutes as a matter of course as the common general knowledge included the use of recombinant β-lactoglobulin and α-lactalbumin to create whey food compositions. It was also argued that the common general knowledge in conjunction with one of two pieces of prior art would establish obviousness. The Delegate rejected the argument based on common general knowledge alone as the evidence did not establish that the requisite information was known and accepted widely enough in the art to be considered common general knowledge. Obviousness was also rejected in relation to the first piece of prior art as it was held that the skilled person at the priority date would not have chosen the claimed combination from amongst the large number of proteins disclosed therein for use in a food product. Finally obviousness was also rejected in relation to the second piece of prior art, which centred around the use of modified α-lactalbumin in food compositions, as the motivation for its modification pointed away from it being combined with β-lactoglobulin.

Lack of Support: Claim 1 does not define the invention in terms of a principle of general application, but instead is very specific in relation to the milk proteins β-lactoglobulin and α-lactalbumin and other ingredients. However, the applicant sought to establish support for the claims based on broad reference to a subset of milk proteins together with various general references to β-lactoglobulin and α-lactalbumin throughout the description, rather than any specific embodiments of such compositions. Instead, the specific embodiment in the specification is directed to compositions containing casein, and highlights the importance of micelles, which the application does not show can be produced using β-lactoglobulin and α-lactalbumin. Consequently, because the applicant has not enabled the invention across the full scope of the claims, the Delegate found the claims do not reflect the technical contribution of the application to the extent of being supported thereby. During examination a consistory clause was added to the specification which mirrored the language of claim 1. However, at [94] the Delegate held that this did not contribute to enablement:

"The mere presence of a consistory clause that mirrors the language of Claim 1 does not address this deficiency. As noted in Regeneron the technical contribution to the art is the product which is enabled by the disclosure, in this case compositions containing specific milk components (including casein), and not the invention itself (or the idea), as set out here in the claims and in the consistory clause."

Insufficiency: Fonterra argued that in order to make anything within the scope of the claims process steps which are not disclosed in the specification and are not part of the common general knowledge needed to be developed. In particular, the products rely on the use of PD cream as a base, but there is no discussion of this base product in the specification, and the examples neither use nor result in a product like the PD cream. The Delegate agreed, finding that the specification provides no guidance, or even a suggestion, that α-lactalbumin and/or β-lactoglobulin could be used as a replacement for casein and would provide the structure, texture, mouthfeel and aggregation properties traditionally attributed to casein. In order to work the invention research involving trial and error would be required to the extent that it would constitute an undue burden on the person skilled in the art.

Inutility: Fonterra also argued that a composition that includes only one (or less than all) characteristics of a dairy food product would not meet the promise made, and that some of the food compositions falling within the scope of the opposed application would not fulfil the promise made. While the Delegate had similar concerns it was held that Fonterra had not provided sufficient evidence to substantiate those allegations.

Conclusion: The Delegate found the application’s claims to lack support and that the disclosure was insufficient for a skilled person to work the claimed invention without undue effort. The Delegate allowed the applicant 2-months to make amendments, but expressed doubt that suitable amendments would now be possible.

Author: Quinn Miller

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