Cargill Incorporated v Dow AgroSciences LLC

[2016] APO 43

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43

Patent Application:                   2005294298

Title:Oil and seeds with reduced saturate levels of fatty acids

Patent Applicant:  Dow AgroSciences LLC

Opponent:  Cargill Incorporated

Delegate:  Dr B. Akhurst

Decision Date:  5 July 2016

Hearing Date:  11 February 2016, with further submissions filed on 25 February 2016, 8 March 2016 and 30 March 2016.

Catchwords:  PATENTS – section 59 opposition to grant of a patent – manner of manufacture – whether a nucleic acid is a manner of manufacture considered – novelty – whether claims include arbitrary features – inventive step – whether broadly drafted method claims are obvious – useful – lack of utility not established – clarity – whether claims defining canola plants that produce as little as 1-100 seeds having a specified oil fraction provide a workable standard suitable to the intended use – lack of clarity established – fair basis – lack of fair basing not established

Representation:  Senior Counsel for the applicant: Craig Smith.

Patent attorney for the applicant:  Tom Gumley of Freehills.

Senior Counsel for the opponent:  Katrina Howard.

Patent attorney for the opponent:  Grant Shoebridge of Shelston IP.

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2005294298

Title:Oil and seeds with reduced saturate levels of fatty acids

Patent Applicant:  Dow AgroSciences LLC

Date of Decision:  5 July 2016

DECISION

Claims 27-29, 31 and 39-40 lack an inventive step.  Claims 1-8 lack clarity.

Dow AgroSciences LLC has 2 months from the date of this decision to propose amendments to overcome these deficiencies.

I award costs according to Schedule 8 against Dow AgroSciences LLC.

REASONS FOR DECISION

Background

1. Dow AgroSciences LLC (Dow) filed patent application 2005294298 on 7 October 2005, via the PCT, claiming priority from US application 60/617,532 filed on 8 October 2004.  Following examination, the application was advertised as accepted on 16 February 2002. 

2. Cargill Incorporated (Cargill) filed a notice of opposition on 16 May 2012 and a statement of grounds and particulars (SGP) on 16 August 2012.  During the evidentiary process, Dow on several occasions proposed amendments to claims.  Those filed on 29 August 2014, were allowed unopposed on 9 January 2015.  After extensions of time were granted to file evidence, and stays to the evidentiary process pending consideration of the amendment requests, evidence in support, answer and reply was completed on 17 May 2013, 7 February 2014 and 9 February 2015, respectively. 

3. The matter was heard on 11 February 2016 at Freehills premises in Sydney.  A request by Cargill at the hearing, to amend the SGP to update the particulars of the opposition, was allowed on 11 March 2016.  In the interests of procedural fairness I allowed the parties a period of time after the hearing to file submissions addressing matters first raised at the hearing, which I confirmed in a letter to the parties on 17 February 2016.  Dow filed its submissions on 25 February 2016. Cargill’s responding submissions appear in the last 5 paragraphs of its letter dated 8 March 2016.

4. On 29 February 2016, although it had not been raised by the opponent, I invited the parties to provide submissions as to the application of the principles in D’Arcy v Myriad Genetics Inc [2015] HCA 35 to a claim in the specification. Dow filed submissions on 29 March 2016.

5. On 15 February 2016, Cargill filed a request for further evidence for matter in its evidence in reply which, because it addressed the amended claims, was not strictly in reply.  This request was granted on 11 March 2016 after which Dow was provided with a month in which to file responding evidence.  No responding evidence was filed and on 12 April 2016, the parties were advised that the hearing was finished. 

   The Evidence

6. Evidence in support consisted of a declaration by:

   • David M. Stalker dated 15 May 2013 (DS#1) with Exhibits DS-1 to DS-9

7. Evidence in answer consisted of declarations by:

   • Richard Keith Downey dated 4 February 2014 (KD) with Exhibits KD-1 to KD-3
   • Jack Brown dated 6 February 2014 (JB) and Exhibits JB1 and JB2

8. Evidence in reply consisted of a declaration by:

   • David M. Stalker dated 5 February 2015 (DS#2) with Exhibits DS-10

9. Further evidence consisted of pages 34-36 of DS#2.

   Grounds of opposition

10. The grounds of opposition were manner of manufacture, novelty, inventive step, utility and section 40 issues.  Cargill advised at the hearing that it no longer pressed the ground of full description. 

    Onus of Proof

11. The request for examination in relation to the patent application was filed on 21 January 2008.  As a consequence, the substantive amendments of the Patents Act1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application.  This includes the amendment to subsection 60(3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition has been made out.  Instead, the onus of proof in this opposition proceeding lies with the opponent, who must establish that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; 79 IPR 426).

    The specification

12. The specification is titled “Oil and seeds with reduced saturate levels of fatty acids”.  On page 1, while vegetable-derived oils have gradually replaced animal-derived oils and fats as the major source of dietary fat intake, saturated fats have remained at about 15-20% of total calorific intake.  Recent recommendations in the US are that saturated fats should be less than 10% of daily calorific intake, and labelling guidelines require plant oils to contain less than 7% or 3.5% by weight of combined saturated fatty acids (with respect to the total amount of fatty acids) to receive a “low saturates” or “no saturates” label, respectively (paras 2 and 3).      

13. At para 3, the characteristics of oils are determined predominately by the number of carbon and hydrogen atoms, as well as the number and position of double bonds comprising the fatty acid chain.  Fatty acid molecules may be represented as (C:D) where C is the number of carbons and D the number of double bonds.  Most oils derived from plants are composed of varying amounts of palmitic (16:0), stearic (18:0), oleic (18:1), linoleic (18:2) and linolenic (18:3) fatty acids.  Conventionally, a fatty acid is “saturated” when its carbon chain contains the maximal number of hydrogen atoms possible with no double bonds - e.g. palmitic and stearic acids.  Mono-unsaturated fatty acids have one double bond e.g. oleic acid, whereas poly-unsaturated fatty acids contain two or more double bonds e.g. linoleic and linolenic acids.  (para 3 of the specification)

14. The specification notes the established health value of monounsaturates, particularly oleic acid, as the major dietary fat constituent (para 5).  Accordingly, at para 5 the specification identifies a need in the art for an edible vegetable oil having a high content of monounsaturates. 

15. Canola oil has the lowest level of saturated fatty acids of all vegetable oils (para 7).  Modification of vegetable oils may be effected chemically (para 8), but typically the fatty acid composition has been modified through traditional breeding techniques by uncovering and selecting for naturally-occurring or induced mutations in the plant genome that affect fatty acid composition, in conjunction with subsequent breeding (paras 9-10).  However, such techniques generally rely on modification or inactivation of genes already present, and the introduction of a new characteristic through mutagenesis often depends on the loss of some trait already present (para 10).  While a few fatty acid modifications have been achieved using mutagenesis, its use to affect such changes is essentially random and non-specific (para 10).

16. At para 11, the specification states:

    “The possibility of modifying fatty acid composition through the use of genetic engineering would, in theory, allow the precise, controlled introduction of specific desirable genes, as well as the inactivation of specific undesirable genes or gene products.  Thus, novel traits completely independent of genes already present could be introduced into plants, or preselected genes could be inactivated or modified.  However, one predicate to making effective use of genetic engineering to modify fatty acid compositions is a reasonably accurate model of the mechanisms at work in the plant cell regulating fatty acid synthesis and processing.”

17. Between paras 13-16, the specification describes the process of fatty acid synthesis in oilseeds.  Fatty acid synthesis is initially carried out in the plastid with the major products being palmitic acid (16:0), stearic acid (18:0) and oleic acid (18:1), this last as a result of efficient desaturation by a delta-9 desaturase enzyme (paras 14-15).  Subsequent desaturation of plant fatty acids occurs in the cytoplasm of the cell and is limited to the desaturation of oleic acid (18:1) to linoleic acid (18:2) and linolenic acid (18:3) (para 16).  Oleic acid may also be elongated to 20:1, 22:1 and 24:1 monounsaturated fatty acids (para 16).  These fatty acids, along with the saturated fatty acids palmitic acid and stearic acid, may then be assembled into triglycerides (para 16).

18. At para 17, the plant and yeast delta-9 desaturases differ in their location in the cell and their substrate specificity.  At para 34, the specification discloses that the ability of delta-9 desaturase genes to significantly (and desirably) affect the fatty acid profile of already-beneficial oil seed crops, particularly to decrease the levels of saturated fats without adversely affecting other aspects of the plant and oil, is unpredictable.  At para 51, the specification discloses that the A. nidulans delta-9 desaturase enzyme reduces the levels of saturated fatty acids, with little or no increases in linoleic and linolenic acids, or even reductions in these polyunsaturates in some cases. 

    The claims

19. There are 40 claims in the opposed specification.  Claims 1, 2, 11, 15, 27 and 31 are independent.  Claims 32- 40 are omnibus claims defining the subject matter of the earlier claims by reference to the description.

20. The principles to be applied in construing the claims are well settled in law and were summarised by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 [118]-[120]. Most relevantly, the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification, including the claims, are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification. While the claims define the monopoly claimed in the words of the patentee’s choosing, the specification should be read as a whole. It is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification. However, terms in the claims which are unclear may be defined or clarified by reference to the body of the specification. The construction of a specification, including the claims, is ultimately a question of law for the Court.

21. Claims 1-5 define a canola plant in terms of the oil fraction of the seed it produces. 

    1.A canola plant that produces seed having an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

    2.A canola plant that produces seed having an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates, wherein at least 8 seeds of the plant each have an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

    3. The canola plant of claim 2, wherein at least 10 seeds of the plant each have an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

    4.The canola plant of claim 3, wherein at least 30 seeds of the plant each have an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

    5.The canola plant of claim 4, wherein at least 100 seeds of the plant each have an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

22. For the reasons provided below, I construe claim 1 to encompass a canola plant that produces one or more seed(s) having the specified oil fraction.  Claims 2-5 explicitly define the minimum number of seeds of the plant which are required to have the specified oil fraction.

23. In its plain meaning, “seed” means one seed or multiple seeds (Macquarie Dictionary Revised Edition 1985).  My construction of claim 1 is consistent with Dr Stalker’s initial construction of accepted claim 1 (to a “canola plant that produces seed having” specified percentages of saturates and oleic acid) as referring to one seed or multiple seeds having the required oil fraction (#1 [84]).  It is also consistent with the construction he proposes for amended claims 2-5, discussed below. 

24. In his reply evidence at #2 [78]-[79], Dr Stalker reconsiders his construction and agrees with Dr Downey’s view [81], that accepted claim 1 refers to multiple seeds having the specified oil fraction based on the plain meaning of “seed” and the commercial application of canola plants as a source of seeds from which oil is derived.  On this basis, Dr Stalker construed accepted claim 1 to mean that although the plant “could include seed with an oil fraction that potentially falls outside the lipid profile” specified in the claim, he nevertheless construes the lipid profile in claim 1 as “representative of the oil that would be produced” from the plant (DS#1 [78]), rather than individual seeds.  Consistent with his construction of accepted claim 1, Dr Stalker construes amended claim 1 as defining the seed oil fraction produced by the plant (DS#2 at [144]).

25. Dr Stalker provides two possible constructions for new claims 2-5.  The first, having regard to the commercial application of a canola plant, is that the canola plant defined in the claim has the specified number of seeds with the defined lipid profile and the lipid profile is representative of the oil produced by the plant (DS#2 [144]).  Dr Stalker’s alternative construction of claim 2-5 is that the plants have the number of seeds defined in the claims with the specified lipid profile, however due to seed-to-seed variability the plant may not produce oil having the oil fractions specified in the claims (DS#2 [145]). 

26. I am not satisfied that amended claim 1 should be construed without regard to the subsequent references in claims 2-5 to a specified number of seeds.  Consistent with Dr Stalker’s alternative construction, I construe amended claims 2-5 as explicitly defining the minimum number of seeds of the plant which “each” have the specified oil fraction.  Construed in the context of claims 2-5, it is reasonable to apply the broader meaning of “seed” to claim 1, such that it encompasses one or more seeds, but not necessarily all seeds from the plant having the required oil fraction.  This construction is consistent with Dr Stalker’s original construction of the relevantly similar accepted claim 1 (#1 [84]).  It is also consistent with claim 27 which explicitly recites a method for reducing saturated fat in the oil fraction of “at least one seed” of a transgenic canola in comparison to wild-type.

27. Claims 6-8 add further limitations to the the oil fraction of the seeds.

    6.The plant of any one of the preceding claims wherein said oil fraction comprises no more than 3% linolenic acid.

    7.The plant of any one of the preceding claims wherein said oil fraction comprises no more than 3.5% linolenic acid.

    8.The plant of any one of the preceding claims wherein said oil fraction has no more than 2.7% total saturates.

28. Claims 9-10 relate to the seed of the canola plant.  Applying the plain meaning of “seed”, claims 9-10 define one seed, or many seeds, having the specified oil fraction. 

    9.Seed produced by the canola plant of any one of claims 1 to 8, the seed having an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

    10.The canola seed of claim 9 having an oil fraction comprising no more than 2.7% total saturates.

29. Claims 11-14 relate to canola oil and its use in fried food.  The oil of claim 11 is “non-chemically modified”, which in its plain meaning means the claimed oil is modified, but modification took place without the use of chemicals.  This construction is consistent with Dr Stalker’s evidence that non-chemically modified oil means “oil not including an exogenous chemical component or a chemical treatment to attain the target profile” (#1 [96]), #2 [146])

    11.Canola oil comprising less than 3.5% total saturates, less than 80% oleic acid and less than 20% total polyunsaturates, wherein said oil is non-chemically modified.

    12.The canola oil of claim 11 having an oil fraction comprising no more than 2.7% total saturates.

    13.A fried food composition comprising potato material and canola oil according to claim 11 or 12.

    14.A method of producing a fried food composition wherein said method comprises frying potato material in canola oil according to claim 11 or 12.

30. Claims 15-24 each define a genetically-modified canola plant.  Claim 15 refers to a polynucleotide defined in terms of its ability to hybridise, under specified conditions, with the full complement of a nucleic acid molecule (i.e. the entire contiguous polynucleotide) encoding an enzyme (a type of protein) represented by SEQ ID NO: 5 (DS#1 [101]).  This enzyme is the Aspergillus nidulans delta-9-CoA desaturase (A. nidulans delta-9 desaturase) (see paras [45], [49] and [51] of the specification).  Commenting on the same hybridisation conditions in accepted claim 12, Dr Stalker considers them low stringency such that the polynucleotide would encompass “a number of known desaturase genes” (#1 [103]-[104]). 

    15.A canola plant comprising at least one polynucleotide, stably incorporated in a genome of said plant, that encodes a delta-9 desaturase protein wherein the full complement of a nucleic acid molecule that encodes a protein of SEQ ID NO:5 maintains hybridization, after wash, with said polynucleotide, wherein said wash conditions are 2x SSC (Standard Saline Citrate) and 0.1 % SDS (Sodium Dodecyl Sulfate) for 15 minutes at room temperature, wherein said plant produces seed having an oil fraction comprising less than 3.5% total saturates and less than 80% oleic acid.

    16.The plant of claim 15, wherein said oil fraction has less than 20% total polyunsaturates.

    17.The plant of claim 15 or claim 16 comprising at least two of said polynucleotides.

    18.The plant of claim 15 or claim 16 wherein said nucleic acid molecule comprises SEQ ID NO: l.

    19.The plant of any one of claims 15 to 18 wherein said wash conditions are 0.1x SSC and 0.1% SDS for 15 minutes at room temperature.

    20.The plant of claim 19 wherein said wash conditions are 0.1x SSC and 0.1 % SDS for 30 minutes at 55° C.

    21.The plant of claim 15 or claim 16 wherein said genome comprises two of said polynucleotides.

    22.The plant of claim 15 or claim 16 wherein said genome comprises three of said polynucleotides.

    23.The plant of claim 15 or claim 16 wherein said polynucleotide is operably linked to a seed-specific promoter.

    24.The plant of any one of claims 1 to 8 or 15 to 24 wherein said plant is at least 100 cm in height with an average seed weight above 3 mg.

1. Claim 25 defines a seed produced by the plant of claims 15-24.  Applying the dictionary at para [106] of the specification “a” seed signifies “at least one” seed.  

   25.A seed produced by the plant of any one of claims 15 to claim 24 the seed having an oil fraction comprising less than 3.5% total saturates, 70% to 78% oleic acid and less than 20% total polyunsaturates.

2. Claim 26 defines a plant produced by the seed of specified earlier claims.

   26.A plant produced by the seed of any one of claims 9, 10 or 25.

3. Claims 27-30 recite a method of reducing the saturated fat in the oil fraction of canola seed(s) by transgenic means.  SEQ ID NO: 1 represents the nucleic acid sequence of the open reading frame of the gene encoding the plant-optimised A. nidulans delta-9 desaturase (paras 45 and 51 of the specification). 

   27.A method of reducing saturated fat in the oil fraction of at least one seed of a transgenic canola plant, as compared to a wild-type oil fraction of seeds of a corresponding wild-type canola plant, wherein said method comprises producing a canola plant that expresses a polynucleotide that encodes a delta-9 desaturase protein wherein a nucleotide molecule that encodes said protein hybridizes with the molecule of SEQ ID NO: 1.

   28.The method of claim 27 wherein the oil fraction comprises less than 80% oleic acid.

   29.The method of claim 27 or 28 wherein said protein causes a reduction in palmitic acid (16:0), a reduction in behenic acid (22:0), and an increase in palmitoleic acid (16:1) in the oil fraction of said seed of said transgenic canola plant relative to said corresponding wild-type canola plant.

   30.The method of any one of claims 27 to 29 wherein said saturated fat is reduced by at least 60%.

4. Claim 31 defines a polynucleotide comprising the nucleic acid sequence of the open reading frame for the plant-optimized, delta-9 desaturase gene as represented by SEQ ID NO: 1 (para 45 of the description).

   31.A polynucleotide comprising a sequence of nucleotides shown in SEQ ID NO: 1.

5. Claims 32-40 define the subject matter of the earlier claims by reference to the description.

   32.A canola plant according to claim 1, substantially as hereinbefore described.

   33.A seed according to claim 9, substantially as hereinbefore described.

   34.Canola oil according to claim 11 or 12, substantially as hereinbefore described.

   35.A fried food composition according to claim 13, substantially as hereinbefore described.

   36.A method according to claim 14, substantially as hereinbefore described.

   37.A canola plant according to claim 15, substantially as hereinbefore described.

   38.A seed according to claim 25, substantially as hereinbefore described.

   39.A method according to claim 27, substantially as hereinbefore described.

   40.A polynucleotide according to claim 31, substantially as hereinbefore described.

   Manner of Manufacture

6. Paragraph 18(1)(a) of the Act requires that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. In D’Arcy v Myriad Genetics Inc (Myriad) [2015] HCA 35, (2015) 89 ALJR 924 at [18] the High Court confirmed that the question posed by the application of s 18(1)(a) may be framed as in National Research Development Corporation (NRDC) [1959] HCA 67 at [14] and [25]; 102 CLR 252 at 269:

   “Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?”

7. In Myriad at [28], the High Court cautioned that while it is necessary for a claimed invention to be an artificially-created state of affairs in a field of economic endeavour in accordance with the principles in NRDC, this is not alone sufficient when a new class of claim involves a significant new application or extension of the concept of manner of manufacture. 

   Myriad considerations

8. Cargill submitted that claims 1 to 12 do not define a manner of manufacture because they do not meet the criteria set out by the High Court in Myriad. 

9. Claim 31 of Dow’s specification defines a polynucleotide sequence.  Although claim 31 was not opposed by Cargill under the manner of manufacture ground, I invited the parties to provide submissions on this claim in light of the High Court’s findings in Myriad with respect to claims to nucleic acids.  Only Dow provided submissions.

10. I will consider claim 31 first, followed by claims 1-12.

    Claim 31

11. In Myriad at [37], the High Court made it clear that it was not concerned with “gene patenting” generally but only with three claims encompassing isolated nucleic acids coding for a mutant or polymorphic BRCA1 polypeptide where the claimed class of nucleic acids was broadly defined in terms of it containing one or more of a large number of specified mutations or polymorphisms (sequence variations) in comparison to the coding sequence for the BRCA1 polypeptide represented by SEQ ID NO: 1. The majority found at [89]-[92] that although the claims were formulated as product claims, the substance of the claims to nucleic acids was the genetic information embodied in, and conveyed by, the nucleic acid sequence. The High Court found that the genetic information was naturally-occurring and had not been “made” by human action and, as a consequence, the claims did not define a manner of manufacture (at [91], [95]).

12. Claim 31 of the opposed application defines a polynucleotide comprising the sequence of nucleotides shown in SEQ ID NO: 1.  In accordance with the principles in Myriad, the substance of claim 31 is the genetic information embodied in, and conveyed by, the nucleic acid sequence. 

13. Relevant to the question of whether the substance of claim 31 was made, SEQ ID NO: 1 represents a nucleic acid sequence that codes for a delta-9 desaturase gene derived from the fungus A. nidulans, which has been codon-optimised for efficient expression of the protein in plants (para 79 of the specification; DS#1 [120]; and consistent with DS#2 at [47], [62]).  Dow submitted that the codon-optimisation is an important man-made variation to the naturally occurring sequence, notwithstanding that the coding regions may code for the same protein. 

14. Claim 31 defines a nucleic acid, SEQ ID NO: 1, in which the inventors have altered codons (nucleotide triplets) to facilitate optimal production of the fungal delta-9 desaturase protein by the protein assembly system in plant cells.  Although SEQ ID NO: 1 codes for the same protein as the naturally-occurring fungal sequence, the fact that it is codon-optimised can be expected to enhance production of the protein in plants, above that which could be expected from the naturally-occurring sequence (consistent with para 79 of the specification and DS#1 at [47]).  In this regard, the genetic information has been modified, unlike the situation in Myriad.  I am satisfied that the information embodied in claim 31 has been made. 

15. The economic utility of the claimed polynucleotide in altering the levels of saturated fats in canola plants, seeds and oils is clear.  Thus, I am satisfied that claim 31 defines an invention that is a manner of manufacture.

    Claims 1-12

16. Cargill submitted that the following circumstances support its view that claims 1 to 12 should be rejected as not being to patentable subject matter in accordance with the principles in Myriad:

    (i)    Claims 1-12 are not limited to transgenic plants or seeds, or oils produced from such plants or seeds, they include plants, seeds and oils created by any means.  

    (ii)   Claims 1-12 are also highly likely to include plants and seeds that are naturally occurring, given that in claims 2-5 only from 8 to 100 seeds on a plant are required to have the specific fatty acid profile.  

    (iii)   The claims also include plants or seeds that are yet to be discovered, identified or created.  

    (iv)  The grant of a patent with respect to such plants or seeds could prevent or hinder research and development of plants for the production of low fat oils, contrary to the public interest. 

17. With respect to submission (i), Dow argued that Cargill’s proposition is entirely speculative, and is contradicted by the fact that Cargill as an established participant in the canola plant industry has not identified such a plant, that would otherwise anticipate the claim.  Regarding (ii) and (iii), Dow argued that identical submissions could be made in respect of any product claim to a new chemical compound - it is at least possible that it already existed in nature - however that it is incumbent on a person challenging the validity of a patent on this basis to do more than merely speculate, they must prove that the relevant claim lacks novelty. 

18. Regarding submission (iv), Dow argued that Cargill seeks to elevate a single factor that was considered by the High Court in Myriad as being relevant to whether there is patentable subject matter, and advance it as a sufficient criterion for establishing lack of patentable subject matter. It argued that every patent has the potential to prevent or hinder research and there is no evidence advanced to support the proposition in relation to the present claims.

19. I agree with Dow that Cargill’s submissions under this ground do not establish that claims 1-12 are not for a manner of manufacture.  However, Cargill’s submissions highlight the broader question of the patentability of claims to plants, seeds and oils insofar as they might be considered a “new class of claim”.  Relevantly, in Grain Pool of Western Australia v The Commonwealth [2000] HCA 14 at [46], (2000) 202 CLR 479 at [46], the High Court confirmed that “there is no intrinsic impediment to the patentability of plant varieties”. It is reasonable to conclude that this would extend to seeds of the plant which are, in effect, the plant in an embryonic state. Regarding the oils encompassed by claims 11-12, I have no reason to believe that this subject matter is anywhere near the boundaries of patentability.

20. Cargill has not established that claims 1-12 do not define a manner of manufacture in accordance with the principles provided in Myriad.

    Claims 1-10

21. Cargill separately submitted that claims 1 to 10 are not to patentable subject matter because they include an indeterminate class of plants and seeds and oils produced therefrom, because it is only necessary that between one and one hundred seeds have the required fatty acid profile.  However, Myriad at [66]-[67] that Cargill relies on does not support finding these claims are not for a manner of manufacture on this basis alone, and consequently this argument must fail.

    New use of an old substance

22. The threshold requirement for a patentable invention is that it must not be apparent on the face of the specification that the claimed invention lacks the necessary quality of inventiveness for it to be a proper subject of letters patent under the Statute of Monopolies (NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 [9]; (1995) 183 CLR 655).

23. Cargill’s submissions relied on the statement of principle in Commissioner of Patents v Microcell Ltd (Microcell) [1959] HCA 71 at [15]; (1959) 102 CLR 232 at 251:

    “We have in truth nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable. A claim for nothing more than that cannot be subject matter for a patent, and the position cannot be affected either by the fact that nobody thought of doing the thing before, or by the fact that, when somebody did think of doing it, it was found to be a good thing to do.”

24. Cargill submitted that the opposed specification acknowledges that it was known to be desirable to achieve oils with low saturated fats; canola plants were known to produce low sat oil; high levels of oleic acids were known to be desirable; transgenic methods to achieve oils with desired characteristics were known; and transformation of plants with Aspergillus delta-9 desaturase was known.  It noted that Dow’s earlier application WO 99/50430 was explicitly incorporated by reference into the opposed specification and that it suggested the use of these methods in canola.  Cargill argued that these known transgenic methods had known properties that made them suitable for use to achieve the production of canola plants that produced seeds and oils with an improved fatty acid profile, in particular, a reduction in total saturates.  On this basis, Cargill concluded that on the face of the specification (which includes the contents of WO 99/50430) there is no invention.

25. Dow argued that Cargill seeks to conflate statements in the application about what was known with common general knowledge; and in addition seeks to infer admissions as to knowledge of a relevant problem, and the taking of obvious steps to achieve something within the scope of each claim.  I agree.  It appears that Cargill relies on the Aspergillus delta-9 desaturase gene and similar nucleic acid sequences being known substances.  However, Microcell refers to the “known material” as “well-known” and the properties as “known generally” (HCA at [13]; CLR at 250), which appears to suggest more is required than it being merely public knowledge. Cargill has not established that the Aspergillus desaturase is well known in the art, or that it is made so by the reference to WO 99/50430 in the opposed specification.  Furthermore, Cargill’s submissions do not establish that the plant, seed and oil products specified in Dow’s claims can be characterised as “known articles”.  As a consequence, I am not satisfied that the claims relate to the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable.

    Manner of manufacture summary

26. The claims define a manner of manufacture.

    Novelty

27. Paragraph 18(1)(b)(i) of the Act provides that an invention, so far as claimed in any claim, must be novel. It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aicken J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 [20]; (1977) 137 CLR 228 at 235:

    “The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”

28. This test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40 [19]; (1990) 91 ALR 513 at 517). To meet this requirement, the prior art must contain “clear and unmistakable directions” to the claimed invention (Bristol-Myers Squibb Co v F H Faulding & Co Ltd [2000] FCA 316 [66] referring to the decision of the UK Court of appeal in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457 at 486).

29. Cargill relied on two prior art documents to establish lack of novelty:

    US 4948811 (Spinner et al.) 14 August 1990 (US’811)

    US 5387758 (Wong, R.S. C. et al.) 7 February 1995 (US’758)

30. The 8 October 2004 priority date was not in dispute.  These documents form part of the prior art base in this opposition.

    Parametritis

31. Cargill’s case for lack of novelty (and inventive step) was based on the feature of “less than 20% total polyunsaturates” in the seed oil fraction or canola oil being an inessential feature of the claims.  Prima facie the presence of this feature in the claims renders it an essential feature of the claimed invention (consistent with Catnic Components v Hill & Smith Ltd [1982] RPC 183 at 228). Nevertheless, Cargill considered it irrelevant to the invention, arguing that nothing in the specification suggests that less than (<) 20% polyunsaturates is part of the inventive step or the invention other than a “throw-away comment” at paragraph 85 about it being preferred.  On this basis, Cargill submitted that the references in the claims to <20% total polyunsaturates can be disregarded for the purposes of novelty (and inventive step) because it is merely an arbitrary parameter, i.e. “parameteritis”, as in Raychem Corp’s Patents (Raychem) [1997] EWHC 372; [1998] RPC 31 at 37 and Williams Advanced Materials Inc v Target Technology Co LLC (Williams) [2004] FCA 1405; (2004) 63 IPR 645.

32. To support its submissions, Cargill drew my attention to Euroceltique S.A. v Sandoz Pty Ltd [2009] APO 21, in which the delegate reviewed and applied the relevant authorities with respect to “parameteritis” in a claim, including Raychem and Williams.  The delegate concluded at [112] that in a case of potential parameteritis, the question to be asked is whether the parameters in a claim “have been chosen to achieve a technical effect, or whether they are an arbitrary convenience”?  Cargill submitted that if <20% polyunsaturates has a technical effect it is the promise of oxidative stability in the oil, but that only some polyunsaturates achieve this, not all.  Relying on Dr Stalker’s evidence (#1 [40]), Cargill argued that linolenic acid is the most relevant to oxidative stability, but the feature of <20% polyunsaturates encompasses low linoleic acid with no reduction in linolenic acid. 

33. The opposed specification para [85] describes oils with <20% polyunsaturated fatty acids as a preferred embodiment.  The production of a canola plant having a seed oil fraction with, among other things, <20% polyunsaturates was a well-known and desired goal in the oil seed community (DS#2 [137]).  In the context of the opposed specification, Dr Brown refers to polyunsaturates at about 20% or less as a “useful level” ([23]).  I conclude from this evidence the requirement in the claims for <20% polyunsaturates in the seed oil fraction of canola plants, seeds and oil, contributes to a technical effect, rather than it being an arbitrary convenience.  It follows that where this feature appears in the claims, it must be disclosed by the prior art for the claims to lack novelty.

    US’811

34. US’811 is in evidence as Exhibit DS-3 and is titled “Salad/cooking oil balanced for health benefits”.  In order to reduce saturated fat intake in a diet, US’811 describes an oil with reduced total saturated fatty acids obtained by chromatographically fractionating fatty acids in canola oil and remixing the fractions at desired concentrations to produce an oil with the desired fatty acid profile (DS#1 [43]-[45] DS#2 [16]; consistent with Downey [31]). 

35. Relying on Dr Stalker’s evidence, Cargill submitted that US’811 discloses all of the features of the claims with the exception of a seed oil fraction or canola oil comprising <20% polyunsaturates.  I have found above that where this feature appears in the claims it is essential to the invention.  It follows that claims 1-14, 16 and 25, and claims 17-24 insofar as they require <20% polyunsaturates, are not anticipated by US’811. 

36. Cargill made no submissions relevant to the novelty of the other claims in light of US’811.  On review of the document, US’811 does not disclose transgenic canola plants or the associated matter in Dow’s additional claims and, as a consequence, Cargill has not established that any claim lacks novelty over US’811.

    US’758

37. US’758 is in evidence as Exhibit DS-4.  It is titled “Production of improved rapeseed exhibiting a reduced saturated fatty acid content” and describes the production of a canola variety with a low level of total saturated fatty acids by mutagenesis of Brassica seeds followed by selection of plants exhibiting a desired low total saturated fatty acid profile (DS#1 [46]).

38. Cargill relied on Dr Stalker’s evidence to establish lack of novelty in light of US’758.  In the context of the accepted claims, Dr Stalker summarised US’758 as disclosing a plant that produces a seed - identified in Table H as D-98-49-176-193 M4 cotyledon - having a total level of saturated fatty acids of 3.15% and an oleic acid level of 62% (#1 [84]).  Relevant to the amended claims, Table H establishes that this seed contains the polyunsaturates linoleic and alpha-linolenic acids in an amount above 32% of the total fatty acid content (consistent with KD [37]).  

1. Dr Downey concludes at [39] that none of the bulk seed or half seed analyses described in Tables G and H of US’758 show a seed having <20% polyunsaturates or oleic acid levels of 70% or greater, and that no transgenic methodologies are disclosed.  Dr Stalker does not dispute this conclusion.  Since key features of Dow’s claims are not disclosed by US’758, this document does not anticipate any claim of the opposed specification.  I find the claims novel in light of US’758.

   Novelty summary

2. The claims are novel in light of the cited prior art.

   Inventive Step

3. Paragraph 18(1)(b)(ii) of the Act provides that an invention, so far as claimed in any claim, must involve an inventive step when compared with the prior art base. Under the provisions of subsections 7(2) and 7(3) of the Patents Act 1990, an invention is taken to involve an inventive step when compared with the prior art base unless it would have been obvious to a person skilled in the art.  ‘Obvious’ means ‘very plain’ (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21 [51] - [52]; (2007) 72 IPR 447 at 461 [51] - [52]). The invention must be obvious in the light of the common general knowledge as it existed in the patent area before the priority date, either on its own or together with information in a document, or combination of documents, that the person skilled in the art could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant and, where necessary, combined.

4. The test for obviousness was provided by Justice Aicken in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 [45]; 148 CLR 262 at 286 as follows:

   “The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”

5. The High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd (Alphapharm) [2002] HCA 59 [51]- [53]; 212 CLR 411 [51]-[53] approved this approach, in addition to that taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had posed the 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 invention] in the expectation that it might well produce a useful [desired result]?”

6. Both approaches require that the person skilled in the art has a reasonable expectation of success, which is explicit in the expectation that an approach “might well” succeed and implicit in steps characterised as routine and to be tried as a matter of course (Generic Health Pty Ltd v Bayer Pharma Aktiengessellscaft [2014] FCAFC 73 at [71]). The reasonable expectation does not require a guarantee of success and includes some possibility that the steps taken will not achieve the intended result (Alphapharm at [74], [76]). A test for obviousness formulated in terms of “worthwhile to try” was rejected by the High Court in Alphapharm at [72].

7. The usual approach to determining inventive step is the problem-solution approach.  Once the problem has been formulated and the common general knowledge and the prior art base has been determined, the question of whether the claimed solution is obvious must be addressed.

   The person skilled in the art

8. The notional “person skilled in the art” is an artificial construct that is used as a tool of analysis “which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step” (AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23], (2015) 89 ALJR 798 at [23]). In general, the skilled person or addressee is the person who works in the art or science with which the invention is connected. He or she is a person, or team, likely to have a practical interest in the subject matter of the invention. While the skilled person may be assumed to be well-versed in the relevant art, such a person must be taken to be non-inventive. (Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 [71] - [72]; 49 IPR 225 [71] - [72] referring to Catnic Components Ltd v Hill &Smith Ltd [1982] RPC 183 at 242 and General Tire [1972] RPC 457 at 485; Minnesota Mining and Manufacturing Company and Another v Beiersdorf (Australia) Limited (Minnesota Mining) [1980] HCA 9 [115]; 144 CLR 253 at 293).

9. The art or science to which the present invention relates is the provision of plants, seeds and edible oils with improved fatty acid profiles.  The expert evidence discussed below establishes that the notional person skilled in the art would possess knowledge and skills relevant to plant breeding and the genetic manipulation of plants in order to modify their characteristics to achieve a desired phenotype.

10. Dr Stalker gained a PhD in Cellular Biology and Biochemistry in 1977 (DS#1 [4]) and before the priority date, he worked in plant biotechnology projects using genetic modification of plants to achieve desired characteristics (DS#1 [5]-[6]).  As a Senior Scientist at Calgene (later Monsanto) between 1986-2000, Dr Stalker had responsibility for research into engineering of fatty acid pathways in oilseed crops and specifically canola.  Most relevantly, the canola research projects involved modifying the seed fatty acid profile of Brassica/canola oil to develop a canola variety which produced oil having saturated fats of 0.5% or less (DS#1 [6]-[7]), including using transgenic methodologies to manipulate expression of the fatty acid synthase enzymes, including desaturases, in canola plants (DS#1 [7], [12]).  Immediately before the priority date, between 2002 and 2005, Dr Stalker worked in a managerial role at a company responsible for the development of transgenic rice plants for the production of pharmaceutical proteins (DS#1 [9]). 

11. Dr Downey holds a PhD in plant breeding genetics; he has over 40 years experience in the canola industry and was the lead researcher in founding canola.  His research has led to major changes in the nutritional quality and customer acceptance of Brassica oils (KD [2], [6]-[7]).  Dr Downey was well aware of the use of canola and the research being conducted on canola in Australia in and before 2004, having conducted a review of the Brassica oilseed breeding programs in 1986 and as the editor of a book titled “Genetically modified canola in Australia” published by the Australian Oilseeds Federation in 2002 (KD [10]-[11]).  Dr Brown holds a PhD in plant breeding and genetics and, before the priority date, worked as an Associate then full Professor in the field of Plant, Soil and Entomological Sciences at the University of Idaho (Exhibit JB-1).  Dr Brown has extensive experience in breeding crop plants, including Brassicaceae oilseed crops, and has been breeding genetically superior canola and rapeseed cultivars in the USA for 22 years (JB [1]). 

12. Although all of the experts were based in America and Canada, at the priority date canola was widely grown and most of the scientists and technicians working around the world in canola would have had a similar level of knowledge (KD [13]).  Consistent with this field of art being global in nature, work conducted in Australia in the area of oil seed research, particularly canola research, was presented at international conferences, and Australian based research was published in international journals (KD [12]).  Both Dr Downey and Dr Stalker have been involved in the field in Australia (KD [10]-[11]; DS#1 [12]).

13. In summary, before the priority date, Dr Stalker had extensive experience using genetic modification of plants to achieve desired characteristics.  Dr Downey and Dr Brown were primarily involved in plant breeding and had extensive experience with canola.  Dr Downey also had an interest in genetic modification of canola.  Although the parties’ experts differ in their particular expertise and experience, I am satisfied that each of these experts has a practical interest in the subject matter of the invention and relevant experience such that their evidence is relevant to the skills and knowledge that can be attributed to the person skilled in the art in this opposition. 

    The problem or starting point

14. Cargill identified the problem addressed by the application as the development of a canola oil with an improved fatty acid profile.  Dow submitted that the evidence does not establish that there was a problem in the art before the priority date. 

15. At the hearing, Dow accepted that the desirability of canola oils with low saturated fats was known before the priority date.  The expert evidence establishes that it was common general knowledge before the priority date that lower saturated fats provided health benefits (DS#1 [18]-[19]) and that oleic and linolenic acid levels were important in applications such as frying which involve high temperatures (DS#1 [39]-[40]; KD [24]).  On balance, I consider a reasonable problem or starting point for inventive step purposes is the provision of a canola oil with a fatty acid profile that provides improved health and/or performance characteristics. 

    The common general knowledge in the art

16. A definition of common general knowledge was provided by Aitken J in Minnesota Mining [1980] HCA 9; 144 CLR 253 at 292:

    “The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade.  It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”

17. All of the experts provide evidence on what was generally known in the field of oil seed research before the priority date.  Much of Dr Stalker’s evidence in this regard is not disputed by Cargill’s experts.  Similarly, much of Dr Downey’s evidence was undisputed.  Considered as a whole, the expert evidence establishes that the following matters were common general knowledge in the art before the priority date:

    ·The levels of intake of saturated fats in humans impacted on health and potentially correlated with cardiovascular disease, and the potential benefits of a reduced intake of saturated fat had been known since the late 1950s.  Food labelling of processed foods in Western countries included an indication as to the type and levels of fats in the food, and it was well understood that foods cooked in oil containing no or low saturated fats were preferable for health reasons to food cooked in oil containing high levels of saturated fats. (DS#1 [18]-[19])

    ·Fatty acids comprise a hydrocarbon chain bound to carboxylic acid group.  The number of carbons can range from 4 up to 20 or 30.  Saturated fatty acids have no double bonds between the carbon atoms, while unsaturated fatty acids include at least one double bond between the carbon atoms in the hydrocarbon chain. (DS#1 [20])

    ·Canola oil is derived from the seeds of Brassica species having low levels of glucosinates and an erucic acid (21:1) content below 2% (DS#1 [21]).  Conventional canola oil normally contains the following approximate levels of fatty acids (DS#1 [22]):

Fatty Acid	% of total fatty acid content
Palmitic acid (16:0)	4-6%
Stearic acid (18:0)	2-4%
Oleic acid (18:1)	55-70%
Linoleic acid (18:2)	20-25%
alpha-Linolenic acid (18:3)	8-15%
C20 and C22 fatty acids	less than 2%
Total saturated fatty acids	approx. 6-8%

·Oleic acid has a carbon-carbon double bond at position 9 of the carbon chain.  Double bonds are present in linoleic acid at positions 9 and 12, and in alpha-linolenic acid at positions 9, 12 and 15 (DS#1 [23]).

·Canola oil can be used for a variety of purposes including food applications (e.g. salad dressing or cooking/frying), or for industrial purposes e.g. as lubricants (DS#1 [24]).  The levels of oleic and linolenic acids were known to be important in frying applications which involve high temperatures, in particular high oleic acid levels and a low linolenic acid level would exhibit greater stability at high temperatures (DS#1 [39]-[40]).  Oleic acid levels below 80% were known to be desirable for frying applications (DS#1 [40]; KD [24]).  Linoleic acid in the oil also contributes to polymerisation build-up on utensils when frying (KD [25]).

·The fatty acid content of oils, including canola oils, could be determined chromatographically (DS#1 [26]).  The oil for analysis could be derived from the cotyledon portion of a single oil seed, in a technique termed “half-seed analysis”.  Alternatively, “bulk seed analysis” is carried out by crushing a number of oil seeds and analysing the oil obtained (DS#1 [27]).  Half-seed analysis was considered a good indicator of the fatty acid levels in bulk seeds from a plant and was widely used in oil seed research (DS#1 [32]).  Nevertheless there may be variability in the oil composition of seeds from the same plant (KD [22]; consistent with DS#1 [28]-[31]).

·Synthesis and degradation of plant fatty acids were known to be interrelated.  Each step is under genetic control with individual genes coding for enzymes that increase carbon chain length or the degree of saturation in the carbon chain.  If a step in the chain is genetically blocked or enhanced the proportion of other fatty acids in the total fatty acid pool will be affected.  Thus, the fatty acid profile of a plant or seed is determined by multiple genes encoding various enzymes. (KD [20]-[21]; JB [5]-[7], [11]).

·A number of strategies were known which enabled canola researchers to produce canola plants exhibiting the desired phenotype including: mutagenesis using chemicals and radiation; cross-breeding; or transgenic manipulation (DS#1 [33]-[35]).  However, before the priority date the canola field did not use transgenic methodologies as commonly as researchers involved in preclinical development of therapeutics (KD [66]).  

·Genes routinely used to obtain a desired phenotype in a plant included those encoding fatty acid synthases (which catalyse the elongation of fatty acids) or fatty acid desaturases (which introduce a double bond into the carbon chain) (DS#1 [35]-[37]).  A number of desaturase enzymes were well known before the priority date.  These genes could be isolated from a number of sources including plants and microbial sources.  Delta-9 desaturases catalyse the formation of a double bond at position 9 in the hydrocarbon chain, and a delta 12-desaturase at position 12. (DS#1 [36]-[37]).

·Post-transcriptional gene silencing or alternatively co-suppression occurs when a number of copies of a gene are introduced into the plant genome, and this is more likely where the introduced gene is homologous to an endogenous plant gene (DS#1 [38]). 

The prior art base

1. Cargill relied on four documents to establish the inventive step ground.  These are:

   US 4948811 (Spinner et al.) 14 August 1990 (US’811)

   US 5387758 (Wong, R.S. C. et al.) 7 February 1995 (US’758)

   US 5965755 A (Serynk J. L. et al.) 12 October 1999 (US’755)

   WO 99/50430 A2 (Dow Agrosciences LLC) 7 October 1999 (WO’430)

   Ascertained, understood and regarded as relevant

2. “Ascertained” means discovered or found out (Commissioner of Patents v Emperor Sports Pty Ltd (Emperor Sports) [2006] FCAFC 26 [29]-[30], (2006) 67 IPR 488). “Understood” means that the person would have “comprehended” the information or “appreciated its meaning or import” (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (Lockwood (No 2)) [2007] HCA 21 at [132], (2007) 235 CLR 173 at 219 [132]). The person skilled in the art could be expected to have regarded a prior disclosure as relevant if it is directed to solving a particular problem or meeting a long-felt want or need as the patentee claims to have done (Lockwood (No 2) HCA [152], (2007) 235 ALR 202). The question of what a person skilled in the relevant art would regard as relevant, when faced with the same problem as the patentee, is to be determined on the evidence (Lockwood (No 2) at [153]).

3. Dow submitted that there is no evidence that the patent documents relied on by Cargill would have been ascertained.  However, subsection 7(3) does not require that it be established as a matter of fact that the documents would have been ascertained.  What must be determined is whether the person skilled in the art seeking information with which to provide a canola oil with a fatty acid profile that provides improved health and/or performance characteristics, could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant and, where necessary, combined, the documents.

4. Dow submitted that the skilled addressee would not look to the patent literature in accordance with the findings in Emperor Sports at [32]. However, the evidence establishes otherwise, for reasons that follow. The evidence of Dr Downey and Dr Brown establishes that it was difficult for canola researchers to keep abreast of all of the large volume of literature in the canola research field before the priority date (KD [14]; JB [18]). While they tend to be broadly read, Dr Downey is “yet to observe a canola researcher who reads every journal, or indeed every patent published on canola” (KD [14]). Dr Brown and Dr Downey did not routinely spend time reviewing patents before the priority date (JB [16]; KD [76]). In contrast, Dr Stalker did so, sourcing them from online patent databases including the USPTO and Esp@cenet sites (DS#1 [14]; DS#2 [131]). Dr Stalker believes that researchers from the oil seed community particularly those involved in the production of plants by transgenic methods would have been aware of, and reviewed, patent literature before the priority date (DS#2 [131]). I conclude from this evidence that some researchers read the patent literature while others, particularly those more involved in plant breeding, were less likely to do so. Since some canola researchers read the patent literature, it is reasonable to conclude that the person skilled in the art relevant to this opposition would consult the patent literature in order to ascertain relevant documents.

5. US’811 (Exhibit DS-3) is titled “Salad/cooking oil balanced for health benefits”, which the abstract discloses as cooking/salad oil compositions with fatty acid content balanced for health purposes.  Dr Stalker was aware of US’811 before the priority date as a result of his involvement with a project to lower the saturated fatty acids of plants (DS#1 [43]).  Dr Brown and Dr Downey consider US’811 of little interest or relevance to canola researchers on the basis that it does not involve plant breeding of any type (JB#1 [17]; KD [30]).  However, I have found above that the person skilled in the art possesses also possesses an interest and skills in the genetic modification of plants.  US’811 relates to the production of oils with a desired fatty acid profile and Dr Stalker confirms that it would be of interest to a researcher interested in lowering the level of total saturated fatty acids in an oil such as canola, which was a well-known goal in the oil seed industry at the priority date (DS#2 [15]).    

6. US’758 (Exhibit DS-4) is titled “Production of improved rapeseed exhibiting a reduced saturated fatty acid content” and describes the production of a canola variety with a low level of total saturated fatty acids by mutagenesis of Brassica seeds followed by selection of plants exhibiting a desired low saturated fatty acid profile (DS#1 [46]).  The US’758 abstract states that the oil of such plants is particularly well suited for cooking applications.  Dr Stalker was aware of US’758 before the priority date (DS#1 [46]) and Dr Downey was aware of the work it discloses (KD [33]). 

1. US’755 is in evidence as Exhibit DS-5.  US’755 is titled “Oil produced from the Brassica napus” and the abstract discloses that the invention relates to a variety of Brassica napus having oil which combines oxidative stability with sufficient for industrial applications with a desirable dietary fatty acid profile. 

2. I have found above that the person skilled in the art would search the patent literature.  I am satisfied that each of US’811, US’758 and US’755 relate to plants and/or seeds and associated oils with fatty acid profiles that prima facie provide oils with improved characteristics.  Thus, I consider it reasonable to conclude that, before the priority date, the person skilled in the art seeking information with which to provide a canola oil with improved health and/or performance characteristics, could be reasonably expected to have ascertained each of US’811, US’758 and US’755, and then understood them and regarded them as relevant.

3. WO’430 is in evidence as Exhibit DS-6.  WO’430 is titled “Modification of fatty acid composition in plants by expression of an Aspergillus nidulans delta-9 CoA desaturase”.  The abstract states that genes encoding this desaturase enzyme have been isolated and that the encoded proteins, when expressed in a plant, can alter the saturate levels of the oil.  The examples demonstrate that expression of this enzyme in corn and tobacco altered fatty acid profiles (DS#1 [61]).  Dr Stalker was aware of WO’430 at the priority date (DS#1 [60], DS#2 [31]) and he believes that WO’430 would have been of interest to those working in the oil seed and canola research community at the priority date.  In contrast, Dr Downey and Dr Brown understand WO’430 to relate only to the exemplified generation of transgenic tobacco and corn rather than canola (KD [48]-[49]; JB [18]).  In my view, the expert evidence establishes that while canola researchers who were primarily plant breeders may not have considered this document relevant to the problem, those involved in the genetic modification of plants to achieve a desired phenotype would have considered it relevant.  Consequently, on the basis of Dr Stalker’s evidence, I find that the person skilled in the art seeking information with which to provide a canola oil with a fatty acid profile that provides improved health and/or performance characteristics, could, before the priority date, be reasonably expected to have ascertained WO’430, and then understood it and regarded it as relevant.

   Obviousness

4. Cargill submitted that claims of the application lack an inventive step in light of three documents taken alone:

   US 4948811 (Spinner et al.) 14 August 1990 (US’811);

   US 5965755 A (Serynk J. L. et al.) 12 October 1999 (US’755);

   WO 99/50430 A2 (Dow Agrosciences LLC) 7 October 1999 (WO’430);

   and the following documents in combination:

   US’755 and WO’430;

   US’755 and US’758.

5. Consistent with its novelty submissions, Cargill approached the ground of inventive step on the basis that any requirement in the claims for <20% polyunsaturates is an inessential feature of the claims.  However, I have found to the contrary and to make out this ground of opposition Cargill must establish that the whole subject matter of the claims, including this feature, is obvious.  

   US’811

6. Cargill opposed claims 11-14 for lack of inventive step in light of US’811.  For these claims to be obvious, Cargill must at least establish the obviousness of a non-chemically modified canola oil comprising <3.5% total saturates, <80% oleic acid and <20% total polyunsaturates.

7. US’811 discloses the production of oil with a desired fatty acid profile by chromatographically fractionating canola oil fatty acids, then remixing the individual fatty acid fractions at the desired concentrations (DS#1 [44]; DS#2 [16]; consistent with KD [31]).  Although there was some disagreement between the experts about the chemical nature of the production process, I am satisfied that the evidence establishes that the oil obtained by the process is not chemically modified (DS#1 [45], [96]; KD [31]; DS#2 [15]-[17]). 

8. US’811 broadly describes the fatty acid composition of the oil as less than about 3% total saturates, oleic acid in the range of about 60% to about 92%, and the linoleic acid and alpha-linolenic acid in ranges which in combination amount to 5-40% polyunsaturates (column 2, lines 29-34).  Preferred embodiments contain between 8-37% polyunsaturates (column 2, lines 43-45).  Cargill noted in particular Example III, in which US’811 discloses an oil having 1.2% saturated fatty acids, 63.3% oleic acid and 31.8% polyunsaturated fatty acids (consistent with DS#1 [96]). 

9. For claims 11-14 to be obvious in light of US’811, Cargill must establish that, before the priority date, the person skilled in the art seeking to provide a canola oil with a fatty acid profile that provides improved health and/or performance characteristics would, as a matter of routine, apply the method of US’811 in a manner that would achieve the oil fractions specified in claim 11.  In this regard, the evidence does not support Cargill’s submission that since a lower level of linoleic acid was known to be beneficial in frying, the person skilled in the art, without the benefit of hindsight, would directly be led to reduce the polyunsaturates in the Example III oil to <20%.  Dr Downey considers the process taught by US’811 as not practical for obtaining industrial levels of canola oil (KD#1 [31]).  Dr Stalker’s evidence after reading the specification that known canola varieties exhibit polyunsaturated levels of <20% (#2 [147], [149]) and the claimed fatty acid profile could be achieved by known methods (#2 [149]; consistent with #1 [97]), does not establish that the combination of features in claims 11-14 was obvious.  

10. Cargill has not established that claim 11 and dependent claims 12-14 are obvious in light of US’811. 

    WO’430

11. Cargill opposed claims 1-40 as lacking an inventive step in light of WO’430.

12. WO’430 is in evidence as DS-6.  It is titled “Modification of fatty acid composition in plants by expression of an Aspergillus nidulans delta-9 desaturase”.  The field of the invention is disclosed as the preparation and use of nucleic acids and genes encoding fungal delta-9 desaturase enzymes to create transgenic plants having altered fatty acid profiles (page 1, lines 9-12).  On page 4, the summary of the invention reveals that a delta-9 desaturase gene from A. nidulans has been isolated and cloned and that the saturate levels of oils found in plant cells can be altered using this enzyme.     

13. Cargill submitted that WO’430 shows that the levels of saturated fatty acids in corn oil and tobacco seeds can be altered by expressing an Aspergillus delta-9 desaturase in a plant cell, and Dr Stalker’s evidence establishes that a significant reduction in saturated fats could be expected in canola seeds using the same phaseolin promoter/fungal desaturase construct.  Responding, Dow submitted that Cargill has not established lack of inventiveness to the level of ‘practical certainty’ that is required.  It argued that WO’430 demonstrates only a small or no reduction in some saturated fatty acids in tobacco and corn, respectively, and there is no evidentiary basis that takes Cargill’s argument higher than an “obvious to try argument” to one that would establish the requisite expectation of success. 

14. The experts agree that WO’430 discloses that saturated fatty acid levels in corn oil and tobacco seeds can be altered by expressing the A. nidulans delta-9 desaturase in the plant cells (DS#1 [61]; KD [51]).  Dr Stalker describes the transgenic methodologies in WO’430 as routine and simple (#1 [61]), which is accepted by Dr Downey with the caveat that at the priority date the use of transgenics in the canola field was not as common as the production of transgenic animals for clinical investigation at the time (KD [66]).

    Claims 1-26 and 32-38

15. The evidence establishes that the person skilled in the art would have considered the tobacco experiments in WO’430 to be more relevant to canola since they disclose the use of the phaseolin promoter to drive seed-specific expression in dicotyledonous plants (DS#1 [62], [64]-[65], which is not disputed by Dr Brown at [67]; DS#2 [67]).  Table 3 in WO’430 establishes that expressing the A. nidulans delta-9 desaturase in tobacco seeds produced a reduction of palmitic acid (16:0) from approximately 10% in control to approximately 7-8.5% in the transformed seeds (DS#1 [62]; KD [53]).  

16. On being asked what results he would expect if the tobacco seed experiments in WO’430 were reproduced in canola seeds, Dr Stalker answers that he would expect similar results to those shown in Table 3 with some level of reduction of saturated fatty acids (DS#1 [66]).  Dr Downey does not dispute this conclusion (KD [68]).  Using the same phaseolin/desaturase construct used in tobacco seeds in WO’430, Dr Stalker would expect a significant reduction in total saturated fatty acids in the canola oil, and could expect a greater reduction by maximising expression of the desaturase by generating plants and seeds homozygous for the transgene (DS#1 [66]).  On that basis, it is reasonable to conclude that in light of WO’430, the person skilled in the art seeking to provide a canola oil with a fatty acid profile that provides improved health and/or performance characteristics, would directly be led as a matter of course to try expressing the A. nidulans delta-9 desaturase in canola using the phaseolin/desaturase construct, in the expectation that it would significantly reduce the level of total saturates in the oil fraction of canola oil. 

17. The tests provided by the Courts for determining the presence of an inventive step in a claim require that the routine steps taken by person skilled in the art will lead them to the claimed invention.  Therefore, it remains to be determined whether expressing the A. nidulans delta-9 desaturase in canola will achieve canola plants, seeds and oil having the oil fractions specified in the opposed claims. 

18. On being asked whether he would expect that a canola plant expressing the A. nidulans delta-9 desaturase would exhibit a saturated fatty acid level of less than (<) 3.5%, Dr Downey answers at [63] that he would not expect any significant decrease, because to reduce total fatty acid levels from about 7% in conventional canola down to 3.5% would require at least a 50% reduction, which has not been demonstrated in the corn and tobacco experiments in WO’430 (KD [51]-[53], [61]-[62]).  At no stage in his reply evidence does Dr Stalker dispute this aspect of Dr Downey’s evidence, nor does he address the requirement of Dow’s claims for <3.5% total saturates, other than to say that he would expect to achieve a “significant reduction” in total saturates using the A. nidulans delta-9 desaturase in canola (DS#1 [66]; DS#2 [60]). 

19. Dr Stalker confirms that it is routine in the art, when conducting transgenic experiments, to select for individual transgenic seeds that exhibit the desired phenotype, and then subject the seed to a further round of selection at the whole plant level in the next generation (DS#2 [40]).  However, Dr Stalker’s evidence does not establish that without the benefit of hindsight, the person skilled in the art would seek to develop or select for a canola plant with specifically <3.5% total saturates. 

20. The opposed specification demonstrates that the initial choice of canola strain is critical to achieving a saturated fatty acid level below 3.5%.  In Example 3, two canola strains, Westar and Nexera 710, were transformed with the A. nidulans delta-9 desaturase gene.  A substantial (43-50%) reduction in total saturated fatty acids was achieved in the transgenic Westar canola (Fig 3 and para 160).  However, since the starting level of saturates was 8.4-9% the levels in the transgenic Westar plants remained well above the <3.5% required by Dow’s claims.  Thus, in the absence of evidence that the person skilled in the art would choose a canola strain with equal or less than conventional levels of total saturates in which to express the transgene disclosed by WO’430, or take other steps to work specifically towards achieving <3.5% total saturates in the oil fraction, Cargill has not established that Dow’s claims to canola plants, seeds and oils having an oil fraction with <3.5% total saturates are obvious in light of WO’430.  It follows that Cargill has not established that claims 1-26 and 32-38 lack an inventive step in light of WO’430.

    Claims 27-30 and 39

21. The method of claim 27 relevantly requires the production of a canola plant that expresses a polynucleotide encoding a delta-9 desaturase protein, with the additional requirement that the polynucleotide coding sequence is capable of hybridising with the polynucleotide molecule of SEQ ID NO: 1.  The method must achieve a reduction in saturated fat in the oil fraction of at least one seed of a transgenic canola, but there are no limits on the magnitude of this reduction.

22. In the absence of any hybridisation conditions, such as temperature, salt concentration or wash conditions, claim 27 encompasses very low stringency conditions (DS#1 [115] commenting on the identical requirements in accepted claim 22).  Furthermore, in contrast to claim 15, claim 27 places no limitation on the extent to which hybridisation occurs.  It logically follows that claim 27 does not require high sequence identity between the expressed polynucleotide molecule and that of SEQ ID NO: 1.  

23. SEQ ID NO: 1 in the opposed specification represents the nucleic acid sequence which codes for the A. nidulans delta-9 desaturase protein (paras 45 and 49, DS#1 [120]).  WO’430 describes the isolation and cloning of the fungal A. nidulans delta-9 desaturase gene and discloses the protein coding sequence as SEQ ID NO: 5 (Example 1).  Thus, the polynucleotide molecules SEQ ID NO: 1 in the opposed application and SEQ ID NO: 5 in WO’430 both encode the A. nidulans delta-9 desaturase (DS#1 [101], last sentence).  However, SEQ ID NO: 1 is a variant of SEQ ID NO: 5, the former having been codon-optimised for expression in plants (DS#1 [75]).    

24. Dr Stalker confirms that a requirement in the claims for a nucleic acid molecule that encodes a delta-9 desaturase protein, is satisfied by the nucleic acid of SEQ ID NO: 5 in WO’ 430 (DS#1 [101] last sentence).  Although Dr Stalker’s evidence was provided in the context of the text of present claim 15, it establishes a factual matter which is relevant to the construction of claim 27.  Referring to the hybridisation conditions set out in claim 15, Dr Stalker expects that “a number of known desaturase genes, including the Aspergillus desaturase disclosed in [WO’430], would most likely fall within the scope” of the polynucleotide in that claim (DS#1 [103]).  Given that no hybridisation conditions are specified in claim 27, nor any limitation placed on the extent of hybridisation, it is reasonable to conclude with practical certainty that the WO’430 SEQ ID NO: 5 nucleic acid molecule, albeit that it is not codon-optimised, will have sufficient complementarity to hybridise to some extent with the molecule of SEQ ID NO: 1 in the opposed specification.  That is all that is required by claim 27.

25. I have found above that in light of WO’430, the person skilled in the art seeking to solve the problem, would directly be led as a matter of course to try expressing the A. nidulans delta-9 desaturase in canola using the phaseolin/desaturase construct taught by WO’430, in the expectation that it would significantly reduce the level of total saturates in the oil fraction of canola oil.  Given the established activity of this desaturase (which is not in dispute), and the fact that canola typically contains less than 80% oleic acid (DS#1 [22]), it inevitably follows that in so doing, the person skilled in the art would carry out a method falling within the terms of claims 27-29.  Consequently, these claims lack an inventive step in light of WO’430.

26. Regarding claim 30, there is nothing in evidence establishing that the person skilled in the art would directly be led as a matter of course to develop a method which necessarily achieves a reduction in saturated fat by at least 60%.  Consequently, it has not been established that this claim lacks an inventive step.

27. Claim 39 recites “A method according to claim 27, substantially as herein described”.  Although the specification exemplifies the invention by expressing the Aspergillus delta-9 desaturase enzyme in Nexera 710 canola, for the reasons that follow claim 39 is not limited to this narrow embodiment.  Relevant to the construction of claim 39, para 50 describes the invention in terms of the canola species in general, not any particular variety:

    “The invention also relates in part to methods for reducing saturated fatty acids in certain plant seeds. These results were surprisingly achieved through the use of a delta-9 desaturase gene to surprisingly produce “no sat” [i.e. <3.5%] levels of fatty acids in plants, preferably oil plants, and still more preferably canola (Brassica)”

28. Relevant to the desaturase, at para 56 of the specification:

    “… the subject invention” is not limited to the use of the exemplified Aspergillus delta-9 desaturase enzyme but includes similar desaturase enzymes (identified by sequence alignment) such as any available in GENBANK.” 

29. This broad description of the desaturase is nevertheless limited in claim 39, to those where the encoding nucleic acid fulfils the hybridisation criteria of claim 27 to which claim 39 is appended.  It follows that omnibus claim 39 does not substantially narrow the scope of claim 27.  Therefore, for the same reasons provided above with respect to claim 27, claim 39 also lacks an inventive step.

    Claims 31 and 40

30. Claim 31 defines a polynucleotide comprising a sequence of nucleotides shown in SEQ ID NO: 1. 

    SEQ ID NO: 1 represents the protein coding region of the A. nidulans delta-9 desaturase gene optimised for expression in plants (paras 45 and 51 of the specification).

31. Dr Stalker describes SEQ ID NO: 1 as representing “a known Aspergillus delta-9 desaturase gene modified for expression in a plant, that is plant codon-optimised” (DS#1 [120]).  Prior to reading the specification, in summarising WO’430 in his first declaration, Dr Stalker relevantly states:

    “46. I note that in Example 9 of [WO’430], there is a detailed discussion concerning modifying the Aspergillus delta-9 desaturase gene for increased expression in plant cells through codon optimisation. I also note that [WO’430] includes disclosures regarding codon optimisation at pages 15 to 17.

    47. The experiments performed in [WO’430] were carried out with the Aspergillus delta-9 desaturase gene in the absence of any codon optimisation, which should result in increased expression of the delta-9 desaturase in plant cells. However, as indicated in paragraph 46 above, [WO’430] includes clear directions to optimise codon usage for the expression of the delta-9 desaturase gene in plant cells. In my view, and I believe the view of those actively working in the relevant field at the priority date of the Opposed Application, codon optimisation for expression in plants cells was a logical/obvious step in the maturation of the project described in [WO’430] and a step which I believe would result in an even greater decrease of total saturated fatty acid beyond that already described in [WO’430].”

32. Dr Stalker subsequently confirms his opinion that modifying a gene for optimal expression in plants was well known and routine in the art at the priority date (DS#1 [103] and [109]).

33. I have found above that in light of WO’430, in seeking to solve the problem, the person skilled in the art would directly be led as a matter of course to try expressing the A. nidulans delta-9 desaturase in canola using the phaseolin/desaturase construct taught by WO’430, in the expectation that it would significantly reduce the level of total saturates in the oil fraction of canola oil.  Dr Stalker’s evidence presented above, which is uncontested by Dow’s experts, establishes that it would have been a matter of routine to codon-optimise the fungal sequence to increase expression of the protein in plants.  On this basis, I find the subject matter of claim 31 lacks an inventive step. 

1. On balance, I prefer the evidence of Dr Downey and Dr Brown, based on their experience in plant breeding, which is in effect, that they would have no reasonable expectation of success in achieving a canola plant with a fatty acid profile that would necessarily fall within Dow’s claims. 

2. Cargill has not established that any of claims 1-7, 9, 11, 13-14 and 32-36 is obvious over the combined disclosure of US’755 and US’758.

   Inventive step summary

3. Claims 27-29, 31 and 39-40 do not involve an inventive step.   

   Utility

4. Paragraph 18(1)(c) of the Act provides that an invention, so far as claimed in any claim, must be useful. The requirements for utility in a claimed invention under section 18(1)(c) were provided by the Full Court of the Federal Court as follows:

   “If the claimed invention does what it is intended by the patentee to do and the end result obtained is itself useful, the invention is useful within the meaning of s 18(1)(c) … As to the first aspect, the invention as claimed must attain the result promised by the patentee”  (Ranbaxy Australia Pty Ltd v Warner-Lambert Co LLC [2008] FCAFC 82 [141]; 77 IPR 449)

   “A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid.  That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility.” (H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 [81], [217]; (2009) 177 FCR 151 [81], [217]).

   Plants containing one or more seeds

5. Above, I have construed each of claims 1-5 (and dependent claims 6-8) to encompass a canola plant that produces as little as 1, 8, 10, 30, or 100 seed(s), respectively having the specified oil fraction.  At the hearing, I asked Dow to provide submissions on whether the plants of claims 1-5 achieve the promise of the invention insofar as these claims encompass plants with only a small proportion of seeds having the specified oil fraction.

6. Relevant to the promise of the invention for claims 1-5, the “Brief Summary of the Invention” in para 35 of the specification states:

   “The subject invention provides “no sat” canola oil [i.e. canola oil with <3.5% total polyunsaturates (para 2 of the specification)]. The invention also relates in part to methods for reducing saturated fatty acids in certain plant seeds. These results were surprisingly achieved by the use of a delta-9 desaturase gene in canola (Brassica). … Included in the subject invention are plants, preferably canola, capable of producing such oils and seeds.  The subject invention also provides seeds and oils from said plants wherein the oils have particularly advantageous characteristics and fatty acid profiles, which were not hitherto attained. The subject invention still further provides a plant-optimized delta-9 desaturase gene. In some preferred embodiments, a preferred plant comprises at least two copies of a delta-9 desaturase gene of the subject invention. Seeds produced by such plants surprisingly do not exhibit effects of gene silencing but rather have further surprising reductions in levels of total saturates.”

7. Dow relevantly submitted that a plant producing at least one seed with the oil fraction specified in claims 1-5 is useful for the purposes of s 18(1)(c) because using half seed analysis, that seed could be identified and the other seed half used to propagate a plant which may be used to create a stable line having an improved fatty acid profile.  This submission finds support in the description at para 88 and the expert evidence (DS#1 [26]; KD at [9] and [22] last sentence).  On this basis, I find that plants containing one or more seeds with the specified oil seed fractions are useful.

   <20% polyunsaturates

8. Cargill’s submissions at the hearing were consistent with its particulars, reproduced below, that the claimed invention does not achieve the promise of the invention in terms of oxidative stability in the oil:

   “In particular the plants, seeds and oil defined in the amended claims do not provide the advantages or technical effects promised by the invention, namely canola oil that exhibits oxidative stability.  In particular, the inclusion of the feature “less than 20% total polyunsaturates” covers oil having conventional levels of linolenic acid and low levels of linoleic acid.  Oxidative stability of canola oil, however, is specifically dependent on a low level of linolenic acid.  Accordingly, canola oil falling within the scope of the amended claims does not satisfy the promise of the invention.”

9. In response, Dow submitted that the specification does not promise that some minimum level of stability will be achieved for all relevant oils, this feature being only one aspect of the invention.  Dow argued that a separate promise is made of having a plant producing seed oil with a low saturated fat content. 

10. Relevantly, para 85 of the specification promises:

    “Oils of the subject invention retain a high degree of oxidative stability but contain lower levels of saturated fatty acids and higher levels of unsaturated fatty acids.  Preferred oils of the subject invention have less than 3.5% total saturated fatty acid content, oleic content of at least 75% (and preferably an surprisingly less than 80%), and a polyunsaturated fatty acid content of less than 20% … . … 18:2 [linoleic acid] and 18:3 [linolenic acid] levels, which contribute to oil instability, are not increased or are preferably reduced (for food applications)” 

11. From para 85, I understand a promise of the invention is seed oil having lower levels of saturated fatty acids and higher levels of unsaturated fatty acids, while retaining a high degree of oxidative stability, this last being dependent on the levels of the polyunsaturates linoleic and linolenic acid not being increased.

12. Conventional canola contains between 28-40% polyunsaturates (DS#1 [22]).  Oxidative stability relevantly relates to low levels of polyunsaturates, in particular linolenic acid (DS#2 [138], consistent with DS#1 [53]).  The information in para 85 supports a conclusion that the levels of other polyunsaturates such as linoleic acid are also important to oxidative stability in an oil.  However, retaining oxidative stability does not necessarily require a reduction in linolenic acid, since para 85 explicitly identifies a reduction in these fatty acids as a preferred embodiment.

13. The specification states at para 22 that prior art high oleic oils retaining fairly high levels of polyunsaturates (principally linoleic or linolenic acids) may still be quite useable for dietary applications, but have inadequate oxidative stability under the more rigorous for industrial applications.  Understood in this context, Dr Stalker’s evidence that oils with a high oleic acid and low linolenic acid content would exhibit greater stability at high temperatures (DS#1 [40]), does not establish that where the claimed oils are not explicitly limited to a low linolenic content, those oils would not be useful in dietary applications, or in other applications after treatment to improve oxidative stability. 

14. As discussed above in the context of “parameteritis”, the expert evidence supports a view that a polyunsaturated fatty acid levels <20% is a useful result and desired goal in the art (JB at [23]; DS#2 [137]). 

15. On balance, I am not satisfied that Cargill has established that claims referring to <20% polyunsaturates do not achieve the promise of the invention in terms of oxidative stability. 

    Utility summary

16. The claimed invention is useful.

    Section 40

17. Cargill submitted that there is a disparity between what is detailed in the specification and what is claimed in that the alleged invention is directed to plants, seeds and oil made by transgenic methodologies but the claims are not limited in this regard.  Cargill submitted that this gives rise to lack of fair basis and lack of definition regarding claims 1 to 14, and it also results in the claims defining subject matter that is not patentable.

    40(3) Clarity

18. Subsection 40(3) of the Act requires that that claim or claims of a specification are clear. A claim is clear if a third party could ascertain, without difficulty, whether or not what he or she proposes to do would fall within the ambit of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60). However, a claim does not lack clarity because it uses inexact language or is difficult to construe, as long as it provides a workable standard suitable to the intended use Minnesota Mining [1980] HCA 9 [46], (1980) 144 CLR 253 at 274).

    Claims 1-8

19. I have construed claims 1-5 (and dependent claims 6-8) as defining a canola plant that produces as little as 1, 8, 10, 30 or 100 seeds, respectively, having an oil fraction comprising the specified fatty acid profile. 

20. Noting that a single canola plant produces hundreds to thousands of seeds (DS#2 [145]), Cargill submitted that claims 1-10 are unclear because it would be practically impossible to determine whether such claims were infringed.  Specifically, that if a person produces canola oil in an industrial environment with a lipid profile other than that defined in claims 1-8, it is unrealistic to expect that they would examine each and every one of thousands of seeds on each of the plants utilised in the production process to determine whether any particular seed or seeds had a lipid profile that falls within the scope of claims 1-8.  Cargill argued that in the normal course of commerce, i.e. large scale production of canola oil from plants, a person cannot be expected to determine whether plants according to any one of claims 1-8 have been utilised.  Therefore, given seed to seed variability within a canola plant, as a practical matter, when a person produces a canola oil with a lipid profile other than that defined in claims 1-8, they would not know whether or not infringement of claims 6 to 10 had occurred. 

21. Dow submitted that the authorities cited by Cargill go to the meaning of the claim language and not broader practical issues.  Dow submitted at the hearing that claims 2-5 provide a practical workable standard since they allow for infringement to be established by analysing the oil seed content of the specified number of seeds.  It argued that Cargill’s argument is highly theoretical and in the absence of any practical example demonstrating, in fact, that a practical difficulty arose as to whether the plant fell within the scope of the claim Cargill has not established that the claims lack clarity. 

22. In my view, the test applied by the Courts is directed squarely at the practicalities involved in a person determining whether they would infringe a patent claim.  Cargill’s submission provides a sound logical basis for a conclusion that a third party would encounter substantial difficulties in determining whether the use of any and all canola plants they have before them would result in infringement of Dow’s claims as I have construed them.  Insofar as claims 1-8 encompass a canola plant defined by its production of individual seeds among many having a specified oil fraction, I find that these claims do not provide a workable standard such that a third party could ascertain whether an act would fall within the scope of the claim.

    Claims 9-10

23. I have construed claims 9-10 as defining one seed, or alternatively multiple seeds, having the specified oil fraction.  Notwithstanding my conclusion above with respect to the claimed plants, the evidence establishes that person skilled in the art could, without difficulty, assay a single seed alone using half-seed techniques, or alternatively bulk seeds from a plant, to determine the oil content (DS#1 [26]-[27]; KD [9]).  On this basis I find claims 9-10 clear in scope.

    Claims 11 and 14

24. Cargill submitted that claims 11 and 14 lack clarity due to the feature in claim 11 that the “oil is non-chemically modified”.  

25. Dr Stalker understands non-chemically modified oil as meaning “oil not including an exogenous chemical component or a chemical treatment to attain the target lipid profile” (DS#1 [96], DS#2 [146]).  Regarding the construction of claim 11, Dr Stalker states:

    “It is clear from the plain meaning of the words used in new claim 11 that the oil defined has been modified in some way by a process other than chemical modification, i.e. non-chemical modification.” (#2 [146])

26. Cargill’s arguments for lack of clarity in claim 11 relies on Dr Stalker’s evidence that “the nature or extent of the modification to the oil” in claim 11 is unclear to him and “unless the nature of the non-chemical modification was specifically referred to in the claim” he could not determine whether any particular oil fell within its scope (DS#2 [146]).  However, any requirement for additional information in the claim is inconsistent with Dr Stalker’s earlier evidence (#1 [96]) in which he determines whether a prior art oil is non-chemically modified by simply asking whether it is chemically modified – i.e. whether there is a chemical change to the fatty acids in the oil or an exogenous chemical added to the oil (DS#1 [96]).  He applies this to one of the prior art documents:  

    “… [US’811] describes canola oil fractionated by physically separating the individual fatty acids of canola oil via column chromatography.  There is no chemical change to the fatty acids in the resultant oil nor is there any exogenous chemical added to the oil.” (DS#1 [96])

27. I am satisfied that the evidence establishes that the skilled addressee could, without difficulty, determine whether any particular oil they may wish to make or use is non-chemically modified.  It follows that claim 11 and dependent claims are clear in this regard. 

28. Cargill’s submissions on clarity grounds did not address the additional features of the claims dependent on claim 11.  However, since I have found claim 11 to be clear in scope, in the absence of evidence to the contrary it is reasonable to conclude that dependent claims 12 (which recites a lower level of total saturates in the oil) and 13-14 (to a fried food composition comprising the oil, and a method of producing a fried food composition using the oil) are clear in scope.  

    Clarity summary

29. Claims 1-8 lack clarity.  Claims 9-14 are clear.

    40(3) Fair basis

30. Subsection 40(3) requires that the claim or claims in a patent specification be fairly based on the matter described in the specification. As the test for fair basis, the High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (Lockwood) [2004] HCA 58 [69]; [2004] HCA 58; (2004) 217 CLR 274 at 300 [69] approved the words of Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95:

    “... the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”

31. In Lockwood [57] the High Court noted the following statement of principle by Barwick CJ in Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240 had been approved by the High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8; (2001) 207 CLR 1 [15]:

    “The question whether the claim is fairly based is not to be resolved ... by considering whether a monopoly in the product would be an undue reward for the disclosure.  Rather, the question is a narrow one, namely whether the claim to the product being new, useful, and inventive, that is to say, the claim as expressed, travels beyond the matter disclosed in the specification.”

32. Cargill opposed claims 1-14 for lack of fair basis.  Firstly, because claims 1-14 are not confined to transgenic plants expressing a delta-9 desaturase gene and the associated seeds and oils.  Secondly, it considered claims 1-10 to lack fair basis insofar they require only a relatively small proportion of the seeds of the plant to have the specified fatty acid profile.

    Claims 1-14 - not limited to transgenic canola (travels beyond)

33. Cargill submitted that the alleged invention plainly lies in showing that a delta-9 desaturase gene can be predictably used in plants including canola to produce oil with desirable characteristics.  It argued that statements in the specification reinforce that “the subject invention” is the technology used to genetically engineer a plant to express delta-9 desaturase to produce oils with a high degree of oxidative stability but lower levels of saturated fatty acids and higher levels of unsaturated fatty acids, and agronomically elite canola seed that results in such oil.  Cargill submitted that the specification contains no real and reasonably clear disclosure of plants made by other than transgenic methods and as a consequence the claims travel beyond the matter disclosed in the specification.  

34. To support its case, Cargill referred to Pfizer Overseas Pharmaceuticals v Eli Lilly and Company (Pfizer) [2005] FCAFC 224 and Astrazeneca AB v Apotex Pty Ltd (Astra) [2014] FCAFC 99, which it submitted addressed circumstances analogous to those presently under consideration. In Pfizer, a claim to a therapeutic method referred to treatment with an orally effective amount of an agent, or salt thereof, broadly defined in terms of its inhibitory activity. However, the specification repeatedly referred a specific class of chemical compounds, leading the majority to find at [275] that the claim read as a whole “travels well beyond the range of compounds disclosed in the body of the specification” and consequently lacked fair basis. In Astra, a claim was construed to encompass a pharmaceutical composition comprising rosuvastatin and a relevant inorganic salt in any form including a tablet made from rosuvastatin coated with a relevant inorganic salt ([414]). The Full Court found at [419] that, when read as a whole, the specification described a pharmaceutical composition in which the active ingredient has been mixed or blended with certain inorganic salts. Furthermore, that there was no suggestion in the specification that the pharmaceutical composition might not consist of such a mixture or blend or that it might be prepared otherwise than by mixing or blending the active ingredient with the relevant inorganic salt ([419]). Thus, in Astra, the Full Court concluded at [421] that the claim was not fairly based because the specification contained no real and reasonably clear disclosure, even in the most general sense, of a pharmaceutical composition in which there might be no mixture of the active ingredient and inorganic salt.

35. Dow submitted that Cargill’s analysis incorrectly focuses on specific disclosures, rather than on the disclosure of the specification as a whole which it submitted does not limit the scope of the disclosure to transgenic plants expressing the A. nidulans delta-9 desaturase gene.  Dow considered the specification to provide proof of concept that a plant capable of having a biosynthetic pathway that produces the seed oil fraction specified in its claims may be produced through genetic processes, or by the use of cross-breeding and mutagenesis.

36. The opposed specification identifies the benefits of oils with low levels of saturated fatty acids (para 2), a high content of monounsaturates (para 5), and polyunsaturates at levels facilitating adequate oxidative stability (paras 22-24).  The specification discloses that vegetable oils may be modified chemically or by genetic engineering (para 8).  However, that the fatty acid composition of such oils is typically modified thorough traditional breeding techniques exploiting naturally-occurring or “created” genetic mutations affecting fatty acid composition (paras 9-10).  The specification discloses that the introduction of a new characteristic through mutagenesis often depends on loss of some trait already present, and only a few types of modified fatty acid compositions in vegetable oils have been achieved using this approach, one example being the decrease of polyunsaturated fatty acids in rapeseed oil, with a concomitant increase in oleic acid and a second being a decrease of saturated fatty acids in rapeseed oil (para 10).   However, para 10 concludes:

    “… the biochemistry of seed oil synthesis is complex, and not well understood; there may be several mechanisms which contribute to the changes in the fatty acid compositions observed in rapeseed oil … . The use of mutagenesis to affect such changes is essentially random, and non-specific.”

1. At para 11, the specification states:

   “The possibility of modifying fatty acid composition through the use of genetic engineering would, in theory, allow the precise, controlled introduction of specific desirable genes, as well as the inactivation of specific undesirable genes or gene products.  Thus, novel traits completely independent of genes already present could be introduced into plants, or preselected genes could be inactivated or modified.” 

2. Supporting Dow’s submission that the specification demonstrates using transgenic technology, that it is in fact possible to create a plant with a genome capable of producing seed with the claimed oils fractions, the description states at para 88:

   “… the subject invention demonstrates that preferred genes can be introduced and used to create stable lines.  Unlike uncharacterized mutations, it is well known in the art that a gene can be introduced and stably maintained in plants. Thus, the analysis set forth herein demonstrates the utility of the subject genes and that canola oil having the indicated characteristics can be attained”.

3. Dow’s expert evidence also supports a conclusion that the specification discloses proof of principle that plants with the oil fractions specified in the claims can be achieved.  Dr Downey at [85] states:

   “… this invention is about is developing plants capable of producing fats and oil that have the stated proportions of fatty acids. There is particular exemplification of this work in the document where it speaks of transgenic technology as one way of forming these plants, and the document also mentions other approaches such as conventional plant breeding and mutagenesis.”

4. Similarly, Dr Brown states at [23]:

   “The key finding is that it is possible to produce an agriculturally adapted plant which has saturated fatty acids of the order of 3% and oleic acid of 70 to 78%. Further, it is possible to create a plant having these profiles and a useful level of polyunsaturated fatty acids at about 20% or less.”

5. In my view, the claims of the opposed specification are distinguished from those considered in Astra and Pfizer on the facts. The specification exemplifies the production of the claimed canola plants using only transgenic technologies (DS#1 [87], DS#2 [4]), and does not disclose how to produce a plant specified in the opposed claims by conventional breeding or mutagenesis (DS#2 [83], [105]-[106]). However, as indicated above, the specification at para 10 broadly discloses that modifications to the fatty acid profile in vegetable oils have been achieved by these latter techniques. Thus, the present case is distinguished from Astra, in that the specification does, in a general sense, disclose the potential for conventional breeding or mutagenesis to be used to generate a plant falling within Dow’s claims. 

6. Relevant to the opponents submissions based on Pfizer, opposed claims 1-8 define a canola plant in terms of the oil fraction of its seed(s). The opposed specification, at paras 2, 5, 85, 89, 91 and the Examples, discloses plants having the oil seed fractions specified in the claims. Thus the body of the specification contains a real and reasonably clear disclosure of what Dow now claims.

7. Regarding Cargill’s submission that the claims lack fair basis because they are not limited to transgenic technologies, I also note that in Lockwood [83] the High Court cautioned:

   “… the statutory test provided by Barwick CJ does not call for any evaluation of whether the breadth of the claims exceeds “the technical contribution to the art embodied in the invention”, merely for an evaluation of whether the claims travel beyond the matter described in the specification”.

8. Furthermore, in Lockwood [69]:

   “The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”

9. I conclude that it is not necessary that claims 1-8 are limited to transgenic canola plants in order to be fairly based.  It follows that Cargill has not established that these claims and dependent claims 9-14 lack fair basis.

   Claims 1-10 - seed number

10. Claims 1-8 define a canola plant in terms of the nature of the oil fraction of the seed it produces.  I have construed claims 1-5 (and dependent claims 6-8) as requiring as little as 1, 8, 10, 30 or 100 seeds of the plant, respectively, to have the specified oil content.  A single canola plant produces hundreds to thousands of seeds (DS#2 [145]).  The fatty acid content of seeds from the same plant may vary (DS#1 [28]-[29]; DS#2 [41]; KD [22]), with the variability as much as ±30% for plants grown in the field (DS#1 [29]).  It therefore follows that claims 1-8 encompass plants in which a substantial proportion of the seeds do not necessarily have the oil fractions specified in claims 1-8 (consistent with DS#2 at [45]). 

11. On this basis, Cargill submitted that claims 1-10 are not fairly based because the purpose of the invention is to provide plants and seeds that produce oils having the fatty acid profile specified in the claims, rather than individual seeds. 

12. Dow submitted that there is no discrepancy between the disclosure and claims 1-10 by reason of the existence of seed variability, which the skilled addressee reading the specification would understand to exist.  Dow did not identify any particular passages in the description relevant to the fair basing of claims 1-5.  However, in line with its utility submissions Dow argued that a single seed of a canola plant having the relevant fatty acid profile can be used to propagate a plant which may be useful in further experimentation and/or that a plant producing at least 8, 10, 30 or 100 seeds is useful because an oil having a useful profile can be produced from such seeds.    

13. Paragraph 50 of the specification summarises the invention as follows:

    “The subject invention provides “no sat” canola oil. The invention also relates in part to methods for reducing saturated fatty acids in certain plant seeds. These results were surprisingly achieved by the use of a delta-9 desaturase gene in canola (Brassica). … Included in the subject invention are plants, preferably canola, capable of producing such oils and seeds.  The subject invention also provides seeds and oils from said plants wherein the oils have particularly advantageous characteristics and fatty acid profiles, which were not hitherto attained. The subject invention still further provides a plant-optimized delta-9 desaturase gene. In some preferred embodiments, a preferred plant comprises at least two copies of a delta-9 desaturase gene of the subject invention. Seeds produced by such plants surprisingly do not exhibit effects of gene silencing but rather have further surprising reductions in levels of total saturates.”

14. Paragraph 50 reveals that there are several aspects to the invention, including the use of transgenic technology to generate plants exhibiting the desired fatty acid profile.  Example 3 describes transformation of plants with the coding sequence for the A. nidulans delta-9 desaturase.  Example 4 describes the sorting and analysing individual seeds to identify those for further development, in the transformed plant and in further generations.  In this disclosure, I accept that the specification provides a real and reasonably clear disclosure at the level of individual seeds from a transformed canola plant.  On this basis, I find the claims are fairly based.

    Fair basis summary

15. The claims are fairly based.

    40(2)(b) Claims define the invention

16. Paragraph 40(2)(b) requires that a complete specification end with a claim or claims defining the invention.  The word “invention” for the purposes of s 40(2) does not mean the “inventive step”, it means “the embodiment which is described, and around which the claims are drawn” (Kimberley Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 [21], 207 CLR 1 at [21]). The requirement that the claims define the invention means that there must be a claim or claims that clearly define the monopoly for which the application has been made. Invalidity will only arise if the claim is “incapable of resolution by a skilled addressee by the application of common sense and common knowledge” (PhotoCure ASA v Queen’s University at Kingston [2005] FCA 344 at [117]; (2005) 64 IPR 314 at 347 [117]).

17. Cargill’s submissions under this ground are that claims 1-14 do not reflect “the subject invention” because they are not confined to plants, seeds or oils that are produced by technology that introduces a delta-9 desaturase gene into a plant.  Alternatively, that claims 1-10 do not define the invention the purpose of which is to provide plants and seeds that produce oils having the fatty acid profile specified in the claims.

18. Cargill has not argued that it is not possible to determine the scope of the claims. Claims 1-14 define the monopoly sought by the applicant and I have found the scope of the claims capable of resolution.  Consequently, Dow’s claims define the invention as required by paragraph 40(2)(b).

    Conclusion

19. The opposition is successful.  Claims 27-29, 31 and 39-40 lack an inventive step.  Claims 1-8 lack clarity.

    Costs

20. It is usual in matters before the Commissioner that costs follow the event.  The parties’ submissions were consistent with this.  Cargill has been successful in its opposition, and therefore I award costs according to Schedule 8 against Dow AgroSciences LLC.

    Barbara Akhurst
    Delegate of the Commissioner of Patents