BASF Corporation
[2019] APO 34
•19 July 2019
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
BASF Corporation [2019] APO 34
Patent Applications: 2017204400 & 2017204506
Title:Pesticidal mixtures
Patent Applicant: BASF Corporation
Delegate: Dr S. J. Smith
Decision Date: 19 July 2019
Hearing Date: 3 April 2019, in Melbourne
Catchwords: PATENTS – examiner’s objections – synergistic mixtures – manner of manufacture – claim directed to a kit – novelty – section 40 – disclosure and support – plausibility – post-filing evidence – inventive step – common general knowledge – combinations – final date for acceptance deferred
Representation: Counsel for the applicant: Mr Craig Smith
Patent attorneys for the applicant: Dr Grant Jacobsen, Dr Chris Vindurampulle and Ms Amanda Jones of Watermark Intellectual Property Pty Ltd
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2017204400 & 2017204506
Title:Pesticidal mixtures
Patent Applicant: BASF Corporation
Date of Decision: 19 July 2019
DECISION
2017204400
The claims are novel and the specification complies with sections 40(2)(a) and 40(3). The claims do not lack inventive step in light of the common general knowledge alone. Claim 5 is not for a manner of manufacture.
Pursuant to regulation 13.4(3), the final date for acceptance is six (6) months from the date of this decision.
2017204506
The specification complies with section 40(2)(a) and 40(3). The claims do not lack inventive step in light of the common general knowledge alone or in combination with the cited prior art. Claim 2 is not for a manner of manufacture.
Pursuant to regulation 13.4(1)(g), the final date for acceptance is three (3) months from the date of this decision.
REASONS FOR DECISION
Background
BASF Corporation (the applicant) filed patent application 2017204400 (the 400 application) on 28 June 2017. The 400 application is a divisional application based on 2013349839, which claims priority from EP 13182466.6 and EP 12193723.9 and has an earliest claimed priority date of 22 November 2012.
The applicant filed patent application 2017204506 (the 506 application) on 30 June 2017. The 506 application is a divisional application based on 2013349890, which claims priority from EP 13182404.7, EP 12193741.1 and EP 13185093.5 and has an earliest claimed priority date of 22 November 2012.
Amendments brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) apply to these applications as they were filed after its commencement.
A first examination report on the 400 application was issued on 25 January 2018 raising an objection of lack of compliance with sections 40(2)(a) and 40(3). The objection to lack of compliance with section 40 was maintained in a second examination report issued on 18 May 2018 and a third examination report was issued on 20 December 2018 including objections in relation to manner of manufacture, sections 40(2)(a) and 40(3), novelty and inventive step.
A first examination report on the 506 application was issued on 25 January 2018 raising an objection of lack of compliance with sections 40(2)(a), 40(2)(aa) and 40(3). After a number of reports in which lack of compliance with section 40 was maintained (and further search and opinion reserved on that basis), a fifth examination report was issued on 20 December 2018 including objections in relation to manner of manufacture, sections 40(2)(a) and 40(3) and inventive step.
The applicant asked to be heard in relation to the outstanding objections to both applications on 24 January 2019. Prior to the hearing, the applicant filed a declaration by one of the inventors of the applications, Burghard Liebmann dated 22 March 2019 (Liebmann).
Pursuant to regulation 13.4(1)(g) when the Commissioner gives an applicant an opportunity to be heard in relation to an examiner’s objection and issues a written decision, the period for gaining acceptance of the application may be extended until three months from the date the decision is issued, or, pursuant to regulation 13.4(3), for a period of longer than three months if the Commissioner is satisfied that acceptance should be postponed.
The standard of proof that applies to the examination of the present application is the balance of probabilities – if satisfied on the balance of probabilities that an application complies with the Act I must accept the application.[1] If I am not so satisfied, I can refuse the application.[2]
[1] Section 49 of the Act.
[2] The Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 at page 54.
The 400 specification
During examination the applicant filed a number of amendments to the 400 specification, and this decision is based on the specification as most recently proposed to be amended.[3]
[3] This includes amendments up to and including item 4 filed on 13 November 2018.
The 400 specification indicates that the invention relates to synergistic mixtures of Bacillus subtilis MBI600 (having accession number NRRL B-50595; compound II) and a second compound selected from a wide range of fungicidal or insecticidal compounds and plant growth regulators (compounds IA, IB and IC, respectively; collectively compound I).[4]
[4] 400 specification, pages 1-6.
It is explained that:
“Bacillus subtilis MBI600 is known as plant growth-promoting rice seed treatment … This strain MBI600 is commercially available as liquid formulation product Integral® (Becker-Underwood Inc., USA).
Several plant-associated strains of the genus Bacillus have been described as belonging to the species Bacillus amyloliquefaciens or Bacillus subtilis are used commercially to promote the growth and improve the health of crop plants (Phytopathology 96, 145-154, 2006). Recently, the strain MBI 600 has been re-classified as Bacillus amyloliquefaciens subsp. plantarum based on polyphasic testing which combines classical microbiological methods relying on a mixture of traditional tools (such as culture-based methods) and molecular tools (such as genotyping and fatty acids analysis). Thus, Bacillus subtilis MBI600 (or MBI 600 or MBI-600) is identical to Bacillus amyloliquefaciens subsp. plantarum MBI600, formerly Bacillus subtilis MBI600. For the purpose of this invention, Bacillus subtilis MBI 600 shall mean Bacillus amyloliquefaciens subsp. plantarum MBI600, formerly Bacillus subtilis MBI600.”[5]
[5] 400 specification, page 6, line 36 – page 6a, line 10.
The specification states the invention is directed to providing pesticidal mixtures which solve problems of reducing the dosage rate and/or enhancing the spectrum of activity and/or combining knock-down activity with prolonged control and/or resistance management and/or promoting plant health.[6] Simultaneous (joint or separate) application of compounds I and II or successive application of compound I and compound II is then said to allow enhanced control of pests and provide enhanced plant health effects.[7] Plant health indicators may be selected from yield, plant vigour, quality and tolerance to abiotic and/or biotic stress.[8]
[6] 400 specification, page 7, lines 37-40.
[7] 400 specification, page 8, lines 8-31.
[8] 400 specification, page 10, lines 19-22.
According to the specification, the mass ratio of any two ingredients in combination is selected to give the desired (synergistic) outcome and will vary depending on the specific compound I.[9] Preferred mass ratios between any two components are “from 75:1 to 1:75, more preferably, 50:1 to 1:50, especially 25:1 to 1:25, advantageously 10:1 to 1:10, such as 5:1 to 1:5.”[10]
[9] 400 specification, page 13, lines 35-37.
[10] 400 specification, page 14, lines 6-8.
The specification goes on to identify a number of preferred inventive mixtures, including ternary, quaternary and quinary mixtures.[11] Mixtures of compound I and II may be coformulated or formulated separately in the form of a kit of parts[12] and details of preferred formulation types are provided.[13] Various fungal plant diseases and animal pests which may be controlled are identified.[14]
The Examples
[11] 400 specification, pages 16-55.
[12] 400 specification, page 55, line 11 – page 56, line 1.
[13] 400 specification, pages 56-61.
[14] 400 specification, pages 64-70.
The 400 specification describes a number of exemplary strategies by which synergy may be assessed against various fungi and animal pests. The specification indicates that the expected efficacies of combinations may be determined using Colby’s formula.[15] The examples include data demonstrating synergistic combinations of triticonazole and B. subtilis MBI600 against Fusarium graminearum on lower roots and mesocotyl of corn, and pyraclostrobin and B. subtilis MBI600 against Rhizoctonia solani on roots and first leaves of corn.[16]
[15] 400 specification, page 75, lines 3-13; page 77, lines 32-41.
[16] Use example FG-6, Use example FG-7, Use example FG-8.
The specification indicates that triticonazole is a C14 demethylase inhibitor and pyraclostrobin is an inhibitor of complex III at Q0 site, that is, they have different modes of action. They are also structurally distinct, as shown below:[17]
[17] Liebmann at [23].
While mixtures comprising pyraclostrobin and triticonazole are not presently claimed, I note that in the examination response of 24 April 2018 (and again as an annexure to the declaration of Dr Liebmann) the applicant provided evidence demonstrating the presence of synergistic activity against rice blast Pyricularia oryzae and early blight caused by Alternaria solani with combinations of B. subtilis MBI600 and each of the specific actives mentioned in the claims as currently amended, and against grey mould Botrytis cinerea with combinations of B. subtilis MBI600 and, relevantly, metalaxyl, pyrimethanil, fludioxonil, dimethomorph, fipronil, thiamethoxam and abamectin.
The claims
The 400 specification ends with nine claims, which are set out in Annex A. Claims 1 and 5 are the only independent claims and claim 1 reads:
Synergistic mixtures comprising, as active components,
1) one fungicidal compound IA selected from the group consisting of
Nucleic acid synthesis inhibitors: metalaxyl,;
Inhibitors of amino acid and protein synthesis: pyrimethanil;
Signal transduction inhibitors: fludioxonil;
Lipid and membrane synthesis inhibitors: dimethomorph;
Inhibitors with Multi Site Action: thiram;
or
2) one insecticidal compound IB selected from the group consisting of
M-2 GABA-gated chloride channel antagonists:
M-2.B fiproles: fipronil;
M-4 nicotinic acteylcholine receptor agonists from the class of neonicotinoids: thiamethoxam;
M-6 chloride channel activators from the class of mectins: abamectin;
M-24 Ryanodine receptor-modulators from the class of diamides: chlorantraniliprole, cyantraniliprole;
and
5) Bacillus subtilis MBI600 as compound II having the accession number NRRL
B-50595.
Importantly, the claim is not to a bare mixture of compound IA/IB and II, each exhibiting their usual activities, but to a synergistic mixture. A synergistic mixture is one in which the observed effect of the mixture is greater than expected, and is distinct from circumstances in which components of a mixture exhibit additive or antagonistic interactions.[18] Accordingly, I understand the claim to be directed only to those combinations of components which give rise to a synergistic effect – that is, this part of the claim is truly limiting, as opposed to being merely a descriptive label. The claim does not define the circumstances under which the mixture is synergistic, but I have no reason to conclude, having regard to the skilled person’s knowledge of these active agents (discussed below) and the disclosure of the specification, that this gives rise to any deficiency in the clarity of the claim.
[18] Colby, S.R. ‘Calculating synergistic and antagonistic responses of herbicide combinations’, Weeds (1967), vol. 15: 20-22.
The claim is to a mixture “comprising” the specified components, and the specification provides an explicit definition of “comprising”:
“Comprises/comprising and grammatical variations thereof when used in this specification are to be taken to specify the presence of stated features, integers, steps or components or groups thereof, but do not preclude the presence or addition of any one or more other features, integers, steps, components or groups thereof.”[19]
Accordingly, the mixture must include at least one compound IA or IB and the defined biopesticide as active components but may also include additional active or inactive components.
[19] 400 specification, page 73, lines 24-27.
I note that no specific GABA-gated chloride channel antagonist is identified in the claim (and the description also does not identify any specific antagonist in those terms), as compared with the other classes listed, which are further limited to one or two specific embodiments. This issue was also identified in the examiner’s third report, as noted below. At the hearing I sought clarification as to whether this was intended to define the entire class, or was present in error. Following the hearing the applicant indicated that it proposed to delete “M-2 GABA-gated chloride channel antagonists” from claim 1.[20] I will proceed on the basis that the applicant will do so, and accordingly not consider this element of the claim further.
[20] Correspondence dated 8 April 2019.
Claims 2-4 define further embodiments of the mixture of claim 1. Specifically, claims 2 and 3 define the mixture of claim 1 comprising compound IA and compound II, and compound IB and compound II, respectively. Claim 4 defines the mixture of claims 1 to 6 (I note it is clear that this should refer to claims 1 to 3) wherein the ratio by weight of compound IA or IB to compound II is from 1:500 to 500:1.
Claim 5 is directed to a kit for preparing a usable pesticidal composition comprising a composition comprising either compound IA or IB and an auxiliary and a composition comprising compound II and an auxiliary. Claim 6 is directed to a pesticidal composition comprising a mixture as defined in any of claims 1 to 4 and a solid or liquid carrier. Claims 7 and 8 are directed to a method for protecting plant propagation material from pests and/or improving the health of plants grown from said plant propagation material by administering a mixture of any of claims 1 to 4 or the composition of claim 6 to the plant propagation material. Claim 9 is directed to plant propagation material comprising the mixture of any of claims 1 to 4 or the composition of claim 6.
The 506 specification
During examination the applicant filed a number of amendments to the 506 specification, and this decision is based on the specification as most recently proposed to be amended.[21]
[21] This includes amendments up to and including item 3 filed on 13 July 2018.
The 506 specification indicates that the invention relates to synergistic mixtures of Bacillus pumilus INR7 (having accession number NRRL B-50153 or NRRL B-50185; compound II) and a second compound selected from a wide range of fungicidal or insecticidal compounds and plant growth regulators, or Bacillus subtilis MBI600 (having accession number NRRL B-50595) (compounds IA, IB, IC and ID, respectively; collectively, compound I).
It is explained that:
“Synergistic mixtures comprising certain fungicidal compounds and inter alia the Bacillus pumilis strain NRRL B-30087 (QST2808) (active ingredient of commercial products SONATA® and BALLAD® Pluis from AgraQuest, Inc. USA) have been disclosed in WO 2009/037242 and WO 2010/139656. However, no mixtures comprising the specific B. pumilis strain INR7 as defined herein are mentioned therein.”[22]
“Bacillus pumilus INR-7 (defined herein as compound II) is also otherwise referred to as BUF-22 or as BU F-33 or similar codes and has been described e.g. in US 2012/0149571 A1.”[23]
[22] 506 specification, page 6, lines 26-30.
[23] 506 specification, page 7, lines 14-15.
The specification states that it would be desirable to provide pesticidal mixtures solving problems of reducing the dosage rate and/or enhancing the spectrum of activity and/or combining knock-down activity with prolonged control and/or resistance management and/or promoting plant health.[24] Simultaneous (joint or separate) application of compounds I and II or successive application of compound I and compound II is said to allow enhanced control of pests and provide enhanced plant health effects.[25] Plant health indicators may be selected from yield, plant vigour, quality and tolerance to abiotic and/or biotic stress.[26]
[24] 506 specification, page 8, lines 15-18.
[25] 506 specification, page 8, line 30 – page 9, line 1.
[26] 506 specification, page 10, lines 42-43.
According to the specification, the mass ratio of any two ingredients in combination is selected to give the desired (synergistic) outcome and will vary depending on the specific compound I.[27] Preferred mass ratios between any two components are “from 75:1 to 1:75, more preferably, 50:1 to 1:50, especially 25:1 to 1:25, advantageously 10:1 to 1:10, such as 5:1 to 1:5.”[28]
[27] 506 specification, page 14, lines 11-13.
[28] 506 specification, page 14, lines 26-28.
The specification goes on to identify a number of preferred inventive mixtures, including ternary, quaternary and quinary mixtures.[29] Mixtures of compound I and II may be coformulated or may be formulated separately in the form of a kit of parts[30] and details of preferred formulation types are provided.[31] Various fungal plant diseases and animal pests which may be controlled are also identified.[32]
The Examples
[29] 506 specification, pages 16-56.
[30] 506 specification, page 56, line 42 – page 57, line 33.
[31] 506 specification, pages 57-62.
[32] 506 specification, pages 65-71.
The 506 specification describes a number of exemplary strategies by which synergy may be assessed against various fungi and animal pests, but the only mixture for which data is provided is pyraclostrobin and B. pumilus INR7, for which synergistic activity is demonstrated against Sclerotina sclerotiorum in soybean and Gaeuannomyces graminis in wheat, as well as in improvement of wheat plant height.[33]
[33] Use example FG-6, Use example FG-7, Use example H-2.
While mixtures comprising pyraclostrobin are not presently claimed, I note that in the examination response of 16 February 2018 (and again as an annexure to the declaration of Dr Liebmann) the applicant provided evidence to support the synergistic activity of the claimed combinations. Specifically, the applicant provided data indicating that B. pumilus INR7, and each of dimethomorph, bifenthrin, thiamethoxam, thiram, thiodicarb, alpha-cypermethrin and metalaxyl individually have low activity against grey mould Botrytis cinerea, but each of the active agents combined with B. pumilus INR7 exhibits a synergistic effect.
The claims
The 506 specification ends with six claims, which are set out in the Annex. Claims 1 and 2 are the only independent claims, and claim 1 reads:
Synergistic mixtures comprising, as active components,
1) one fungicidal compound IA selected from the group consisting of metalaxyl, dimethomorph and thiram;
or
2) one insecticidal compound IB selected from the group consisting of thiodicarb, bifenthrin, alpha-cypermethrin and thiamethoxam;
and
5) Bacillus pumilus INR7 having the accession number NRRL B-50153 or NRRL B-50185 as compound II wherein the ratio by weight from compound IA or IB to compound II is from 100:1 to 1:1.
As with claim 1 of the 400 application, the claim is not to a bare mixture of component IA/IB and II, each exhibiting their usual activities, but to a synergistic mixture, and the same considerations as set out in relation to claim 1 of the 400 application apply to this claim.
The claim is to a mixture “comprising” the specified components, and the specification provides an explicit definition of “comprising”:
“Comprises/comprising and grammatical variations thereof when used in this specification are to be taken to specify the presence of stated features, integers, steps or components or groups thereof, but do not preclude the presence or addition of any one or more other features, integers, steps, components or groups thereof.”[34]
Accordingly, the mixture must include at least one compound IA or IB and the defined biopesticide as active components but may also include additional active or inactive components.
[34] 506 specification, page 82a, lines 1-4.
Claim 2 is directed to a kit for preparing a usable pesticidal composition comprising a composition comprising either compound IA or IB and an auxiliary and a composition comprising compound II and an auxiliary. Claim 3 is directed to a pesticidal composition comprising a mixture as defined in claim 1 and a solid or liquid carrier. Claims 4 and 5 are directed to a method for protecting plant propagation material from pests and/or improving the health of plants grown from said plant propagation material by administering a mixture of claim 1 or composition of claim 3 to the plant propagation material. Claim 6 is directed to plant propagation material comprising the mixture of claim 1 or composition of claim 3.
The person skilled in the art
Before addressing each of the grounds of objection in turn, I will consider the relevant skilled person in relation to this application, as many of the grounds of objection are answered by reference to the person skilled in the art:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”[35]
[35] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70].
The hypothetical skilled person works in the field with which the invention is connected, and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[36] In this case, the invention relates to combinations of pesticidal agents, and so the skilled person would be expected to have knowledge of these agents, and the application and formulation of combinations thereof.
[36] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]-[72].
As noted above, the applicant filed a declaration by Dr Liebmann. Dr Liebmann is an inventor of the present application, and therefore is not himself a non-inventive person. However, he clearly has a practical interest in the subject matter, and at the hearing I discussed his evidence with the applicant, who indicated that his explanation was intended to be reflective of the common general knowledge. I have no evidence to suggest that his evidence is idiosyncratic and not representative of what was commonly known, and so I will proceed on the basis that Dr Liebmann’s evidence is indicative of what the notional skilled person would have known or understood at the relevant date.
Manner of manufacture
The objections
The examiner’s objection to the 400 application in relation to manner of manufacture indicated that claim 5 is directed to a kit of known integers and is therefore not a patentable combination:
“Claim 5 is not for a manner of manufacture within the meaning of Sub-section 18(1) of the Patents Act. This claim merely defines a kit or pack of known integers, and therefore does not define a ‘patentable combination’.
Whilst there may be patentable subject matter when known integers are applied simultaneously or sequentially to produce a new product or interacting mixture, the claim has not defined how the kit or pack, by its construction, will in normal use ensure the simultaneous or sequential application of the integers.”
A corresponding objection was raised in relation to the 506 application:
“Claim 2 is not for a manner of manufacture within the meaning of Sub-section 18(1) of the Patents Act. This claim merely defines a kit or pack of known integers, and therefore does not define a ‘patentable combination’.
Whilst there may be patentable subject matter when known integers are applied simultaneously or sequentially to produce a new product or interacting mixture, the claim has not defined how the kit or pack, by its construction, will in normal use ensure the simultaneous or sequential application of the integers.”
The law
It is a requirement of paragraph 18(1)(a) that an invention be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies, and it is well established that for a combination to be patentable there must be a working interrelationship, or potential working interrelationship, between the component integers.[37]
Consideration
[37] See, e.g. British Celanese Ltd v Courtalds Ltd (1935) 52 RPC 171; Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142; Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19; 194 CLR 171.
Claim 5 of the 400 application is directed to a kit comprising one of a composition comprising component IA or IB and an auxiliary, and a composition comprising component II and an auxiliary. Claim 2 of the 506 application is directed to a kit comprising one of a composition comprising component IA or IB and an auxiliary, and a composition comprising component II and an auxiliary. It is apparent that each of components IA, IB and II as defined in these claims are known and no working interrelationship, or potential working interrelationship, is apparent from the claims as drafted.
The applicant did not make submissions in relation to the manner of manufacture objections and indicated an intention to delete these claims. I agree with the examiner that these claims are not for a manner of manufacture, and at the hearing I indicated that I would provide the applicant with an opportunity to make this amendment, and any other amendment necessary, by way of the extended time for gaining acceptance afforded by regulation 13.4.
Novelty
The objection
A novelty objection was raised in relation to the 400 application in light of a document identified in a search carried out by the examiner:
“Claims 1-9 are not novel in view of D9 [AU 2013326645 A1].
D9 is an Australian patent application having a publication date later than the priority date of the present application but having a priority date earlier than that of the present application and therefore is prior art information relevant to novelty in accordance with s7(1)(c) of the Act.
D9 discloses a synergistic pesticidal mixture comprising any one of: metalaxyl, pyrimethanil, fludioxonil, dimethomorph, thiram, fipronil, thiamethoxam, abamectin, chlorantraniliprole, cyantraniliprole; together with a biopesticide that can be bacillus subtilis including the MBI600 strain with accession number NRRL B-50595 (see p. 23 ln. 38 and the claims in D9). Therefore claims 1-9 are not novel in view of D9.”
The law
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) provides that an invention is taken to be novel unless it is not novel in light of the prior art base. Information in a document forms part of the prior art base for the purpose of novelty if it was published before the priority date of a claim. Information is also part of the prior art base for the purposes of novelty if it was contained in a specification published after the priority date of the claim under consideration and, if that information is, or were to be, the subject of a claim of the specification, that claim has, or would have, a priority date earlier than that of the claim under consideration (referred to as “whole of contents” novelty).
It is well established that the general test for lack of novelty is the reverse infringement test, as set out by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd:[38]
“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”.
[38] [1977] HCA 19 at [20]; 137 CLR 228 at 235.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed.[39]The level of disclosure required is set out in General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd[40] (with references omitted):
“To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented. A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”
[39] See Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517.
[40] General Tire & Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] RPC 457 at 486.
The specificity of a disclosure is important when considering anticipation, as highlighted by the majority in AstraZeneca AB v Apotex Pty Ltd:[41]
“The metaphor of planting the flag has been taken up in this Court. For example, in ICI Chemicals, the Full Court at [51], after noting the metaphor, remarked that, in that case, the appellant’s argument involved the skilled addressee rummaging through a ‘flag locker’ to find a flag which the prior art document possessed and could have planted. In Apotex Pty Ltd and Another v Sanofi-Aventis and Another [2008] FCA 1194; (2008) 78 IPR 485 (‘Sanofi-Aventis (2008)’), Gyles J at [91] adopted a different metaphor, remarking that ‘anticipation is deadly but requires the accuracy of a sniper, not the firing of a 12 gauge shotgun’. Each metaphor underlines the importance of the specificity required in order for a prior art document to anticipate an invention as claimed.”
The disclosure of D9
[41] [2014] FCAFC 99; 107 IPR 177 at [294].
D9 discloses pesticidal mixtures comprising at least one pesticidally active anthranilimide compound I of formula (I) as shown below (which does not encompass the compounds IA or IB defined in the present claims) and at least one further pesticidally active compound II chosen from a number of classes, including biopesticides and the classes of fungicidal compounds IA defined in the present claims, in synergistically effective amounts.[42] The list of possible compounds II in D9 extends over more than five pages.
[42] D9, pages 2-10.
D9 states that in some embodiments the mixture of the invention may contain up to four active compounds II and may also contain further active ingredients.[43] D9 identifies each of the presently named actives as a suitable compound II or further active,[44] and in particular, D9 identifies Bacillus subtilis MBI600 as defined in the present claims as one of a range of possible biopesticides which may constitute compound II,[45] stating:
“According to one embodiment of the inventive mixtures, the at least one biopesticide II is Bacillus amyloliquefaciens subsp. plantarum MBI600. These mixtures are particularly suitable in soybean.”[46]
[43] D9, page 13, lines 1-11, page 104, lines 5-8.
[44] D9, pages 7-8, 105, 107.
[45] D9, page 23, lines 37-39, page 25, lines 26-39, page 26, lines 14-15.
[46] D9, page 27, lines 19-21.
The examples of D9 relate to combinations of specific compounds I with chemical pesticides II. None of the examples includes a biopesticide compound II, and each of the examples relates to a binary mixture (i.e. only one compound II combined with one anthranilimide compound I).
Consideration
Having considered the applicant’s written submissions, I advised the applicant that further oral submissions at the hearing were not necessary. The applicant, in its written submissions, submitted that 1) D9 does not in fact have an earlier priority date than the present claims and 2) none of the claimed combinations are specifically taught in D9, the focus of which is the ability of a class of pesticidally active anthranilimide compounds to form synergistic mixtures with other pesticides. The applicant pointed to the many such other pesticides listed in D9.
I have not found it necessary to consider the respective priority claims of the 400 application and the citation. It is apparent that the applicant of D9 had not actually prepared a synergistic composition comprising a chemical pesticide and Bacillus subtilis MBI600, and I agree with the applicant that D9 discloses a great many pesticides with which the anthranilimide compound I may be combined,[47] and this may be in binary, ternary, etc. mixtures. In my view, D9 does not identify combinations comprising the components defined in the present claims with the specificity required for anticipation – it does not “plant the flag” at the claimed invention. Accordingly, I consider that the claims of the 400 application are novel in light of D9.
[47] Applicant’s written submissions at [58].
Section 40
The objections
In maintaining section 40 objections to both the 400 and 506 applications, the examiner referred to the recent decision of the UK Supreme Court in Warner-Lambert Company LLC v Generics (UK) Limited (t/a Mylan) and ors (Warner-Lambert).[48] In summary, the objections indicate that the examiner considers the specification as filed to be speculative, and in the absence of a cogent technical theory supporting broad applicability of synergy at the filing date, the post-filing evidence of synergy cannot be relied on to support the sufficiency of the specification. While the objections are framed in terms of section 40(2)(a), it is indicated that the claims also lack support as required by section 40(3) for similar reasons. Relevant parts of the objection in relation to the 400 application are as follows:
[48] [2018] UKSC 56.
“The attorney has referred to Warner-Lambert Company LLC v Apotex Pty Limited (No 2) [2018] FCAFC 26 in the previous responses. However, this case was decided under the old provisions of s40(2)(a) and so is of little guidance in this case.
Instead, the Evolva decision of this office went some way to adopting some of the principles of UK/EU law and set out the new requirements of s40(2)(a) thus:
‘Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
(a) Is it plausible that the invention can be worked across the full scope of the claim?
(b) Can the invention be performed across the full scope of the claim without undue burden?" (Evolva SA [2017] APO 57 paragraph 45).
In essence, this decision regarded that the test for s40(2)(a) is one of undue burden and plausability. The concept of plausability has just recently been set out in detail in Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 (the UK Warner-Lambert decision), where it was held that it is a requirement that a ‘patent should disclose not just what the invention is and how to replicate it, but some reason for expecting that it will work. Plausability was the standard to which the patentee was expected to demonstrate this.’ (paragraph 23).
In response to the last report, the attorney has substantially narrowed the claims and so at present it is acknowledged that there is no undue burden of experimentation to perform the claimed invention. However, the specification and claimed invention fails the plausability test. This is because the originally filed specification is entirely speculative in nature and simply asserts that synergy is present in thousands of combinations selected from very long lists of compounds with no experimental data to back up the claims of synergy. The only combination tested was that including pyraclostrobin and so it is plausible that other strobilurin type fungicides might provide synergistic combinations with the claimed bacteria, but not any of the combinations presently claimed.
The UK Warner-Lambert decision states with reference to an EPO Technical Board decision at paragraph 40:
‘Sufficiency of disclosure must be satisfied at the effective date of the patent, i.e. on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent.’
Therefore the data provided by the attorney on 24 April 2018 cannot provide a disclosure of the claims because it was filed after the filing date. As the attorney points out, common general knowledge and a coherent technical theory can provide some plausibility that an invention can work and thus obviate the need for experimental data. However, no theory has been presented other than that synergy is possible between the claimed bacteria and other compounds. But just because synergy can exist between some combinations, this does not mean it can exist between any combinations as synergy is entirely unpredictable in nature…
Therefore it remains outstanding that the specification does not comply with the requirements of s40(2)(a). For similar reasons, the claims also lack support as required by s40(3).”
Relevant parts of the objection in relation to the 506 application are as follows:
“The examiner agrees with the attorney that the Raising the Bar Act 2012 was indeed intended to align many parts of our Patents Act with UK and EU legislation, including s40(2)(a). It is also agreed that there is currently little Australian judicial guidance for interpreting this part of the Act and so UK and EU legislation is what can highly persuade current Australian examination decision making. With this in mind, the UK Supreme Court recently handed down a landmark decision on disclosure requirements in Warner-Lambert Company LLC v Generics (UK) Ltd [2018] UKSC 56 (the UK Warner-Lambert decision hereinafter). In particular, this case elaborated on the concept of the ‘plausibility’ test in addition to the undue burden test for sufficient disclosure in that:
A ‘patent should disclose not just what the invention is and how to replicate it, but some reason for expecting that it will work. Plausability was the standard to which the patentee was expected to demonstrate this.’ (paragraph 23).
…
In the present case, it is acknowledged that there is no undue burden of experimentation to perform the claimed invention but it does not pass the plausibility test. This is because the originally filed specification is entirely speculative in nature and simply asserts that synergy is present in thousands of combinations selected from very long lists of compounds with no experimental data to back up the claims of synergy. The only combination tested was that including pyraclostrobin and so it is plausible that other strobilurin type fungicides might provide synergistic combinations with the claimed bacteria, but not any of the combinations presently claimed.
In response to the last report, the attorney has cited an EPO decision that seems to support the notion that evidence filed after the filing date of a specification can be used to provide sufficiency of disclosure. However, the UK Warner-Lambert decision also addresses this issue in detail, where it states with reference to an EPO Technical Board decision at paragraph 40:
‘Sufficiency of disclosure must be satisfied at the effective date of the patent, i.e. on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent.
This does not mean that subsequent data is never admissible in a dispute about sufficiency, but the purpose for which it is admitted is strictly limited.’
Therefore the data provided by the attorney on 16 February 2018 cannot provide a disclosure of the claims because it was filed after the filing date and it does not serve to confirm any theory originally disclosed in the patent as filed. The only theory that has been presented at the filing date is that synergy is possible between the claimed bacteria and other compounds. But just because synergy can exist between some combinations, this does not mean it can exist between any and all combinations, as synergy is entirely unpredictable in nature.”
As mentioned previously, the report regarding the 400 application also includes a clarity objection:
“Claim 1 lacks clarity in that it refers to M-2 GABA-gated chloride channel antagonists but does not list which ones after the colon. Clarification is requested.”
Given the applicant’s intention to amend the claim as discussed previously, it is not necessary to consider this objection further.
The law
The disclosure and support requirements introduced by the Raising the Bar Act are closely connected. Paragraph 40(2)(a) as amended by the Raising the Bar Act requires that the claimed invention be described in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art. This requires that the specification provide sufficient information to enable the skilled person to perform the invention across the scope of the claims without undue burden or the need for further invention.[49] Subsection 40(3) as amended by the Raising the Bar Act requires that the claims must be supported by matter disclosed in the specification. The requirement of support can be summarised as requiring that the scope of the claims “should correspond to the technical contribution to the art”.[50] Support requires “the description to be the base which can fairly entitle the patentee to a monopoly of the width claimed”[51] and requires that “the claims should not extend to subject-matter which, after reading the description, would still not be at the disposal of the person skilled in the art.”[52]
[49] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), pages 46-48.
[50] EXXON/Fuel Oils (T409/91) [1994] OJ EPO 653 at 659. See also Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), pages 48-49.
[51] Schering Biotech Corp.’s Application [1993] RPC 249 at 252.
[52] EXXON/Fuel Oils (T409/91) [1994] OJ EPO 653 at 659.
The amendments to these provisions were intended to align the Australian requirements with those of overseas jurisdictions, in particular, the UK and Europe.[53] While these provisions have been considered by the Federal Court in Encompass Corporation v InfoTrack Pty Ltd,[54] the grounds were disposed of without the need to articulate a generally applicable approach – the Respondent did not advance a case of lack of enablement. In considering the provisions delegates of the Commissioner have, in accordance with the instruction in the Explanatory Memorandum, relied on decisions relating to the corresponding provisions in the UK and Europe.[55] This has included adoption of “plausibility” (that is, a requirement that the disclosure make the claimed invention plausible) as an element of the sufficiency test.[56]
[53] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), pages 47, 49.
[54] [2018] FCA 421; 130 IPR 387.
[55] See, e.g. CSR Building Products Limited v United States Gypsum Company [2015] APO 72, Evolva SA [2017] APO 57; 133 IPR 147, INTER AQUA ADVANCE A/S v Bent Urup Holding ApS [2018] APO 43, Grant Fisher v ToolGen Incorporated [2018] APO 65, Gary B Cox v MacroGenics, Inc. [2019] APO 13.
[56] See, e.g. Evolva SA [2017] APO 57; 133 IPR 147, Grant Fisher v ToolGen Incorporated [2018] APO 65, Gary B Cox v MacroGenics, Inc. [2019] APO 13.
The examiner approached the objections principally on the basis of section 40(2)(a), but also noted that similar reasons supported an objection under section 40(3). The applicant submitted that in this case, the more appropriate ground under which the examiner’s concern should be considered is support, rather than disclosure. In the applicant’s submission, while plausibility may be a consideration in relation to section 40(2)(a) where it relates to working out how to identify what falls within the scope of the claims and whether there is an undue burden, plausibility where directed to speculative claiming relates to section 40(3) in Australia. I also understand the applicant to draw a distinction between the threshold required to prevent speculative claiming as opposed to the consideration of whether there is a technical contribution to the art, which I understand the applicant to submit carries a risk of setting the relevant threshold too high.
I consider that in following the guidance in the Explanatory Memorandum that “[t]he intention is that paragraph 40(2)(a) be given, as close as is practicable, the same effect as the corresponding provisions of UK legislation and the European Patent Convention”,[57] plausibility is appropriately considered in relation to section 40(2)(a). I agree with the applicant that this concept is also of relevance to section 40(3), but while I accept that the threshold for plausibility is not high, it is clear from the Explanatory Memorandum that the requirement that “the scope of the claims must not be broader than is justified by the extent of the description, drawings and contribution to the art”[58] requires more than textual consistency. I cannot see that it is possible to consider support without considering whether there is a contribution to the art and what it is. In this regard, a plausible assertion might be considered to provide a contribution to the art, as the Deputy Commissioner observed in Evolva SA[59] (Evolva):
“the recent UK decisions referred to above seem to me to be founded in the principle that the scope of the monopoly, as defined in the claims, must correspond to the technical contribution the patentee has made to the art. If the assertions made in the specification are not plausible then it cannot be reasonably said that the patentee has made a contribution to the art. Moreover, the requirement set out in Regeneron that the claim (or of a term used within a claim) be based on a reasonable prediction, or an assertion that the invention works across the full scope of the claim be plausible or credible, appears to me to be consistent with, or an alternative means of articulating, the concept of a principle of general application as set out by Lord Hoffmann in Kirin-Amgen. An assertion in a patent specification could hardly be considered a principle with broader applicability if the skilled reader would not consider it plausible from a technical viewpoint.”[60]
[57] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), page 47.
[58] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), page 49.
[59] [2017] APO 57; 133 IPR 147.
[60] Evolva at [43].
I agree with his observations, and they demonstrate the congruence between the notion of plausibility as understood in relation to section 40(2)(a) and the requirement of section 40(3) that the scope of the claims correspond to the contribution to the art.
The affinity of the corresponding provisions as they appear in the EPC was also described by the EPO Technical Board of Appeal:
“Although the requirements of Article 83 and Article 84 are directed to different parts of the patent application, since Article 83 relates to the disclosure of the invention, whilst Article 84 deals with the definition of the invention by the claims, the underlying purpose of the requirement of support by the description, insofar as its substantive aspect is concerned, and of the requirement of sufficient disclosure is the same, namely that the patent monopoly should be justified by the actual technical contribution to the art.”[61]
[61] EXXON/Fuel Oils (T409/91) [1994] OJ EPO 653 at 662.
The Supreme Court in the UK recently provided further guidance with regard to the plausibility consideration in Warner-Lambert with respect to a second medical use (Swiss style) claim. In a majority decision, the conclusions of the lower courts with regard to the plausibility threshold were overturned, with Lord Sumption (with whom Lords Reed and Briggs agreed) stating:
“They [the Court of Appeal] considered that the threshold was not only low, but that the test could be satisfied by a ‘prediction … based on the slimmest of evidence’ or one based on material that was ‘manifestly incomplete’. Consistently with that approach, they considered (paras 40, 130) that the Board’s observations in SALK laid down no general principle. I respectfully disagree. The principle is that the specification must disclose some reason for supposing that the implied assertion of efficacy in the claim is true. … The test is relatively undemanding. But it cannot be deprived of all meaning or reduced, as Floyd LJ’s statement does, to little more than a test of good faith. Indeed, if the threshold were as low as he suggests, it would be unlikely to serve even the limited purpose that he assigns to it of barring speculative or armchair claims.”[62]
[62] Warner-Lambert at [36].
The applicant submitted that the question of where to draw the line in order to exclude speculative claiming in any given case is difficult, noting that the decision in Warner-Lambert, in which a majority of the Supreme Court overturned the Court of Appeal and the trial judge, illustrates this. I agree with the applicant that the question of whether an assertion is plausible will not always be straightforward. Indeed, Lord Hodge, despite disagreeing with Lord Sumption’s conclusion regarding sufficiency, agreed with his view that “the patentee must disclose in its patent, when read in the light of the common general knowledge, the contribution to the art which justifies his monopoly” as well as “some scientific reason for thinking that the medicament might well have the claimed therapeutic effect.”[63] As stated by Lord Sumption, “[p]lausibility is not a term of art, and its content is inevitably influenced by the legal context”,[64] but it is clear that plausibility is a technical consideration and a relatively undemanding test.[65]
[63] Warner-Lambert at [179].
[64] Warner-Lambert at [37].
[65] I note that the applicant indicated that a low threshold was appropriate, given that the Act also requires that an invention be useful, and that setting the threshold too high could lead to the incongruous outcome of a specification being insufficient to support a claim to subject matter which it was later able to anticipate.
In relation to context, the applicant noted that the present claims are product claims, and referred to Lord Sumption’s focus on second medical use claims:
“Section 14 of the Patents Act and the corresponding provisions of the EPC assume that an invention will be sufficiently disclosed if the specification enables it to be ‘performed’. In the case of a patent for a new product or process, that assumption is almost always correct. The skilled person will discover that it works by replicating it in accordance with the specification. But the assumption is not correct in the case of a second use patent. The invention is not the compound or the process of its manufacture. The skilled person already knows how to make the product from the prior art disclosed in the original patent. The invention consists in the new purpose for which the product is to be manufactured. If sections 14(3) and 72(1)(c) are read literally and as an exhaustive statement of the requirement of sufficiency, all that needs to be disclosed is the new purpose, which is enough to enable it to be administered to a patient suffering from the relevant condition. The skilled person does not need to know how or why the invention works to replicate it. The result would be that the knowledge which made the identification of the new purpose inventive need not be disclosed at all.
The main problem about this result is that it would enable a patent to be obtained on a wholly speculative basis. Without some disclosure of how or why the known product can be expected to work in the new application, it would be possible to patent the manufacture of known compounds for the purpose of treating every conceivably relevant condition without having invented anything at all, in the hope that trial and error might in due course show that the product was efficacious in treating at least some of them.”[66]
[66] Warner-Lambert at [19]-[20].
The applicant therefore submitted that the specific requirements for second medical use claims articulated by Lord Sumption do not apply to the present claims. It is true that for a simple product claim, the technical contribution may be equated with non-obvious novelty.[67] However, while claim 1 of each the present applications is clearly directed to a product, and not a use or process, they are not “simple” in the sense that the compositions have the added limitation of being synergistic. It is, in my view, consistent with the UK and European case law[68] and the Explanatory Memorandum,[69] that the specifications must make it plausible or credible that the combinations of agents defined in the claims will actually result in synergistic mixtures in order for the technical contribution to the art to support the claims.
The role of post-filing evidence
[67] Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12; [2009] RPC 12 at [95].
[68] See, e.g. Regeneron Pharmaceuticals, Inc. v Kymab Limited [2018] EWCA Civ 671 at [235]-[238]; Merck Sharp and Dohme Limited v Shionogi & Co Limited [2016] EWHC 2989 (Pat) at [234]; T 1735/12; Evolva at [44]. I note, however, that the concept of plausibility arises more often in the context of inventive step in European decisions.
[69] Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 (Cth), page 48.
As mentioned previously, there is evidence establishing that it is, in fact, the case that synergistic combinations of B. subtilis MBI600 and B. pumilus INR7 with each of the chemical pesticides defined in the claims of the 400 and 506 applications, respectively, can be made. However, that evidence was not present in the specifications as filed and so there is a question as to the use that can be made of this post-filing evidence.
I note that in my view there is a distinction to be made between evidence as to what a skilled person would have understood from a specification at the relevant date, which would generally be of assistance in considering sufficiency,[70] and post-filing data (i.e. establishing efficacy) of the sort provided in this case. The observations below relate to this latter category of evidence.
[70] Noting the observation of the Court of Appeal in Regeneron Pharmaceuticals, Inc v Kymab Limited [2018] EWCA Civ 671 at [209] that “the skilled person may use his or her common general knowledge to supplement the information contained in the specification” – that is, the requirement that sufficiency is a characteristic of the disclosure is tempered to the extent that the common general knowledge may be used to supplement the disclosure.
This is a matter which has not received attention following the implementation of the Raising the Bar Act, and so, in accordance with the guidance in the Explanatory Memorandum, I will have regard to UK and European case law as to the role of such evidence in relation to questions of support and sufficiency.
In Warner-Lambert Lord Sumption quoted[71] the EPO Technical Board of Appeal in SALK INSTITUTE/AP-1 complex:[72]
“Sufficiency of disclosure must be satisfied at the effective date of the patent, ie on the basis of the information in the patent application together with the common general knowledge then available to the skilled person. Acknowledging sufficiency of disclosure on the basis of relevant technical information produced only after this date would lead to granting a patent for a technical teaching which was achieved, and, thus, for an invention which was made, at a date later than the effective date of the patent. The general principle that the extent of monopoly conferred by a patent should correspond to, and be justified by, the technical contribution to the art, has to be kept in mind.”
[71] Warner-Lambert at [40].
[72] T 0609/02.
Lord Sumption went on to state:
“This does not mean that subsequent data is never admissible in a dispute about sufficiency, but the purpose for which it is admitted is strictly limited. Where the asserted therapeutic effect is plausible in the light of the disclosure in the patent, subsequent data may sometimes be admissible either to confirm that or else to refute a challenger’s contention that it does not actually work … it cannot be a substitute for sufficient disclosure in the specification.”
That post-filing data, in itself, will not render an otherwise insufficient specification sufficient is also a common refrain in decisions of Boards of Appeal of the EPO.[73] In view of the Explanatory Memorandum, I find this, and the reasoning of Lord Sumption, highly persuasive. This is also consistent with the express words of section 40: it is the specification that must disclose the invention sufficiently and support the claims. I will follow this guidance of the UK and the EPO in relation to the use of post-filing evidence.
[73] For example, T 0950/13, T 1364/08, T 1602/10, T 1255/11.
The applicant submitted that the post-filing evidence in this case both 1) supplemented the evidence contained in the specifications and 2) refuted the contentions of the examiner (the challenger in this case) regarding the unpredictability of synergy.
Consideration
In Evolva[74] the Deputy Commissioner considered paragraph 40(2)(a), and having drawn guidance from European and UK decisions, adopted the following approach to assessing a clear enough and complete enough disclosure:
What is the scope of the invention as claimed?
What does the specification disclose to the skilled person?
Does the specification provide an enabling disclosure of all the things that fall within the scope of the claims, and in particular:
(a) Is it plausible that the invention can be worked across the full scope of the claim?
(b) Can the invention be performed across the full scope of the claim without undue burden?
[74] Evolva at [45].
To determine whether the requirements of support are satisfied the following steps were set out in CSR Building Products Limited v United States Gypsum Company[75]:
i. construe the claims to determine the scope of the invention as claimed,
ii. construe the description to determine the technical contribution to the art, and
iii. decide whether the claims are supported by the technical contribution to the art.[75] [2015] APO 72 at [115].
It is clear that these two approaches have significant overlap, and in this case I will consider the submissions and considerations relevant to these grounds together, following these approaches.
I have discussed the disclosure of the specifications and the scope of the claims previously. It suffices to note here that the specification of the 400 application provides no experimental data relating to mixtures of B. subtilis MBI600 and the chemical pesticides defined in the present claims, although there is experimental evidence of synergistic mixtures with two other chemical pesticides. Similarly, the specification of the 506 application provides no experimental data relating to mixtures of B. pumilus INR7 and the chemical pesticides defined in the claims, although there is experimental evidence of synergistic mixtures with another chemical pesticide. There is no evidence in either specification of any mixtures which are not synergistic.
While the specifications, given what they present as the invention, can be understood to assert that it would be expected that synergistic combinations would result upon combination of B. subtilis MBI600 and B. pumilus INR7 with other chemical pesticides, including those of the present claims, they do not provide any underpinning explanation for this assertion.
Dr Liebmann commented on the plant health promoting effects of various Bacillus isolates and the likelihood of these isolates giving rise to synergistic effects in combination with chemical pesticides:
“Plant health promotion from the use of a single isolate may be by way of numerous secreted factors such as enzymes, toxins or other molecules that act directly on pests and pathogens (both at the root level or when applied topically). Secreted enzymes may also increase bioavailability of nutrients in the soil, improving plant nutrition. The presence of Bacillus in soil may also mitigate against environmental stresses such as drought and salinity by modulation of plant gene expression, which in turn impacts hormonal signals and metabolism.
The molecular mechanisms by which Bacillus promotes plant health are not well understood. Further, the combination of plant growth promotion factors possessed by any given Bacillus isolate can be unique to that isolate. As such, plant health-promoting activities of different isolates vary and only selected Bacillus strains may have pesticidal activity.
Because of the multiple operating factors of a relevant Bacillus isolate, where a synergistic effect is observed in respect of a chemical pesticide, there is an increased likelihood of a synergistic effect similarly occurring with another chemical pesticide as there is a greater likelihood that the mechanism of action of the chemical pesticide will similarly be distinct from the mechanism or mechanisms of action of the bacterial secreted factors.”[76]
[76] Liebmann at [16]-[18].
Dr Liebmann highlighted the structural differences between pyraclostrobin and triticonazole (depicted previously), and stated:
“Given the synergism between Bacillus subtilis MBI600 and fungicidal compounds having these significantly different chemical structures, and based also on the matters that I describe in paragraphs 11 and 12 above, I considered and still consider that it was likely that synergism would also occur with the other known pesticidal compounds that are listed in the application.”[77]
[77] Liebmann at [24]. I questioned the reference to paragraphs 11 and 12 at the hearing, and I understand that paragraphs 17 and 18 should have been referred to instead. I have proceeded on that basis.
Dr Liebmann further stated:
“WO2014/079773[78] discloses at pages 75-82 synergism between Bacillus pumilus INR7 and Pyraclostrobin, in treating fungal disease (two different fungal species) as well as improving plant height.
I expected that synergism would also occur with the other compounds listed in the application. For similar reasons to those in paragraphs 11 and 12 above, I expected that synergism would also likely be demonstrated with pesticides having other chemical structures.”[79]
[78] WO2014/079773 is the published PCT application corresponding to the parent of the 506 application, and the examples correspond to those present in the 506 application as filed.
[79] Liebmann at [29]-[30]. I questioned the reference to paragraphs 11 and 12 at the hearing, and I understand that paragraphs 17 and 18 should have been referred to instead. I have proceeded on that basis.
Dr Liebmann’s evidence seems to be a clear statement from a skilled person, in declaratory form, that supports a conclusion that the specifications as filed are sufficient, when considered by a skilled person equipped with the common general knowledge. It must be accorded some weight, and there is no evidence to the contrary. I will say, however, that I have had some difficulty following Dr Liebmann’s reasoning – that is, it is not immediately clear to me why the observation of synergy between a particular Bacillus and a chemical pesticide having a given mechanism of action makes it more or less likely that synergy will be observed with a different chemical pesticide with a different mechanism of action. At the hearing I raised this concern. The applicant submitted that Dr Liebmann’s evidence is that there are often numerous secreted factors that can operate in different ways, not all of which are directly pesticidal but may be supportive of the plant in other ways, and insofar as that might assist a plant to have resistance to attack that is then supported by a chemical pesticide, this might give rise to synergy in a different manner than between two chemical pesticides. The applicant also suggested that Dr Liebmann’s evidence could be understood as a suggestion that having observed synergy with one or two combinations, a skilled worker would be motivated to test other combinations because they might well be synergistic despite the fact that they might work in different ways.
This latter submission, in the absence of any further reasoning, seems troublingly similar to the position rejected by Lord Sumption in Warner-Lambert, referring to Lord Hoffmann’s observation in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc[80] that “it is hard to see how the notion that something is worth trying or might have some effect can be described as an invention in respect of which anyone would be entitled to a monopoly”, when commenting on the evidence of a declarant who indicated that the data in the specification would “inspire you to analyse its activity in a broad range of pain models”.[81]
[80] [2008] UKHL 49; [2008] RPC 28 at [28].
[81] Warner-Lambert at [53].
However, the submission that synergy might result from the combination of chemical pesticides with supportive factors secreted by the Bacillus isolate, while not clearly articulated in those terms by Dr Liebmann, is generally consistent with his evidence, and seems credible. Dr Liebmann’s expectation was also correct, as established by the post-filing data, which can in this case be seen as confirming what would be understood from the specification as filed by a skilled addressee equipped with the common general knowledge. This leads me to a view that the applicant’s rebuttal of the examiner’s position that synergy is “entirely unpredictable” is, at least in the present circumstances, well-founded.
Ultimately, Dr Liebmann’s statement that he considered it “likely” that synergism would occur in the claimed combinations on the basis of the information in the specifications as filed is expressed in declaratory form, there is no evidence before me to contradict it, and it is supported by the post-filing data. In these circumstances I cannot maintain that it is not plausible that the invention defined in each application can be worked across the full scope of the claims, and the examiner accepted, and I have no reason to doubt, that it would not be an undue burden to work the invention claimed in each application across its full scope. Similarly, I do not think it can be said that the contribution to the art is limited to the examples, or to combinations containing only pesticides from the same classes as the examples. It follows that I am not satisfied that the claims are broader than the technical contribution to the art. I conclude that it has not been established that the specifications do not comply with the disclosure and support requirements of section 40.
Inventive step
The objections
The examiner indicated that the claims of both the 400 application and the 506 application lack inventive step in light of the common general knowledge, referring to a number of documents as indicative of the common general knowledge. The objection to the 400 application reads:
“Claims 1-9 do not involve an inventive step in view of the common general knowledge in the art.
As mentioned in objection 4 above, this objection is raised in the alternative to objection 4.
Each of the fungicides and insecticides defined in claim 1 are all very well known in the art (see for example D10 and D11). Bacillus subtilis, including the claimed MBI600 strain, is also well known in the art. It is also well known to combine biopesticides such as bacillus subtilis with other pesticides to form synergistic pesticide mixtures (see D1-D8, D10 and D11).
The problem to be solved in the present application is; there is a need for an alternative synergistic pesticidal mixture that has reduced dosage rate and/or enhanced activity.
In view of this problem, given that bacillus subtilis MBI600 has been shown to be synergistic in other pesticide combinations, the skilled person would be directly led as a matter of routine to try the claimed invention with a reasonable expectation of success. Such a solution would be arrived at through a routine trial and error, non-inventive process by the skilled person utilising their common general knowledge as referenced above. Therefore all of claims 1-9 lack an inventive step in view of the common general knowledge in the art.”
The objection in relation to the 506 application reads:
“Claims 1-6 do not involve an inventive step in view of the common general knowledge in the art.
Each of the fungicides and insecticides defined in claim 1 are all very well known in the art (see for example D1-D3). Bacillus pumilus, including the claimed INR7 strain, is also well known in the art (see D4). It is also well known to combine biopesticides such as bacillus pumilus with other pesticides to form synergistic pesticide mixtures (see D1-D3).
The problem to be solved in the present application is; there is a need for an alternative synergistic pesticidal mixture that has reduced dosage rate and/or enhanced activity.
In view of this problem, given that bacillus pumilus has been shown to be synergistic in other pesticide combinations, the skilled person would be directly led as a matter of routine to try the claimed invention with a reasonable expectation of success. Such a solution would be arrived at through a routine trial and error, non-inventive process by the skilled person utilising their common general knowledge as referenced above. Therefore all of claims 1-6 lack an inventive step in view of the common general knowledge in the art.”
The law
Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim when considered alone or together with the information mentioned in subsection 7(3).
Subsection 7(3) defines the relevant information as:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
Having identified the common general knowledge and any relevant information as defined in subsection 7(3), the test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention, as set out by Aickin J:
“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.”[82]
[82] Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12; (1981) 148 CLR 262 at 286.
The High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd[83] approved this approach as well as that taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd,[84] of asking whether the person skilled in the art would be directly led as a matter of course to try what was claimed in the expectation that it might well produce a useful or desired result. Importantly, the reformulated Cripps question does not preclude the possibility that person skilled in the art might be directly led to try more than one alternative expecting that each may well produce a useful or desired result.[85]
[83] [2002] HCA 59; 212 CLR 411 at 432-433, [50]-[53].
[84] [1970] RPC 157 at 187.
[85] Mylan Health Pty Ltd (formerly BGP Products Pty Ltd) v Sun Pharma ANZ Pty Ltd (formerly Ranbaxy Australia Pty Ltd [2019] FCA 28 at [192], Nichia Corporation v Arrow Electronics Australia Pty Ltd [2019] FCAFC 2 at [91]-[93].
Where a claim is directed to a combination of known integers obviousness is not established merely by identifying each of those features in the prior art or the common general knowledge – the question is whether the combination of those features is obvious.[86] In this regard, the High Court’s observation is apposite:
“It is the selection of the integers out of ‘perhaps many possibilities’ which must be shown to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.”[87]
[86] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9; 1A IPR 231 at 256, Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at 429, [41].
[87] Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 at 429, [41].
The inventive step objections were raised in the alternative to the section 40 objections, reflecting the potential squeeze between obviousness and sufficiency. I have decided above that the specifications are sufficient on the basis that the existence of synergy in the claimed combinations is plausible. However, while I agree with the examiner that this certainly raises a question as to obviousness, the squeeze between these grounds is imperfect. In this regard, I note the comments of Carr J in GlaxoSmithKline UK Limited v Wyeth Holdings LLC:[88]
“…GSK relied upon a number of alleged squeezes between the prior art and sufficiency. The submission was that the Patent, the priority documents and the application as filed are no more enabling than the prior art. Therefore, the Patent must be invalid, as one or other of these objections must succeed. I do not accept this submission. As I have indicated in my judgment, the disclosures of the Patent, the priority documents, and the application as filed, are very different from the disclosure of the prior art relied upon. The former documents disclose that protein 2086 is a credible and serious candidate for inclusion in a Men B vaccine; that there would be a fair prospect that this antigen would treat a broad range of Men B strains; and that coverage could be increased by inclusion of one or more PorAs. The prior art does not provide this disclosure, nor does it render it obvious.”
[88] [2016] EWHC 1045 at [258].
That is, it is important to distinguish between what is taught by the prior art and what is disclosed in the specification under consideration.
The problem
In my view the problem addressed by both specifications can reasonably be formulated as the provision of pesticidal mixtures which solve problems of reducing the dosage rate and/or enhancing the spectrum of activity and/or combining knock-down activity with prolonged control and/or resistance management and/or promoting plant health. At the hearing the applicant submitted that the problem was not particularly directed to synergistic combinations, but was directed to useful combinations with, among other things, decreased loading of chemical pesticides – which is enhanced in synergistic combinations. I agree with that submission.
Common general knowledge
It seems to be uncontroversial that the chemical pesticides recited in the claims are part of the common general knowledge.[89] Similarly, I take from Dr Liebmann’s evidence that a skilled person would be familiar with the use of Bacillus as a biopesticide:
“Bacillus is a genus of Gram-positive, rod-shaped bacteria that is ubiquitous in nature, particularly soil. Bacillus species isolated from soil form part of the rhizosphere – a region of soil surrounding a plant root where the biology and chemistry of the soil is influenced by the root.
There is a significant body of literature which describes the complex and varied mechanisms for broad pesticide activity of Bacillus by way of secreted factors and effects on plant gene expression … In brief, Bacillus can promote plant health by:
(i)antagonism of pest and pathogens,
(ii)promotion of host nutrition and growth, and
(iii)stimulation of plant host defences.”[90]
[89] 400 specification, page 7, lines 11-12: “The remaining compounds IA, IB as well as their pesticidal action and methods for producing them are generally known.” 506 specification, page 7, lines 34-35: “The remaining compounds IA, IB as well as their pesticidal action and methods for producing them are generally known.”
[90] Liebmann at [14]-[15].
Dr Liebmann also referred to an article titled ‘Identification and characterization of novel genetic markers associated with biological control activities in Bacillus subtilis’[91] as showing:
“…that strains of Bacillus exist that have no defined biocontrol capabilities, and that some commercial strains of Bacillus that are used as biopesticides share some genes in common, but are otherwise genotypically distinct. This reinforces what was well known to me, which was that the effectiveness of different Bacillus isolates in terms of their biocontrol capabilities could vary greatly.”[92]
[91] Joshi, R. and McSpadden Gardener, B.B. ‘Identification and characterization of novel genetic markers associated with biological control activities in Bacillus subtilis’, Phytopathology (2006) vol. 96: 145-154.
[92] Liebmann at [19].
I note that this article also states:
“Subtilex (Becker Underwood, Ames, IA) contains B. subtilis strain MBI600, which has been indicated for use against Fusarium, Aspergillus, and Rhizoctonia spp. on roots of soybean and peanut and against Botrytis spp. infection of vines, strawberry, and cucumber, powdery mildew of tomato, and brown rust of cereals.”
This is consistent with the reference in the 400 specification to the MBI600 strain being commercially available. I will proceed on the basis that B. subtilis MBI600, and its activity, is part of the common general knowledge.
The assertion in the examiner’s objection that B. pumilus INR7 is well known has not been contested by the applicant in its submissions or in Dr Liebmann’s evidence, and so I will proceed on the basis that it forms part of the common general knowledge.
It seems to me that the combination of pesticidal actives is also known and routine in the art, and that the potential for synergistic outcomes from such combinations is understood. In this regard I note Dr Liebmann’s observations that “[t]here is a long history in the agricultural industry of using pesticidal mixtures”[93] and:
“BASF has pursued patent protection globally for approximately 1000 patent families directed to synergistic combinations of pesticides. These patents span the last 40 years. These patents demonstrate that synergism can be achieved with pesticides of different classes, and which have very different chemical structures.”[94]
Inventive step in light of the common general knowledge alone
[93] Liebmann at [7].
[94] Liebmann at [8].
While each of the components of the combinations claimed in the 400 application and the 506 application, and the making of combinations, was known in the art, given the broad formulation of the problem, the starting point for the invention must also be at a level of generality, and the skilled person is faced with the field of known pesticides in seeking to solve the problem.
While prima facie it would seem a routine exercise for a skilled person to make and test combinations of pesticides in seeking useful combinations, the applicant submitted that the field of pesticides is vast, which is clearly the case, and that a skilled person would have no expectation that any given combination would be effective. In this regard, the applicant submitted with respect to the 400 application:
“What the inventors … found specifically was that Bacillus subtilis MBI600 was able to achieve a synergistic effect in combination with each of pyraclostrobin and triticonazole. It was the establishment, by experimental evidence, of the ability of Bacillus subtilis MBI600 to achieve those synergistic effects that provided the necessary support for the claims.
But the fact that such synergism could be predicted from those experimental results does not mean that it was predictable from the common general knowledge alone.”[95]
[95] Applicant’s written submissions at [66]-[67].
Similarly, in relation to the 506 application the applicant submitted that “the disclosure of experimental evidence in the prior art of other Bacillus isolates in mixtures that achieve synergy does not mean that a skilled person would be directly led as a matter of course to select the claimed Bacillus pumilus INR7 isolate.”[96]
[96] Applicant’s written submissions at [75].
These submissions are broadly consistent with Dr Liebmann’s evidence regarding the genotypic distinctiveness of Bacillus strains and corresponding varying biocontrol capabilities.[97]
[97] Liebmann at [17]-[19].
In considering the present facts, I am mindful of the guidance of the majority of the High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd,[98] who referred with approval to the observations of Judge Rich in In re O’Farrell in rejecting an “obvious to try” approach to inventive step:
“The admonition that ‘obvious to try’ is not the standard under §103 has been directed mainly at two kinds of error. In some cases, what would have been ‘obvious to try’ would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. … In others, what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising filed of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it.”[99]
[98] [2002] HCA 59; 212 CLR 411 at 442-443, [76].
[99] (1988) 853 F 2d 894 at 903.
The High Court also noted that the danger of misusing hindsight is particularly acute when considering a claim to a combination.[100]
[100] [2002] HCA 59; 212 CLR 411 at 423-424, [21].
In this case, although the components of the claimed combinations were known, and it could be said that they were “obvious to try”, there is nothing to suggest why a skilled person, would, in the absence of hindsight and faced with the substantial field of available pesticides, be motivated to select B. subtilis MBI600 or the chemical pesticides defined in the claims of the 400 application, or B. pumilus INR7 or the chemical pesticides defined in the claims of the 506 application, with an expectation that a combination of those agents would solve the problem, or more particularly, provide a synergistic mixture. In these circumstances I cannot conclude that the invention claimed in either the 400 application or the 506 application lacks inventive step in light of the common general knowledge alone.
For completeness, I note that the applicant submitted that given that the components of the mixtures are well known, the absence of any previous combination of these components, despite the activity in the field, is a secondary indicator of inventive step. However, in the circumstances I have not needed to have regard to secondary evidence.
Inventive step in light of the prior art documents – the 400 application
No inventive step objection has been raised to the 400 application in light of any of the cited prior art documents during examination, and with the exception of Zhou, X.G. et al. ‘Field evaluation of a beneficial Bacillus strain for biocontrol of sheath blight in rice’, Phytopathology (2011) vol. 101:S204 (cited as D2 in the report) I did not discuss these documents as possible section 7(3) documents at the hearing. Accordingly, the applicant has not made detailed submissions in relation to these documents.[101]
[101] In its written submissions at [73] the applicant submitted that none of the documents “provides encouragement for the selection of any combination falling within the claims, let alone one involving the necessary expectation of success.”
I have reviewed the documents and I do not think it is appropriate to form a concluded view without any issues having been properly ventilated during examination and subsequently at the hearing, but I do consider that it would be appropriate for further consideration of inventive step in light of the prior art to be undertaken by an examiner. Accordingly, and noting that further amendments to the specification are to be made during an extended period for gaining acceptance, the application will be returned to examination for consideration of whether or not any inventive step objection should be raised in light of any prior art documents.
Inventive step in light of the prior art documents – the 506 application
No inventive step objection in light of the cited prior art documents has been raised during examination of the 506 application and I did not discuss these documents as possible section 7(3) documents at the hearing. However, the applicant, in its written submissions, submitted that:
“D1-D3 are directed to synergistic pesticidal mixtures. D1 and D2 each disclose a chemical compound of specific structure in combination with at least one other pesticide. Bacillus pumilus is disclosed generally as one pesticide (i.e. an antifungal control agent) that may be selected from a long list of pesticides. D3, conversely, discloses the synergistic combination of a specific fungicidal strain, namely, Bacillus subtilis with NRRL Accession No. B-21661 or Bacillus pumilus with NRRL Accession No. B-30087, with at least one other pesticide selected from a long list.
…the disclosure of experimental evidence in the prior art of other Bacillus isolates that achieve synergy does not mean that a skilled person would be directly led as a matter of course to select the claimed Bacillus pumilus INR7 isolate. Each of D1-D3 provides no encouragement for the selection of any combination falling within the claims. Further, none of the cited documents provides any direction or suggestion that Bacillus pumilus INR7 could be combined with other pesticides as claimed to achieve an expectation of success (i.e. synergy).”[102]
[102] Applicant’s written submissions at [74]-[75].
I have, with a view to expediting the further prosecution of this application and having regard to the applicant’s submissions, considered whether the claims lack an inventive step in light of each of the documents identified in the report.
WO 2011/147953 A1 (D1) discloses synergistic mixtures of a specific insecticidal compound I (shown below; not defined in the present claims) and one or more of a large number of fungicidal compounds (compound II), wherein the fungicidal compounds II include the chemical fungicides defined in the present claims, and “antifungal biocontrol agents, plant bioactivators” including B. pumilus, with B. pumilus having NRRL No. B-30087 identified as a preferred biocontrol agent.[103] D1 exemplifies binary synergistic combinations of compound I and pyraclostrobin,[104] but indicates that the mixtures of the invention may include multiple compounds II.[105]
[103] D1, pages 1-4, page 22, lines 1-5.
[104] D1, pages 58-60.
[105] D1, pages 4-5.
Despite the lack of identification of the specific B. pumilus strain of the present claims in D1 it would seem reasonable to conclude that a skilled person would choose as a matter of routine any known fungicidal B. pumilus strain, including B. pumilus INR7, in following the teaching of the document. However, although the combinations of D1 may include more than one compound II,
there are a large number of possible compounds II listed. D1 provides a number of preferred ternary, quaternary and quinary combinations, but none of these include a biocontrol agent. Considering the disclosure of the document as a whole, while both the chemical fungicides and B. pumilus are identified in the list of compounds II, I do not understand there to be a clear suggestion or direction in D1 towards the combination of these components. I am not satisfied that a skilled person would, in light of the disclosure of D1, be directly led to the presently claimed combinations.
Both WO 2010/139656 A2 (D2) and WO 2009/037242 A2 (D3) are identified in the present application. D2 discloses synergistic fungicidal mixtures comprising a chemical fungicide of formula I, shown below, and a further fungicidal component selected from three specified chemical fungicides, B. subtilis strain having NRRL Accession No. B-21661 and B. pumilus strain having NRRL Accession No. B-30087 (and mutants, variants and metabolites).[106] D2 also indicates that the mixture may also be mixed with any of a large number of other chemical and biological actives, including chemical pesticides defined in the present claims, and B. pumilus.[107] D2 exemplifies a number of synergistic combinations, including combinations of compounds of formula I with B. subtilis strain having NRRL Accession No. B-21661.[108]
[106] D2, pages 1-2.
[107] D2, pages 13-18.
[108] D2, pages 21-22.
D3 discloses synergistic combinations comprising B. subtilis strain having NRRL Accession No. B-21661 or B. pumilus strain having NRRL Accession No. B-30087 (and mutants, variants and metabolites) and at least one of a range of chemical pesticides.[109] D3 does not include any worked examples.
[109] D3, pages 1-3.
Given the specific identification of Bacillus strains in D2 and D3, the absence of a suggestion in these documents that other strains may be used in place of these strains, and noting Dr Liebmann’s evidence regarding the variation among strains, I am not satisfied that a skilled person would be led to combinations comprising the strain of the present claims in light of D2 or D3 together with the common general knowledge.
Enebak, S.A. and Carey, W.A. ‘Evidence for induced systemic protection to fusiform rust in loblolly pine by plant growth-promoting rhizobacteria’, Plant Disease (2000) vol. 84:306-308 (D4) discloses the use of B. pumilus INR7 individually as a seed treatment significantly reducing the rust infection of loblolly pine seedlings. D4 does not suggest use in combinations and I am not satisfied that a skilled person, in light of the disclosure of D4, would be led to the presently claimed combinations.
Accordingly, I am not satisfied that the claims of the 506 application lack inventive step in light of the common general knowledge alone or together with any of the cited prior art.
Conclusion
On balance, I consider that the specifications of the 400 application and the 506 application comply with the disclosure and support requirements of section 40, and the claims of the 400 application are novel and have an inventive step in light of the common general knowledge. I consider that the claims of the 506 application are inventive in light of the common general knowledge and the cited prior art documents.
However, I find that claim 5 of the 400 application and claim 2 of the 506 application are not for a manner of manufacture, and I note the applicant’s intention to amend claim 1 of the 400 application to delete “M-2 GABA-gated chloride channel antagonists”. Further, I will return the 400 application to examination for further consideration of inventive step in light of the prior art.
Typically the applicant would, pursuant to regulation 13.4(1)(g), be allowed a period of three months from the date of the decision to gain acceptance of the applications. However, in the case of the 400 application, an examiner will require some time to consider inventive step in light of the prior art, and I consider it appropriate that a longer period be substituted, as provided by regulation 13.4(3). I will allow the applicant a period of six (6) months from the date of this decision to gain acceptance of the 400 application.
Dr S. J. Smith
Delegate of the Commissioner of PatentsAnnex A: Claims of the 400 application
1. Synergistic mixtures comprising, as active components,
1) one fungicidal compound IA selected from the group consisting of
Nucleic acid synthesis inhibitors: metalaxyl,;
Inhibitors of amino acid and protein synthesis: pyrimethanil;
Signal transduction inhibitors: fludioxonil;
Lipid and membrane synthesis inhibitors: dimethomorph;
Inhibitors with Multi Site Action: thiram;
or
2) one insecticidal compound IB selected from the group consisting of
M-2 GABA-gated chloride channel antagonists:
M-2.B fiproles: fipronil;
M-4 nicotinic acteylcholine receptor agonists from the class of neonicotinoids: thiamethoxam;
M-6 chloride channel activators from the class of mectins: abamectin;
M-24 Ryanodine receptor-modulators from the class of diamides: chlorantraniliprole, cyantraniliprole;
and
5) Bacillus subtilis MBI600 as compound II having the accession number NRRL
B-50595.
2. The mixture according to claim 1 comprising compound IA and compound II.
3.The mixture according to claim 1 comprising compound IB and compound II.
4.The mixture according to any one of claims 1 to 6, wherein the ratio by weight from compound IA or IB to compound II is from 1:500 to 500:1.
5. A kit for preparing a usable pesticidal composition, the kit comprising:
a) a composition comprising component IA as defined in any one of claims 1 to 4 and at least one auxiliary; or
b) a composition comprising component IB as defined in any one of claims 1 to 4e and at least one auxiliary; and
c) a composition comprising component II as defined in claim 1 and at least one auxiliary.
6.A pesticidal composition, comprising a liquid or solid carrier and a mixture as defined in claim 1.
7. A method for protection of plant propagation material from pests and/or improving the health of plants grown from said plant propagation material, wherein the plant propagation material is treated with an effective amount of a mixture as defined in any one of claims 1 to 4 or with an effective amount of a composition as defined in claim 6.
8.The method as claimed in claim 7, wherein the compounds as defined in any one of claims 1 to 4 are applied simultaneously, that is jointly or separately, or in succession.
9.Plant propagation material, comprising the mixture as defined in any of claims 1 to 4 or a composition as defined in claim 6 in an amount of from 0.01 g to 10 kg per 100 kg of plant propagation material.
Annex B: Claims of the 506 application
1. Synergistic mixtures comprising, as active components,
1) one fungicidal compound IA selected from the group consisting of metalaxyl, dimethomorph and thiram;
or
2) one insecticidal compound IB selected from the group consisting of thiodicarb, bifenthrin, alpha-cypermethrin and thiamethoxam;
and
5) Bacillus pumilus INR7 having the accession number NRRL B-50153 or NRRL B-50185 as compound II wherein the ratio by weight from compound IA or IB to compound II is from 100:1 to 1:1.
2. A kit for preparing a usable pesticidal composition, the kit comprising:
a) a composition comprising component 1) as defined in claim 1 and at least one auxiliary; or
b) a composition comprising component 2) as defined in claim 1 and at least one auxiliary; and
c) a composition comprising component 5) as defined in claim 1 and at least one auxiliary.
3.A pesticidal composition, comprising a liquid or solid carrier and a mixture as defined in claim 1.
4. A method for protection of plant propagation material from pests and/or improving the health of plants grown from said plant propagation material, wherein the plant propagation material is treated with an effective amount of a mixture as defined in claim 1 or a composition as defined in claim 3.
5.The method as claimed in claim 4, wherein the compounds as defined in claim 1 are applied simultaneously, that is jointly.
6.Plant propagation material, comprising the mixture as defined in claim 1 or a composition as defined in claim 3 in an amount of from 0.01 g to 10 kg per 100 kg of plant propagation material.
4
18
0