Novozymes North America, Inc. v DSM IP Assets B.V
[2018] APO 37
•8 June 2018
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Novozymes North America, Inc. v DSM IP Assets B.V. [2018] APO 37
Patent Application: 2010305447
Title:Process for the preparation of a fermentation product from lignocellulose containing material
Patent Applicant: DSM IP Assets B.V.
Opponent: Novozymes North America, Inc.
Delegate: Dr S. J. Smith
Decision Date: 8 June 2018
Hearing Date: 1 November 2017, in Canberra
Catchwords: PATENTS – opposition to the grant of a patent – grounds of clarity, fair basis, best method, utility, novelty and inventive step –s 24(1)(a) ‘grace period’ provisions considered, citation disregarded – lack of novelty not established – consideration of s 114 – inventive step – matter of routine to combine the claimed steps – lack of inventive step of some claims established in light of combination of documents – claims not directed to a mere collocation or mere working directions – lack of manner of manufacture ground not established – lack of clarity, fair basis, best method and utility grounds not established – costs awarded against the applicant
Representation: Counsel for the applicant: Mr Ben Fitzpatrick
Patent attorney for the applicant: Dr Louis Tsai and Mr David Longmuir of Phillips Ormonde Fitzpatrick
Counsel for the opponent: Ms Katrina Crooks
Patent attorney for the opponent: Dr Kieran Williams and Dr Jacinta Flattery-O’Brien of Shelston IP Pty Ltd
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2010305447
Title:Process for the preparation of a fermentation product from lignocellulose containing material
Patent Applicant: DSM IP Assets B.V.
Date of Decision: 8 June 2018
DECISION
Claims 1-4, 9-13, 19-22, 24, 26 and 34 lack inventive step. DSM IP Assets B.V. is allowed two months from the date of this decision to file suitable amendments.
I award costs according to Schedule 8 against DSM IP Assets B.V.
REASONS FOR DECISION
Background
Patent application 2010305447 was filed by DSM IP Assets B.V. (DSM) on 5 October 2010 under the provisions of the Patent Cooperation Treaty. The application claims priority from EP 09172586.1 which was filed on 8 October 2009.
Acceptance of the application was advertised on 25 September 2014. Novozymes North America, Inc. (Novozymes) filed a notice of opposition under section 59 on 2 January 2015 and a hearing was held in Canberra on 1 November 2017.
DSM proposed post-acceptance amendments to the specification on 21 September 2015 which were allowed unopposed on 25 January 2016 and this decision is in relation to the specification as amended.
The Opposition
The statement of grounds and particulars was filed on 2 April 2015 and an amendment to the statement was allowed on 26 April 2017. The statement of grounds and particulars identifies the following grounds of opposition: manner of manufacture, novelty, inventive step, utility, best method, clarity and fair basis.
A further amendment to the statement of grounds and particulars was allowed after the hearing on 7 December 2017 to align the particulars with submissions made at the hearing. I provided DSM with an opportunity to provide submissions in relation to the particulars introduced by that amendment and those submissions were filed on 21 December 2017.
Evidence
The evidence filed during the evidentiary periods is summarised in the table below:
Evidence Declarant Exhibits Date of declaration Reference In Support
Tony Vancov
TV-1 to TV-19
30 June 2015
Vancov 1
In Answer
Joan Kelly
JK-1 to JK-4
5 February 2016
Kelly
In Reply
Tony Vancov
TV-20 to TV-23
11 April 2016
Vancov 2
Kelly Reynolds
-
10 April 2016
Reynolds
Onus
The request for examination of this application was filed on 8 April 2013 and consequently substantive amendments of the Patents Act 1990 (the Act) brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present application. This includes the amendment to subsection 60(3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. The onus of proof in this opposition proceeding therefore rests with the opponent, who must demonstrate that it is clear or practically certain that a valid patent cannot be granted.[1]
[1] F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; 50 IPR 305 at 319, [67]; Commissioner of Patents v Sherman [2008] FCAFC 182; 79 IPR 426 at [18].
The specification
The specification relates to a process for the preparation of a fermentation product from lignocellulosic material comprising enzymatic hydrolysis of the lignocellulosic material and fermentation of sugars. In particular, the specification describes the preparation of ethanol from lignocellulosic material. The specification ends with 10 figures and 34 claims. Claim 1 is the only independent claim.
Before construing the specification, I note the comments of Middleton J in Eli Lilly and Company Limited v Apotex Pty Ltd[2]:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”
[2] [2013] FCA 214; 100 IPR 451 at [139].
The person skilled in the art
It is well established that many of the issues in an opposition 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.”[3]
[3] 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.[4] As discussed above, the present specification is directed to enzymatic hydrolysis of lignocellulosic plant material into sugars and fermentation of those sugars, or more generally the production of valuable products such as ethanol from lignocellulosic material, and therefore the person skilled in the art will have experience or a practical interest in this field.
[4] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]-[72].
The key declarants in this opposition are Dr Vancov and Dr Kelly. Dr Vancov has experience in the production of ethanol from lignocellulosic material, with his work focussed on lignocellulosic bioprocessing technologies for converting agricultural and forestry waste to ethanol/other value-added products.[5] Dr Kelly’s research includes working with microorganisms for applied biotechnological processes, such as enzymatic hydrolysis, and including production of bioethanol.[6] Novozymes submitted that Dr Kelly lacks appropriate experience to be considered a relevant skilled person as her work focuses on microorganisms that could be used in bioethanol production, rather than the production of bioethanol per se and noted that her only scientific article relating to ethanol production predates the priority date by 12 years; DSM accepted that both declarants are qualified to provide evidence in this matter but noted a lack of publications by Dr Vancov in relation to bioethanol production by enzymatic hydrolysis of lignocellulosic material before the priority date.[7] While conscious of the matters raised by the parties I am reasonably satisfied that both declarants have backgrounds that enable them to understand the specification and provide evidence in relation to what a person skilled in the art knew or would have done at the relevant date.
[5] Vancov 1 at [2].
[6] Kelly at [2], [25].
[7] Novozymes’ written submissions at [49]-[51]; DSM’s written submissions at [43], [46].
DSM also made submissions questioning whether Dr Vancov’s evidence was prepared prior to reviewing the specification or if he was impermissibly led. In particular, DSM pointed to Dr Vancov’s reference to Celluclast+Novozym 188 having been shown in TV-4 to have a maximum activity between 55°C and 60°C when reviewing other prior art documents prior to reviewing the specification,[8] and submitted that this supports an inference that the declarant was led. I agree that this seems a surprising feature to highlight prior to reviewing the claims. However, I am not convinced that the only possible explanation for this is that the declarant was impermissibly led. Novozymes provided an additional declaration by Dr Vancov at the hearing regarding which parts of his declaration were made prior to reviewing the specification. I do not consider it necessary to have regard to that declaration under regulation 5.23 as in my view it confirms what is already in evidence.
[8] Vancov 1 at [55], [69], [73], [76].
Where there is conflicting evidence I will decide which evidence should be given greater weight.
The invention as described
Background of the invention
The specification states that lignocellulosic plant material, or feedstock, such as wheat straw, corn stover and rice hulls, is a renewable energy source and can be converted into valuable products, such as bioethanol. This involves enzymatic conversion of the (ligno or hemi)-cellulose present in the feedstock into reducing sugars which are converted into ethanol by microorganisms.[9]
[9] Page 1, lines 11-16.
The specification states the production of sugars from pretreated lignocellulosic feedstock (hydrolysis) typically takes place over 6-168 hours at temperatures of 45-50°C, and during this process the cellulose is partly converted into reducing sugars. To minimise thermal inactivation the period of elevated temperature is minimised as much as possible.[10] Fermentation takes place following hydrolysis at a temperature of 30-33°C. During this process remaining (hemi)cellulosic material is converted into reducing sugars by the enzymes present from the hydrolysis step and ethanol is produced. Fermentation is finished when the (hemi)cellulosic material is converted into fermentable sugars and all the fermentable sugars are converted into ethanol, carbon dioxide and microbial cells. The overall period of hydrolysis and fermentation may take up to 7 days.[11]
[10] Page 1, line 32 - page 2, line 5.
[11] Page 2, lines 6-16.
According to the specification, enzymes are added to each batch of feedstock to maximise the yield and rate of release of fermentable sugars from pretreated feedstock in a given process time. The specification indicates that costs for enzyme production, feedstock to ethanol yield and investment are major cost factors in overall production costs. Reduction of enzyme usage is achieved by applying enzyme products with broader and/or higher activity, requiring investment in research and development of these enzyme products.[12]
[12] Page 2, lines 22-30.
Thermostable cellulolytic enzymes derived from Talaromyces have been used for hydrolysis and are described in WO 2007/091231, but the specification indicates that no disclosure is given for how to optimise the process of hydrolysis and fermentation.[13]
The aim of the invention
[13] Page 3, lines 1-4.
Against this background, the specification states that:
“An aspect of the invention is therefore to provide a process in which the hydrolysis step and fermentation step are conducted at optimal temperature conditions. Another aspect of the invention is to provide a process involving hydrolysis and fermentation having a reduced process time. Further aspect of the invention is to provide a process, wherein the dosage of enzyme may be reduced and at the same time output of useful fermentation product is maintained at the same level. Another aspect is to provide a process wherein risk of contamination by contaminating microorganisms, is reduced. Another aspect is to provide a process wherein the dry-matter content is increased. Another aspect is to provide a process involving hydrolysis and fermentation, wherein the process conditions of the fermentation are optimized.” [14]
Nature of the invention
[14] Page 3, lines 17-26.
The specification states that the invention provides a process comprising enzymatic hydrolysis of lignocellulosic material having a dry matter content of 14% or more at greater than 55°C for 40 hours or more using a stable enzyme composition that has a temperature optimum of 55°C or greater (and other defined thermostability parameters), followed by fermentation with a Saccharomyces yeast that is able to ferment at least one C5 sugar.[15]
[15] Page 3, line 27 - page 3a, line 3.
According to the specification, cellulolytic enzymes of Talaromyces applied to pretreated lignocellulosic material show maximal conversion rates at temperatures of 50-70°C, and remain active under such conditions for 14 days or more.[16] The specification describes many advantages associated with use of such thermostable enzymes, including overall process time reduction, use of lower enzyme dosages and longer hydrolysis times, lower risk of contaminating microorganisms, and reduced cooling costs.[17] The specification provides a general description of appropriate dry matter contents and conditions for fermentation[18] and indicates that depending on the particular lignocellulosic material and pretreatment conditions the various reaction conditions may be adapted by the skilled person to achieve a desired conversion of lignocellulose to sugar.[19]
The Examples
[16] Page 25, line 29 - page 26, line 2.
[17] Pages 26-32.
[18] Page 20, line 33 - page 24, line 24.
[19] Page 19, lines 28-31.
The specification ends with six examples. Examples 1 and 2 refer to the method of hydrolysis and fermentation described in WO 2010/018105 (in evidence as exhibit TV-6), which describes hydrolysis using a Talaromyces emersonii enzyme product Filtrase®NL and fermentation using Saccharomyces cerevisiae 23NG. Example 1 describes hydrolysis of pretreated wheat straw (10% w/w) using the enzyme composition at 56°C for 20 or 72 hours followed by fermentation at 33°C for 6 days or 48 hours, respectively. The example shows that the longer hydrolysis and shorter fermentation period results in similar ethanol production over a shorter total period (5 days total) than the shorter hydrolysis and longer fermentation period (7 days total). Example 2 describes hydrolysis of pretreated wheat straw (10% w/w) using the enzyme composition at 56°C and a concentration of 0.20 or 0.09 g enzyme composition per g feedstock dry matter for 72 or 120 hours, respectively, followed by fermentation at 33°C for 48 hours. The example shows that similar ethanol production can be obtained with a lower enzyme dose by using a longer hydrolysis period. Examples 3 and 4 describe hydrolysis of 10% w/w feedstock at 56°C using the same enzyme composition as used in Example 1, followed by recovery and reuse of the enzyme composition in a subsequent hydrolysis process.
Example 5 describes hydrolysis of pretreated wheat straw and corn stover (10% w/w) at 60°C and pretreated corn fibre (13.8% w/w) at 50°C using an experimental broad spectrum cellulase preparation for 72 hours, followed by fermentation with BIE252 (a S. cerevisiae strain adapted to metabolise xylose and arabinose described in EP 10160622.6) at 33°C for 72 hours.
Example 6 describes hydrolysis of pretreated corn stover (20% w/w) using TEC-210 (described in WO 2011/000949) at 62°C for 144 hours, followed by fermentation with yeast strain RN1016, a C5 fermenting S. cerevisiae strain. Prior to the hearing DSM advised the Commissioner that the experiments reported in Example 6 were conducted after the filing date of the specification.[20]
[20] Correspondence dated 11 July 2016.
The invention as claimed
The principles to be applied in construing claims are well established,[21] and a “generous measure of common sense should be used” in construing claims.[22]
[21] H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at 254, [118]-[120].
[22] Product Management Group Pty Ltd v Blue Gentian LLC [2015] FCAFC 179 at [36].
The entire claim set is reproduced at Annex A. Claim 1 reads:
Process for the preparation of a fermentation product from lingo-cellulosic [sic] material, comprising the following steps:
a) optionally pre-treatment;
b) optionally washing;
c) enzymatic hydrolysis;
d) fermentation; and
e) optionally recovery of a fermentation product;
wherein in step c) a stable enzyme composition that has a temperature optimum of 55°C or more and retains at least 10% of its initial activity for 40 hours or more at 55°C, is used, the hydrolysis time is 40 hours or more and the hydrolysis temperature is 55°C or more, and wherein the activities of the stable enzyme composition are thermostable, and wherein the dry matter content of the lignocellulosic material in the hydrolysis step c) is 14% (w/dmw) or more, and wherein in step d) the fermentation is conducted with a yeast of the genus Saccharomyces that is able to ferment at least one C5 sugar.Process for the preparation of a fermentation product
The claim is directed to a process for the preparation of a fermentation product from lignocellulosic material. That is, the process claimed is one in which lignocellulosic material is converted into a fermentation product. The steps of pre-treatment, washing and recovery of fermentation product are optional and the steps of enzymatic hydrolysis and fermentation are mandatory. The specification indicates that a range of fermentation products may be produced according to the invention, such as amino acids, vitamins, lactic acid and ethanol.[23]
[23] Page 25, lines 1-6.
With regard to the enzymatic hydrolysis step the claim defines a lower limit for the hydrolysis temperature and the dry matter content, but not an upper limit, i.e. the hydrolysis temperature must be 55°C or more, and the dry matter content of the lignocellulosic material, expressed in terms of dry matter weight (dmw), must be 14% (w/dmw) or more. This raises the question of whether the claim includes embodiments in which these parameters are such that enzymatic hydrolysis cannot proceed. While the enzymatic hydrolysis step is characterised by certain parameters, I also understand it to be, from a consideration of the context of the claim, limited by the functional definition of the step. That is, if the parameters are selected such that the step does not achieve the function of enzymatic hydrolysis, then in my view such a step does not, on a common sense reading, fall within the scope of the claim. This construction is consistent with the context of the specification.
Stable enzyme composition
The specification states:
“Stable enzyme composition herein means that the enzyme composition retains activity after 30 hours of hydrolysis reaction time, preferably at least 10%, 20%, … 99% or 100% of its initial activity after 30 hours of hydrolysis reaction time. Preferably the enzyme composition retains activity after 40, 50, … 450, 500 hours of hydrolysis reaction time.”[24]
[24] Page 5, line 32 - page 6, line 3.
A composition for use in the method of the invention comprises at least two activities, typically comprises more than two activities, and may comprise at least one cellulase and at least one hemicellulase.[25]
[25] Page 7, line 32 - page 8, line 1.
The specification also defines thermostable:
“Herein, this means that the activity has a temperature optimum of 40°C or higher, for example about 50°C or higher, such as about 60°C or higher … Activities in a composition for use in the invention will typically not have the same temperature optima, but preferably will, nevertheless, be thermostable.”[26]
Temperature optimum
[26] Page 8, lines 20-25.
The specification states:
“According to the invention, in the hydrolysis step, a stable enzyme composition is used, that has a temperature optimum of 55 degrees C or more, preferably of 60 degrees C or more, or of 65 degrees or more. Temperature optimum is determined by measuring activity of the enzyme composition at different temperatures and plotting the activity against temperature, and then determining the optimum temperature i.e the temperature at which the highest activity is found.”[27]
[27] Page 5, lines 28-31.
It is apparent from the evidence that this is different from the meaning usually ascribed to temperature optimum in the art, which takes into consideration both enzyme activity and enzyme stability[28] but the declarants differed as to whether in the context of the specification “temperature optimum” should be understood according to the definition provided in the specification or that usually adopted in the art.
[28] Vancov 1 at [32]; Kelly at [48].
In Dr Kelly’s view temperature optimum as used in the specification should be understood according to its usual meaning in the art:
“Temperature optimum is a term commonly used in the field and refers to the temperature at which the enzyme or enzyme composition is optimum taking into account both enzyme activity and enzyme stability. Although I note that the Opposed Application at page 5 lines 28 to 31 refers to the temperature optimum as being the temperature at which the highest activity is found, I do not consider that the term is being used in this way in the Opposed Application.
The activity of an enzyme mix may increase with temperature but the stability, the length of time the enzyme remains active, will generally be reduced. Many of the advantages of the Opposed Application are achieved through the use of a stable enzyme composition which retains its activity for long periods at elevated temperatures of 55°C or more. As set out on page 19 line 33 to page 20 line 1 ‘[t]he high temperature during hydrolysis has many advantages, which include working at the optimum temperature of the enzyme composition…’ …
In the context of the Opposed Application specification as a whole, which is focused on and exemplifies thermostable enzymes, it does not make sense to me for the term temperature optimum to be referring solely to maximum enzyme activity. In my view the stable enzyme compositions for use in the invention are required to incorporate an element of stability in addition to retain activity at elevated temperatures.”[29]
[29] Kelly at [48]-[50].
In contrast, Dr Vancov understood temperature optimum in the claims to mean the temperature at which the enzyme exhibits maximum activity:
“it is clear that the term ‘temperature optimum’ as used throughout the Opposed Application only takes into account enzyme activity and not enzyme stability. Indeed, this interpretation is reinforced by the inclusion in claim 1 of the term ‘stable enzyme composition’ and the phrase ‘retains at least 10% of its initial activity for 40 hours or more at 55°C’, as these would be redundant if the term was to be interpreted as Dr Kelly asserts.”[30]
[30] Vancov 2 at [59].
Dr Vancov stated that the “temperature at which an enzyme exhibits maximum activity, at least in respect of cellulases, is usually calculated by measuring filter paper unit (cellulose) activity at various temperatures over a 1 hour period.”[31]
[31] Vancov 1 at [134].
There is clearly a tension between what is stated in the specification and the plain meaning of “temperature optimum”. The question to be considered is whether the specification has set up a dictionary, such that the meaning in the specification prevails over the plain meaning. The nature of the dictionary principle has been discussed in British Thomson-Houston Co Ltd v Corona Lamp Works Ltd[32]:
“We have to scan the Specification with the closeness which is required in the case of any instrument conferring a monopoly, but, subject to this, all we can legitimately do is apply the ordinary rules for the construction of written instruments. One of these, which is relevant in the case before us, is that the instrument must be read as a whole. The Claiming Clauses, for example, are not to be taken as standing in complete isolation. For if the Patentee has used in these clauses expressions which he has already adequately interpreted in the body of his Specification, he is entitled to refer to the Specification as a dictionary in which the meaning of the words he uses has been defined.”
[32] (1922) 39 RPC 49 at 67.
When the specification sets up a dictionary it is “incumbent on a patentee … to make his intention plain to those who read the specification.”[33] While not traditionally phrased, the specification provides a clear indication of how temperature optimum is to be determined, and the declarants both understand what is meant by that portion of the specification. In considering whether this constitutes a dictionary, I find having regard to the location and context of the relevant passage in the specification useful. The relevant passage is found in the “Detailed description of the invention”, in which the invention is “described in all its embodiments”.[34] The paragraph following the relevant passage is phrased as a traditional dictionary, that is, “[s]table enzyme composition herein means …”. While the absence of traditional language in relation to temperature optimum could suggest that the passage does not establish a dictionary, the location of the passage next to what is clearly a dictionary, coupled with the unequivocal language of the passage, leads me to a view that the location and context of the passage are consistent with it being used as a dictionary.
[33] Minerals Separation North America Corporation v Noranda Mines Ltd. (1952) 69 RPC 81 at 94.
[34] Page 5, lines 21-23.
I understand that this does not make sense to Dr Kelly in the context of the specification and I agree that thermostability is presented as an important element of the invention described. However, the claim includes multiple requirements for enzyme stability. Considering the words of the specification and the location and context in which they are used, I am reasonably satisfied that the specification establishes a dictionary whereby “temperature optimum” is the temperature at which the highest activity is found.
Retains at least 10% of its initial activity for 40 hours or more at 55°C
The enzyme composition used in the hydrolysis step must retain at least 10% of its initial activity for 40 hours or more at 55°C. The description does not elaborate on determination of this feature, for example, how the activity is to be measured. In this regard, Dr Vancov stated:
“As there are several known methods available for measuring enzyme activity, it is not immediately clear to me how the % retained activity of the enzyme composition in the Opposed Application is to be measured. I note that Figure 3 (and the associated figure legend) of the Opposed Application shows a method where % retained activity after 40 hours of hydrolysis of feedstock is determined for an enzyme composition. As this is the only method described in the Opposed Application for measuring retained enzyme activity, this is the method I would employ…”[35]
[35] Vancov 2 at [58].
It is apparent that Dr Vancov is aware of a number of methods by which enzyme activity could be measured. In the absence of any explicit limitation in the claims or the description as to suitable methods, I consider that this parameter could be measured in any way known to a skilled worker. I note that in light of this requirement for activity retention in the claim the reference to the enzyme composition as “stable” appears to be redundant.
Saccharomyces that is able to ferment at least one C5 sugar
Wildtype Saccharomyces is not able to ferment C5 sugars, such as xylose and arabinose, and accordingly the Saccharomyces required by the claim must have been modified to have this capability. The specification indicates that such a modified microorganism and its preparation are described in WO 2008/041840.[36]
Appended claims
[36] Page 23, lines 7-25.
Claims 2-18 narrow the parameters of the stable enzyme composition with respect to the duration of retention of initial activity. Claim 19 defines the fermentation time as from 18-120 hours. Claim 20 requires that the enzyme composition is derived from a microorganism of genus Talaromyces. Claims 21 and 22 define that step c) is conducted until 70% or more and 90% or more, respectively, of available sugar in the lignocellulosic material is released. Claim 23 specifies that the dosage of enzyme composition is 6 mg protein / g dry matter weight or lower. Claim 24 defines that the dry matter content of the lignocellulosic material in the hydrolysis step is 14-33% (w/dmw) or more. Claim 25 defines the process of any one of the preceding claims wherein after the fermentation product is recovered the resulting slurry containing the enzyme is recycled to the hydrolysis step. Claims 26 and 27 define the process of any one of the preceding claims wherein the product of the hydrolysis step is subject to solid-liquid separation and (part of) the liquid fraction is fed to step d) or recycled to step c), respectively. Claim 28 defines the process of any one of the preceding claims wherein the product of the hydrolysis step is subject to solid-liquid separation, the liquid fraction is fed to an ultrafiltration unit and the filtrate is fed to step d) and the retentate recycled to step c). Claims 29-32 are appended to claim 28 and define the use of part of the filtrate to feed production fermenters.
Claim 34 defines a fermentation product prepared by the process of any one of claims 1 to 33, and is limited to products when prepared by those processes.
Omnibus claim
Claim 33 is an omnibus claim which defines the process according to claim 1 “substantially as hereinbefore described with reference to any one of the examples.” Accordingly, claim 33 defines the subject of claim 1 wherein the features of the claim are limited by reference to, according to the words of the omnibus claim, “any one of the examples”. As discussed above, the only example which prima facie falls within the scope of this claim is Example 6, and at the hearing I asked for submissions on how this claim should be construed and both parties provided post-hearing submissions.
DSM submitted that claim 33 should not be construed by reference to any one example in isolation from the other examples and that to do so would be to depart from a common sense approach to construction, given that Examples 1-4 are directed only to specific aspects of the claimed process.[37] Accordingly, in DSM’s submission, claim 33 could include a process using the enzyme composition of Examples 1 or 2 and the C5 fermenting yeast strain of Example 5. Novozymes submitted that the claim should be understood as referring to any one example which falls within the scope of claim 1.[38] I agree that this is consistent with the words of the claim and I cannot see any basis in the claim to adopt the construction advocated by DSM. In my view, the claim refers to any one of the examples of the specification. I note that DSM indicated that if I accepted Novozymes’ construction it would seek to amend the claim to make it clearer that it encompasses a collective consideration of the Examples.[39]
[37] DSM’s submissions filed 21 December 2017 at [4]-[6].
[38] Novozymes’ submissions filed 20 November 2017.
[39] DSM’s submissions filed 21 December 2017 at [7].
Following from its construction, Novozymes submitted that it cannot be determined from the information provided whether the hydrolytic enzymes used in Examples 5 and 6 have maximum activity at 55°C or more and retain 10% of initial activity after 40 hours at 55°C as required by claim 1, and that in the absence of any example clearly falling within the scope of claim 33 the claim is effectively redundant. While the use in Example 6 of TEC-210 at 62°C for 144 hours suggests that the enzyme would have the desired properties, there is no explicit indication that that is the case, and Dr Vancov indicated uncertainty in this regard.[40] In the alternative, Novozymes submitted that if Examples 5 and/or 6 were construed to fall within the scope of claim 33 then the invention defined by claim 33 would not be fully described insofar as the “experimental broad spectrum cellulase preparation” of Example 5 and the C5 fermenting yeast RN1016 used in Example 6 are not adequately identified.[41]
[40] Vancov 2 at [44].
[41] While Novozymes referred to full description “in the Kimberly-Clark sense”, I note that subsection 41(2) provides that where an invention involves the use of a micro-organism for which the deposit requirements have not been satisfied the requirements of subsection 40(2)(a) may be satisfied if the micro-organism is reasonably available to a person skilled in the relevant art – this was considered in Commonwealth Scientific and Industrial Research Organisation v Bio-care Technology Pty Ltd and Ecoscience Corporation [1999] APO 21.
While there is no clear indication in the specification that the enzyme cocktail TEC-210 has the properties defined in claim 1, in my view the use of the enzyme cocktail in an example of the invention supports a reasonable inference that, in the absence of any evidence to the contrary, TEC-210 is an enzyme composition having the claimed properties. Accordingly, I understand claim 33 to be directed to the process of claim 1 wherein the features of that claim are limited by reference to Example 6.
This then leads to a question I raised at the hearing of whether the C5 fermenting yeast RN1016 is reasonably available (within the context of subsection 41(2)) – and whether accordingly there is a lack of full description. DSM did not make any submissions as to the availability of RN1016 and neither declarant has referred to this point. I note that Office practice is to regard a microorganism as being reasonably available if the specification discloses a method by which the public can access a sample of the microorganism[42] and the present specification does not disclose any such method. However, the current question arises in the context of an opposition to grant and there is no evidence on this point either supporting or contradicting the availability of the microorganism. Accordingly, while the absence of any submission from DSM that the yeast is reasonably available suggests that there may be a lack of sufficiency, in the absence of any evidence, and noting the heavy onus in this opposition proceeding, I am not satisfied that it is appropriate to pursue the ground of full description under s 60(3). However, I note that the amendment of the omnibus claim to refer to a collective consideration of the examples referred to by DSM would appear to address any issue in this regard.
[42] Patent Manual of Practice and Procedure at 2.7.3.3, effective date 11 January 2016.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims be clear. This requirement is satisfied if a person could ascertain “whether or not what he proposes to do falls within the ambit of the claim”.[43]
[43] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60.
Novozymes submitted that if it was not accepted that temperature optimum refers to the temperature of maximum enzyme activity then the claims lack clarity as the manner in which temperature optimum is to be calculated is unclear. I have considered the evidence of the declarants in construing the claims, and concluded that within the context of the specification temperature optimum refers to the temperature of maximum enzyme activity. Novozymes’ opposition on this basis therefore falls away.
Novozymes also submitted that if the method by which the retention of enzyme activity required by claim 1 is not understood to be limited to the method of Figure 3, then the claims lack clarity as it is not clear how the feature is to be determined.[44] I have discussed this feature above. Novozymes has not explained why any of the known methods for measuring enzyme activity referred to by Dr Vancov could not be used by a skilled person to determine the proportion of retained activity and accordingly Novozymes has not established that the claims lack clarity on this basis.
[44] Novozymes’ written submissions at [108]-[109].
Novozymes has not established that the claims lack clarity.
Novelty
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).
Novozymes submitted that claims 1-18, 20-24 and 34 lack novelty in light of WO 2010/018105 A1 (TV-6) in the name of DSM IP Assets B.V. TV-6 was filed on 4 August 2009 and published on 18 February 2010, after the claimed priority date but before the filing date of the opposed application, and accordingly is a whole of contents document. TV-6 is referenced as the source of the method of hydrolysis and fermentation adopted in Example 1 of the opposed application and discloses the hydrolysis of lignocellulosic material using an enzyme preparation derived from Talaromyces emersonii. According to TV-6 such an enzyme preparation can be used to carry out effective hydrolysis at high temperature, low pH and when high dry matter contents (for example 15% or more) are used.[45]
[45] TV-6 at pages 2-3.
DSM submitted that it is entitled to rely on the grace period provisions of subsection 24(1) in relation to TV-6 and TV-6 therefore does not constitute relevant prior art.
The grace period
As the information in TV-6 was made publicly available before 15 April 2013, the provisions of section 24 as they applied before that date are relevant to the present matter. [46]
[46] Item 133(4) of Schedule 6 of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
At the relevant time subsection 24(1) provided:
For the purpose of deciding whether an invention is novel or involves an inventive step or an innovative step, the person making the decision must disregard:
(a)any information made publicly available, through any publication or use of the invention in the prescribed circumstances, by or with the consent of the nominated person or patentee, or the predecessor in title of the nominated person or patentee; and
(b)any information made publicly available without the consent of the nominated person or patentee, through any publication or use of the invention by another person who derived the information from the nominated person or patentee or from the predecessor in title of the nominated person or patentee;
but only if a patent application for the invention is made within the prescribed period.
The parties accepted that this provision applies to whole of contents citations, consistent with the Commissioner’s usual practice in this regard.[47]
[47] See Biogen Idec MA Inc [2014] APO 25; Rozenberg & Co Pty Ltd. v Velin-Pharma A/S [2017] APO 61.
Novozymes submitted that properly understood, “the invention” referred to in paragraph 24(1)(a) must be the same invention as “an invention” recited in the preamble – the use of an antecedent in paragraph 24(1)(a) makes this clear from a plain reading of the provision and is consistent with the purpose of this provision being to protect against inadvertent disclosures by the inventor.[48] Accordingly, in Novozymes’ submission although TV-6 contains clear and unmistakeable directions to the invention presently claimed it does not disclose the same invention, the presence of different inventors is a clear indication that the invention of TV-6 and the present application are not the same for the purpose of this provision, and therefore the requirements of section 24 are not satisfied.
[48] The Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, page 119. I do not understand the purpose to have changed as a consequence of the amendment.
DSM submitted that section 24 qualifies the prior art base to be considered in relation to novelty and inventive step, not the invention, and that it would be inconsistent with the provision to find that a document that anticipates the claimed invention is not a disclosure of the invention.
I accept that the provision may be understood in different ways. It could be read, as Novozymes submitted should be the case, as requiring that information may only be disregarded if it discloses the same invention as claimed. It could also be read to give effect to the reference to inventive or innovative step in the preamble, such that publication of an invention related to the claimed invention such that it is relevant to inventive or innovative step (or novelty) must be disregarded. To my mind, by referring to inventive or innovative step the provision clearly anticipates a situation in which the published invention is not identical to the claimed invention under consideration, notwithstanding the use of an antecedent. This is a beneficial provision and so as a matter of statutory construction should be given a “fair, large and liberal” interpretation.[49] I therefore prefer the latter approach and I do not consider that it is necessary for the document to be excluded to disclose “the same” invention as the application under consideration. While Novozymes submitted that the reference to inventive step merely prevents the use of a novelty destroying disclosure being disregarded for novelty but cited for inventive step, in my view this is not consistent with the beneficial nature of the provision, or, as discussed below, its intended meaning. The reference in the Explanatory Memorandum to the purpose of the grace period being “to cover circumstances where an inventor has inadvertently disclosed their invention prior to seeking patent protection” could be considered to support Novozymes’ argument, but the provision itself is silent with respect to inventorship, and I can see no basis to use contextual information to add requirements in relation to which the provision is silent.
[49] See, e.g., AB v Western Australia [2011] HCA 42; (2011) 244 CLR 390 and IW v City of Perth [1997] HCA 30; (1997) 191 CLR 1.
I agree with the delegate in Merial New Zealand Limited v Jurox Pty Ltd[50] (Merial) who considered a similar fact situation and concluded that the intended meaning of section 24 was put beyond doubt by amendments introduced by the Raising the Bar Act, in which the reference to “information made publicly available, through any publication … of the invention” in paragraph 24(1)(a) was replaced with “information made publicly available”. The Explanatory Memorandum states (emphasis added):
“The first problem with the current provision is that it only applies to publication or use of the invention. This means that the grace period could be taken only to apply to information that could deprive an invention of novelty, not to information that could deprive an invention of an inventive or innovative step. For example, the grace period would not apply in a circumstance where the patentee disclosed the work they had done, or a prototype that led directly to their invention.”[51]
[50] [2016] APO 63 at [60]-[64].
[51] The Explanatory Memorandum, Intellectual Property Laws Amendment (Raising the Bar) Bill 2011, page 119.
From this I understand that the grace period prior to the amendments was intended to apply to disclosures relevant only to the ground of inventive/innovative step, and that the amendments were not intended to change the meaning. While the Explanatory Memorandum accepts that a different interpretation of the provision prior to amendment was possible and the wording of the provision as it now stands avoids such ambiguity, it provides support for the construction I have adopted, which is also consistent with the decision of the delegate in Merial to exclude documents not disclosing “the same” invention as claimed from the prior art base under this provision.[52]
[52] [2016] APO 63 at [64].
I conclude that the provision should be understood to give effect to both the novelty and inventive/innovative step aspects of the preamble, and the information to be disregarded is that which is made available by the publication or use of an invention which is related to the subject invention such that it is relevant for novelty or inventive/innovative step purposes, irrespective of the identified inventors.
Therefore, in my view neither the subject matter nor the inventor listing of TV-6 preclude its exclusion from the prior art base under section 24. In filing the application for TV-6 it is reasonable to assume that DSM consented to the subsequent publication of the document in accordance with the provisions of the PCT so the relevant provision is paragraph 24(1)(a). TV-6 was published on 18 February 2010 and the present application was filed on 5 October 2010. Accordingly, the requirements of regulations 2.2(1A) and 2.3(1A) have been met.
It follows that TV-6 must be disregarded for novelty and inventive step purposes.
Conclusion on novelty
Given that the only document relied on by Novozymes for establishing lack of novelty is excluded from the prior art base, the ground of lack of novelty is not made out.
Fair basis and the priority date of the claims
Fair basis
It is a requirement of subsection 40(3) of the Act that the claims must be fairly based on the matter described in the specification.
The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd[53] (Lockwood) approved the question set out by Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd[54]:
“the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”
[53] [2004] HCA 58; 217 CLR 274 at [69].
[54] [1988] FCA 162; (1988) 81 ALR 79 at 95.
Lockwood makes clear that the question of fair basis is to be determined on the basis of what is described in the specification, not on the basis of the technical contribution to the art.[55] As Bennett J put it in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth, the analysis is “whether, as a matter of drafting, the claims can be said to reflect what is disclosed or stated in the body of the specification.”[56]
[55] [2004] HCA 58; 217 CLR 274 at [50]-[54].
[56] [2011] FCAFC 132 at [64].
Novozymes submitted that there is no disclosure in the specification of the specific combination of features defined in the claims. In Novozymes’ submission, DSM has claimed a combination invention and the recitation of broad ranges of dry matter weights, hydrolysis temperatures and times, enzyme characteristics and dosages and fermentation time, with no indication that specific values within those ranges should be combined, is insufficient to provide fair basis.
The description includes a consistory statement which aligns with claim 1 and clearly identifies the combination which is claimed.[57] The description goes on to describe suitable enzyme compositions; hydrolysis conditions, including high temperature for a period of 40 hours or more and the use of high levels of dry matter; and fermentation conditions, including the use of a C5 sugar fermenting microorganism. As outlined above, the examples of the specification do not (with the exception of Example 6) fall within the scope of the present claims, due to the use of a lower dry matter weight and non-C5 sugar fermenting microorganism in Examples 1-4 and a lower dry matter weight in Example 5.
[57] Page 3, line 27 - page 3a, line 3.
However, while the description recites ranges of suitable dry matter weights, hydrolysis temperatures and times, enzyme characteristics, and fermentation times, including options which fall outside the scope of the claims under consideration, these are not narrower than the invention claimed or the consistory statement.[58] In addition, the specification does not suggest, and I do not understand, the examples as limiting embodiments of the invention described. I do not view the broader disclosure in the body of the description as inconsistent with the consistory statement, which provides a clear indication of the combination which forms the invention claimed. In my view the claims are broadly consistent with what the specification as a whole describes as the invention.
[58] Noting Bennett J’s comments in Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth [2011] FCAFC 132 at [91].
Novozymes also submitted that to the extent that the claimed invention relates to an optimised integrated process, as understood by Dr Kelly,[59] the claims encompass processes that are not optimised or integrated. Novozymes submitted that insofar as any invention is described it is limited to the specific parameters of Example 6 and to the extent that the claims are not so limited they travel beyond the subject matter of the description.[60] This submission appears to focus on the technical contribution to the art, rather than the consistency between the invention that is claimed and that which is described. As discussed above, I consider that the claims are broadly consistent with what the specification describes as the invention. I can see no basis to conclude that the invention described is limited to Example 6. In my view the claims do not travel beyond what is described.
[59] Kelly at [42]-[46].
[60] Novozymes’ written submissions at [231]-[232].
Novozymes has not established that the claims lack fair basis.
Priority date
Novozymes submitted that there is not a real and reasonably clear disclosure of the invention as claimed in the priority document and accordingly the present claims are not entitled to the earliest claimed priority date. Since TV-6 was published after the earliest priority date but before the filing date, if the claims were not entitled to the earliest claimed priority date TV-6 would be available as a potential subsection 7(3) citation. However, given my decision above that TV-6 is excluded from the prior art base pursuant to section 24, and in the absence of any evidence that the state of the common general knowledge differs depending on the earliest priority date, the question of whether the claims are entitled to the earliest priority date is of no consequence to the outcome of the opposition and it is therefore unnecessary to decide this point.
Novozymes also submitted that the claims claim matter that was in substance disclosed as a result of the amendment, and therefore are, pursuant to subsection 114(1) and regulation 3.14(b) entitled to a priority date of the date the relevant statement of proposed amendments was filed (that is, 21 September 2015). This is relevant because, to the extent the claims are entitled only to that deferred priority date, Novozymes submitted that the claims lack inventive step in light of the published specification.
It is well established that the test for whether matter is in substance disclosed is similar to that used to assess fair basis which is set out above. Subsection 114(1) provides that:
Where a claim of a complete specification claims matter that was in substance disclosed as a result of amending the specification, the priority date of the claim must be determined under the regulations.
Regulation 3.14 is the relevant regulation, and states that
If subsection 114(1) of the Act applies to a claim of a specification, the priority date of the claim is:
(a)…
(b) in any other case – the date of filing of the statement of proposed amendments that resulted in the disclosure referred to in subsection 114(1) of the Act.
The operation of section 114 was considered by the Full Court in AstraZeneca AB v Apotex Pty Ltd[61] (AstraZeneca). In that case claims were directed to a pharmaceutical composition comprising rosuvastatin or a pharmaceutically acceptable salt thereof and an inorganic salt in which the cation is multivalent, and were amended to exclude inorganic salts where the counter anion is a phosphate. The Full Court observed that while the compositions claimed as a result of the amendment were disclosed in the specification as filed, and there was nothing to suggest that use of phosphate as a counter ion was essential, di- and tri-basic calcium phosphate were stated in the specification to be preferred inorganic salts, and tribasic calcium phosphate was the inorganic salt used in each of the examples. The Court therefore found that the amended form of the claims was “fundamentally inconsistent” with the specification before amendment, and that the unamended specification did not contain a real or reasonably clear disclosure of what was claimed as a result of the amendments.[62] This is therefore an example of a situation where a narrowing amendment resulted in a claim to matter in substance disclosed as a result of the amendment.
[61] [2014] FCAFC 99; 107 IPR 177.
[62] [2014] FCAFC 99; 107 IPR 177at [245]-[247].
As I understand it, Novozymes’ submission is that to the extent that the claims could be considered fairly based, the only basis is found in Example 6, which was introduced in the amendments filed on 21 September 2015. That is, in Novozymes’ submission the specification as accepted does not contain a real and reasonably clear disclosure of the combination of features defined in the present claims. I note that the Full Court in AstraZeneca did not decide whether the relevant comparison in relation to section 114 was with the specification “as filed” or immediately prior to amendment.[63] Like in AstraZeneca the parties have not suggested that anything turns on this point, and I will proceed on the basis that the relevant comparison is with the specification prior to amendment. I have found above that the claims are fairly based on the specification as it currently stands and while that conclusion did not turn on the inclusion of Example 6, it is nevertheless necessary to consider whether there is a disclosure of the claimed matter in the specification prior to amendment, that is, in the accepted specification.
[63] [2014] FCAFC 99; 107 IPR 177at [237].
The accepted specification includes a consistory statement that aligns with claim 1 as accepted, and differs from the present claim 1 as follows: i) the enzyme composition is stable; ii) the enzyme composition retains at least 10% of its initial activity for 40 hours or more at 55°C; iii) the hydrolysis temperature is 55°C; and iv) the activities of the stable enzyme composition are thermostable.[64] However, in my view each of these features is identified as part of the invention as described in the accepted specification. The definition given in the specification of the enzyme composition to be used in the hydrolysis step refers to the enzyme composition being stable[65] and to activities in the enzyme composition being thermostable.[66] The summary of the invention in the specification as accepted refers to an embodiment in which hydrolysis is conducted at 55°C or more.[67] Further, the meaning of stable enzyme composition given in the specification is that activity, preferably at least 10%, is retained after 30 hours of hydrolysis reaction time[68] and preferably activity is retained after 40 or more hours of hydrolysis reaction time.[69] Accordingly, I consider that the present claims (other than claim 33 and claim 34 insofar as appended to claim 33, which I will discuss further below) define a combination of features that is disclosed as in the specification as accepted.
[64] Page 3, line 27 - page 3a, line 3.
[65] Page 5, lines 25-27.
[66] Page 8, line 20.
[67] Page 4, lines 1-3.
[68] Page 5, lines 32-34.
[69] Page 6, lines 1-3.
Based on the disclosure of the features of the combination of present claim 1 in the specification as accepted, and for the reasons given above in relation to fair basis (noting that, other than an amendment to the consistory statement and the inclusion of Example 6, the description as it stands is unchanged from the accepted description), I am satisfied that there is a real and reasonably clear disclosure of the claimed subject matter in the specification prior to amendment. I do not consider that this is a situation akin to that considered in AstraZeneca; in my view the claims are not inconsistent with the specification pre-amendment. Accordingly, I will proceed on the basis that the priority date of the claims other than claim 33 and claim 34 insofar as appended to claim 33 is, at the latest, the filing date of the specification.
The exception to the above is the omnibus claim 33 (and claim 34 insofar as it is appended to claim 33). I have decided above that the scope of claim 33 is limited to Example 6. Example 6 was introduced in the amendments filed on 21 September 2015. This example refers to a specific thermostable enzyme cocktail and a specific C5 fermenting yeast strain, neither of which are mentioned in the specification as originally filed, although as noted above I understand the enzyme composition to fall within the scope of claim 1. The disclosure of a class does not necessarily provide a real and reasonably clear disclosure of each of the members of that class[70] and in this case I am not satisfied that the general disclosure of thermostable enzymes having particular parameters in the specification prior to amendment provides a real and reasonably clear disclosure of the very specific integers of claim 33, and indeed Example 6 indicates that TEC-210 was fermented according to the procedures described in WO 2011/000949, which was evidently published after the present application was filed. It follows that I find the priority date of claim 33 (and claim 34 insofar as it is appended to claim 33) to be 21 September 2015.
[70] [2014] FCAFC 99; 107 IPR 177 at [244].
Inventive step
Subsection 7(2) of the Act 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:
i.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;
ii.being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded as relevant and, in the case of information mentioned in paragraph (b), combined as mentioned in that paragraph.
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.”[71]
[71] 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[72] approved this approach as well as that taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd,[73] 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.
[72] [2002] HCA 59; 212 CLR 411 at 432-433, [50]-[53].
[73] [1970] RPC 157 at 187.
In both of these approaches a person skilled in the art must have a reasonable expectation of success. This is explicit in the expectation that an approach “might well” succeed, and implicit in the characterisation of steps as to be taken as a matter of routine.[74] The reasonable expectation of success does not require that success is guaranteed, and allows for some possibility that the steps taken might not achieve the intended result.[75] However, the taking of routine steps with a reasonable expectation of success is distinguished from steps which the skilled addressee would consider “worthwhile to try”.[76]
[74] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73; 314 ALR 91 at [71].
[75] [2002] HCA 59; (2002) 212 CLR 411 at [74], [76].
[76] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73; 314 ALR 91 at [71].
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.[77]
The problem
[77] 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].
I agree with the parties that the problem addressed by the present specification at a broad level is efficient production of ethanol from lignocellulosic material, and in particular optimisation of the hydrolysis and fermentation of lignocellulosic material.[78]
Common general knowledge
[78] DSM’s written submissions at [7]-[10]; Novozymes’ written submissions at [158].
Common general knowledge is the background knowledge and experience available to all those working in the relevant art:
“The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[79]
[79] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 1A IPR 231 at 255-256.
However, it is not enough that information is recorded in a document, even if that document is widely circulated – it is only part of the common general knowledge when it is generally known and accepted:
“information does not constitute common general knowledge merely because it might be found, for example, in a journal, even if widely read by persons in the art … Reference in this regard is made to the words of Luxmoore J in British Acoustic Films (1936) 53 RPC 221 at 250, cited by Lehane J in Aktiebolaget Hässle v Alphapharm Pty Ltd (1999) 44 IPR 593; [1999] FCA 628 at 605 [39]:
In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”[80]
[80] Ranbaxy Laboratories Limited v AstraZeneca AB [2013] FCA 368; 101 IPR 11 at [217].
The evidence establishes that the common general knowledge at the priority date included the knowledge that:
·lignocellulose forms the structural framework of plant cell walls and comprises cellulose, hemicellulose and lignin[81]
[81] Vancov 1 at [26]; Kelly at [21].
·the steps in the conversion of lignocellulose containing biomass to ethanol typically include:[82]
[82] Vancov 1 at [27]; Kelly at [20]-[24].
i.pretreatment of the biomass to increase accessibility to cellulose and hemicellulose during the hydrolysis step
ii.hydrolysis to release constituent sugars from cellulose and hemicellulose (saccharification) – this may be chemical or, preferably, enzymatic[83]
iii.fermentation of the sugars by yeast or bacteria
·enzymatic hydrolysis on an industrial scale was typically carried out for 24-72 hours[84]
·saccharification and fermentation steps may be performed sequentially (“separate hydrolysis and fermentation” or SHF) or simultaneously (“simultaneous saccharification and fermentation” or SSF)[85]
·wildtype S. cerevisiae was the yeast most commonly used in fermentation of lignocellulosic material and is able to ferment hexose sugars but not pentose sugars[86]
·microorganisms, including S. cerevisiae, had been genetically engineered to enable fermentation of C5 and C6 sugars.[87]
[83] Vancov 1 at [29]; Kelly at [25].
[84] Vancov 1 at [33]; Kelly at [29].
[85] Vancov 1 at [28]; Kelly at [32].
[86] Vancov 1 at [36]; Kelly at [33].
[87] Vancov 1 at [36]; Kelly at [36]-[39].
In relation to the usual temperature at which hydrolysis was carried out, Dr Kelly stated:
“Most enzymes used in the hydrolysis of lignocellulosic material have an optimum temperature at which the enzyme works best and this is one of the factors in the process that would be optimised. For standard commercially used enzymes in hydrolysis as at the Priority Date, this optimum temperature was generally in the region of about 45°C to 50°C … Most of the available and commonly used hydrolytic enzyme preparations, including commercially available enzymes used in lignocellulosic hydrolysis, such as Novozym 188 and Celluclast, have a temperature optimum for the hydrolysis of lignocellulosic material, and were commonly used commercially in the hydrolysis of lignocellulosic substrates, at around 50°C.”[88]
[88] Kelly at [29].
Dr Vancov stated that “[e]nzyme hydrolysis of lignocellulosic matter at 50-55°C for 24-72 hours was commonly used by researchers and commercial plants as at 8 October 2009”[89] but accepted that Novozym 188 and Celluclast were commonly used at around 50°C,[90] which is consistent with contemporaneous evidence apparent from other documents filed as evidence in this matter. For example, Viikari, L. et al. (2007) ‘Thermostable enzymes in lignocellulose hydrolysis’, Advances in Biochemical Engineering/Biotechnology, vol. 108, pages 121-145 (TV-4), which is asserted by Novozymes to be representative of the common general knowledge, states that: “In a separate hydrolysis and fermentation process, the first total hydrolysis stage is carried out at about 45-50 °C with the present commercial enzymes”.[91] I note that TV-4 subsequently exemplifies use of commercial enzymes at higher temperatures, but this is in the context of comparative experiments, with no indication that such use is routine.[92] I conclude that it was common general knowledge and routine to employ hydrolysis temperatures of 45-50°C, but not 55°C, when using conventional, commercially available enzyme compositions.
[89] Vancov 1 at [33].
[90] Vancov 2 at [21].
[91] TV-4 at page 127. Similarly, Jørgensen, H. et al. (2007) ‘Liquefaction of lignocellulose at high-solids concentrations’, Biotechnology and Bioengineering, vol. 96, pages 862-870 (TV-7) reports hydrolysis by Celluclast and Novozym 188 at 50±1°C, and WO 2006/056838 A1 (TV-8) and Varga, E. et al. (2004) ‘High solid simultaneous saccharification and fermentation of wet oxidized corn stover to ethanol’, Biotechnology and Bioengineering, vol. 88, pages 567-574 (TV-9) also report hydrolysis by Celluclast and Novozym 188 at 50°C.
[92] Pages 133-136.
Novozymes adduced evidence establishing that a blend of Novozym 188 and Celluclast retains 71% of its initial glucose release activity after an initial 40 hour incubation at 56°C with 14% dry matter pretreated wheat straw.[93] While this experiment establishes that the enzyme composition retains activity as required by claim 1, it does not establish that use of the enzyme composition in this manner was well known or routinely undertaken.
[93] Reynolds at [3].
It is convenient at this point to comment on the terminology used in relation to the hydrolytic enzymes. I understand (and have adopted) references to commercial or conventional enzymes/enzyme mixes to refer to commercially available enzymes, such as those derived from Trichoderma reesei,[94] which as indicated above, are typically used at 45-50°C. In contrast, I understand (and have adopted) references to thermostable enzymes to relate to enzymes which are efficient/retain activity at higher temperatures than commercial/conventional enzymes.
[94] Kelly at [79].
Dr Vancov stated that thermostable enzymes were known before the priority date:
“As enzymes are usually more efficient at higher temperatures but susceptible to becoming heat-inactivated, enzymes with optimum temperatures of 60C or more were developed. Such enzymes (known as thermostable enzymes) were well known to me and other researchers interested in the hydrolysis of lignocellulosic matter as at 8 October 2009 and were used in the production of ethanol from lignocellulosic material at that time.”[95]
[95] Vancov 1 at [34].
Dr Vancov referred to a reference book ‘Biofuels’[96] as a book he had read and was regularly consulting as at the priority date.[97] Dr Vancov stated that this book was also owned and read by his colleagues.[98] Novozymes submitted that chapters of this text (exhibited as TV-4 and TV-12) are representative of the common general knowledge. While I agree that the book is a contemporaneous source of information regarding the state of the art, and includes information that was common general knowledge, as noted above a piece of information does not become common general knowledge because it is widely read or distributed, but when it becomes part of “the common stock of knowledge relating to the art” and I do not understand Dr Vancov’s evidence in relation to this book in its entirety to reach that level. TV-4 is a chapter of this book and contains in Table 1 a summary of thermostable cellulases derived from a number of microorganisms. However, the evidence does not establish that the enzymes recited in this table were common general knowledge and Dr Vancov acknowledged that Trichoderma reesei enzymes were widely used and thermostable enzymes were being developed at the priority date.[99]
[96] (Edited by L. Olsson) Advances in Biochemical Engineering/Biotechnology, vol. 108, Springer-Verlag, 2007.
[97] Vancov 1 at [40].
[98] Vancov 1 at [43].
[99] Vancov 2 at [23].
Dr Kelly agreed that “thermostable enzyme mixes derived from thermophilic microorganisms were known as at the priority date”[100] and that such enzymes are potentially advantageous and were being investigated at the priority date, but noted that significant research was also directed to improvements to Trichoderma reesei, the most widely used and studied cellulolytic microorganism.[101] Dr Kelly stated that thermostable enzymes were not being routinely used at the priority date, were not commercially available and were still in an experimental phase.[102] This is consistent with the reference in TV-4, published shortly before the priority date, to thermostable enzymes gaining “wide industrial and biotechnical interest”[103] which is language inconsistent with their use being common practice at that time.
[100] Kelly at [79].
[101] Kelly at [31].
[102] Kelly at [89].
[103] Page 123.
I conclude that the existence of thermostable enzymes was common general knowledge at the priority date, but the use of such enzymes was not routine in an industrial context.
Regarding the dry matter content of lignocellulosic material, Dr Kelly stated that “[t]ypically, dry matter content will be in the order of 5-10%”. While Dr Kelly acknowledged that increasing dry matter content (i.e. to above around 10-12%) would be advantageous, she stated that it may cause problems at an industrial scale. In particular, Dr Kelly pointed to possible problems with ethanol yield due to accumulation of inhibitors such as cellobiose.[104] In contrast, Dr Vancov stated:
“Hydrolysis of lignocellulosic material with dry matter weights in the region of 15% was known as at 8 October 2009. As yields of hexose and pentose sugars are dependent on the amount of starting material, there was a lot of interest in processing starting material with a higher dry matter weight, and I was aware of investigations in this regard as at 8 October 2009.”[105][104] Kelly at [24].
[105] Vancov 1 at [35].
To the extent that the experts seem to differ with regard to what is “high” dry matter weight the contemporaneous evidence is of assistance. Kristensen, J.B. et al. (2009) ‘Yield-determining factors in high-solids enzymatic hydrolysis of lignocellulose’, Biotechnology for Biofuels, vol. 2:11 (JK-4) states that “[t]welve to fifteen per cent total solids is often considered the upper limit at which pre-treated biomass can be mixed and hydrolysed in conventional stirred tank reactors” but that hydrolysis at up to 32% total solids has been reported at the laboratory scale.[106] The authors of Jørgensen, H. et al. (2007) ‘Liquefaction of lignocellulose at high-solids concentrations’, Biotechnology and Bioengineering, vol. 96, pages 862-870 (TV-7) acknowledged the desirability of high solid concentrations to facilitate an ethanol concentration that is economically feasible, but noted that “operating the hydrolysis at solids concentrations above 10%-15% poses technical problems” and at laboratory scale “results reported at solids concentrations above 10% are scarce”.[107] However, the authors of TV-7 did note a reported maximum of 15-20% dry matter content at pilot scale and TV-4 states that “the raw material consistency should be at least 15% (d.w.) to reach an ethanol concentration of 4-5%”.[108] These observations, made in the context of background information in the articles, are broadly consistent with the evidence of Drs Vancov and Kelly.
[106] Page 2.
[107] Page 863.
[108] Page 128.
I conclude that hydrolysis of lignocellulosic material with a high dry matter content was known to be desirable, but that there were associated complexities. The contemporaneous evidence supports a view that it is dry matter weights over 10-15% that are associated with technical problems. Given the information in the contemporaneous documents and the evidence of the declarants, I understand that it was common general knowledge that dry matter weights of up to 15% could be readily utilised but that dry matter weights beyond that would not be routinely adopted.
I note that Dr Kelly commented that C5 fermenting Saccharomyces and thermostable enzymes were not being used in commercial processes at the priority date.[109] However, I am not satisfied that a particular element must have been used on an industrial scale for it to have been well known – the knowledge of the declarants and the contemporaneous evidence support a view that these were known at a general level, despite not being used commercially.
Inventive step in light of the common general knowledge alone
[109] Kelly at [70], [132].
Novozymes submitted that claims 1-34 lack inventive step in light of the common general knowledge alone. Specifically, Novozymes submitted that the importance of each of the individual features of the claimed process (that is, the use of thermostable enzymes, high dry matter weights and C5 fermenting microorganisms) is common general knowledge, and would be adopted when seeking to optimise a hydrolysis and fermentation method.
Dr Vancov’s evidence indicates that prior to reviewing the present specification he was asked by Shelston IP to “comment on what was commonly known in the field of bioconversion of lignocellulose-containing material as at 8 October 2009.”[110] While I have discussed many of Dr Vancov’s comments in this regard above, it is useful to consider how Dr Vancov arrived at his conclusion in relation to efficient conversion of lignocellulosic biomass to ethanol. Having outlined the four typical steps (pretreatment, hydrolysis, fermentation, concentration), Dr Vancov noted that enzymatic hydrolysis was preferred, and that where enzymatic hydrolysis was used pretreatment is important as it increases accessibility of the enzymes to cellulose and hemicellulose, and may include heat, mechanical, acid, alkali and solvent treatment. Dr Vancov then stated that cooling lignocellulosic biomass after high temperature pre-treatment to enable enzymatic hydrolysis is time-consuming and costly, and that accordingly thermostable enzymes were developed.[111] Dry matter weight was then identified by Dr Vancov as an important consideration in the yield of sugars, as the sugar yield is dependent on the amount of starting material.[112] Dr Vancov stated that saccharification resulted in hexoses and pentoses, which can be fermented into ethanol by organisms such as yeast, but that wildtype Saccharomyces cannot efficiently ferment pentoses to ethanol. He then indicated that microorganisms (such as Saccharomyces cerevisiae and Zymomonas mobilis into which pentose metabolic pathways had been introduced) that could ferment both hexoses and pentoses to utilise all the sugars released by hydrolysis were known to him at the priority date.[113] He concluded with the following statement:
“In order to efficiently convert lignocellulosic biomass to ethanol, it is important to:
(a) optimise the pretreatment step to improve access of enzymes to principally cellulose and hemicellulose;
(b) optimise the enzymatic hydrolysis step to increase the yield of hexose and pentose sugars e.g., by employing enzymes that are more efficient at higher temperatures and/or utilising starting material with a high solid load; and(c) optimise the fermentation step to increase the yield of ethanol, e.g., by employing microorganisms that can ferment both hexoses and pentoses.”[114][110] Vancov 1 at [25].
[111] Vancov 1 at [27]-[34].
[112] Vancov 1 at [35].
[113] Vancov 1 at [36].
[114] Vancov 1 at [37].
Importantly, Dr Vancov in this passage has identified in general terms the features of the claimed invention, i.e. use of enzymes efficient at high temperatures, use of a high dry matter weight starting material, and use of C5 fermenting microorganisms. Dr Kelly did not disagree that these are, among others, strategies that a skilled person would consider[115] and, having regard to the invention as claimed, this is clearly powerful evidence. DSM submitted that Dr Vancov’s identification of these features was indicative of his having been impermissibly led or informed of the features of the invention. For example, my attention was drawn to Dr Vancov’s statement in his second declaration that he used “high dry matter”/“high solid load” as search terms because production of commercially viable quantities of ethanol requires a dry matter content of at least 15%,[116] in comparison to the statement in his first declaration that hydrolysis of dry matter weights in this region were known at the priority date and yields of hexose and pentose sugars are dependent on the amount of starting material.[117] To my mind these statements are not inconsistent and contemporaneous evidence[118] supports Dr Vancov’s statements in both declarations.
[115] Kelly at [45], [82]-[83].
[116] Vancov 2 at [36].
[117] Vancov 1 at [35].
[118] For example, TV-4 at page 128; TV-7 at pages 862-863.
I am not satisfied that Dr Vancov having been impermissibly led is the only reasonable conclusion to draw in the circumstances. I have outlined above the considerations mentioned by Dr Vancov prior to arriving at his conclusion, and his conclusion seems consistent with his foregoing evidence and an objective of increasing efficiency. I accept that there were other possible approaches, as outlined by Dr Kelly – for example, improving enzyme stability and/or activity by protein engineering and genetic manipulation, and optimisation of production of cellulases in Trichoderma reesei.[119] Dr Vancov stated that he had referred to “the most obvious starting points”,[120] which were acknowledged by Dr Kelly to be “among many other attractive options being explored.”[121] The features identified by Dr Vancov are reflected in various of the documents in evidence in this proceeding[122] and indeed Dr Vancov’s evidence that he had contacted groups before the priority date seeking yeast strains that could ferment hexoses and pentoses,[123] and I accept Dr Vancov’s evidence in this regard. However, Dr Vancov’s conclusion regarding important features to optimise does not, in my view, go so far as to establish that the claimed invention lacks inventive step in light of the common general knowledge alone.
[119] Kelly at [30]-[31].
[120] Vancov 2 at [28].
[121] Kelly at [45].
[122] For example, Dashtban, M. et al. (2009) ‘Fungal bioconversion of lignocellulosic residues: Opportunities and perspectives’, International Journal of Biological Sciences, vol. 5, pages 578-595 (TV-11) states that high temperature and low pH tolerant enzymes are preferred for hydrolysis due to the reliance of pretreatment strategies on heat and acid, and particularly identifies thermophilic fungal enzymes as having “good potential to be used for hydrolysis of lignocellulosic residues at industrial scale” (at page 585). This document also indicates that Saccharomyces cerevisiae has advantages that make it a good candidate for fermentation processes, and many successful attempts have been made to improve xylose fermentation by this yeast (at page 586).
[123] Vancov 1 at [86].
Similarly, I have found above that it would be a matter of routine for a person skilled in the art to use the enzyme compositions of TV-5 in the claimed process. I have discussed above the disclosure in Example 16 of compositions losing ~4-9% activity after 24 hours, with less than 5-7% further loss over 5 days. Given that disclosure, I am satisfied that the subject matter of claims 2-4 and 9-13 (that is, retention of at least 10% of initial activity at 55°C after 100 hours and retention of at least 80% of initial activity after 40 hours at 55°C) would be arrived at as a matter of routine in light of the disclosure of TV-5 and any one of TV-10 to TV-12 and therefore those claims lack inventive step. However, while it may well be the case that the enzyme preparations disclosed in TV-5 have the stability properties of claims 5-8 and 14-18, there is no explicit evidence that that is the case and I am not convinced that I can draw a sound inference to that effect. Accordingly, I cannot find that those claims lack inventive step in light of the combination of TV-5 and any one of TV-10 to TV-12.
Claim 19 defines the fermentation time as being in the range of 18-120 hours. TV-10 exemplifies fermentation periods of approximately 70 to 120 hours.[186] TV-12 discloses conversion of most sugars using RWB 218 within 35-80 hours.[187] Dr Vancov’s uncontradicted evidence is that fermentation times in excess of 18 hours were well known at the priority date.[188] I conclude that a skilled worker would use such a fermentation time as a matter of routine and arrive at the subject matter of claim 19 without invention in light of the combination of TV-4 or TV-5 and any one of TV-10 to TV-12.
[186] Figures 5-7.
[187] Pages 199-201.
[188] Vancov 1 at [146].
Claim 20 requires that the enzyme composition is derived from a microorganism of genus Talaromyces. TV-4 refers to Talaromyces emersonii as producing cellulases that retain activity at elevated temperatures[189] and refers specifically to an exoglucanase from this species in Table 1. While TV-4 does not disclose the relevant stability parameters of Talaromyces enzymes, I note that the present specification indicates that Talaromyces emersonii is a suitable source of enzyme compositions for use in the invention[190] and therefore I will proceed on the basis that such enzyme compositions have the parameters defined in claim 1. As noted previously TV-5 exemplifies compositions derived from Talaromyces emersonii. Claim 20 therefore lacks inventive step in light of the combination of TV-4 or TV-5 and any one of TV-10 to TV-12.
[189] Page 124.
[190] Page 6, lines 4-13.
Claims 21 and 22 define the process of the preceding claims wherein hydrolysis is carried out until 70% or more or 90% or more, respectively, of the available sugar in the lignocellulosic material has been released. In the examples of TV-4 hydrolysis is carried on until this point.[191] TV-5 also discloses hydrolysis to this extent.[192] Further, it is apparent that a high level of conversion of lignocellulosic material to sugars would be desirable.[193] I am satisfied that claims 21 and 22 lack inventive step in light of the combination of TV-4 or TV-5 and any one of TV-10 to TV-12.
[191] Page 136.
[192] Tables 12 and 13.
[193] Kelly at [71].
Claim 23 defines the dosage of the enzyme composition as 6 mg protein / g dry matter weight or lower. TV-4 discloses enzyme dosages of 5 or 10 FPU (filter paper units)/g substrate.[194] TV-5 also discloses enzyme loading in FPU (e.g. 25 FPU/g substrate[195]). However, there is no evidence as to how these dosages correspond to that claimed, and Dr Vancov indicated that the dosage claimed does not take into consideration enzyme purity or activity.[196] Dr Kelly asserted that the dosage claimed is a low dosage by industry standards[197] and the specification also indicates that this is a low dose.[198] Novozymes submitted that the use of the lowest possible enzyme dosage is not inventive.[199] However, the parties did not point to and I have not identified any evidence as to what a standard dosage in mg protein/g dry matter for any particular enzyme composition is and what level of variation a skilled person might undertake as a matter of routine. Accordingly I cannot find that claim 23 lacks inventive step.
[194] Page 131; Figures 4-7, pages 134-137.
[195] Page 37, lines 10-12.
[196] Vancov 1 at [63].
[197] Kelly at [72].
[198] Page 20, lines 4-17.
[199] Novozymes’ written submissions at pages 75, 78.
Claim 24, which defines a dry matter content of 14-33% (w/dmw) or more, does not add any additional requirement over claim 1 and therefore also lacks inventive step in light of the combination of TV-4 or TV-5 and any one of TV-10 to TV-12 as I have concluded that it would be routine to use a dry matter weight in the order of 15% (w/w).
Claim 25 defines a process wherein after recovery of the fermentation product, the resulting slurry containing the enzyme is recycled to the hydrolysis step. There is limited evidence in relation to enzyme recycling. Dr Vancov asserts that enzyme recycling was well known and refers to a number of documents in support of this proposition.[200] TV-4 is silent in relation to enzyme recycling. TV-5 indicates that thermostable enzymes have a “potential for recycling of the enzyme preparation”[201] but does not go further than that. Dr Kelly stated that enzyme recycling was an active area of research but that there was no consensus as to a routine approach.[202] In any event, the question is, as set out in Minnesota Mining, not whether the integer was known, but whether it would have been obvious, or a matter of routine, to combine this feature with the other features of the claims. In the present case, Dr Vancov identified a number of features as desirable to optimise at the outset, but did not refer to enzyme recycling until considering the examples of the present specification. Further, the reference in TV-5 is to potential for recycling without further elaboration. I am not satisfied that the evidence establishes to the requisite standard that a skilled person would, without the benefit of hindsight, arrive at the subject matter of claim 25 as a matter of routine in light of the combination of TV-4 or TV-5 and any one of TV-10 to TV-12 and the common general knowledge.
[200] Vancov 1 at [103].
[201] Page 3, lines 7-12.
[202] Kelly at [117]-[120].
Claim 26 defines a process wherein the product of the hydrolysis step is subjected to solid-liquid separation and (part of) the liquid fraction is fed to the fermentation step. Dr Vancov stated that he did not consider there to be anything “new or surprising” in this use of the hydrolysis filtrate.[203] I understand Dr Vancov’s evidence to mean that he considers that solid-liquid separation of the hydrolysis mixture followed by fermentation of the sugar-containing liquid fraction is a step that is not unusual, that is, it is a step that would routinely have been carried out in a hydrolysis and fermentation process. While Dr Kelly commented on enzyme recycling (as discussed above), she did not disagree with Dr Vancov’s view in relation to the subject matter of claim 26, which does not include enzyme recycling. I conclude that solid-liquid separation followed by fermentation of the liquid was a matter of routine, and that a person skilled in the art would arrive at the subject matter of claim 26 as a matter of routine. Consequently this claim lacks inventive step in in light of the combination of TV-4 or TV-5 and any one of TV-10 to TV-12 and the common general knowledge
[203] Vancov 1 at [154].
Claim 27-32 relate to enzyme recycling. For the same reasons as given in relation to claim 25, I cannot find that they lack inventive step.
Claim 33 is an omnibus claim and I have discussed its construction previously. There is no evidence to support a conclusion that the specific thermostable enzyme composition and yeast used in claim 33 are not inventive in light of the combinations of documents and the common general knowledge.
Claim 34 defines a fermentation product prepared by the process of any of the preceding claims and it follows that claim 34 lacks inventive step for the same reasons as claim 1.
Novozymes also submitted that the claims lack inventive step in light of TV-5 combined with any one of TV-4 or TV-7 to TV-9. That is, TV-5 does not disclose hydrolysis of lignocellulosic material having a dry matter weight of 14% or more, but TV-4 refers to hydrolysis of high dry matter weight material and TV-7 to TV-9 disclose processes in which high levels of dry matter are hydrolysed. In Novozymes’ submission the skilled person could reasonably be expected to combine the documents and use a dry matter weight of at least 15% in the process of TV-5. However, even if that is accepted, none of these documents disclose the use of a C5 fermenting Saccharomyces and I have found above that use of such a microorganism would not be a matter of routine in light of the common general knowledge. It follows that Novozymes has not established that the claims lack inventive step in light of the combination of TV-5 with any one of TV-4 or TV-7 to TV-9.
Conclusion
Claims 1-4, 9, 10, 19-22, 24, 26 and 34 lack inventive step in light of the combined disclosure of TV-4 and any one of TV-10 to TV-12. Claims 1-4, 9-13, 19-22, 24, 26 and 34 lack inventive step in light of the combined disclosure of TV-5 and any one of TV-10 to TV-12. It has not been established that claims 5-8, 14-18, 23, 25 or 27-33 lack inventive step.
Manner of manufacture
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. Novozymes submitted that the invention claimed does not define a manner of manufacture, and referred to two specific forms of that ground: principally, that the claims define a collocation of known integers, and also that the claims lack inventive character/are directed to mere working directions.
Collocation of known integers
It is well established that in order to be patentable a combination of known integers must have a working interrelationship.[204] Novozymes submitted that the claimed invention merely defines a collocation of integers, each of which is known, specifically:
·use of thermostable enzymes for enzymatic hydrolysis at temperatures of at least 60°C[205]
·enzymatic hydrolysis times of greater than 40 hours[206]
·hydrolysis of lignocellulosic material having a dry matter weight ~15%[207]
·fermentation of sugars with Saccharomyces capable of fermenting at least one C5 sugar.[208]
[204] 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.
[205] WO 2007/091231 is referenced in the specification as a source of such enzymes; TV-4, page 133.
[206] Specification, page 1, line 33 – page 2, line 1.
[207] TV-4, page 128.
[208] WO 2008/041840 is referenced in the specification as a source of such a microorganism.
Novozymes submitted that each of these integers/parameters is chosen for an independent reason and the specification fails to describe an advantage associated with the combination or any relationship between the parameters selected. In this regard Dr Vancov stated that “the process described in the Opposed Application merely brings together several well known elements without any optimisation and without yielding any surprising results”.[209]
[209] Vancov 2 at [66].
DSM submitted that the claimed process is an integrated, interrelated process, and comprises one step (enzymatic hydrolysis) which produces the starting material for the next step (fermentation), and also referred to references in the specification to the interrelationship between the elements.[210] Given that upstream elements of the process, such as dry matter content, can impact the fermentation step, in DSM’s submission there cannot be said to be no working interrelationship between the steps.
[210] Pages 25-29.
To my mind, although the individual integers of the process may be known, there is clearly a working interrelationship between the integers. In the enzymatic hydrolysis step the chosen enzyme hydrolyses the lignocellulosic material having the defined dry matter weight, and the product of hydrolysis is then fermented in the fermentation step. In addition, the specification (i.e. Examples 1 and 2) demonstrates that the parameters of the hydrolysis step can impact the fermentation step. I am not satisfied that there is no working interrelationship between the elements of the claimed combination and therefore Novozymes has not established that the claims define a mere collocation.
Lack of inventive character
There is a threshold of inventiveness on the face of the specification necessary for a claim to satisfy the manner of manufacture requirement. In NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd[211] the High Court said:
“if it is apparent on the face of the specification, when properly construed, that the quality of inventiveness necessary for there to be a proper subject of letters patent under the Statute of Monopolies is absent, one need go no further.”
[211] [1995] HCA 15; (1995) 183 CLR 655 at [9].
In Novozymes’ submission, even if some interrelationship between the hydrolysis and fermentation steps can be established, “the alleged invention is a mere optimisation of a known process to produce an old product, achieved without inventive ingenuity”.[212] Novozymes referred in particular to Commissioner of Patents v Lee[213] in which it was held that instructions relating to the particular operation of a known apparatus for the manufacture of charcoal constituted a working direction and did not amount to a manner of manufacture. This is one example of a number of cases in which it has been established that directions for carrying out a known process, or operating a known article or machine, to produce an old result are not patentable.[214]
[212] Novozymes’ written submissions at [125].
[213] [1913] HCA 22; (1913) 16 CLR 138.
[214] Summarised in Grant v Commissioner of Patents [2006] FCAFC 120; 69 IPR 221 at [15].
In my view the presently claimed invention is more than mere working directions. The claimed invention does not merely involve adaptation of the operation of an existing apparatus or process. While the fermentation product being produced is “old”, the specification does not suggest that the use of a high dry matter weight starting material with a thermostable enzyme preparation is known, or that the combination of such a hydrolysis step with fermentation by a C5 sugar fermenting microorganism is known. Accordingly, I am not satisfied that the process of the present claims can be fairly categorised as mere optimisation of a process which is known on the face of the specification. It follows that I do not consider the claimed invention to constitute mere working directions or to lack inventiveness on the face of the specification.
Conclusion
Novozymes has not established that the claims are not directed to a manner of manufacture.
Best method
It is a requirement of paragraph 40(2)(a) of the Act that the complete specification must provide the best method known to the applicant of performing the invention. This is an additional requirement to the requirement that the specification describe the invention fully.[215] However, there is no requirement that the best method must have actually been performed, as long as it is disclosed.[216]
[215] Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27; 117 IPR 415 at [109].
[216] New England Biolabs, Inc v F. Hoffmann-La Roche AG [2004] FCA 1651 at [33].
What is required to provide a best method of performance depends on the facts of the case:
“It can be accepted that there are cases where the claim is to a product or class of products and the best method requirement is satisfied by a description of the best embodiment known to the patentee at the relevant time. It can also be accepted that there are cases where the claim is to a product and there is no requirement to provide a method of using that product. It is also the case that there is no requirement actually to have carried out the best method and that a prediction will suffice. However, it is necessary to understand the invention itself. ... The nature of the invention will determine what is ‘best’ in the circumstances.”[217]
[217] Les Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27; 117 IPR 415 at [129].
In Expo-Net Danmark A/S v Buono-Net Australia Pty Ltd (No 2) Bennett J stated that for the best method ground to be made out “it must be established that there was a better method known to the applicant at the date of filing the patent than the one described in the specification.”[218]
[218] [2011] FCA 710 at [15].
It is clear that it is necessary to consider:
i.what is the invention for which a best method must be provided;
ii.what method is described in the specification; and
iii.was the applicant aware of a better method?
The High Court in Kimberly Clark Australia Pty Ltd v Arico Trading International Pty Ltd made clear that for the purpose of paragraph 40(2)(a), the invention is “the embodiment which is described, and around which the claims are drawn.” [219] However, it is necessary to have regard to what is described as the invention by the specification as a whole.[220] The invention in this case lies in a process for fermentation of lignocellulosic material via a combination of enzymatic hydrolysis and fermentation steps characterised by certain parameters, principally, use of a thermostable hydrolytic enzyme preparation, use of a high dry matter weight lignocellulosic material and use of a Saccharomyces that is capable of fermenting at least one C5 sugar. The claims define the specific parameters of the process. In my view this process is the invention for which a best method must be provided.
[219] [2001] HCA 8; 207 CLR 1 at [19]-[21].
[220] Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd [2017] FCAFC 138 at [117].
Novozymes submitted that if Example 5 is considered to represent the best method known to the applicant of performing the invention (noting that Example 5 includes a relatively high dry matter weight and a fermentation step using Saccharomyces capable of fermenting C5 sugars, although it does not fall within the scope of the present claims), then the reference to an “experimental broad spectrum cellulase” makes clear that something is known to the applicant which has not been described in the specification. That is, the applicant must have more information about the cellulase than has been provided. However, it is apparent that Example 5 does not fall within the scope of the present claims and I am not satisfied that a failure to disclose all relevant information regarding the cellulase used in this example gives rise to a failure to describe the best method in these circumstances.
The specification provides a general description of the invention as claimed and how to carry it out, and the declarants have not suggested that they would be unable to carry out the claimed invention in view of the description of the invention. None of the examples present at the time of filing fall within the scope of the claims and the experiments reported in Example 6 were carried out after the filing date. As noted above it is not necessary that the best method have been carried out, as long as it is disclosed. I see no reason to conclude that the general description of the invention as claimed cannot, in the absence of any evidence to the contrary, be considered as providing the best method known to the applicant of performing the invention. Novozymes has provided no evidence that DSM was aware of a better method of carrying out the claimed invention at the filing date than has been disclosed. Accordingly, Novozymes has not established this ground of opposition.
Utility
Paragraph 18(1)(c) of the Act requires that the claimed invention be useful. Utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd with Emmett J stating:
“A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility.”[221]
[221] [2009] FCAFC 70; 81 IPR 228 at [81].
Novozymes submitted that the claimed invention does not work over the full scope of the claims insofar as the claims do not specify:
· a maximum hydrolysis temperature, noting that enzymes denature at high temperatures; or
· a maximum dry matter content, noting that enzymes require an aqueous environment.
I understand these submissions to mean that because of the lack of upper limits on the hydrolysis temperature and the dry matter content, the claim encompasses processes in which enzymatic hydrolysis (and ultimately production of a fermentation product) will not result due to inactivation of the enzymes. However, the claims are directed to a process for the preparation of a fermentation product, involving a step of enzymatic hydrolysis, and as discussed previously I understand this step to be limited by its functional definition. If the parameters selected are such that the relevant step cannot fairly be characterised as enzymatic hydrolysis, then in my view such a step does not, on a common sense reading, fall within the scope of the claim. While it would be expected that within the scope of the claims there will be embodiments that are more or less effective, it follows from my construction of the claims that Novozymes has not established that the claims lack utility.
Conclusion
The opposition succeeds on the ground of inventive step with regard to claims 1-4, 9-13, 19-22, 24, 26 and 34. I will allow DSM a period of time to propose suitable amendments.
Costs
It is usual in matters before the Commissioner that costs follow the event and I see no reason to depart from this approach. I will award costs according to Schedule 8 against DSM.
Dr S. J. Smith
Delegate of the Commissioner of PatentsAnnex A: The claims
1. Process for the preparation of a fermentation product from lingo-cellulosic material, comprising the following steps:
a) optionally pre-treatment;
b) optionally washing;
c) enzymatic hydrolysis;
d) fermentation; and
e) optionally recovery of a fermentation product;
wherein in step c) a stable enzyme composition that has a temperature optimum of 55°C or more and retains at least 10% of its initial activity for 40 hours or more at 55°C, is used, the hydrolysis time is 40 hours or more and the hydrolysis temperature is 55°C or more, and wherein the activities of the stable enzyme composition are thermostable, and wherein the dry matter content of the lignocellulosic material in the hydrolysis step c) is 14% (w/dmw) or more, and wherein in step d) the fermentation is conducted with a yeast of the genus Saccharomyces that is able to ferment at least one C5 sugar.2. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 60 hours.
3. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 80 hours.
4. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 100 hours.
5. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 200 hours.
6. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 300 hours.
7. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 400 hours.
8. Process according to claim 1 wherein the stable enzyme composition used retains at least 10% of its initial activity after 500 hours.
9. Process according to claim 1 wherein the stable enzyme composition used retains at least 20% of its initial activity after 40 hours.
10. Process according to claim 1 wherein the stable enzyme composition used retains at least 40% of its initial activity after 40 hours.
11. Process according to claim 1 wherein the stable enzyme composition used retains at least 60% of its initial activity after 40 hours.
12. Process according to claim 1 wherein the stable enzyme composition used retains at least 70% of its initial activity after 40 hours.
13. Process according to claim 1 wherein the stable enzyme composition used retains at least 80% of its initial activity after 40 hours.
14. Process according to claim 1 wherein the stable enzyme composition used retains at least 90% of its initial activity after 40 hours.
15. Process according to claim 1 wherein the stable enzyme composition used retains at least 95% of its initial activity after 40 hours.
16. Process according to claim 1 wherein the stable enzyme composition used retains at least 97% of its initial activity after 40 hours.
17. Process according to claim 1 wherein the stable enzyme composition used retains at least 99% of its initial activity after 40 hours.
18. Process according to claim 1 wherein the stable enzyme composition used retains at least 100% of its initial activity after 40 hours.
19. Process according to any one of the preceding claims, wherein the fermentation time is from 18 to 120 hours.
20. Process according to any one of the preceding claims, wherein the enzyme composition is derived from a microorganism of genus Talaromyces.
21. Process according to any one of the preceding claims wherein step c) is conducted until 70% or more of available sugar in lignocellulosic material is released.
22. Process according to claim 21 wherein step c) is conducted until 90% or more of available sugar in lignocellulosic material is released.
23. Process according to any one of the preceding claims wherein the dosage of enzyme composition is 6 mg protein / g dry matter weight or lower.
24. Process according to any one of the preceding claims, wherein the dry matter content of the lignocellulosic material in the hydrolysis step c) is 14-33% (w/dmw) or more.
25. Process according to any one of the preceding claims wherein in step e) after recovery of the fermentation product, the resulting slurry containing enzyme is recycled to step c).
26. Process according to any one of the preceding claims wherein the product of hydrolysis step c) is subjected to solid liquid separation and (part of the) the liquid fraction is fed to fermentation step d).
27. Process according to any one of the preceding claims wherein the product of hydrolysis step c) is subjected to solid liquid separation and (part of) the liquid fraction is recycled to step c).
28. Process according to any one of the preceding claims wherein the product of hydrolysis step c) is subjected to solid liquid separation and the liquid fraction is fed to an ultrafiltration unit, wherein the filtrate is fed to fermentation step d) and the retentate is recycled to step c).
29. Process according to claim 28, wherein part of the filtrate is used to feed the production fermenters for the production of microorganisms used in the process.
30. Process according to claim 28 or claim 29 wherein part of the filtrate is used to feed the production fermenters for the production of enzyme.
31. Process according to claim 29 or claim 30 wherein part of the filtrate is used to feed the production fermenters for the production of enzyme.
32. Process according to any one of the claims 28 to 31 in which the filtrate is used to feed production fermenters in batch, fed batch and or continuous culture mode.
33. Process according to claim 1, substantially as hereinbefore described with reference to any one of the examples.
34. A fermentation product prepared by the process of any one of claims 1 to 33.
0
33
0