Deb Worldwide Healthcare, Inc v Gojo Industries Inc
[2015] APO 20
•12 May 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Deb Worldwide Healthcare, Inc v Gojo Industries Inc. [2015] APO 20
Patent Application: 2006252070 and 2011224144
Title:Foamable Alcoholic Composition
Patent Applicant: Gojo Industries Inc.
Opponent: Deb Worldwide Healthcare, Inc
Delegate: Keith Wagg
Decision Date: 12 May 2015
Hearing Date: 17 February 2015 in Melbourne
Catchwords: PATENTS – Novelty – whole of contents novelty – inventive step – claims novel and inventive – some claims lack utility – claims define the invention – specifications provide full descriptions – opportunity to amend
Representation: Patent applicant: I. Horak of Counsel, assisted by Dr D. Angus, Collison and Co.
Opponent:C Dimitriadis SC and C Cunliffe of Counsel, assisted by Corrs Chambers Westgarth Solicitors.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006252070 and 2011224144
Title:Foamable alcoholic composition
Patent Applicant: Gojo Industries Inc.
Date of Decision: 12 May 2015
DECISION
Claims 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 15 and 16 of 2011224144 lack utility. The applicant is given 2 months from the date of this decision to propose suitable amendments to overcome the finding on application number 2011224144. All other grounds of opposition are found to be unsuccessful. Subject to appeal of this decision, I direct application number 2006252070 proceed to grant. Amendment to the Statement of Grounds and Particulars allowed.
REASONS FOR DECISION
Background
Patent application number 2006252070 (‘070) in the name of Gojo Industries Inc. (the applicant) was advertised as accepted by the Commissioner on 11 August 2011. A subsequent patent application, 2011224144 (‘144), was filed on 20 September 2011 claiming divisional status from ‘070. On 09 November 2011 a notice of opposition to the grant of ‘070 was filed by Deb World Healthcare, Inc. (the opponent). On 28 June 2012 ‘144 was advertised as accepted by the Commissioner and a notice of opposition filed by the opponent on 27 September 2012.
The request for examination for both of these applications was filed prior to 15 April 2013. As a consequence, substantive amendments of the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent applications. 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. I also note that any subsequent reference to the Patents Act relates to the Patents Act 1990, prior to amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
The specifications
The ‘070 and ‘144 specifications both relate to foamable alcoholic compositions. The ‘070 specification ends with 7 claims and 1 Figure with claims 1, 6 and 7 being independent product claims and claim 2 being an independent method claim. The ‘144 specification ends with 17 claims and 1 Figure with claims 1, 10, 11 being independent product claims and claim 2 being an independent method claim. Both sets of claims were amended after acceptance. The descriptions of both applications are largely identical.
What is the invention as described
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139]:
"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."
The background to the invention
Both specifications relate to foamable alcoholic compositions. On page 1 of both specifications it is noted that consumers seem to prefer foamed products ([0003]). Alcoholic products are said to be popular as skin sanitizers ([0005]) and the undesirable defoaming properties of adding alcohol, such as the foam collapsing, is noted and the specifications acknowledge that aerosol-based alcoholic foams are known but are generally more expensive to manufacture.
The aim of the invention
The aim of the invention can be gleaned from both specifications at [0013]:
“Commercially available non-aerosol alcoholic foams have been formulated with specific perfluoroalkyl phosphate surfactants and dispensed from a foaming pump mechanism. But the foam thus produced is fleeting, and will immediately begin to deflate or liquefy into a water-thin liquid. When the alcoholic foam is dispensed from a common foaming pump mechanism, some of the foam is left within the tubes of the dispenser, and, as the foam breaks down, the composition often drips out of the dispenser. This dripping not only wastes product, it makes the area around the dispenser look unsanitary and may result in damage to walls and floors, as well as resulting in a slip hazard if the product is dripping on the floor. Thus, there is a need for stabilized foamable alcoholic compositions.”
This passage suggests to the reader that the aim is to provide a stable foam that does not drip from a dispenser.
The nature of the invention
As mentioned in the above paragraph the invention relates to foamable alcoholic compositions which are stable and hold their form rather than collapsing and causing issues such as dripping from the dispenser. The compositions have at least about 40% alcohol. The choice of alcohol is said to be one that typically has antimicrobial properties such as short chain alkanols (see paragraph [0024]).
The composition also contains a surfactant which adds the foaming properties to the composition (see paragraphs [0026]-[0027]). This is referred to as the foaming surfactant. The foaming surfactant differs between the ‘070 and the ‘144.
The foaming surfactant is defined in the ‘070 to be selected from the group containing siloxane polymer surfactants of a specified Markush structure (see claim 1) and combinations thereof. The ‘144, however, includes siloxane polymer surfactants without a Markush structure and also includes anionic, cationic, and zwitterionic fluorosurfactants and combinations thereof (see claim 1).
The foamable composition of the ‘070 contains a polymeric or oligomeric cationic foam stabilizer. The ‘144 only comprises the polymeric or oligomeric cationic foam stabilizer when the foaming surfactant comprises a fluorosurfactant.
The amount of foaming surfactant is said to be “not particularly limited, so long as an effective amount to produce foaming is present.” At [0032] the specification then goes on to discuss possible percentages in [0033]-[0036].
The polymeric or oligomeric cationic foam stabilizers are discussed at [0040] and they are specifically said to include polyquaterniums:
“Polymeric foam stabilizers include polyquaternium polymers. In general, a polyquaternium polymer is one that is designated as such by the CTFA. Polyquaternium polymers may be characterized by containing a quaternary ammonium group.”
This passage is followed by a table of INCI polyquaterniums which is said to be a non-limiting list of them.
The specifications go on to further define the foam stabilizers at [0041]-[0045] with [0046] discussing the amount of foam stabilizer to be used. Stating that “[i]n one embodiment, foam stabilizer is present in an amount of from about 0.005 to about 4 weight percent active, based upon the total weight of the alcoholic composition.”
The weight ratio is further discussed at [0048].
The examples
The examples are identical in both the ‘070 and the ‘144. Either a fluorosurfactant is used, such as DEA C8-C18 perfluoroalkylethyl phosphate, a siloxane, such as PEG-10 dimethicone, with some examples containing both. The polyquaternium used includes polyquaternium 11. Humectants are also used and the amount of ethanol is 65.50% and water is added at around 30% to make up the 100%. The foams are rated out of 5 for quality and stability, with a rating of 5 for quality meaning the foam is creamy, dense with small, tight bubbles and a rating of 5 for stability meaning the foam remains after about 60 minutes.
The Claims
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification".
Claim 1 of ‘070 reads:
“A foamable composition comprising:
at least about 40 weight percent alcohol, based upon the total weight of the alcoholic composition; and
a foaming surfactant selected from the group consisting of siloxane polymer surfactants and combinations thereof, wherein said siloxane polymer surfactant is represented by the formulaR2 – Si(CH3)2-[O-Si(CH3)2]a-[O-Si(CH3)R3]b-O-Si(CH3)2-R2
where R2 and R3 independently include a methyl group or a moiety that is represented by the formula
-(CH2)3-O-(CH2CH2O)c-[CH2CH(CH3)O]d-(CH2CH2O)eH
with the proviso that both R2 and R3 are not CH3, where a is an integer from about 3 to about 21, b is an integer from about 1 to about 7, c is an integer from about 0 to about 40, d is an integer from about 0 to about 40, and e is an integer from about 0 to about 40, with the proviso that a ≥ 3 x b and that c + d + e ≥ 5; and
a polymeric or oligomer cationic foam stabilizer.”
Claim 2 is an independent claim to a method for reducing dripping from a dispenser using a foamable composition that is identical to that of claim 1. Claims 3-5 are dependent on claims 1 and 2.
Claim 7 is an independent claim to a foamable alcoholic composition which is identical to claim 1 except that the polymeric or oligomeric foam stabilizer is limited to a group comprising a list spanning pages 30-32.
Claim 6 is an independent claim and differs in that the alcoholic content is at least 50% and the siloxane polymer is referred to as a surfactant, rather than a foamable surfactant and in about 0.002 to about 4 wt. %. The polymeric or oligomeric foam stabilizer is present in about 0.005% to about 4 wt. %.
Claim 1 of ‘144 reads as follows:
“A foamable alcoholic composition comprising:
at least about 40 weight percent alcohol, based upon the total weight of the alcoholic composition; and
a foaming surfactant selected from the group consisting of siloxane polymer surfactants, anionic, cationic, and zwitterionic fluorosurfactants, and combinations thereof, with the proviso that when the foaming surfactant comprises a fluorosurfactant, the foamable alcoholic composition further comprises a polymeric or oligomeric cationic foam stabilizer, wherein the foamable alcoholic composition has a viscosity of less than about 100 mPas.”Claim 2, like in the ‘070, is to a method for reducing dripping in a dispenser. Claims 3-9 and 17 are dependent on claims 1 and 2.
Claim 10 is an independent claim to an antimicrobial composition with identical features of claim 1.
Claim 11 is an independent claim to an alcoholic composition comprising at least 40 weight % alcohol and a foaming surfactant selected from a list consisting of those on page 30. Claims 12-16 are dependent on claim 11. The polymeric or oligomeric cationic foam stabilizer is present at claim 12 in a ratio of 3.5:1 to about 14.5:1.
With the exception of claim 11 of the ‘144 the claims of both applications relate to compositions comprising three ingredients:
(a)at least 40 weight %, and in some cases higher, alcohol;
(b)a foaming surfactant which is a defined siloxane polymer in the ‘070 and has a viscosity limitation when it is a fluorosurfactant in the ‘144; and
(c)a polymeric or oligomeric cationic foam stabilizer (usually an amine or quarternium).
The opposition
The statement of grounds and particulars on the ‘070 was filed on 07 February 2012 and subsequently amended and allowed on 03 March 2014. The statement of grounds and particulars for the ‘144 was filed on 21 December 2012 and subsequently amended and allowed on 15 July 2013. The grounds of opposition identified for the ‘070 were: that the claims are not novel; lack utility; that the claim does not describe the invention fully, including a best method of performance; and the claims do not define the invention. The same grounds were raised against the ‘144 as well as the ground that the claims do not involve an inventive step.
At the hearing the statement of grounds and particulars for ‘144 was amended to add that claim 17 was anticipated. As the ground of novelty was already raised, and the claims had been amended I see no reason not to allow the amendment. Therefore this amendment to the statement is allowed.
The parties relied upon evidence by several declarants and it was agreed that evidence from either case could be used interchangeably with the other.
Evidence in support of the opposition to the ‘070 consists of a declaration from Dr Peter Richardt (Richardt #1) and a declaration by Stephen Marcus Stern (Stern #1). Evidence in answer consists of a declaration by John Alexander Staton (Staton). Evidence in reply consists of a declaration by Dr Peter Richardt (Richardt #2). Further evidence was filed and consisted of a declaration by Stephen Marcus Stern (Stern #2). I will refer to the relevant parts of the evidence where appropriate.
Evidence in support of the opposition to the ‘144 consists of a declaration from Dr Peter Richardt (Richardt #3). Evidence in answer consists of a declaration by Dr Malcolm Nearn (Nearn #1)
Evidence in reply consists of a declaration by Dr Peter Richardt (Richardt #4). Further evidence was filed and consisted of a declaration by Stephen Marcus Stern (Stern #3). I will refer to the relevant parts of the evidence where appropriate.
During the evidence in answer period for both the ‘070 and the ‘144 both applications were amended. The effect was that the defined siloxane polymer was added to the claims of the ‘070 and ‘144 had the proviso of limited viscosity when a fluorosurfactant was used added to its claims.
At the hearing, the opposition was limited to the grounds of novelty based on prior art information; inventive step; sufficiency; that the claims fail to define the invention and inutility.
Novelty
It is a requirement of subsection 18(1) of the Patents Act (the Act) that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art base. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
A citation may also be part of the prior art base under Subsection 7(1) if it is information contained in a published specification filed in respect of a complete application where: the information is, or were to be, the subject of a claim of the specification, the claim has, or would have, a priority date earlier than that of the claim under consideration; and the specification was published after the priority date of the claim under consideration; and the information was contained in the specification on its filing date and when it was published. This is referred to in the parlance as a “whole of contents” citation.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20]; 137 CLR 228 at 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement".
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
Whole of contents novelty
In addition, in order to raise a “whole of contents” objection, it must be possible to draft a notional claim (assuming there is not an actual claim to the relevant subject matter) that is fairly based on the disclosure of the prior specification relied upon (Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282; (2011) 91 IPR 209 at [178]). However, the test basically mirrors that for novelty in that if there is a disclosure which amounts to clear and unmistakable directions, it would be the subject of a valid claim.
AU2006259687 (Asmus)
Asmus was published on 28 December 2006 and has a priority date of 13 June 2005. Because the earliest priority date the opposed applications is 26 October 2005 Asmus was relied on as a whole of contents particular for the ground of lack of novelty.
Disclosure of Asmus and the ‘070
Asmus relates to foamable alcohol compositions, systems and methods of use (see title and abstract).
The alcoholic content of the examples in Asmus is 65.00%. This is within the scope of all of the claims of the ‘070.
Asmus uses a number of siloxane surfactants in the compositions made. On table 1 on pages 19-20 there are PEG and PEG/PPG substituted dimethicones mentioned and some used are hydroxyl terminated. There was no dispute over whether or not these surfactants fall within the scope of claim 1 of ‘070.
Asmus does not specifically refer to a foam stabilizer but rather refers to “builders”.
In Dr Richardt’s first declaration he notes at [28]:
“Builders
Asmus describes that builders which can be used to stabilize the foamable alcohol composition from page 7 line 20 to page 9 line 20. Asmus discloses that these builders may be present at concentrations less than or equal to 0.1% or about 0.06% (at page 8 lines 7 to 9). Asmus describes several specific builders which can be used. These builders include polymers, including polyquaterniums (from page 8 line 29 to page 9 line 8).”Here he notes that polyquaterniums are there but it is clear it is included in a list of possibilities. He mentions what polyquaterniums meant to him at the priority date at [29].
“Before 28 December 2005, I was aware from my experience of developing personal care products that polyquaterniums were:
(a) cationic polymers;
(b) which could be used in non-ionic systems; and
(c) often used in personal care products for their desirable skin-feel qualities (as they give a creamy effect, which is popular in personal care products).”He uses this to explain how he would read the disclosure of Asmus at [30].
“If I had read Asmus before 28 December 2005, I would have understood that:
(a) polyquaterniums could be used in the foamable alcohol composition to fulfil the dual functions of stabilizing the alcohol foam and improving skin feel. This was desirable, since alcohol has a drying effect on skin which could be countered by the inclusion of a skin feel agent.
(b) the use of the named foam stabilizers (including the polyquaterniums) might also change the rheology of the composition, by thickening the composition. But Asmus discloses that polyquaterniums could be included in foamable alcohol products, indicating that the inclusion of the polyquaternium could be done without resulting in thickening to an extent that prevented foaming of the alcohol composition.”
Mr Staton notes that none of the examples in Asmus use polyquaternium compounds (Staton #1 at [30])
“At page 8, line 29-30 Asmus specifically mentions that polyquaternium 4 and polyquaternium 10 would be useful as builders, then on page 9 makes reference to polyquaternium 1 to polyquaternium 47. However none of the actual working examples in Asmus, which appear on pages 18 through to 34, actually contain any polyquaternium compounds at all. I could not see any specific example in Asmus where the composition had included any polyquaternium compound to stabilize a foam, or stabilize an alcoholic foam. For purposes of clarity, Table 1, page 19, lists two Silicone Quaternary compounds, but these are not quaterniums according to INCl. Although Asmus specifically mentions polyquaternium 4 and polyquaternium 1 on (page 8, line 30), there does not appear to be any support in the listed examples showing that such compounds would work to stabilize an alcoholic foam. The foam builders that Asmus lists as potentially being included as part of the composition are shown on page 7, line 20-32, page 9, line 21, under the heading "Builders", such as poly(ethylene oxide), hydroxyethyl cellulose, and hydroxypropyl cellulose, with some embodiments featuring possibly poly( ethylene oxide), particularly with a· molecular range of 200,000 to 4,000,000. The actual specific examples of foam builders shown in Asmus are summarised in Table 2, page 20 and include ethylcellulose, PEG-150, pentaerythrityl tetrastearate, hydroxypropoyl guar, butylated polyvinyl pyrrolidone, cetyl hydroxyethylcellulose, polyvinyl pyrrolidone, ethylene oxide/propylene oxide block copolymer and polyethylene glycol. None of these compounds are examples of cationic polymers or cationic oligomers. There are no cationic oligomers or cationic polymers described as foam builders in the examples given at page 23 through to page 34. The polyquaterniums mentioned in Asmus are all chemically different, as different monomers combine to form each polymer.”
Then at [36] Mr Staton goes on:
“With regards to the method of dispensing the foam in Asmus used in the examples, the dispenser used is mentioned on page 21, lines 4-6 as well as a description of the foam collection vial used to collect the foam sample from the pump dispenser in order to determine foam height. No mention though is made in Asmus relative to methods for reducing dripping from the foam pump dispenser.”
Dr Richardt agrees in Richardt #2 at [16]:
“Mr Staton notes (at paragraph 30 of the Staton declaration) that none of the examples in Asmus use polyquaternium compounds. I agree.”
Mr Staton and Dr Richardt disagree in that Dr Richardt is of the opinion that it is apparent from Asmus that polyquaterniums can be used as foam stabilizers (“builders”) in the absence of examples, since the desirability of using polyquaterniums would have been readily apparent to him at 28 December 2005 (see Richardt #2 at [18]).
Dr Richardt also notes at [14] and [38]-[42] of Richardt #1 and again at 24 that if he was trying to identify a cationic emulsifier for use as a foam stabilizer in 28 December 2005 he would contact suppliers.
In Richardt #1 the declarant was presented with Asmus and the other two documents used in this opposition at the same time. The applicant argued in the oral hearing that by providing Dr Richardt with the Luviquat document, which is specifically about a polyquaternium (see below), at the same time as the Asmus document he was conscious of polyquaterniums and then when he read the Asmus document and the section on builders, the polyquaterniums stood out to him. The applicant argued that had the witness been shown only the Asmus document he would not have pointed to the polyquaterniums over any of the other non-cationic builders listed. Therefore questions arise as to how much weight can be given to Dr Richardt’s view point on this matter.
Dr Richardt notes that polyquaterniums are included, and “could” be used. This is not saying that he “would” use them. I agree with this point of view.
Both declarants agree that there are no examples in Asmus where a cationic stabilizer or polyquaternium is used.
To arrive at an infringement of the current claims, rather than following the examples of Asmus, the person skilled in the art would have to choose to use a specific dimethicone, such as the dimethicone PEG 12, and then choose to use a polyquaternium based on a mention of them in the document. The question of novelty is whether or not there are clear and unmistakable directions to do this. The flag has to be clearly planted. From a mention of polyquaterniums in a list spanning two pages and a surfactant selected from a large table, I do not consider that this disclosure stands out as a flag to the totality of the claimed invention of ‘070.
While it is not necessary for there to be a worked example, the person skilled in the art would have to be more likely than not to arrive at the destination of an infringement and from the disclosure there appears to be a far greater chance of the person skilled in the art arriving at a destination outside of the scope of the current claims.
It follows that the dependent claims and the other independent claims 2, 6, and 7 are novel as there are no clear and unmistakable directions to use oligomeric or polymeric cationic stabilizers.
Disclosure of Asmus and the ‘144
Claims 1, 2, 3, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 are alleged to lack novelty over Asmus.
Asmus and claims 1-10, 17
Asmus discloses foamable compositions with at least 40 % alcohol and surfactants along with additional ingredients but the viscosity is not specifically measured in these examples.
Richardt#3 makes the following statements about the viscosity in Asmus at [58]-[59]:
“Asmus describes (at page 9 line 24 to page 10 line 4) that the compositions of the invention will typically be of very low viscosities at 23 ºC. Asmus states that a composition in a pre-dispensed condition, i.e., in a “pre-formed” state in a dispenser prior to being dispensed, can have a viscosity within the range from 0.5 to 100 cPs at 23 ºC, and in some examples of between about 0.5-20 cPs. Asmus specifies that viscosity is measured using a Brookfield viscometer Model LVT, and specifies the equipment used and the experimental conditions (page 22 lines 23 to 32). Asmus gives the viscosity for certain compositions made in accordance with the teaching of the specification in Tables 5 and 6 (pages 25 to 27). I note that all of the compositions for which viscosity was measured have a viscosity of less than 20 cPs.
Further, for the reasons set out in paragraphs 54-57 above, if I was making a compositions in accordance with the directions in Asmus before 28 December 2005, I would try to make the composition with a viscosity of as close to 50 cPs as possible, to ensure that the composition has good foam density. Because of high alcohol content of the composition, I consider that it would be difficult to make a composition with an alcohol content of higher than 50 cPs. As a matter of practice, I would dispense any composition that I made following the directions in Asmus through a foaming hand pump to ensure that the composition gave the appropriate effect (that is, that the foam which was created was of suitable density and stability, so that it does not drip and does not clog the dispenser), and adjust the formulation if necessary (for example, by increasing the amount of surfactant) to ensure that the product had an appropriate viscosity.”Richardt#3 further states at [67]:
“Given the matters set out in paragraphs 58-59 above, it is clear to me that any foamable alcoholic composition made in accordance with the description in Asmus would have a viscosity of less than about 100 mPas, given that the range specified on page 9 lines 26-31 specifies a range from 0.5 to 100 cPs.”
The applicant has responded in their submissions at [37]:
“It should be borne in mind that to prove lack of novelty the disclosure of viscosity in ASMUS must be linked to a particular composition within the scope of the claims of the ‘144 Application. It is not enough to show that other different compositions described by ASMUS might have a viscosity of less than 100 mPas.”
They also highlight that the language used by Dr Richardt is vague pointing to “some embodiments” without indicating which embodiments have the requisite viscosity. They argue that there are no directions within Asmus to prepare the requisite composition such that the person skilled in the art would inevitably (in all cases) be guided to prepare a composition with a viscosity of less than 100 mPas.
The examples referred to in Asmus which have the low viscosity ignore other integers in the claims (submissions [42]). They state at [44] that it would be open for the person skilled in the art to produce a composition with a viscosity of greater than 100 mPas (or 100cPs). It is also pointed out in paragraph 38 of the applicant’s submissions that page 9 of Asmus teaches that:
“It will also be appreciated that the addition of an emollient and/or other optional ingredients (discussed herein) can also have an affect (sic) on viscosity (either positively or negatively).”
I consider that because there is no specific example in Asmus in which the viscosity is measured that is said to be within the scope of claims 1-10 and 17, and that clearly each ingredient in the composition will affect viscosity, I cannot conclude that there are clear and unmistakable directions to claims 1-10 and 17 of ‘144 without further evidence in which examples are made and shown to have the requisite viscosity.
Asmus and claim 11
Claim 11 only requires a foamable alcoholic composition with at least 40% alcohol, which is not in dispute, and a particular foaming surfactant.
Richardt #3 at [133] makes the following statement:
“My understanding from Asmus is that all dimethicone surfactants, including those listed in claim 11, can be used in a foamable alcoholic composition. Moreover, Asmus expressly discloses that dimethicone copolymers –that is, polymers of dimethylsiloxane with polyoxyethylene (PEO) and/or polyoxyproylene (PPO) side chains can be used in the compositions (at page 5 line 26 to 31). That is, Asmus suggests that some of the surfactants disclosed in claim 11 (including PEG-20/PPG-23 dimethicone, bis-PEG/PPG-20/20 dimethicone, PEG 23/PPG 6 dimethicone, PEG 20/PPG 23 dimethicone, PEG5/PPG3 methicone, bis-PEG 20 dimethicone) are suitable for use in a foamable alcohol composition.”
In responding submissions the applicant relied on their submissions in respect of claim 1 of ‘144.
It is clear that dimethicone surfactants are used in Asmus, however, there is no reference provided to those listed in claim 11. While I agree with Dr Richardt that Asmus suggests the use of dimethicones, I do not consider a “suggestion” to be clear and unmistakable directions to the specific dimethicones listed in claim 11. As a result, I do not find that claim 11 lacks novelty over Asmus and it follows that dependent claims 12-16 are also novel.
WO 2005/030917 A1 (Koivisto)
Koivisto was published on 7 April 2005 and was raised as a particular against ‘144 for the ground of novelty.
Koivisto is directed towards high alcohol gel like and foaming compositions with viscosities less than 4000 cPs (see title and abstract). The alcohol content of the gels is approximately 52% by weight (see page 1). Koivisto utilises fluorosurfactants as the foaming surfactant (see page 15) and further additives to achieve a commercially suitable formulation including foam stabilizers (see pages 16-17).
Claims 1, 2, 3, 4, 8, 9, 10 are alleged to lack novelty over Koivisto
The opponent submitted that Koivisto discloses foamable compositions from 60% to about 70% for disinfecting purposes (submissions paragraph 131, Richardt#3 paragraph 44). This is disclosed in Koivisto at page 1 lines 15-16 and page? 8 lines 15-16.
As pointed out by Richardt#3 at [45] and in the submissions at [131] a fluorosurfactant is also disclosed and these include amphoteric (zwitterionic), non-ionic and anionic fluorosurfactants (page 1 lines 11 to 12, page 7 lines 21 to 22, page 8 lines 17 to 18, page 15 line 17 to page 16 line 6). The use of a fluorosurfactant was not in dispute.
Koivisto mentions foam stabilizers on page 16 lines 1-13. The disclosure is on page 19 as follows:
“Examples of compatible foam stabilizers that can optionally be employed include lactic acid esters of monoglycerides, cationic emulsifiers, triquaternized stearic phospholipid complex, hydroxystearamide propyltriamine salts, lactic acid monoglycerides, food emulsifiers such as glyceryl monostearate, propylene glycol monostearate, sodium stearoyl lactylate, silicone wax, an encapsulated oil, Microcapsule Mineral Oil.
A preferred foam stabilizer used in the present foamable composition is cetyl betaine. A preferred combination of foam stabilizers is that of butyleneglycol, butoxyethanol and n-propanol.”The reference to cationic emulsifiers is relied on by the opponent to anticipate the claims. In Richardt#4 at paragraph 23 he states that he understands “cationic emulsifiers” in Koivisto to include polymeric foam stabilizers such as polyquaterniums (which are also cationic). Dr Nearn’s view is that cationic emulsifiers do not include cationic polymers and Dr Richardt believes they do.
Based on the general nature of the disclosure and on looking at the reference in Koivisto above I do not feel that a broad reference to cationic emulsifiers in a list of other foam stabilizers and then followed by preferred foam stabilizers which are not cationic emulsifiers amounts to clear and unmistakable directions.
Koivisto does not identify the viscosity of the foamable alcoholic composition and Dr Richardt is of the opinion that it is likely that the compositions would have a viscosity between about 20 to 50 cPs (Richardt #3 [60] and [61]).
Dr Nearn’s view is that experiments would be necessary (Nearn #1 [24]).
Because it appears each ingredient can have an effect on viscosity and as it follows with my logic with Asmus. I favour the opinion of Dr Nearn and believe that without evidence to show that the viscosity of the compositions of Koivisto are within the scope of claim 1, I do not find that it is novelty destroying and thus the dependent claims are also novel. Therefore I find that claims 1, 2, 3, 4, 8, 9, and 10 are novel over Koivisto.
Conclusion on novelty
I find that in view of the evidence presented that this ground of opposition fails and that ‘070 and ‘144 are both novel over Asmus and Koivisto.
Inventive step
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (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. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 Aickin J stated:
"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."
The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 approved this approach.
The opponent alleged a lack of inventive step against claims 1, 2, 3, 4, 8, 9 and 10 in light of Koivisto and BASF Technical Information for Luviquat PQ11(Luviquat)
Koivisto is directed towards foamable alcoholic compositions and it was clear from the declarants of both parties that the person skilled in the art would read patent specifications. There was no dispute that Koivisto would be ascertained, understood and regarded as relevant.
Luviquat
Luviquat was published in May 1997 and the opponent submitted that it was part of the common general knowledge at the priority date of the opposed applications. Luviquat is a technical document about a product available from BASF.
Luviquat discusses polyquaternium-11 and says it can be used in alcoholic foams but only gives limited examples of them. They include a shaving foam with only a minor amount of stearyl alcohol; a mousse with 10% ethanol and 10% Luviquat; and a face cleansing lotion with 20% alcohol and 0.5% Luviquat.
As pointed out by the applicant, the Luviquat document has no disclosure of high alcohol content foams.
The next question is whether or not Luviquat can be considered to be part of the common general knowledge.
There is no evidence that BASF was contacted by the opponent and it is not clear how widely distributed this document was in Australia. Dr Richardt mentioned he would contact producers, such as BASF, before seeing the Luviquat document (paragraph 14 in Richardt #1).
In Richardt #1 at [49[ the declarant states:
“If I had been trying to develop a foamable alcohol composition in accordance with Koivisto before 28 December 2005, I would as a matter of course have approached technical suppliers, including BASF, to ask them to provide me with ingredients that could be used as cationic emulsifiers in a foam system. Further, I would expect a supplier such as BASF would have recommended polyquaterniums for this purpose.”
The applicant’s own declarant had the Luviquat document on his shelf so I am confident it was readily available to the person skilled in the art. Staton #1 at [48] he says:
“Whilst reviewing the Luviquat PQ-11 document it struck me as though I had seen this before and I referred to my own reference library and retrieved our own copy of Luviquat PQ-11 document that we had obtained from the Australian distributor of the product and was in my possession prior to 28 December 2005.”
The question is then would the person skilled in the art as a matter of routine be directly led from the prior art to the invention. Dr Richardt has stated that he would of, as a matter of routine, when developing foams, contact suppliers such as BASF which would have meant he would have been given the Luviquat document. The issue is would it have been routine on reading Koivisto for a person skilled in the art to combine it with Luviquat. The process of developing foams discussed by Dr Richardt might be that he was merely trying to avoid infringement or it might be that he was conducting genuine inventive research. I do not feel that Dr Richardt was thinking of genuine research but rather, if he was looking for an alternative composition to that in Koivisto he would have contacted BASF.
However, there remains no evidence from BASF as to whether or not this document would have been definitively provided to anyone enquiring or the nature of the enquiry that would have been made. Though, given that Mr Staton was aware of it, I am confident it was distributed and the person skilled in the art had access to it.
Would the person skilled in the art combine the Luviquat document with Koivisto?
Very little evidence has been put forward on whether or not it would be obvious to combine these two documents. It could be that the person skilled in the art was merely trying to avoid infringing the Koivisto patent. Then they would have to choose to combine it with the Luviquat document. Koivisto only makes reference to cationic surfactants and before listing preferred foam stabilizers. This disclosure is on page 19 and mentioned above for novelty.
In Richardt #2 he states at [11] that:
“I agree with Mr Staton’s observation at paragraph 18 of the Staton declaration that alcohol is generally a foam suppressant. For this reason, if I was asked to design a foaming alcohol product at 28 December 2005, I would pay particular attention to any competing products, technical literature (e.g. data sheets) or patent literature I could identify in which a foaming product using alcohol was disclosed, since these products and/or literature would provide a good basis for my development efforts. Where I am aware of a particular technical difficulty (such as the defoaming effects of alcohol), I will pay particular attention to the composition disclosed in any literature (including any patents or patent literature and any technical documents, such as data sheets from suppliers) where the technical difficulty has been overcome.”
He continues at [12]:
“I agree with Mr Staton’s observation at paragraph 19 that if I was designing a foaming hand hygiene wash, I would include a surfactant, a foam booster and/or stabiliser (noting that the same ingredient may perform both functions), and a diluent as a matter of course.”
He then agrees that humectants, emollients and thickeners could also be added.
I agree with the submission that polyquaterniums are broadly cationic surfactants. However, the list on page 19 includes other broad terms which do not lead to the claimed invention.
100. It appears that any number of ingredients could have been added to Koivisto without resulting in the claims of ‘144.
101. There is no evidence that the person skilled in the art would be directly led as a matter of routine to combine the Luviquat document with Koivisto. Without this issue being resolved, I cannot say that the ‘144 clearly lacks an inventive step in the light of these two documents.
Utility
102. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be useful. The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228. Emmett J at 247 [81] stated:
"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."
Utility of claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 14, 15 and 16 of ‘144 and claims 1-7 of ‘070
103. The Stern declaration annexed SMS2 which introduced into evidence information from the US prosecution of the US family member of the opposed applications. In the US application a ratio of foaming surfactant to foam stabilizer has been introduced into the claims to overcome objections there. The US attorney states the following on page 11 of SMS2. This was used to support a lack of utility ground, the issue being that the invention only works when the stabilizer and foam are in certain ratios and that this must be followed in order to achieve the promise of the invention.
“Moreover, even if the ratio of foaming surfactant to the foam stabilizer can be considered to be a result-effective variable, the results of optimizing this variable were unexpectedly good. In this regard, the attached Declaration of Amanda J. Copeland shows that the claimed ratios produce unexpectedly good stabilized foam, while compositions outside of the claimed ratios do not. These results could not have been predicted based upon Barger.
In addition, the attached Declaration of Copeland demonstrates that the claimed ratio of foaming surfactant is key to obtaining a stabilized foamable composition.” My emphasis
104. It is this last sentence that formed the basis of this ground. However, I think that in the context of the preceding paragraph it is clear that it is saying that the foams work very well within this ratio but it is not clear and unequivocal evidence of the foam not working at all outside of this ratio.
105. The Copeland declaration was introduced by Stern as SMS3 and shows detailed experiments where a fluorosurfactant and a polyquaternium were used. These experiments did show that a certain ratio is required when using a fluorosurfactant. This is relevant only to the claims in which a fluorosurfactant is used. It is therefore not relevant to the ‘070 claims.
106. The experiments conducted in the Copeland declaration show that the foam stabilizer taught by Koivisto, such as glycerin or cetyl betaine, do not work. However the cationic polymers such as polyquaternium-11 do work, but only in specific ratios when a fluorosurfactant is used.
107. The experiments showed that a ratio of 15:1 foaming surfactant to foam stabilizer yielded a stabilized foam, however, ratios of 600:1, 0.025:1 and 1:1 did not. As mentioned above, paragraph [0013] of both specifications makes it clear that the promise of the invention is that the foam produced is stable.
108. It therefore is necessary for the a foam made with a fluorosurfactant and polyquaternium-11 to be present in the ratio worked out by the experiments undertaken in SMS3 and in line with those claimed in the US. I therefore conclude that claims 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 15 and 16 of ‘144 lack utility because everything within the scope of the claims, which includes ratios outside the range worked out in SMS3, is not useful and will not form foams. I see no reason why the ‘070 claims are not useful.
Sufficiency and the claims fail to define the invention for both ‘070 and ‘144
109. It is a requirement of subsection 40(2) of the Act that the specification must describe the invention fully. The High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25]; 207 CLR 1 at 17 explained this requirement as:
"The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?"
110. The opponent argued that because the foaming surfactant to foam stabilizer ratio is essential to the working of the invention when fluorosurfactants are used, this should be reflected in the patent. This follows from the utility argument. However, there are examples in the specification which enable the person skilled in the art to put the invention into practice. Some trial and error is permitted and as a result I find that the specifications are sufficient.
111. The opponent purported that the ‘144 does not disclose a method of how to measure viscosity nor is the viscosity of the actual examples of the ‘144 provided. However, both declarants were quickly able to discuss the standard techniques of measuring viscosity and the applicant put forward in the hearing that it was like measuring temperature to the skilled addressee; you do not need to tell them to use a thermometer or how to use it. I accept this argument given the ease of discussion the declarants had on the topic and the disclosures of Asmus on viscosity also supported this view. Therefore I find that this ground of opposition fails for the ‘144.
Conclusion
112. The opposition fails on the grounds of novelty, inventive step, sufficiency and that the claims fail to define the invention. However, the opposition succeeds on the ground that claims 1, 2, 3, 4, 7, 8, 9, 10, 11, 14, 15 and 16 of ‘144 lack utility. I am of the view that this matter may be overcome by amendment and consequently the applicant is allowed 2 months from the date of this decision to propose suitable amendments.
113. Subject to appeal, I direct that ‘070 proceed to grant.
Costs
114. The parties submitted that costs should follow the event. I see no reason to depart from that result. The opposition has been successful against ‘144, I therefore award costs according to Schedule 8 against the applicant.
Keith Wagg
Delegate of the Commissioner of Patents
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