Abbott Medical Optics, Inc. v Alcon Laboratories, Inc
[2011] APO 79
•26 September 2011
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Abbott Medical Optics, Inc. v Alcon Laboratories, Inc. [2011] APO 79
Opponent:Abbott Medical Optics, Inc.
Delegate:Dr B. Akhurst
Decision Date: 26 September 2011
Hearing Date: 7 October 2010 and 11 May 2011 in Canberra, then completed by further written submissions filed on 30 August 2011 and 6 September 2011.
Catchwords: PATENTS - section 59 - opposition to the grant of a patent - claims construction - novelty - claims lack novelty over prior published information - claims lack novelty in light of the prior use of a product in accordance with the manufacturer’s instructions - strict proof requirement - inventive step - claims lack inventive step over published prior art - clarity in view of typographical error - opposition succeeds on the grounds of novelty, inventive step and clarity.
Representation: Patent applicant: Glenn McGowan SC, instructed by patent attorney Dr Simon Weisman of FB Rice & Co., Sydney.
Opponent:Dr Linda Govenlock (Senior Associate) and Dr Trevor Davies (Partner), patent attorneys of Allens Arthur Robinson, Sydney.
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2004201867
Title: Process for cleaning and disinfecting contact lenses
Patent Applicant: Alcon Laboratories, Inc.
Date of Decision: 26 September 2011
DECISION
The opposition succeeds. The subject matter of claims 1-5, 9 and 11-17 is not novel. Claims 1 and 2 lack an inventive step. Claim 20 is not clear. The amendments to the claims filed under section 104 on 11 May 2011 are similarly deficient. Alcon is allowed 2 months to file amendments to overcome the deficiencies in the claims. Costs are awarded against Alcon Laboratories, Inc.
REASONS FOR DECISION
Background
Patent application 2004201867 was filed by Alcon Laboratories, Inc (‘Alcon’) on 30 April 2004, as one of a series of divisional applications derived from application 76730/94 and claiming priority from US basic document 08/113,142 filed on 27 August 1993. The related applications are listed below, with subsequent applications each divided from the one above.
Application No Filing date Status
76730/94 24 August 1994 Lapsed
71874/98 11 June 1998 Sealed as patent No. 733386
54175/01 2 July 2001 Lapsed
2004201867 30 April 2004 Accepted
2011202183 11 May 2011 Filed
Application 2004201867 was advertised accepted on 3 January 2008. A notice of opposition to grant of a patent was filed on 2 April 2008 by Advanced Medical Optics, Inc., followed by a statement of grounds and particulars on 2 July 2008. On 16 September 2009, the notice of opposition was amended under regulation 5.3B to change the name of the opponent to Abbott Medical Optics, Inc. (‘Abbott’).
Abbott filed no evidence in support despite gaining an extension of 3 months to 2 January 2009 in which to do so.
Evidence in answer was served on 2 November 2009, consisting of statutory declarations by
· Dr Masood Chowhan dated 26 October 2009 (Chowhan#1), and
· Dr Howard Ketelson dated 26 October 2009.
Evidence in reply was completed on 30 April 2010, consisting of statutory declarations by
· Dr Linda Jane Govenlock dated 1 February 2010 with exhibits LJG-1 to LJG-21, and
· Mr Stanley Huth dated 22 April 2010 (Huth#1) with exhibits SH-1 to SH-5.
After Alcon objected to the admissibility of parts of Abbott’s evidence in reply, Abbott advised that three prior art documents exhibited as LJG-3 to LJG-5 were particularised and properly served in reply, and that it did not intend to rely on other exhibits.
On 2 July 2009, during the evidentiary stages, Alcon filed a request under section 104 to amend the claims of the specification, which amendment was advertised allowed on 25 February 2010. The hearing proceeded on the basis of the accepted specification including these amendments. At the hearing, Dr Weisman handed in a further amendment request under section 104 but later asked that this not be processed, pending the result of the opposition and the potential requirement for further amendments. I note that there is no statutory basis upon which such a request could be granted. As a consequence, and as no fees were paid, the Commissioner treated this amendment request as withdrawn.
Abbott presented arguments at the hearing on 7 October 2010 that were not particularised. After hearing all other matters in respect of the opposition, the hearing was adjourned. On 2 December 2010, the Commissioner allowed Abbott’s request of 20 October 2010 to amend the statement and grounds and particulars to provide further and better particulars.
On 16 December 2010 Abbott filed further evidence consisting of a statutory declaration by
· Mr Stanley Huth dated 10 December 2010 (Huth#2) with exhibits SH-6 to SH-8.
Alcon filed responding evidence on 28 March 2011 consisting of a statutory declaration by
· Dr Masood Chowhan dated 25 March 2011 (Chowhan#2).
The hearing resumed on 11 May 2011 in Canberra, at which representatives appeared for both parties. On the same day, without mentioning it at the hearing, Alcon proposed amendments to the claims which were advertised on 18 August 2011 for opposition purposes.
On 20 May 2011, after the matter had been heard, Alcon filed additional submissions and attachments. After the delegate advised that the hearing officer considered these submissions to be consistent with those made at the hearing on 11 May 2011, and that the evidentiary value of the attachments appeared low, on 9 June 2011 Alcon requested leave to serve further evidence under Regulation 5.10(4).
Alcon served the further evidence on 10 June 2011, which consisted of a statutory declaration by
· Dr Masood Chowhan dated 9 June 2011 (Chowhan#3) with exhibits MC-1 and MC-2.
Abbott served responding evidence on 1 and 2 August 2011 consisting of statutory declarations by
· Mr Stanley Huth dated 28 July 2011 (Huth#3) with exhibits SH-9 to SH-10,
· Mr Christopher John Bird dated 28 July 2011,
· Mr Peter Dominic Ryan dated 28 July 2011, and
· Mr Roy Alvin Kim dated 29 July 2011
The hearing was completed by way of written submissions and responding submissions filed by each party on 30 August 2011 and 6 September 2011, respectively. Alcon filed additional submissions on 22 September 2011. These further submissions were not considered relevant and did not add significantly to the submissions already on file. Consequently, responding submissions were not sought.
Standard of proof
The onus of proof in opposition proceedings lies with the opponent, who must establish that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [29], [67]; (2001) 50 IPR 305 at 311 [29], 319 [67]; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18], [22]; (2009) 79 IPR 426 at 430 [18], 432 [22]).
The primary facts are to be established on the balance of probabilities, but the ultimate facts - the facts leading directly to a conclusion of a lack of novelty or a conclusion of obviousness - must be proved to the level of practical certainty (Justice Besanko in Aspirating IP Ltd v Vision Systems Ltd [2010] FCA 1061 at [35]; (2010) 88 IPR 52 at 63 [35])
Grounds of Opposition
The grounds for opposing the grant of a patent under section 59(b) and (c) of the Patents Act 1990 are identified in the statement of grounds and particulars as:
· Manner of manufacture
· Novelty
· Inventive step
· Utility
· Section 40 issues
The specification
Before the priority date, products for treating contact lenses had generally been classified based on their intended use or function e.g. as cleaners, disinfectants, rewetting drops or conditioning solutions. Attempts to accomplish two or more functions with a single product had had limited success because combining components tended to reduce their effectiveness. As a consequence, from a purely scientific standpoint, this practice had been discouraged.
The title of the application is “Process for cleaning and disinfecting contact lenses”. On page 1A, the invention is described as “an improved process wherein contact lenses can be cleaned and disinfected with a single product containing polycarboxylates, polysulfonates or polyphosphates”. The description teaches that these agents effectively remove deposits of proteins and other materials from contact lenses. Preferred polycarboxylates/polycarboxylic acids are citric acid and its sodium, potassium or ammonium salts or mixtures thereof; succinic, tartaric, malonic and maleic acids and salts thereof; ethanol diglycinate or diethanol glycinate (page 4, line 27-32), having a molecular weight of approximately 90-600 (page 6, lines 31-34). A preferred concentration of these compounds for cleaning contact lenses is said to be generally within the range 0.013-0.13 moles/L (M) (para bridging pages 6-7).
The description ends with four examples. Example 1 provides the preferred cleaning and disinfecting solution, which contains in w/v amounts Polyquad® 0.001 % (+10 % excess), sodium chloride 0.48 %, disodium edetate (disodium ethylenediaminetetraacetic acid (EDTA)) 0.05 %, citric acid monohydrate 0.021 %, sodium citrate dihydrate 0.56 %, in purified water at pH 7.0. This preferred solution is identified in Example 2 as Alcon’s product Opti-Free® Rinsing, Disinfecting and Storage solution (‘Opti-Free® RDS’) (page 9, lines 6-8). Examples 2-4 demonstrate the ability of various solutions, including Opti-Free® RDS, to remove dansyl lysozyme deposited on contact lenses under laboratory conditions.
The claims and their construction
There are 21 claims under consideration in the accepted application. Claim 1 is the only independent claim on which claims 2-21 are ultimately dependent. The proper construction of claims 1 and 2 was contentious at the hearing, and therefore I will first construe these claims in order to appreciate their scope.
The principles to be applied in construing a patent specification are well settled in law (Flexible Steel Lacing Company v Beltreco Ltd [2000] FCA 890 at [70] - [81]; (2001) 49 IPR 331 at 347 [70] - [81], Pfizer Overseas Pharmaceuticals v Eli Lilly and Company [2005] FCAFC 224 at [247] - [250], 68 IPR 1 at 52-54 [247] - [250]). Briefly and most relevantly to this opposition, the claims, cast in precise language, mark out the legal limits of the monopoly granted by the patent. What is not claimed is disclaimed. While the claims are construed in the context of the specification as a whole, it is not legitimate to vary the boundaries of monopoly as fixed by the words of the claim, by adding words or glosses drawn from other parts of the specification. However, reference may be made to the rest of the specification to ascertain the meaning of technical terms and to resolve ambiguities in the construction of the claims. In general, a presumption should be made against redundancy in the claims, but this is not an absolute and invariable rule in the face of other, weighty considerations (David Kahn Inc v Conway Stewart & Co Ltd [1974] RPC 279 at 308).
Claim 1
Claim 1 reads as follows:
1. A method of cleaning a contact lens with a single solution comprising polycarboxylate(s) or corresponding acid(s) or a combination thereof in an amount effective to clean the lens, wherein said method comprises soaking the lens in the single solution for a time and under conditions sufficient to remove protein deposits attached to the lens wherein said time and said conditions do not only disinfect the lens or remove debris.
I will discuss the construction of the various elements of this claim.
A method of cleaning a contact lens with a single solution comprising polycarboxylate(s) or corresponding acid(s) or a combination thereof in an amount effective to clean the lens …
Alcon, referring to elements of the description, contended that “cleaning” referred to the removal of tightly-adherent proteins from a lens and that disinfection was not essential to the cleaning process. Supporting this view, I note that the specification and the expert witnesses separately refer to cleaning and disinfection (see the Title of the specification; page 6; Chowhan#1 at [4]; Huth#1 at [17], [43]); and the description at page 6, separately identifies “cleaning agents” and “antimicrobial agents”. Therefore, I am satisfied that in the context of this application, cleaning and disinfecting are distinct processes, and the method of cleaning a lens is not limited to disinfection of the lens.
What matter is to be cleaned from the lens? The description refers to deposits of the tear protein lysozyme, in addition to inorganic calcium salts and mixed deposits in which calcium links protein, lipid or mucus-type soilants and microbial cells (page 5, lines 17-35). Mr Huth describes modest-to-heavy protein deposits which may be loosely or less adherent, or strongly adhered to the lens (Huth#1 at [21], [37]). I therefore construe the phrase “method of cleaning a contact lens” to mean a method of freeing a lens from any or all of the above soilants, where present on the lens. It follows that the claimed method encompasses the removal of tightly-adherent proteins where these are present, but the method is not limited to this feature.
The term “single solution” refers to the components in one liquid composition (Chowhan#2 at [12]). Alcon submitted that the requirement for the solution to contain an “effective amount” of polycarboxylate(s) and/or corresponding acid(s) makes it an essential feature that protein removal must at least be achieved by these compounds. I do not agree. I consider that in its plain meaning, the phrase “polycarboxylate(s) or corresponding acid(s) or a combination thereof in an amount effective to clean the lens”, merely defines in functional terms the concentration of these components in the single solution. Although the amount is not explicitly defined in claim 1, I consider that the person skilled in the art could determine an effective concentration of any given polycarboxylate, corresponding acid or combination thereof, by routine experimentation. The preferred amount is 0.013 to 0.13 M (para bridging pages 6-7).
Claim 1 therefore defines a single solution containing an amount of one or more polycarboxylates, or one or more corresponding acids, or a combination of one or more polycarboxylates and one or more corresponding acids, in a concentration that is capable of cleaning the lens in the absence of other cleaning agents. However, the single solution “comprising” polycarboxylate(s) and/or corresponding acid(s) is not restricted to these compounds in the absence of other components, including other cleaning agents. Construing against redundancy in view of dependent claim 12, which requires the solution to be surfactant-free, claim 1 encompasses a single solution containing surfactant. While the terms of claim 1 require the solution to contain a sufficient amount of polycarboxylate(s) and/or corresponding acid(s) to clean a lens, there is nothing in the wording of this claim that requires this agent to primarily clean the lens when the method is performed.
… wherein said method comprises soaking the lens in the single solution for a time and under conditions sufficient to remove protein deposits attached to the lens wherein said time and said conditions do not only disinfect the lens or remove debris.
The method that “comprises” soaking the lens is not restricted to this step, in the absence of other steps. “Soak” is defined by the Macquarie dictionary as “to lie in and become saturated or permeated with water or some other liquid”, and I have no reason to believe that the person skilled in the art would give this term a different meaning. I accept Alcon’s submission that “remove” encompasses complete and substantial displacement of the deposited protein.
The “time and conditions” under which a lens is soaked in the solution are functionally defined and must be sufficient to achieve complete or substantial displacement of adherent protein deposits, where present, from the contact lens. Where additional cleaning agent(s) are present in the single solution, the time and conditions would reflect the combined activity of the polycarboxylate(s) and/or corresponding acid(s) and the additional agent(s).
I consider that for any given solution, the person skilled in the art would be able to determine appropriate times and conditions by routine experimentation. The description provides times and conditions for the preferred solution (see for example page 7, lines 12-13 and Examples 3 and 4). Rubbing/rinsing the lenses during the cleaning process is not an essential “condition”, since this is described as merely a preferred embodiment in the description, and Examples 3-4 demonstrate the efficacy of a cleaning method that does not involve a rubbing/rinsing step.
The proviso “wherein said time and said conditions do not only disinfect the lens or remove debris” requires that the time and conditions under which the lens is soaked must necessarily achieve something in addition to disinfection or the removal of debris. Where adherent deposits are present on lens, the proviso would be satisfied by the removal of these deposits in addition to disinfection or the removal of debris. In the absence of adherent deposits, disinfection and the removal of debris is sufficient.
The specification does not attribute any antimicrobial properties to the polycarboxylate(s) or corresponding acid(s). Therefore, in the embodiment involving disinfection, the single solution must contain an antimicrobial agent in addition to the polycarboxylate(s) and/or corresponding acid(s).
In summary, claim 1 defines a method of cleaning a lens that achieves something more than just disinfection or the removal of debris. The method is carried out using only the one solution, which contains polycarboxylate(s) or corresponding acid(s) or a combination thereof in a concentration that is capable of cleaning a lens in the absence of other cleaning agents. However, the solution may contain other components, such as surfactant. Claim 1 is not limited to a method in which the polycarboxylate(s) and/or corresponding acid(s) primarily clean the lens. Where disinfection is to be achieved, the solution includes an antimicrobial agent. The method comprises soaking a lens in the solution for a time and under conditions sufficient to effect complete or substantial displacement of adherent protein deposits, where these are present on a lens.
Claim 2
Claim 2 further defines the components of the solution of claim 1.
2.The method according to claim 1, wherein the single solution comprises one protein removal agent consisting essentially of polycarboxylate(s) or corresponding acid(s) or a combination thereof in amount(s) effective to clean the lens.
Claim 2 limits the method of claim 1 to the use of a single solution comprising one protein removal agent which is substantially composed of polycarboxylate(s) and/or corresponding acid(s), but not to the exclusion of minor amounts of other components in that one agent (Atlas Powder Co v ICI Australia Operations Pty Ltd [1989] APO 10; (1989) 15 IPR 34 at 39, applied). The amount of one or more polycarboxylates or one or more corresponding acids or a combination of one or more polycarboxylates and one or more corresponding acids in that one agent, is functionally defined as that “effective to clean the lens”. However, the single solution “comprising” one protein removal agent may contain additional protein removal agents, including surfactant.
Claims 3-21
Each of claims 3-6 is dependent on all earlier claims. Claim 3 requires the solution and the soaking step to be at a physiological pH. Claim 4 specifies that the solution is free of surfactant when it comprises citrate or edetate. Claim 5 requires that the lens is soaked for at least 4 hours to remove protein deposits attached to the lens. Claim 6 adds a pre-treatment step in which the solution is applied to the lens for a time and under conditions sufficient to remove debris and disinfect the lens before soaking the lens in the solution. Claims 7-8 restricts the pre-treatment step of claim 6 to rubbing the solution over the surface of the lens and doing so for at least 10 seconds, respectively.
Each of claims 9-16 is dependent on all earlier claims. Claim 9 limits the methods of the earlier claims to further comprising a rinsing step to wash away the removed protein deposits, and claim 10 to performing the method daily. Claim 11 specifies that the protein deposits are removed by virtue of chemical interaction with the polycarboxylate(s) or corresponding acid(s). Claim 12 requires the solution to be surfactant-free. Claim 13 specifies the concentration of polycarboxylate or corresponding acid as between 0.013 M-0.13 M. Claims 14-15 specify the polycarboxylate(s) or corresponding acid(s). Claim 16 adds to the solution an ophthalmically-acceptable antimicrobial agent, and dependent claim 17 limits the agent to polyquaternium-1. Claims 18-19 are dependent on all earlier claims, and define the lens to be cleaned as a soft polymer lens with a water content of at least about 40% and an ionic polymer lens, respectively.
Claim 20 specifies a single solution at neutral pH, comprising in w/v amounts about 0.02 % citric acid; about 0.056 % sodium citrate; about 0.05 % disodium EDTA; about 0.48 % sodium chloride; and about 0.001 % polyquaternium-1. Alcon’s withdrawn amendment request altered the sodium citrate concentration to 0.56 % to correct a typographical error.
Claim 21 is dependent on claims 1-20 and defines the method by reference to the examples.
Novelty
A claimed invention is deprived of novelty if it has been given to the public before the priority date, either by prior use of a product or process, or by publication of information that equates to the claimed invention (Justice Bennett in Danisco A/S v Novozymes A/S (No 2) [2011] FCA 282 at [248]; (2011) 91 IPR 209 at [248]). It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20]; (1977) 137 CLR 228 at 235:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement.”
This test is satisfied if the alleged anticipation discloses all of the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40 at [19]; (1990) 16 IPR 545 at 549). To meet this requirement, the prior art must contain “clear and unmistakable directions” to the claimed invention (Pfizer Overseas Pharmaceuticals v Eli Lilly and Co [2005] FCAFC 224 at [314]; (2006) 68 IPR 1 at 67 [314]). However, if the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in such a way that would not do so, the patentee’s claim will not be anticipated (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1971) 1A IPR 121 at 138). Where a prior publication does not explicitly disclose all of the integers of the claimed invention, it would still deprive the claimed invention of novelty if (i) the skilled reader understands the disclosures of the prior publication to include a missing integer, and (ii) if the document contains a direction to use a process that inevitably or inexorably results in something within the claim (Justice Bennett in Danisco (No 2) [2011] FCA 282 at [248]; (2011) 91 IPR 209 at [248]).
Information is part of the prior art base for the purposes of novelty if it was in a publicly available document or made publicly available through doing an act before the priority date (see the definition of “prior art base” in Schedule 1 of the Act).
Abbott relied on three published patent documents to establish lack of novelty as follows:
US 5503647 (Chowhan, M. A. et al) 6 August 1991 (US ’647)
US 4599195 (Schäfer, D. et al.) 8 July 1986 (US’195)
US 4808239 (Schäfer, D. et al.) 28 February 1989 (US’239)
For prior use, Abbott has particularised:
Bausch & Lomb’s ReNu® Multi Purpose Solution (‘ReNu® MPS’), and
Opti-Free® Rinsing Disinfecting and Storage Solution (‘Opti-Free® RDS’).
I will first consider the patent documents and then the Opti-Free® and ReNu® solutions.
US 5503647 (US’647)
US’647 relates to compositions useful for disinfecting hydrophilic contact lenses and for the preservation of products for treating such lenses. A preferred composition at column 5, lines 7-17 is identical to Opti-Free® RDS. While Alcon conceded that US’647 taught the preferred solution of the opposed application, it submitted that the document did not disclose an infringing act.
The reference that Abbott relied on to support its novelty argument is the statement at column 3, lines 17-20 of US’647:
“The compositions of the present invention can be used as a cold, chemical disinfecting and storage solution for all types of soft contact lenses, particularly Group IV lenses.”
I note the paragraph continues with further, alternative applications for the solution:
“The compositions can also be used as a preserved saline solution for rinsing and as an in-the-eye drop to rehydrate lenses.”
The question as to whether US’647 provides clear and unmistakable directions to infringe Alcon’s claims can only be answered in the affirmative if, given the teaching of US’647, the person skilled in the art would store a lens in need of cleaning by soaking it in the preferred solution of US’647 for a time and under conditions sufficient to remove protein deposits attached to the lens, wherein said time and conditions do not only disinfect the lens or remove debris. In order to fulfil this requirement, it would at least have to be shown that:
(i) it is more likely than not that the lens for storage is in need of cleaning, and
(ii) the lens would more likely than not be stored in the solution for a time and under conditions sufficient to remove protein deposits attached to the lens, and wherein said time and conditions do not only disinfect the lens or remove debris.
No evidence was adduced on point (i). As to (ii), other than the statement relied on by Abbott, US’647 contains no further reference to storage of a lens, and none to soaking a lens. Immediately preceding 27 August 1993, it was known that a polycarboxylate solution is useful in the disinfection of contact lenses and/or as a storage solution for contact lenses (Chowhan#1 at [5]; Huth#1 at [19]). However, the evidence does not support the preferential use of the preferred solution of US’647 as a storage solution. Instead, both the experts broadly describe it as a lens care solution containing a disinfecting agent (Chowhan#1 at [6]; Huth#1 at [20]). As a consequence, and given that US’647 identifies other applications, I cannot find that it is more likely than not that the person skilled in the art would use the solution taught by US’647 for the application most favourable to Abbott’s case. I conclude that the opposed claims novel are novel in view of US’647.
US 4599195 (US’195) & US 4808239 (US’239)
US’195 & US’239 are related applications by the same inventors, with Alcon Laboratories, Inc. as the assignee.
Disclosure of US’195
US’195 is entitled “Solution and method for removing protein, lipid, and calcium deposits from contact lenses”. Example 2 describes a method of cleaning soft contact lenses heavily deposited by extended wear, by soaking for 2 hours at 37ºC in an aqueous solution comprising 2.5 % w/v (0.086 M) EDTA, 2.5 % w/v (0.13 M) citric acid, surfactant and urea at pH 6.4. Example 3 describes a method of cleaning lenses after extended wear, using an aqueous solution containing 0.086 M EDTA, 0.13 M citric acid, urea and an alternative surfactant, at pH 6.2, wherein the lens is soaked in the solution for 3 hours at 25ºC. Each of these methods achieved “complete removal of lens deposits” confirmed by microscopic examination of the lens.
Disclosure of US’239
US’239 is entitled “Method of cleaning contact lens using compositions containing polyether carboxylic acid surfactant”. The Abstract teaches that the cleaning compositions remove, among other things, protein deposits. At Example 2, US’239 teaches a method for cleaning soft contact lenses heavily deposited by extended wear, by soaking them for 2 hours at 37°C in an aqueous single solution containing 0.086 M EDTA, 0.13 M citric acid, surfactant and urea at pH 6.4. The method completely removed lens deposits.
Novelty in view of US’195 and US’239
Both US’195 and US’239 relate to cleaning contact lenses to remove deposits of proteins, lipids and calcium that form when the lens are worn by the human eye (Dr Ketelson at [6]; US’195 column 1, lines 37-46; US’239 column 1, lines 44-53). The deposited material resulting from extended wear is consistent with the deposits described by the opposed application (page 5, lines 17-35). I consider that the deposits would be understood by the person skilled in the art to comprise adherent deposits and debris.
The concentrations of citric acid and EDTA in the solutions of US’195 and US’239 individually fall within the preferred effective amount taught by the present application. None of the expert witnesses in addressing US’195 or US’239, suggest that the combined concentration may be other than an effective amount. Dr Ketelson discusses the documents at length, but rather than suggesting the concentration would not be effective, his evidence at [5]-[10] is to the effect that the skilled artisan reading US 195 or US 239 before the priority would not understand from the documents that polycarboxylate(s) and/or corresponding acid(s) would necessarily clean contact lenses in the absence of surfactant, because the documents do not explicitly teach this feature.
At the hearing, Mr McGowan asserted that the acid pH of the solutions of US’195 and US’239 places the disclosure of these documents outside of the present claims. However, a solution with a physiological pH is not specified in claims 1-2, appearing only in dependent claim 3. Construing against redundancy claims 1 and 2 encompass a solution outside a physiological pH.
The person skilled in the art, following the directions contained in Examples 2 or 3 of US’195, or Example 2 of US’239, would carry out a method of cleaning a contact lens using a single solution comprising polycarboxylic acids in an amount effective to clean the lens (0.086 M EDTA and 0.13 M citric acid), wherein said method comprises soaking the lens in the single solution for a time and under conditions sufficient to remove protein deposits attached to the lens (US’195: 2 hours at 37 ºC or 3 hours at 25 ºC; US’239: 2 hours at 37 ºC; each exemplified method “completely removed lens deposits”) wherein said time and said conditions removed adherent deposits and debris (the methods “completely removed lens deposits”). Therefore, US’195 and US’239 separately anticipate claim 1 of the opposed application.
In addition to surfactant, the solutions of US’195 and US’239 each contain one protein removal agent consisting essentially of polycarboxylic acid(s) in an amount effective to clean the lens (EDTA and citric acid, either singly or in combination), anticipating claim 2.
The additional features of claims 3-8, 10-17 and 20-21 are not disclosed by either US’195 or US’239. I have no evidence before me that would establish that the saline equilibration taught by US’195 and US’239 constitutes rinsing the lenses, as required by claim 9. Similarly, I have no evidence that the polymeric hydrogel lenses of US’195 and US’239 fall within claims 18-19. Consequently, it has not been shown that the subject matter of claims 3-21 of the opposed application lacks novelty in the light of US’195 and US’239.
In summary, the subject matter of claims 1-2 is anticipated by the separate disclosures of US’195 and US’239.
Prior use and prior publication
By way of amendment, Abbott has particularised for novelty purposes information made publicly available through doing an act before the priority date. Specifically, the prior use of Bausch & Lomb ReNu® MPS and Opti-Free® RDS lens care solutions. Abbott’s further evidence exhibited package inserts containing instructions for use for each of these products. Both the prior use of a product described in a brochure and the brochure as a prior publication were considered relevant for novelty purposes by Justice Besanko in Aspirating IP Limited v Vision Systems Limited [2010] FCA 1061 at [289] - [293]; (2011) 88 IPR 52 at [289] - [293]).
On 4 May 2011, via the delegate, I requested that the parties fully address the disclosure of the Opti-Free® RDS package insert in regard to the novelty of the opposed claims. Both parties have done so, and Alcon has filed further evidence and submissions on this point. Therefore, I do not believe that it would be a denial of natural justice to consider in this opposition, whether a method of using Opti-Free® RDS in accordance with the instructions in its package insert constitutes a prior publication of the claimed invention.
ReNu® Multi-Purpose Solution
The Bausch & Lomb ReNu® MPS package insert, exhibited as SH-8, discloses a solution containing the polycarboxylate disodium edetate at 0.1 % w/v (0.003 M). This concentration is less than “an amount effective to clean the lens” (Chowhan#2 at [16]; Huth#3 at [10]). Since ReNu® MPS does not fall within the single solution of claim 1, the use of the solution cannot anticipate the novelty of the opposed claims.
Opti-Free® Rinsing, Disinfecting and Storage solution
The text of Alcon’s Opti-Free® RDS package insert in evidence as exhibit SH-7 has been reproduced and attached to this decision as Annex A.
Alcon’s submissions were essentially as follows:
· No infringement would occur by following the instructions in the package insert because the opponent has not demonstrated that there were any adherent protein deposits remaining on contact lenses allegedly soaked in Opti-Free® RDS before the priority date, or that adherent proteins were actually removed using the single solution as claimed.
· No practicable mode of producing the result is shown, because there is no evidence that adherent protein deposits were actually removed from contact lenses soaked in Opti-Free® RDS solution as claimed.
· The package insert does not provide an enabling disclosure because it merely discloses a method of removing adherent protein deposits using the daily cleaning solution.
· The package insert provides no clear and unmistakable directions to do that which is claimed because no protein remains to be cleaned by the claimed method and no cleaning occurs by the claimed method.
· No inevitable result occurred because there is no data and no experiments to show that that occurred.
Was Opti-Free® RDS and the package insert SH-7 publicly available before the priority date?
For Opti-Free® RDS and its package insert to be relevant to the novelty of the present claims, section 7(1)(a) of the Patents Act requires these to have been publicly available before 27 August 1993. The opposed specification and its priority document indicates that Opti-Free® RDS was prior art and marketed by Alcon (2004201867 at page 4 line 33 to page 5, line 10; US 08/113,142 at page 4). Mr Huth explicitly confirms that Opti-Free® RDS was commercially available at least in the USA before the priority date of the opposed application (Huth#2 at [2]). Despite this evidence, Alcon in its submissions, and its employee Dr Chowhan (Chowhan#2 at [8]), explicitly did not concede that Opti-Free® RDS was commercially available before 27 August 1993.
Notwithstanding that the burden of proof lies with the opponent in an opposition proceeding, it is well recognised that the evidential burden may shift according to the state of the evidence from time to time, particularly in a case such as the present, where knowledge of the relevant facts may lie mainly with the applicant (see for example the Acting Deputy Commissioner in Austoft Industries Ltd v Cameco Industries, Inc. [1996] APO 26; (1996) 35 IPR 140 at 142-143). In this case, Abbott have provided evidence to establish that Alcon’s product Opti-Free® RDS was available to the public before 27 August 1993. Alcon, which developed and produced the product, should be in a unique position to know and be able to provide evidence as to when the product was available to the public. However, despite having ample opportunity to do so, Alcon provided no submissions or evidence to contradict Abbott’s evidence. Accordingly, I consider that Abbott has succeeded in establishing that Opti-Free® RDS was offered for sale to the public before 27 August 1993.
It is not in dispute that a contact lens care product is sold with a product information sheet (package insert) to provide the consumer with information on the product, and directions for its use (Huth#2 at [4]; Chowhan#2 at [5]). Alcon’s Opti-Free® RDS package insert carries the revision date May 1992 and states that the document was published in the USA. Mr Huth describes exhibit SH-7 as “the package insert sold with Alcon’s Opti-Free® solution” (Huth#2 at [10]). Dr Chowhan explicitly refers to this statement by Mr Huth, and does not contradict it (Chowhan#2 at [5]). While Dr Chowhan discusses the alleged prior use of Opti-Free® RDS in accordance with the instructions in the exhibited package insert before 27 August 1993 (Chowhan#2 at [5], [11], [13]), at no point does he dispute that the product and package insert were sold together. On balance, I am satisfied that Opti-Free® RDS was sold with the package insert before the priority date.
Offering Opti-Free® RDS for sale before the priority date, together with the package insert SH-7, places these within the prior art base for the purposes of novelty, since it clearly constitutes making information available to at least one member of the public who, in that capacity, was free, in law and equity, to make use of it, in the absence of any associated obligation of confidentiality (Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd [2008] FCAFC 139 at [124]; (2009) 78 IPR 20 at [124]).
Alcon’s package insert describes the use of Opti-Free® RDS in a chemical disinfection system for clear and tinted soft (hydrophilic) contact lenses. Opti-Free® RDS is acknowledged as the preferred cleaning solution in the opposed application (Example 1 and page 9, lines 6-8). The package insert provides explicit instructions for use of the product (Chowhan#2 at [11]). Therefore, what must be determined is whether the skilled reader before the priority date would have understood the prior publication (the package insert), and/or the prior use of the product in accordance with the instructions in the package insert, to disclose a missing integer, or alternatively, whether the package insert contains a direction to use a process that inevitably or inexorably results in something within the opposed claims.
Does the package insert contain a direction that, if followed, would inevitably or inexorably result in something within the opposed claims?
The Opti-Free® RDS package insert, under the heading “Directions for disinfecting your lenses”. provides a 3-step process consisting of Steps 1. “Clean”, 2. “Rinse”, and 3. “Store”.
Alcon’s claim 1 is to a method of cleaning a contact lens with a single solution comprising polycarboxylate(s) or corresponding acid(s). Only Step 3 uses Opti-Free® RDS as a single solution. In order for a cleaning method to be put into effect, it must be performed on a lens that is in need of cleaning. It is Step 3 of the directions that is under scrutiny, and therefore it must be determined whether the lens is in need of cleaning after Steps 1 and 2 have been completed.
Step 1 of the directions consists of applying a daily cleaning solution (either Opti-Free® Daily Cleaner or Opti-Clean® II Daily Cleaner) to the surface of each lens and rubbing for about 20 seconds. Step 2 involves applying a few drops of Opti-Free® RDS to each lens surface, rubbing for 1 or 2 seconds, then thoroughly rinsing both surfaces for at least 10 seconds. Alcon contended that after the performance of these steps, no protein remains to be cleaned from the lens. In contrast, Abbott submitted that it is reasonable to conclude from the evidence that residual protein deposits would have remained on the lens.
The composition of the Opti-Free® Daily Cleaner or Opti-Clean® II Daily Cleaner is provided by formulation detail reports, dated 6 May 2011 and in evidence as exhibits MC-1 and MC-2, respectively (Chowhan#3 at [4]-[5]). The daily cleaning solutions each contain as active cleaning agents the surfactant Polysorbate 21 (Tween 21) and the abrasive Nylon 11 (MC-1, MC-2 and Chowhan#3 at [7]). On the basis of the information in these reports, Dr Chowhan confirms that the Opti-Free Daily Cleaner and Opti-Clean II Daily Cleaner in the formulation detail reports are those referred to in the package insert SH-7, and that the composition of these solutions has not changed since 1989 (Chowhan#3 at [6]).
Dr Chowhan in his third declaration at [7] states that the daily cleaning solutions each contain Polysorbate 21 and Nylon 11 “in an amount sufficient to effectively remove deposits including adherent protein deposits from the surface of contact lenses”. In his last paragraph, he makes the unsubstantiated statement:
“9. THAT, as a person skilled in the art I firmly and sincerely believe that application of 1 or 2 drops of a daily cleaner i.e., Opti-Free® Daily Cleaner or Opti-Clean® II Daily Cleaner as is [sic] existed before the priority date of the opposed application and in accordance with the express directions for use provided in Exhibit SH-7 to the Huth declaration of December 10, 2010, is sufficient in and of itself to remove protein deposits including adherent protein deposits from the surface of the contact lenses. Accordingly I firmly and sincerely believe that rubbing contact lenses for at least 20 seconds with 1 or 2 drops of a daily cleaner as it existed before the priority date of the opposed application and as instructed in Exhibit SH-7 would have necessarily removed any protein deposits including adherent protein deposits from the surface of the contact lenses i.e. prior to the application of Opti-Free® RDS solution.” (Emphasis in original)
Mr Huth in his third declaration states the opposite:
“12. I do not agree with Dr Chowhan’s statement in paragraph 9, that all of the protein deposits “would necessarily” have been removed by rubbing with a surfactant-containing cleaning solution (Opti-Free® Daily Cleaner or Opti-Clean® II) prior to storing the lenses in the Opti-Free® RDS Solution.”
Mr Huth points to Example 2 of the opposed application and three published journal articles, to substantiate his conclusion that rubbing and rinsing, or just rinsing, with a surfactant-containing solution does not remove all protein deposits from contact lenses (Huth#3 at [4]-[9]). However, Mr Huth provided no direct evidence specifically on the effectiveness of Alcon’s daily cleaners, which contain an abrasive in combination with surfactant. Therefore, while Mr Huth’s evidence establishes that the presence of surfactant does not necessarily result in complete removal of protein deposits, it does not establish the effectiveness of the combined agents in the daily cleaners. However, there are other documents in evidence that provide additional information.
Annexed to Alcon’s submissions filed for the hearing on 11 May 2011, were product disclosure information sheets for each of the daily cleaning solutions. Abbott did not object to the annexures, which were not previously in evidence. Dr Chowhan states that these information sheets “provide an accurate representation of Alcon’s Opti-Free® Daily Cleaner and Opti-Clean® II Daily Cleaner solutions that have been marketed by Alcon since after the priority date of the opposed application” (Chowhan#3 at [3]). Based on the formulation details reports MC-1 and MC-2, Dr Chowhan confirmed that the formulation of the Opti-Free® Daily Cleaner and Opti-Clean® II Daily Cleaner solutions has not changed since 9 November 1989 (Chowhan#3 at [6]), and that these are daily cleaners referred to in the package insert SH-7 (Chowhan#3 at [5]). Therefore, I consider it reasonable to conclude that the product disclosure information annexures provide an accurate representation of these daily cleaners since 9 November 1989, well before the priority date of the application.
Annexure I to the 11 May 2011 submissions provides information on the Opti-Free® Daily Cleaner, and relevantly includes the statements:
“Opti-Free® Daily Cleaner combines cleaning agents to provide concentrated cleaning action which safely and effectively removes deposits from lens surfaces. Regular use will help keep lenses clearer longer and improve wearer comfort. For continued wearing comfort, also use Opti-Free® Enzymatic Cleaner weekly, or as directed by your eye care practitioner. [Emphasis added]
.
.
Opti-Free® Daily Cleaner is especially formulated to effectively remove mucus, oil, proteinaceous, cosmetic and other deposits from soft (hydrophilic), rigid gas permeable (silicone acrylate and fluorosilicone acrylate) and hard contact lenses.”
Therefore, although the product information sheet refers to “effective removal” of the lens soilants, the effectiveness is qualified by the earlier statement that regular use will “help keep lenses clearer for longer” and that enzymatic cleaning is required for “continued wearing comfort”.
“Enzymatic cleaning” refers to the use of a proteolytic enzyme to remove protein deposits from contact lenses (Chowhan#1 at [4]; Dr Ketelson at [9]; Huth#1 at [21]; Chowhan#2 at [17]). The explicit statement in the Opti-Free® Daily Cleaner information sheet that additional cleaning is required, directed specifically at the removal of protein deposits, strongly suggests that the daily cleaning solution, while it may effectively remove some protein, it does not remove all of the protein deposited on a contact lens during normal wear.
Annexure II, the product information sheet for the Opti-Clean® II Daily Cleaner is briefer, but describes the cleaning action of this solution in similar words:
“OPTI-FREE® RDS-CLEAN II Daily Cleaner is especially formulated to effectively remove mucus, oil, proteinaceous, cosmetic and other deposits from soft (hydrophilic), silicone hydrogel, gas permeable (silicone acrylate and fluorosilicone acrylate) and hard contact lenses.”
Since this statement substantially reiterates the words of the second paragraph reproduced above for the Opti-Free® Daily Cleaner, I consider that the term “effectively remove” should be interpreted consistently with its appearance in the Opti-Free® Daily Cleaner information sheet, as removing some but not all of the deposited protein.
Consistent with the Opti-Free® Daily Cleaner information sheet, under the heading “General Directions” the package insert SH-7 unequivocally instructs the user to:
“Clean your lenses weekly with an enzymatic cleaner (i.e., OPTI-FREE® Enzymatic Cleaner)”.
A weekly clean with enzyme would be redundant if the daily cleaners were fully effective at steps 1 and 2 in the Opti-Free® RDS package insert. The directions in the product disclosure statement for Opti-Free® Daily Cleaner, and for Opti-Free® RDS before the priority date, indicates that the manufacturer did not consider the daily cleaners, when used in accordance with the instructions provided, to be sufficient to remove all protein deposits from contact lens.
Dr Chowhan in his second declaration at [11] confirms the information provided in the package insert, that the daily cleaning solutions “helps remove harmful microorganisms and debris from the surface of the lenses”. Furthermore, Dr Chowhan states:
“I believe the directions for use expressly require using both the daily cleaner and Opti-Free® RDS solution to achieve disinfection, and that using the daily cleaner is an essential feature necessary to achieve disinfection by the method disclosed in [Alcon’s Opti-Free® RDS package insert].” (Emphasis added) (Chowhan#2 at [11])
Therefore in this earlier evidence, Dr Chowhan describes the action of the daily cleaner as to facilitate the disinfection process, in contrast to providing a method of cleaning the lens per se. This is consistent with the information in the package insert which, rather than purporting to describe a method of cleaning and disinfecting contact lenses, refers to a “disinfection system” and provides “directions for disinfecting your lenses”.
On balance, I consider that that Steps 1 and 2 as taught by the package insert, in addition to helping remove harmful microorganisms and debris (package insert and Chowhan#2 at [11]), extends to the substantial removal of less adherent protein deposits (Huth#1 at [22], [27]), but not to the complete removal of all protein deposits attached to the lens. I am satisfied that more strongly adherent protein deposits would remain on the lens at the completion of Steps 1 and 2. It follows that immediately prior to the performance of Step 3 of the method taught by the Opti-Free® RDS package insert, the contact lens qualifies as “a lens in need of cleaning”.
The Opti-Free® RDS package insert at Step 3 “Store”, instructs the user to completely submerge the lens in the single Opti-Free® RDS solution and to soak for at least 4 hours or overnight. Opti-Free® RDS is identical to the preferred solution of the opposed application. Soaking for 4 hours or overnight is encompassed by Alcon’s claim 1 and explicitly claimed at claim 5. Therefore, the package insert teaches at Step 3, albeit in the context of the daily 3-step disinfection process, a method of treating a contact lens with a single solution comprising polycarboxylate(s) or corresponding acid(s) or a combination thereof in an amount effective to clean the lens (Opti-Free® RDS) wherein said method comprises soaking the lens in the single solution for a time and under conditions sufficient to remove protein deposits attached to the lens (4 hours or overnight). It follows that the Opti-Free® RDS package insert provides an enabling disclosure of the method of opposed claims 1-5 and 11-12, which when performed on a contact lens that I have found to be in need of cleaning, would inevitably or inexorably produce the claimed result of removing protein deposits attached to the lens and disinfecting the lens. Following Step 3, the package insert recommends that the lens are rinsed with Opti-Free® RDS prior to insertion in the eye to remove any particulate material on the lens surface, as required by opposed claim 9. Opti-Free® RDS contains citric acid, sodium citrate and disodium edetate, compounds specified in claims 13-15, and the antimicrobial agent polyquaternium-1 (package insert at column 1, para 3), fulfilling the requirements of claims 16-17.
Alcon submitted that the onus is on the opponent to prove by performing its own repetition that the prior use would have inevitably produced the claimed result. However, in the present case, the prior use is not of an analogous solution and/or an analogous method of cleaning a contact lens. The prior use at Step 3 is of the same solution, which is applied to the same object (i.e. a contact lens in need of cleaning) using the same process steps as presently claimed. Alcon has, throughout prosecution of the application and at the hearing, submitted that their discovery is that polycarboxylates and corresponding acids remove among other things strongly adherent protein deposits from a contact lens. Alcon submitted at the hearing that the claimed solution achieves complete or substantial displacement of protein deposits attached to the lens. It follows that disinfection and complete or substantial displacement of protein deposits attached to the lens must necessarily be entailed during the performance of Step 3. I am therefore satisfied that the subject matter of claims 1-5, 9 and 11-17 is not novel in the light of the prior publication of Alcon’s Opti-Free® RDS package insert dated May 1992.
Claims 6-8 and 21 of the opposed application contain additional or alternative method steps that are not disclosed by the package insert. As to claim 10, given that the package insert directs that lenses are to be disinfected each time they are removed (column 3, para 5), and the method is indicated for use on daily and extended wear lenses (column 1, last para), the method taught by the package insert is at least as likely to be performed less often than daily. I have no evidence before me that would establish that the soft hydrophilic contact lenses referred to by the package insert fall within claims 18-19. Opti-Free® RDS is not encompassed by claim 20, due to the typographical error in the sodium citrate concentration. Consequently, the subject matter of opposed claims 6-8, 10 and 18-21 is novel over the disclosure of the Opti-Free® RDS package insert.
Would the person skilled in the art understand the prior art information to include a missing integer?
The package insert SH-7 teaches a method of disinfecting contact lenses by a three step process involving a daily cleaning solution and Opti-Free® RDS, and in addition that the lenses should be cleaned weekly with an enzymatic cleaner. The evidence establishes that before the priority date the person skilled in the art did not know that a polycarboxylate solution would remove all or substantially all of modest to heavy adherent deposits from a contact lens (Chowhan#1 at [7]; Huth#1 at [21]; Dr Ketelson at [9]). It follows that the person skilled in the art would not understand the package insert SH-7 to disclose a method of cleaning a contact lenses using a single solution comprising polycarboxylate(s) or corresponding acid(s) as presently claimed.
Prior use
In respect of prior use, Alcon submitted that an allegation of public prior use must be strictly proved, citing Justice Waddell in Windsurfing International Inc v Petit [1984] 2 NSWLR 196; (1985) 3 IPR 449 at 450). However, Windsurfing was concerned with the novelty of an invention in circumstances where there was doubt as to a witness’ accurate recollection and oral account of past events (Windsurfing IPR at 488 - 489). The present case is distinguished, in that it does not rely on oral evidence. The evidence is a published package insert that I have found to have been sold with Alcon’s Opti-Free® RDS before the priority date. There is no question as to what may have been done, since the document provides explicit directions for use of the product (Chowhan#2 at [11]). What is important in this case is whether a prior use was performed before the priority date in a manner that would make the information publicly available as required by section 7(1)(a) of the Patents Act.
I have found above that the package insert contains an enabling disclosure of a method falling within opposed claims 1-5, 9 and 11-17. As it relates to public disclosure through doing an act, sections 18(1)(b)(i) and 7(1)(a) of the Act are concerned with whether the invention is made available by conduct, not anticipation by conduct as such (Insta Image [2008] FCAFC 139 at [122]; (2009) 78 IPR 20 at [122]). Before the priority date, a member of the public using Opti-Free® RDS in accordance with the package insert would have performed a public use of the invention that was not hidden from the public and was not use that was accidental, unintended or secret. There was nothing to prevent a member of the public from examining each of the solutions and their effect on the contact lenses to which they were applied. The information gleaned from such an inspection, would for the purposes of practical utility, be equal to that given in the opposed patent, and would enable a person skilled in the art to put the claimed invention into practice. It follows that the prior use of Opti-Free® RDS in accordance with the instructions provided in the package insert, anticipates the invention of opposed claims 1-5, 9 and 11-17 (Insta Image [2008] FCAFC 139; (2009) 78 IPR 20 at [122], [144], [150]-[151], applied).
Non-compliant prior use
Abbott submitted that non-compliance of contact lens users was a well known problem before the priority date and that it is reasonable to assume that not all users followed lens care instructions at all times. Abbott provided evidence from three contact lens users that establishes that on occasion, these contact lenses users would skip the clean and rinse steps of a disinfection process and just store their lenses overnight. However, none of these declarants explicitly states that they used Opti-Free® RDS in this manner. Consequently, Abbott have not established that a non-compliant prior use occurred before the priority date that would anticipate the claimed invention.
Inventive step
The test for obviousness is whether it would have been a matter of routine to proceed to the claimed invention.
“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.” (Aicken J in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12 at [45]; (1981) 148 CLR 262 at 286)
More recently, the High Court in Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59 at [51] - [53]; 212 CLR 411 at [51] - [53] approved the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187 in which Graham J had posed the question:
“Would the notional research group at the relevant date in all the circumstances directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce a useful [desired result]?”
Abbott relied on three published patent documents to establish lack of inventive step as follows:
US 5503647 (Chowhan, M. A. et al) 6 August 1991 (US ’647)
US 4599195 (Schäfer, D. et al.) 8 July 1986 (US’195)
US 4808239 (Schäfer, D. et al.) 28 February 1989 (US’239)
In this case, the person skilled in the art is a pharmaceutical/formulation chemist in the field of optometry and with expertise in the field of contact lens care. The problem addressed by the opposed claims is to provide improved products and processes for cleaning contact lenses in an efficacious but convenient manner.
US 5037647
US’647 is directed to lens care solutions useful for the disinfection and preservation of contact lenses, rather than to cleaning solutions. I do not consider that the person skilled in the art researching the above problem would have ascertained, understood and regarded this document as relevant to the provision of cleaning solutions and methods. It follows that the claimed invention is not obvious in view of US’647.
US 4599195 & US 4808239
US’195 and US’239 are both directed to a similar problem, and consequently I am satisfied that the skilled person seeking to solve the problem would have ascertained understood and regarded each of these documents as relevant.
Claims 1 and 2
As discussed above, US’195 and US’239 each provide solutions and methods for cleaning contact lenses. Given that each of the documents provides a solution to the problem, I am satisfied that the person skilled in the art would directly be led as a matter of course to use the methods taught by US’195 or US’239, in order to clean contact lenses, in the expectation that it might well produce a useful, desired result. It follows that the subject matter of claims 1 and 2 lacks an inventive step over the subject matter of US’195 and US’239.
Claims 3-21
I have found that neither US’195 nor US’239 disclose the additional features of claims 3-21. It is clear from the evidence that it was not known before the priority date of 27 August 1993 that polycarboxylate(s) and/or corresponding acid(s) could effectively clean contact lenses of modest to heavy adherent deposits (Chowhan#1 at [7]; Huth#1 at [21], [37]; Dr Ketelson at [9]). It is clear from US’195 and US’239 that the surfactant is an essential component of the solutions disclosed by these documents (Dr Ketelson at [6], [8]; Huth#1 at [35]). Therefore, the person skilled in the art wishing to clean a contact lens before the priority date, having read US’195 or US’239 would not, as a matter of routine, omit the surfactant from the solution (Chowhan#1 at [4], [7]). I have no evidence before me to suggest that the person skilled in the art would, as a matter of routine, make the changes necessary to modify the solutions and methods of use to arrive at the invention of claims 3-21. Therefore, Abbott have not established that the subject matter of claims 3-21 lacks an inventive step in view of US’195 and US’239.
ReNu® MPS package insert
The ReNu® MPS package insert does not disclose the single solution as claimed, nor the method of cleaning a contact lens. I have no evidence before me that establishes that it would have been a matter of routine for the person skilled in the art to proceed from the disclosure of this package insert to the method as claimed. Consequently, I find the subject matter of claims 1-21 to involve an inventive step over the disclosure of the ReNu® MPS package insert.
Opti-Free® Rinsing, Disinfecting and Storage solution
The Opti-Free® RDS package insert discloses a method of disinfecting a lens and refers to a cleaning step. Mr Huth exemplifying US’195 and US’239, states that it was known to include polycarboxylates in multipurpose solutions for cleaning a lens (Huth#1 at [20] - [21], [25], [27], [30]). Therefore I am satisfied that the person skilled in the art researching the problem I have identified, would ascertained, understood and regarded as relevant the prior publication and prior use of Opti-Free® RDS in accordance its package insert.
The evidence establishes that polycarboxylates alone were not known to be effective in removing more adherent protein deposits from a contact lens (Chowhan#1 at [7]; Dr Ketelson at [9]; Huth#1 at [21]). On its face, the information in the package insert does not teach the person skilled in the art that polycarboxylate(s) and/or corresponding acid(s) are capable of cleaning lenses, instead it teaches that lenses should be cleaned with an enzymatic cleaner. As a consequence, I conclude that the person skilled in the art would not directly be led as a matter of course from the prior published information, or the prior use of Opti-Free® RDS, to the invention as presently claimed. It follows that the claimed invention involves an inventive step over this prior art.
Manner of Manufacture
Section 18(1)(a) requires that an invention must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. Manner of manufacture is assessed by asking whether the claimed invention lacks the necessary quality of inventiveness on the face of the specification (NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd [1995] HCA 15 at [9]; (1995) 183 CLR 655 at 655).
Abbott’s submissions under this ground were that the claims represent the use of a known substance in a known way using known properties that inherently make it suitable for that use. However, on the face of the specification, it is not apparent that the ability of polycarboxylate(s) or corresponding acid(s) to remove attached or adherent protein deposits from a contact lens was known. Abbott has not established that the claimed invention is not a manner of manufacture.
Utility
Lack of utility is established when a claim includes subject matter that will not produce the desired result (H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 at [81]; (2009) 81 IPR 228 at 247 [81]).
Abbott’s submissions in relation to inutility are as follows:
(i)Insofar as the claims recite a method of cleaning and disinfecting a contact lens, but do not explicitly recite the presence of an antimicrobial agent in the cleaning solution, the method claimed would not achieve cleaning and disinfection of a lens.
(ii) Insofar as the claimed invention encompasses the use of any polycarboxylates or corresponding acid or combination thereof in any single solution the claimed methods encompasses embodiments that would not be capable of cleaning and disinfection of a contact lens.
I have construed the claims to include the presence of an antimicrobial agent in the single solution where disinfection is required by the claim. Moreover, polycarboxylate(s) and/or corresponding acid(s) that do not produce the desired result are explicitly excluded from the claims, by the requirement that the solution to contain these agents in “an amount effective to clean the lens”. Consequently, Abbott has not established that the claimed invention lacks utility.
Section 40 issues
At the hearing Abbott advised that they did not press section 40(2) issues. Section 40(3) of the Act requires that the claim or claims in a patent specification “must be clear and succinct and fairly based on the matter described in the specification”.
Clarity
A claim is lacking in clarity if a third party could not ascertain whether an act would fall within the scope of the claim (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59 at 60).
Abbott submitted that the scope of the claims is inherently unclear and a number of terms in the claims were identified as vague and ambiguous. However, none of the expert witnesses appeared to have difficulty in applying a meaning to the terms used in the claims. I have found above that a meaning and scope can be attributed to the claims by application of the normal rules of construction, which resolve the clarity issues raised by Abbott. I am satisfied that claims 1-19 and 21 are clear.
As a result of the typographical error identified by Alcon, claim 20 defines a solution with a combined concentration of polycarboxylate/polycarboxylic acids which is less than the effective amount required by its dependency on claim 1 (Chowhan#2 at [16]). In view of the conflict between the dependant and independent claim, I find that the claim 20 is unclear.
Fair basis
The test for fair basis was given by the High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 at [69]; (2004) 217 CLR 274 at 300 [69] as:
“… 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.”
Abbott’s submissions were in effect, that Alcon’s claims were too broad and that the elements that overcome the problems in the prior art need to be in the claims, including that the single solution be surfactant-free; that the polycarboxylate(s) or corresponding acid(s) effect cleaning of the lens; that the single solution have a neutral pH; that the claims should be restricted to solution and methods exemplified.
In respect of fair basis, High Court in Lockwood v Doric at [68] observed:
“The comparison which s 40(3) calls for is not analogous to that between a claim and an alleged anticipation or infringement. It is wrong to employ “an over meticulous verbal analysis”. It is wrong to seek to isolate in the body of the specification “essential integers” or “essential features” of an alleged invention and to ask whether they correspond with the essential integers of the claim in question.”
The description identifies and exemplifies embodiments involving the use of polycarboxylate(s) and/or corresponding acid(s) as a protein removal agent, in the absence of disinfection (at page 3, line 28 to page 4, line 2). I cannot agree therefore, that the specification does not provide a real and reasonably clear disclosure of a method of cleaning a contact lens using polycarboxylate(s) or corresponding acid(s) in the absence of disinfection. In respect of the issues raised by Abbott, I find the claims are fairly based. Abbott’s concerns with the broadness of the claims are more appropriately addressed in the consideration of novelty.
CONCLUSION
Abbott has succeeded in its opposition. The subject matter of claims 1-5, 9 and 11-17 is not novel. Claims 1 and 2 lack an inventive step. Claim 20 is not clear. Although Alcon filed a request to amend the specification on 11 May 2011, those claims are similarly deficient. However, it is possible to overcome the deficiencies I have identified by amendment of the claims. I therefore allow Alcon 2 months from the date of this decision to propose such amendments.
COSTS
Abbott submitted that costs should follow the event. Alcon contended that the failure of the opponent to file evidence in support and in raising the prior use allegation at the last possible opportunity has significantly prejudiced the applicant, and does not demonstrate a commitment by Abbott to expeditious disposal of the opposition. Alcon requested that Abbott pay the costs incurred by Alcon by reason of the late amendment to the statement of grounds and particulars.
I accept that Abbott’s actions have prolonged the opposition. However, I consider that Alcon has also prolonged the hearing unnecessarily by not answering the prior use allegations adequately in their responding evidence to Abbott’s further evidence, which necessitated their filing further evidence after their “further submissions”, filed a week after the hearing finished on 11 May 2011, were rejected. Furthermore, Alcon has twice sought to introduce additional evidence under the guise of submissions, and has again filed further submissions more than two weeks after the hearing was concluded on 6 September 2011.
Overall, the conduct of the opposition by both parties has been regrettable. Each party has been disadvantaged by the actions of the other. Consequently I believe it is appropriate that costs should follow the event. Abbott has been successful in their opposition. I award costs against Alcon Laboratories, Inc.
Dr B. Akhurst
Delegate of the Commissioner of Patents
ANNEX A: Text contained within the package insert for Opti-Free® RDS (Exhibit SH-7).
Please read carefully and keep this package insert for future use in case you have a problem.
Alcon
OPTI-FREE® Rinsing, Disinfecting and Storage Solution
For use in a chemical (not heat) disinfection system for clear and tinted soft (hydrophilic) contact lenses. OPTI-FREE Solution can be used as part of a care program for soft (hydrophilic) contact lenses when prescribed in a frequent replacement program.
OPTI-FREE Rinsing, Disinfecting and Storage Solution, a gentle, effective, thiomerosal-free and sorbic acid-free formula, is especially formulated for soft contact lens wearers. OPTI-FREE Solution has been shown safe and effective for individuals with eyes sensitive to thiomerosal. For use as recommended by your eye care practitioner.
DESCRIPTION: OPTI-FREE Rinsing, Disinfecting and Storage Solution is part of the OPTI-FREE Disinfection System. OPTI-FREE Solution is a sterile, buffered, isotonic, aqueous solution containing a citrate buffer and sodium chloride, with edetate disodium 0.05% and POLYQUAD® (polyquarternium-1) 0.001% as preservatives.
ACTIONS: OPTI-FREE Rinsing, Disinfecting and Storage Solution destroys harmful microorganisms on the surfaces of lenses when used in a chemical (not heat) disinfection system. OPTI-FREE Solution also removes loosened deposits and traces of cleaning solution when used as a rinsing solution.
OPTI-FREE Solution can be used to dissolve OPTI-FREE and OPTI-ZYME® Enzymatic Cleaning Tablets.
No saline solution is required with the OPTI-FREE Disinfection System.
INDICATIONS (Uses): CHEMICAL (NOT HEAT) LENS CARE SYSTEMS - For the disinfection, rinsing and storage of daily and extended wear soft (hydrophilic) contact lenses.
CONTRAINDICATIONS (Reasons Not To Use): Patients allergic to any ingredient in OPTI-FREE Rinsing, Disinfecting and Storage Solution should not use this product.
WARNINGS: Never touch the dropper tip of the container to any surface, since this may contaminate the solution
PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE EYE. It is essential that you follow your eye care practitioner’s direction and all labelling instructions for proper use of your lens care products. EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF VISION: THEREFORE IF YOU EXPERIENCE EYE DISCOMFORT, EXCESSIVE TEARING, VISION CHANGES, REDNESS OF THE EYE, IMMEDIATELY REMOVE YOUR LENSES AND PROMPTLY CONTACT YOUR EYE CARE PRACTITIONER.
PRECAUTIONS:
· Always wash and rinse your hands before handling your lenses.
· Always use fresh OPTI-FREE Rinsing, Disinfecting and Storage Solution in your lens storage case. NOTE: After inserting your lenses, always empty your lens storage case, rinse and allow to air dry. Never reuse the solution in your lens storage case.
· Store at room temperature.
· Keep the container tightly used when not in use.
· Use before the expiration date marked on the container and cartons.
· Keep this and all medications out of the reach of children.
ADVERSE REACTIONS (Problems and what to do): The following problems may occur while wearing contact lenses:
· Eyes stinging, burning or itching (irritation)
· Excessive watering (tearing) of the eyes
· Unusual eye secretions
· Redness of the eyes
· Reduced sharpness of vision (visual acuity)
· Blurred vision
· Sensitivity to light (photophobia)
· Dry eyes
If you notice any of the above problems, immediately remove and examine your lenses. If the problem stops and the lenses appear to be undamaged, thoroughly clean, rinse and disinfect the lenses and reinsert them. If the problem continues or a lens appears to be damaged, IMMEDIATELY remove your lenses and IMMEDIATELY consult your eye care practitioner. Do not reinsert a damaged lens.
If any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularisation or iritis may be present. Seek immediate professional identification of the problem and treatment to avoid serious eye damage. See your Instructions for Wearer’s booklet for more information.
GENERAL DIRECTIONS:
· Always wash and rinse your hands before handling your contact lenses.
· Always handle the same lens, the right or left, first in order to avoid mix-ups.
· Clean your lenses weekly with an enzymatic cleaner (i.e., OPTI-FREE® Enzymatic Cleaner).
Directions for Disinfecting Your Lenses:
The OPTI-FREE Disinfection System consists of a daily cleaner (i.e., OPTI-FREE® Daily Cleaner or OPTI-CLEAN II Daily Cleaner) and OPTI-FREE Rinsing, Disinfecting and Storage Solution. When used as directed below:
· The daily cleaner helps remove harmful microorganisms and debris from the surfaces of the lenses.
· OPTI-FREE Solution destroys harmful microorganisms on the surface of the lenses and removes loosened deposits and traces of daily cleaner.
Your lenses must be cleaned with a daily cleaner and stored in OPTI-FREE Solution each time you remove them. Both steps are necessary to provide disinfection. One step does not replace the other. Always follow these three steps.
STEP 1 CLEAN
Wash hands and rinse thoroughly before handling lenses.
Remove your lenses and clean by applying 1 or 2 drops of a daily cleaner (i.e. OPTI-FREE Daily Cleaner or OPTI-CLEAN II Daily Cleaner) to each lens surface. Rub the lens for about 20 seconds in the palm of you hand using the forefinger of the other hand. Be sure to clean each side of the lens.
STEP 2 RINSE
Apply a few drops of OPTI-FREE Solution to each lens surface and rub for 1 or 2 seconds; then thoroughly rinse both surfaces of the lens with OPTI-FREE Solution for at least 10 seconds to remove all traces of cleaner.
STEP 3 STORE
As the final step in disinfection fill your storage case with enough fresh OPTI-FREE Solution to cover the lenses. Place the lenses in your storage case and check to see that the lenses are completely submerged. Close your storage case tightly. Leave your lenses in your unopened storage case overnight or for at least 4 hours.
Before Wearing
Rinsing of lenses with fresh OPTI-FREE Solution prior to insertion in the eyes is recommended to remove any particulate material on the lens surfaces.
After you remove your lenses from the lens case empty and rinse your lens storage case and allow it to air dry. Refill the case with fresh OPTI-FREE Solution immediately before the next use of the case.
How supplied: OPTI-FREE Rinsing, Disinfecting and Storage Solution is supplied in sterile 4 fl. oz. (118 mL), 8 fl. oz. (237 mL) and 12 fl. oz. (355 mL) plastic bottles. The containers and cartons are marked with lot number and expiration date.
Lenses: OPTI-FREE Rinsing, Disinfecting and Storage Solution is indicated for use in the chemical (not heat) disinfection system and for rinsing and storage of daily and extended wear, clear and tinted soft (hydrophilic) contact lenses. For use as recommended by your eye care practitioner.
U.S. Patent Nos 4407791
and 4525345Printed in the USA
*U.S. Patent No. 3931, 319 and others.
Mfd for:
Alcon ®
VISION CARE
ALCON LABORATORIES INC
FORT WORTH TEXAS, 76134
Revised: May 1992
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