Bausch & Lomb Inc v Allergan, Inc

official notice

decision of a delegate of the commissioner of patents

Application : No. 628926 in the name of Bausch & Lomb Incorporated

Title: Method and Composition for Cleaning and Disinfecting Contact Lenses

Action: Opposition by Allergan, Inc. under section 59 of the Patents Act 1952

Decision: Issued .
Abstract: Opposition is successful in relation to the grounds of lack of compliance with section 40, lack of novelty and obviousness.
An unparticularised document taken into account by the delegate because it may be determinative of the opposition. Claims found to be obvious even though a person skilled in the art would arrive at the claimed invention for different reasons to the inventor.

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 628926 by Bausch & Lomb Incorporated and Opposition thereto by Allergan, Inc. under section 59 of the Patents Act 1952

background

Bausch & Lomb Incorporated filed patent application 49989/90 (628926) on 20 February 1990, which claims priority from US application 313643 which was filed on 21 February 1989.

Patent application 628926 was advertised accepted on 24 September 1992. Allergan, Inc. filed notice of opposition on 24 December 1992 and a statement of grounds and particulars on 25 January 1993.

The normal evidentiary cycle was completed on 7 October 1994. The applicant requested and was granted leave to serve further evidence. The serving of this further evidence and evidence in response by the opponent was completed on 7 April 1995.

The opposition was heard in Sydney on 16 and 17 November 1995. Bausch & Lomb were represented by Ms Julia Baird of counsel, assisted by Dr Colin Bodkin and Dr John McCann, patent attorneys of Spruson & Ferguson, Sydney. Allergan was represented by Mr Bruce Caine of counsel, assisted by Dr Peter Stearne, patent attorney of Davies Collison Cave, Sydney. Mr Martin Voet of Allergan also attended. Mr Mark O’Donnell of F B Rice & Co attended as an observer.

Subsequent to the hearing, I advised both parties that I would inform myself of a particular document included in evidence and referred to at the hearing but not particularised. Both parties served additional evidence in relation to this document which I refer to in this decision as the MIMS document.

A continuation of the hearing (the later hearing) was heard in Sydney on 4 June 1997 to consider the additional evidence filed in relation to the MIMS document. At this later hearing, Bausch & Lomb was represented by Ms Julia Baird of counsel, assisted by Dr Colin Bodkin, patent attorney of Spruson & Ferguson, Sydney. Allergan was represented by Dr Peter Stearne and Mr James Siely, patent attorneys of Davies Collison Cave, Sydney. Mr Mark O’Donnell of F B Rice & Co attended as an observer.

On 9 May 1997, Bausch & Lomb filed a statement of proposed amendments which includes a number of proposed changes to the claims. These amendments have not yet been allowed.

As the application was filed before but accepted after the commencement of the Patents Act 1990, section 59 of the Patents Act 1952 applies to the grounds of opposition but Chapter 5 of the Patent Regulations 1991 applies to the opposition procedures.

THE SPECIFICATION

The specification, as accepted, relates to a method and composition for cleaning contact lenses particularly by simultaneously cleaning and disinfecting the lenses using an aqueous system containing an antimicrobial agent and a proteolytic enzyme.

The specification provides a summary of prior art methods of cleaning and disinfecting contact lenses. Enzyme cleaners have been used to remove proteinaceous deposits from contact lenses. Conventionally the process of cleaning and disinfecting contact lenses has been a two stage process. The first step consists of cleaning the lenses by soaking then in an enzyme cleaning solution at ambient temperature for up to 12 hours. Following this, the next step involves separate disinfecting of the lenses by contacting them with a solution containing either an oxidative chemical or an antimicrobial agent at ambient temperature or exposing the lenses to elevated temperatures for specified periods of time.

More recent methods of removing proteinaceous material from contact lenses while disinfecting them include a single step method of cleaning and disinfecting the lenses in an aqueous solution of proteolytic enzymes at temperatures of between 60⁰C and 100⁰C. This method requires the use of electrical apparatus and elevated temperatures. Another method involves the immersion of the lenses in a solution containing peroxide and a peroxide-active enzyme. This method requires an additional neutralising step before the lens can be worn.

The specification refers to initial studies looking at the effect of using proteolytic enzyme tablets in combination with a disinfecting solution containing hexamethylene biguanide polymers as the antimicrobial agent. These studies revealed that the antimicrobial agent was rendered less effective for killing certain microorganisms.

The present invention is based on the discovery that the disinfecting ability of antimicrobial agents is most effective under conditions of suitable osmolality. When the osmolality level is too high, the antimicrobial agents are less effective for killing certain microorganisms. The present invention therefore envisages the use of proteolytic enzymes in combination with antimicrobial agents to simultaneously clean and disinfect contact lenses, the disinfection being most effective at suitable osmotic conditions.

The specification provides a summary of the invention with a number of statements which correspond to the independent claims. This is followed by a detailed description of the invention.

A list of suitable proteolytic enzymes is provided and it is indicated that these enzymes are known in the art. Then follows a definition of an effective amount of enzyme which is that which removes a substantial portion of the proteinaceous deposits which occur during normal wear in a reasonable time. The precise amount of enzyme depends on various identified factors.

The next passage of relevance defines antimicrobial agents as non-oxidative chemicals which derive their antimicrobial activity through a chemical or physiochemical interaction with the organisms. A list of suitable antimicrobial agents is provided and includes quaternary ammonium salts and biguanides with the preferred antimicrobial agents being biguanides. Various biguanide compounds are known in this art.

The specification defines a disinfecting amount of antimicrobial agent as being that which will at least partially reduce the microorganism population in the formulations employed. Preferably a disinfecting amount is that which will reduce the microbial burden by two log orders in four hours and more preferably by one log order in one hour. Most preferably, a disinfecting amount is one which eliminate the microbial burden on the lens when used in a regimen for the recommended soaking time.

According to the specification, antimicrobial agents at simulated commercial concentrations are rendered less effective in environments having high osmotic values. The osmotic value rendering the agent ineffective will vary from agent to agent. However the determination of suitable osmotic ranges can easily be found by routine experimentation. A preferred range of osmotic values has been found to be less than about 800 mOsm./kg.

There are 41 examples provided. I note here that the first 36 of these examples rely on testing against one organism only viz. Serratia marcescens. Examples 37 to 41 deal with tests relating to the cleaning efficacy of the solution.

The specification, at acceptance, ends with 29 claims, 5 of which are independent and 2 of which are omnibus claims. The 5 independent claims, as accepted, are as follows:

“1. A method for simultaneously cleaning and disinfecting contact lenses comprising contacting the lenses with an aqueous system containing an antimicrobial agent and a proteolytic enzyme for a time sufficient to clean and disinfect the lenses, wherein the osmotic value of said aqueous system does not substantially inhibit the activity of said antimicrobial agent.

14.A method for simultaneously cleaning and disinfecting contact lenses comprising the steps of:

dissolving a proteolytic enzyme in a disinfecting solution containing from about 0.00001 to about 0.5 percent by weight/volume of an antimicrobial agent and from about 0.01 to about 2.5 percent by weight/volume of a buffering agent and wherein said solution has a final osmotic value of less than about 800 mOsm./kg. water and
contacting said lenses with said solution at ambient temperatures for a period of time sufficient to clean and disinfect said lenses.
15.      An improved method for simultaneously cleaning and disinfecting contact lenses with proteolytic enzymes and antimicrobial agents, characterised by contacting the lenses with an aqueous system containing the enzyme and the antimicrobial agent, and maintaining the osmotic value of the system at a level which does not substantially inhibit the activity of the antimicrobial agent.
17.      A composition for simultaneously cleaning and disinfecting contact lenses said composition comprising water, a disinfecting amount of an antimicrobial agent and an effective amount of a proteolytic enzyme, wherein the final osmotic value of the composition is less than about 800 mOsm./kg. water.
27.      An aqueous composition for cleaning and disinfecting contact lenses, said composition having a pH of about 6.5 to about 8.5 and comprising about 0.00003 to about 0.05 percent by weight/volume of an antimicrobial agent, an effective amount of a proteolytic enzyme, and wherein the final osmotic value of said composition is less than about 800 mOsm./kg. water.”

THE PROPOSED AMENDMENTS

The proposed amendments include the replacement of the consistory statements in the accepted specification with new consistory statements in line with proposed new claims. The amended claims include only two independent claims as follows:

“1. A method for simultaneously cleaning and disinfecting contact lenses, comprising contacting the lenses with an aqueous system containing a proteolytic enzyme and an antimicrobial agent and for a time sufficient to clean and disinfect the lenses, said antimicrobial agent being a quaternary ammonium salt used in opthalmic applications or a biguanide; wherein the final osmotic value of said aqueous system does not substantially inhibit the activity of said antimicrobial agent.
13. A composition for simultaneously cleaning and disinfecting contact lenses, said composition comprising water, an effective amount of a proteolytic enzyme and a disinfecting amount of an antimicrobial agent, said antimicrobial agent being a quaternary ammonium salt used in opthalmic applications or a biguanide; wherein the final osmotic value of said composition does not substantially inhibit the activity of said antimicrobial agent and is less than 800 mOsm./kg. water.”

I have underlined the significant alterations to the accepted claims. The method and composition claims now specify the type of antimicrobial agent used as originally referred to in accepted claim 6. The method claim also includes the qualification that the final osmotic value should not substantially inhibit the activity of the antimicrobial agent. The composition claim now also refers to the final osmotic value not substantially inhibiting the activity of the antimicrobial agent.

STATEMENT OF GROUNDS AND PARTICULARS

The amended statement of grounds and particulars, filed on 16 July 1993, contains three grounds of opposition viz. lack of novelty, obviousness and non-compliance with section 40 of the Patents Act 1952.

In relation to the ground of lack of novelty, the particulars list 15 documents including various patent specifications and journal articles.

With respect to obviousness, the particulars refer to the 15 documents particularised in relation to lack of novelty. The particulars also identify examples of what was part of the common general knowledge in the art. Relevant amongst these examples are the assertions that the osmolality of commercially available contact lens care solutions was generally less than 800 mOsm./kg water and that contact lens enzyme cleaners have enhanced cleaning activity at low osmolalities.

There are two particularised section 40 matters which I will refer to later in my decision.

EVIDENCE

The evidence in support consists of statutory declarations by:

Peter Stearne, a patent attorney representing the opponent. The declaration exhibits 12 of the 15 particularised documents. There is also a second declaration by Dr Stearne with two exhibits relating to the availability of certain documents in Australia.
Joan Martin, concerning the availability of a number of publications in Australia.
Russell Lowe who states that he is, and has been since 1982, a clinical optometrist and that he is and has been for a number of years a lecturer and instructor in various courses related to contact lenses at the University of Melbourne. Mr Lowe points out that he is the author/co-author of a number of scientific publications and other works. There are 6 exhibits to this declaration.
Ian Griffith who indicates that he is a senior lecturer in pharmaceutical microbiology at the Victorian College of Pharmacy. There are 5 exhibits.
Stanley Huth who declares that he is and has been a director since 1992 of contact lens care products research at Allergan Pharmaceuticals Inc. which I understand to be the more recent name of the opponent company. Mr Huth indicates that he has been employed at Allergan since 1976 during which time he has held various professional positions. There are 6 exhibits.

The evidence in answer consists of statutory declarations by:

Joy Barnitz who states that she is a senior scientist and group leader of microbiology research at the applicant company. She indicates that she works in the personal products division which deals with formulations for contact lens care products. She does not indicate how long she has held this position or what her previous work experience has been. There are 2 exhibits.
Noel Brennan who declares that he is, and has been since 1992, reader and associate professor in the Department of Optometry at the University of Melbourne. Before this, Professor Brennan indicates that he has held lecturing positions in the same department since 1984. Professor Brennan states that he is registered as an Optometrist, is a member or affiliate of numerous professional societies and associations in the field of optometry and has authored over 130 publications. There are 11 exhibits to the declaration.

The evidence in reply consists of statutory declarations by:

Kate Ambrus who states that she has been employed by the opponent company for 18 years in various positions mainly in research microbiology. Her current position requires her to supervise and carry out tests on the efficacy of various disinfectants for contact lenses. The declaration contains an annex setting out various test results.
Stanley Huth. This is a second declaration by Mr Huth. There is one exhibit.
Russell Lowe. This is a second declaration by Mr Lowe.

The further evidence consists of statutory declarations by:

John McCann who is a patent attorney representing the applicant. There is one exhibit.
Noel Brennan. This is a second declaration by Professor Brennan. There are 8 exhibits.

The evidence in response consists of statutory declarations by:

Katherine Stern, who declares that she has been employed by the opponent company as a biostatistician since 1989. There are two exhibits to her declaration.
Robert Thomas, concerning the availability of a certain publication in Australia.
Stanley Huth. This is a third declaration by Mr Huth. There is one exhibit.
Russell Lowe. This is a third declaration by Mr Lowe. There are two exhibits.

The additional evidence consists of statutory declarations:-

on behalf of the applicant by:

Joy Barnitz. This is a second declaration by Ms Barnitz. There is one exhibit.

on behalf of the opponent by:

Kate Ambrus. This is a second declaration by Ms Ambrus.

Nancy Brady, who declares that she has been employed by Allergan, Inc. as a technician and professional since 1975. Ms Brady refers to a test she conducted in 1987 on various Bausch & Lomb products. There are four exhibits.

on behalf of the applicant by:

Anne Jones, who indicates that she is Technical Services Manager for Bausch & Lomb, Australia and that she is responsible for managing Bausch & Lomb’s regulatory procedures in New Zealand. There is one exhibit which is an application for market approval of a Bausch & Lomb product in New Zealand.
Joy Barnitz. This is a third declaration by Ms Barnitz. There is one exhibit which appears to be the same application for marketing approval as that exhibited to the Jones declaration.

on behalf of the opponent by:

Kate Ambrus. This is a third declaration by Ms Ambrus. There are 11 exhibits.

Nancy Brady. This is a second declaration by Ms Brady.

SUBMISSIONS

The submissions at the initial hearing took two days to complete with the opponent’s submissions in chief taking almost a day and a half. Both parties also provided me with written summaries of their submissions. I will refer to the submissions where appropriate in my decision.

At the later hearing, both parties provided me with written summaries in support of their submissions. I will also refer to these submissions where appropriate in my decision.

DECISION

PROCEDURAL MATTERS

During the course of the initial hearing, a number of procedural issues arose.

Mr Caine provided written submissions dealing with the question of manner of manufacture. In the course of his providing oral submissions on this ground, Ms Baird objected that this was not a ground identified in the statement of grounds and particulars. I ruled that this ground was not available to the opponent as it had not been included in the statement of grounds. The applicant is entitled to know the case it has to answer at an early stage in the proceedings. Certainly, it seems to me that there would be a denial of natural justice if the opponent was allowed to introduce a new ground of opposition at the hearing. It would also make the provision of a statement of the grounds of opposition redundant.

In the course of providing submissions on the ground of lack of novelty, Mr Caine referred to a document which is an extract from the 1988 MIMS Annual, a publication of Intercontinental Medical Statistics (Australasia) Pty Ltd. This document is identified in and exhibited to the third Lowe declaration i.e. a declaration served as part of the evidence in response by the opponent to the further evidence served by the applicant. Ms Baird objected that this document had not been particularised and therefore should not form part of the opposition. Mr Caine argued that the applicant had been aware of the document since the Lowe declaration had been served in 7 April 1995 which was some seven months before the hearing. If the applicant had been concerned about this particular document, it was open to the applicant to request leave to serve further evidence in relation to this document. The applicant had already served further evidence in relation to other matters. I indicated that I would decide on the permissibility of the document in the opposition subsequent to the hearing.

Both parties provided me with oral submissions on the MIMS document at the hearing.

As I advised the parties in a letter on 9 January 1996, I think that, in the normal course of events, allowing the MIMS document to be included in this opposition would seem to me to be contrary to the whole purpose of requiring the opponent to provide a statement of grounds and particulars.

However I am conscious of the significance of this particular document. It seems to me in receiving submissions from both sides at the initial hearing on the disclosures in the MIMS document that it is a document which could clearly be determinative of the opposition. As a consequence, I am loathe to exclude the document due to a failure in the procedure.

Therefore, in accordance with regulation 5.11, I informed myself of this document in determining the opposition. Although I had already received submissions from both parties at the initial opposition hearing, I gave the applicant the opportunity to provide evidence in relation only to the MIMS document.

I would add that I do not agree with Mr Caine’s submission that the MIMS document should be allowed as part of the opposition because the applicant was at liberty to request leave to serve further evidence. Whether or not the applicant chose to serve further evidence in relation to another matter, I do not believe that the applicant is required to take action to resolve any procedural anomalies caused by the opponent.

At the hearing, Mr Caine provided submissions in relation to section 40 matters which Ms Baird pointed out had not been particularised. However, as Ms Baird did not press the matter, and as both parties provided argument in relation to these unparticularised issues, I will consider them in this decision.

I must say that Allergan’s case at the initial hearing involved a number of instances where procedural requirements of Chapter 5 of the Patent Regulations 1991 had not been followed. While it is the Commissioner’s duty to reach a just and fair decision based on all the material available, the Commissioner also has a duty to ensure that both parties are not disadvantaged by the way the other party conducts its case. It seems to me that, where procedural requirements are consistently ignored, the question of whether or not the other party has received natural justice is a real one. I am satisfied that in the present case the applicant has not been excessively disadvantaged given the above rulings. However I am sure that where the number of breaches in the procedures were large, this would have to be taken into account when considering any remedies to those breaches individually.

At the later hearing, Dr Stearne questioned whether or not his submissions could extend to the question of lack of inventive step based on the MIMS document. Ms Baird argued that my letter of 9 January 1996 to both parties clearly indicated that I was considering the MIMS document only in relation to the ground of lack of novelty. The relevant portion of the letter is as follows:

“At the hearing into the above matter held in Sydney, on 16 and 17 November 1995, I indicated that I would subsequently provide a ruling as to whether the MIMS Annual, 1988 Australian edition, could be relied on to support the ground of novelty in this opposition.”

Dr Stearne argued that the remainder of the letter did not clearly limit the later hearing to just the ground of lack of novelty. In addition, the MIMS document was also referred to in the evidence in relation to the ground of lack of obviousness.

I indicated that I had informed myself of the MIMS document because, in my view, it could be clearly be determinative of the opposition. I came to this decision only in relation to the ground of lack of novelty. Therefore, the later hearing should proceed only in relation to this ground and not in relation to the ground of obviousness.

Also at the later hearing, both parties agreed that they wished to direct their submissions to the claims as proposed to be amended rather than the claims as accepted.

Subsequent to the hearing, I advised both parties that I would decide the present opposition in relation to the claims as accepted but that, if the opponent was successful in establishing any of the grounds of opposition, I would also consider the claims as proposed to be amended to see if these claims would overcome any of the successful grounds. I indicated that I would not consider delaying the issue of this present decision until after the proposed amendments were allowed because I did not think that such a further delay was warranted.

SECTION 40

There are two particularised section 40 matters.

Claims 1 to 6, 14 to 22, 27 to 29 and claims dependent thereon which are not limited to the use of biguanides are speculative, too wide and not fairly based. Reference is made to page 3 of the description which refers to biguanides.

The specification does not support the use of any biguanides and the claims which generally refer to any biguanides are too wide and not fairly based.

No submissions were made on behalf of the opponent on these points at the hearing. It seems to me that the specification clearly envisages the use of other compounds besides biguanides as antimicrobial agents. I note page 9 of the specification where various compounds are listed including (but not exclusively) various types of biguanides. I am satisfied that there is a real and reasonably clear disclosure (CCOM Pty Ltd v Jiejing Pty Ltd, 28 IPR 481, (1994) AIPC 91-079) of the use of compounds other than biguanides as antimicrobial agents. I am also satisfied that there is a real and reasonably clear disclosure of biguanides in general, provided of course that the particular biguanide in combination with the disinfectant provides an aqueous solution whose osmotic value does not substantially inhibit the activity of the antimicrobial agent.

Consequently I do not believe that the opponent has established the ground of lack of compliance with section 40 on those issues raised in the particulars.

However, section 40 matters were raised at the hearing. As I indicated above, I will consider these matters as both parties provided argument on them at the hearing.

The opponent raised three main issues:

What does “not substantially inhibit” mean?

What amount of antimicrobial agent is required?

What antimicrobial agent should be used?

What does “not substantially inhibit” mean?

The opponent’s argument is that this term, which has not been specifically defined in the body of the specification, could include any osmolality from extremely low to extremely high. The only disclosure in the specification is to an osmolality of less than 800 mOsm./kg water. Claims using this term are too broad as there is no support for osmolality above 800 mOsm./kg water. An important consequence of this indefinite terminology is that a competitor could not determine whether a competing product did or did not fall within the scope of the claims. Also, the term “not substantially inhibit” cannot be equated with an osmolality of less than 800 mOsm./kg water because dependent claims refer to this level of osmolality.

The applicant’s counter-argument is that none of the opponent’s declarants have had any difficulty in understanding this term. In any case, claim 1 defines the invention by result and the specification tells how to carry out that invention.

I find that there are two aspects of this term that I need to consider. The first is what does “not substantially inhibit” mean as opposed to, for example, only partial inhibition? The second aspect is what effect does this term have on the interpretation of what osmotic value is needed.

With respect to the first aspect, it is not really apparent to me from the claim what substantial inhibition is. Therefore I turn to the body of the specification and I cannot really find any assistance here. On page 12 of the specification, I note that, in relation to the examples, the comment is made that the log order reduction of the various antimicrobial agents tested was significantly reduced at high osmotic values. One could conclude from this that the activity of the antimicrobial agents was significantly inhibited at high osmotic values. However, this does not sit well with the definition on page 9 of a “disinfecting amount” of antimicrobial agent which suggests that the antimicrobial agent needs only to partially reduce the microorganism population. From this, I assume that any reduction is satisfactory. The examples, even at high osmotic values, show partial reduction (except for examples 35 and 36). One interpretation of substantial inhibition may be that therefore there is no reduction at all of any organism. However this would seem to be complete inhibition of the activity of the antimicrobial agent. I also note that, at various passages in the specification, the antimicrobial agent is said to be “less effective” at higher osmotic levels. Again this does not sit well with the “disinfecting amount” definition requiring only partial reduction. Therefore, it seems to me that the specification provides no clear indication of what “substantially inhibit” means.

As a result, I find that the term “not substantially inhibit” in the claims is not clear. Further, I find that the specification does not fully describe the invention because it does not adequately disclose to the person skilled in the art what substantial inhibition is.

Given this, it is difficult to then interpret the osmotic value required.

In this respect, I note that all of the examples use an osmolality of 801 mOsm./kg water or less. However I also note the second paragraph on page 10 of the specification which reads as follows:

“Moreover, it should also be understood that the particular osmotic value rendering any given antimicrobial agent ineffective will vary from agent to agent. The determination of the suitable osmotic range for any particular antimicrobial agent can be easily determined by routine experimentation by one skilled in the art. However, a preferred range of osmotic values has been found to be less than about 800 mOsm./kg water and more preferable about 200 to about 600 mOsm./kg water at antimicrobial agent concentrations of less than about 0.05% (w/v).”

The question I have to decide is whether or not this is sufficient to clarify the wording used in the claim of “not substantially inhibit” in relation to the actual osmotic value required.

The applicant argues that the opponent’s declarants have had no difficulty in construing this passage in the claim. In this respect, paragraph 23 of the first Lowe declaration sets out Mr Lowe’s interpretation of this part of the claim. Mr Lowe indicates that the particular passage is not clear to him but that with reference to the body of the specification he interprets this wording to mean osmotic conditions less than about 800 mOsm./kg water.

This approach in interpreting the claim would seem to be in line with at least one of the rules of construction set out in Decor Corp v Dart Industries, 13 IPR 385, the first five of which I set out below:

The claims define the invention which is the subject of the patent. These must be construed according to their terms upon ordinary principles. Any purely verbal or grammatical question that can be answered according to ordinary rules for the construction of written documents is to be resolved accordingly.

It is not legitimate to confine the scope of the claims by reference to limitations which may be found in the body of the specification but are not expressly or by proper inference reproduced in the claims themselves. To put it another way, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification.

Nevertheless, in approaching the task of construction, one must read the specification as a whole.

In some cases the meaning of the words used in the claims may be qualified or defined by what is said in the body of the specification.

If a claim be clear, it is not to be made obscure because obscurities can be found in particular sentences in other parts of the document. But if an expression is not clear or is ambiguous, it is permissible to resort to the body of the specification to define or clarify the meaning of words used in the claim.

I think rules 2 and 5 are of particular relevance in the present case. It seems to me that Mr Lowe has interpreted the particular passage in the claim by referring to the body of the specification because the meaning of the wording in the claim has provided him with some uncertainty along the lines suggested in rule 5. However, I think Mr Lowe, in doing this, has disregarded rule 2. The body of the specification clearly indicates that 800 mOsm./kg water or lower is only a preferred range of osmotic values. The passage of the specification I have referred to above clearly indicates that other osmotic values are envisaged. Therefore I do not think Mr Lowe is entitled to impose on to the particular passage in the claim the meaning that he has.

It is incumbent on the applicant to provide claims which unambiguously set out the extent of monopoly sought. In the present case, I do not believe that the applicant has done so. I agree with the opponent that a competitor would not know whether a competing product did or did not fall within the scope of claim 1. This is true even if reference is had to the body of the specification where the term “not substantially inhibit” is not clearly explained.

In summary, I find that claims 1 and 15 are not clear due to the wording “not substantially inhibit”. Those claims which are appended to claims 1 and 15 and which do not have specific osmotic ranges are also lacking in clarity. I also find that the specification does not fully describe the invention because there is no clear guidance as to what substantial inhibition is, given the definition of “disinfecting amount” in the description.

What amount of antimicrobial agent is required?

The opponent contends that claims 1 to 16 (except claim 14) do not specify the amount of antimicrobial agent. They require that the antimicrobial agent and the enzyme disinfect the lenses but this is unclear in the light of the definition of the term “disinfecting amount” in the body of the specification. Because the claims use different terminology to this specific definition of disinfecting amount, the scope of the claims is unclear. On the other hand the applicant argues that the amount of antimicrobial agent is limited to that amount which allows simultaneous cleaning and disinfecting to occur. The body of the specification clearly exemplifies a number of different amounts of antimicrobial agent that can be used.

While the applicant argues that the amount is merely that which allows simultaneous cleaning and disinfecting to occur, I believe that the amount of antimicrobial agent included in the solution has an effect on the time taken to clean and disinfect, the amount of disinfection which takes place and the degree to which the osmolality of the solution needs to be considered. To this extent, it is an important consideration in the composition of the claimed solution. However, I do not have the same concerns as the opponent has with the different terminology used in the body of the specification. I believe that I am entitled to assume that the amount of antimicrobial agent is that which will disinfect and a disinfecting amount is that which will at least partially reduce the microorganism population.

What concerns me more about the lack of specific definition of the amount of antimicrobial agent is that claims 1 and 17 embrace a method and composition in which the solution to the problem of reduced antimicrobial agent activity at high osmotic levels could merely be to increase the amount of antimicrobial agent in the solution. (In this respect, I note the comparison between examples 31-36 and examples 13-18.) In other words, the amount of antimicrobial agent can be adjusted rather than the osmotic level of the solution to increase disinfecting activity. I have come to this conclusion because these claims make no specific reference to any adjusting of the osmotic level let alone the use of a tonicity adjusting agent or surfactant which are referred to in the body of the specification to adjust the osmotic level.

The paragraph bridging pages 7 and 8 of the specification refers to such a tonicity adjusting agent for adjusting the osmotic level to enhance the activity of the antimicrobial agent. While this paragraph is worded to indicate that the tonicity adjusting agent is an optional component, I note that all of the examples use such an agent in the form of NaCl. The specification provides no other indication of how the osmolality is to be adjusted. It seems to me that a person skilled in the art would, at the very least, be entitled to assume that the invention includes the step of adjusting or maintaining the level of osmolality to prevent reduction in activity of the disinfecting agent. Certainly there is no suggestion in the specification that the invention merely involves increasing the amount of antimicrobial agent to increase its activity for a particular level of osmolality.

Therefore I do not think that there is a real and reasonably clear disclosure of a method or composition which does not include an adjusted osmotic level. As such, I find that claims 1 and 17 are not fairly based on the matter disclosed in the specification. To the extent that the claims appended to claims 1 and 17 also do not disclose this feature, then they also lack fair basis.

On this matter, I note that, of the other independent claims, claims 14 and 27 specify the amount of antimicrobial agent and the osmolality of the solution at levels which do not suggest that the amount of antimicrobial agent has been increased and claim 15 defines the active step of maintaining the osmolality at a level which does not inhibit the antimicrobial agent activity.

What antimicrobial agent should be used?

According to the opponent, the specification provides no proper basis for the claiming of any antimicrobial agent other than those limited number of antimicrobial agents specified in the examples. The specification does not demonstrate that other antimicrobial agents are inhibited at all in their activity by osmolality. The applicant’s viewpoint is that, according to paragraph 71 of the first Brennan declaration, a person of ordinary skill in the art could, given the examples in the specification, predict that it is necessary to ensure that the osmolality of a solution of proteolytic enzyme with any non-oxidative antimicrobial agent is such that activity of the antimicrobial agent is not inhibited.

In the paragraph bridging pages 8 and 9 of the specification, a definition of antimicrobial agents is given as “non-oxidative organic chemicals which derive their antimicrobial activity through a chemical or physiochemical interaction with the organisms.” This is followed by a list of suitable antimicrobial agents. Some of these are exemplified.

It seems to me that the opponent’s argument is really directed at the utility of the invention. I believe that there is a real and reasonably clear disclosure of a range of antimicrobial agents. The specification discloses the best method of performing the invention by exemplifying some of these agents. I believe that that is all the applicant is required to do in drafting a specification. I find that the specification provides support for the claimed antimicrobial agents.

Other section 40 issues

As a subsidiary point to a section 40 issue that I have dealt with already, the opponent argues that claim 15 and the body of the specification are bad because of the use of the term “maintaining” in the claim. There is no help in the body of the specification as to how or how long the osmotic value should be maintained. Therefore the specification fails to disclose the best method of performing the invention claimed in claim 15. In response, the applicant contends that the specification on pages 7 and 8 discloses a method for maintaining the osmotic value of the system.

The paragraph bridging pages 7 and 8 describes a tonicity adjusting agent which can be used to “adjust the osmotic value of the final cleaning and disinfecting solution to more closely resemble that of human tears and to maintain a suitable level for optimum activity by the antimicrobial agent”. I believe that the best method of performing this aspect of the invention has been provided. With respect to the clarity of the claim, I believe that the person skilled in the art would appreciate that the osmotic value of a system should be maintained until the cleaning and disinfecting had been completed. I do not find any section 40 defects in relation to this matter.

One issue which was not actively pursued at the hearing by the opponent relates to claims 28 and 29 which are omnibus claims. These claims refer to any one of the examples in the body of the specification. Both parties concluded that not all of the examples do in fact achieve the aim of simultaneous cleaning and disinfecting. I note particularly examples 35 and 36 where there is no disinfection at all.

In interpreting these claims, I need to go to the body of the specification. I note that, on page 9 of the specification, a disinfecting amount of antimicrobial agent is described as being that which will at least partially reduce the microorganism population in the formulations employed. Preferably a disinfecting amount is that which will reduce the microbial burden by two log orders in four hours and more preferably by one log order in one hour. In studying the examples, there are some which do not reduce the microbial burden by two log orders in four hours but which do provide partial reduction in microorganisms. From this, I am of the opinion that all but examples 35A and B and 36A and B fall into the scope of claims 28 and 29. Thus I do not consider that claims 28 and 29 offend against section 40.

Another issue that I have noted in considering the opposed claims concerns the composition defined in claim 27. This claim does not define that the composition is for simultaneous cleaning and disinfecting.

It is clear from the description, for example page 3, that the present invention is directed at a method and composition for simultaneous cleaning and disinfecting contact lenses. This is also clear form the applicant’s declarants and Ms Baird’s submissions in relation to the MIMS document. As claim 27 does not specify this aspect of the invention, I find that claim 27 offends against section 40 as it does not define the present invention.

In summary, I have found that claims 1 and 15 are not clear due to the wording “not substantially inhibit”. Those claims which are appended to claims 1 and 15 and which do not have specific osmotic ranges are also lacking in clarity. I have also found that the specification does not fully describe the invention because there is no clear disclosure of what substantial inhibition is. Claims 1 and 17 and relevant dependent claims are not fairly based on the matter disclosed in the specification because they do not specifically disclose the feature of maintaining the osmotic value at a level which reduces inhibition of the antimicrobial agent’s activity. Claim 27 offends against section 40 because it does not define the present invention.

In relation to the proposed new claims, I consider that claims 1 and 13 are not fairly based because they do not specifically disclose the feature of maintaining the osmotic value at a level which reduces inhibition of the antimicrobial agent’s activity. Claim 1 is not clear due to the wording “not substantially inhibit”. Even though claim 13 includes an actual value of the osmotic level, it also is not clear because of the wording “not substantially inhibit”. Similarly to the unamended specification, the specification as proposed to be amended does not fully describe the invention because there is no clear disclosure of what substantial inhibition is.

THE TEST RESULTS

Both parties provided me with a number of test results. I have had some difficulty in interpreting some of these because the evidence does not provide me with complete data particularly in relation to the compositions of a number of the solutions being tested.

The first Barnitz test results

These results, which were included in the first Barnitz declaration, are directed at “the microbial efficacy for log reduction of S.marcescens as a function of osmolality for various enzymes and NaCl, KCl and glycerol as osmolality adjusting agents”. The results are undated. There appears to be no indication of what antimicrobial agent is used. In this respect, Exhibit JTB-1 consists of only one page. There are a number of solutions listed which are identified by numbers. However I do not have before me in evidence any indication of what those numbers represent. Exhibit JTB-2 provides a one page summary of some of the results. However again there is no indication of the nature of the numbered solutions. These test results therefore provide me with no assistance. The only significant information I can gain from these results is that Dr Barnitz, who is employed by the applicant, chose to conduct these tests only against S.marcescens and that osmolality was one of the parameters measured.

The second Barnitz test results

These results, which were included in the second Barnitz declaration, come from a microbiocidal test performed on 6 May 1986. While the test results specify the compositions used by codes without any indication of what those codes represent, Dr Barnitz indicates in her declaration that these solutions include ReNu which is a Bausch & Lomb antimicrobial agent sold as Bausch & Lomb Sensitive Eyes Soaking Solution and an enzyme which is marketed as Bausch & Lomb Sensitive Eyes Effervescent Cleaning Tablets. The tests were carried out on 5 organisms including S.marcescens. Dr Barnitz indicates in her second declaration that neither ReNu nor ReNu with an enzyme was effective against A.fumigatus. However Dr Barnitz draws particular attention to the results associated with S.marcescens. Dr Barnitz concludes from these results that ReNu by itself achieves complete kill against S.marcescens but ReNu with an enzyme tablet is essentially ineffective against S.marcescens. The test results are somewhat indefinite about the other organisms. Some organisms are killed more effectively with ReNu and the enzyme compared with ReNu alone while others show little difference.

These results do not include any measure of the level of osmolality of the solutions.

The first Ambrus test results

These test results are referred to in Ms Ambrus’ first declaration. The dates of carrying out the tests are not given. I assume that the tests were carried out after the priority date of the present claims. There are 4 test organisms studied including S.marcescens. The tests involved the use of ReNu by itself and ReNu plus an enzyme. Other products are also tested. Ms Ambrus draws the conclusion from these test results that there is no difference in the disinfection efficacy of the antimicrobial agent whether alone or in combination with an enzyme. The results are varied. For some product combinations, the antimicrobial agent’s activity remains the same, for others it is increased when an enzyme is included and for others there is some reduction in activity. I note that, for S.marcescens, there appears to be some reduction in activity of the antimicrobial agent when it is combined with an enzyme where both antimicrobial agent and enzyme are Bausch & Lomb products but that this is not the case with other combinations of products where, in some cases, there is an increase in the antimicrobial agent’s activity when it is combined with an enzyme. There is no indication of the level of osmolality of the solutions.

The second Ambrus test results

These results are included in the second Ambrus declaration. They refer to tests which presumably were carried out after the priority date of the present claims and after the first set of tests carried out by Ms Ambrus. The results show that there appears to be no change in the effectiveness of the antimicrobial agent whether or not an enzyme is included in the solution when using Bausch & Lomb products similar to those discussed in the MIMS document. The tests have been carried out only on S.marcescens. These results differ from the results in relation to S.marcescens in the first Ambrus test results in that the log drop is significantly higher in the second set of results. The two results for the combination of antimicrobial agent and enzyme show log drops to be >5 (total kill) and 4.2 whereas the two reading for the antimicrobial agent without enzyme are both >5. Thus there is some slight reduction in activity for one of the readings in relation to the antimicrobial agent and an enzyme compared with the antimicrobial agent by itself. Such inhibition would seem to be insignificant in these results. The level of osmolality for the combination of antimicrobial agent and enzyme is given as approximately 650 mOsm./kg water.

The Brady test results

These results are included in the first Brady declaration. The tests were carried out in October 1987 using ReNu Disinfecting Solution and ReNu Enzymatic Tablets. The tests were performed on 4 organisms but not on S.marcescens. The summary attached to the exhibited results includes the observation that there is no significant difference when the disinfecting solution is combined with the enzyme although there might be a slight decrease in activity against C.albicans. There is no measure of the osmolality of the solutions.

The Bausch & Lomb test results

These results form 6 of the exhibits of the third Ambrus declaration. At the later hearing, Ms Baird did not dispute that these test results originated from Bausch & Lomb. Some of the tables of results are not particularly helpful in that there is no clear indication of what, if any, antimicrobial agent is being used. However, paragraph 4.8 of the third Ambrus declaration asserts that these results compare log reduction of S.marcescens for ReNu Disinfecting Solution and ReNu Disinfecting Solution with ReNu Effervescent Enzyme. At least the summary of results provided in paragraph 4.8 provides such a comparison.

I note that the exhibits include results in relation to two other organisms besides S.marcescens. However Ms Ambrus’ summary contains results only in relation to S.marcescens. This summary does not include the osmolality of each solution. I am unable to confirm the accuracy of Ms Ambrus’ summary as I do not have before me any indication of the nature of the solutions listed in each of the sets of test data in the exhibits. For example Ms Ambrus’ summary has listed one or two solutions from each exhibit but I observe that the corresponding exhibits have generally six or more of the solutions containing an enzyme. On the information before me, I am unable to determine why Ms Ambrus’ summary includes some solutions but not others.

However, what information there is in the summary clearly shows that an antimicrobial agent’s activity is inhibited when an enzyme is included in the solution. Ms Ambrus makes the point however that even with this inhibition the antimicrobial agent is still effective against S.marcescens with an average log reduction of 3.0 when an enzyme is included. I note that the average log reduction achieved by the antimicrobial agent without an enzyme being present is 6.0 according to this table. At the later hearing, Ms Baird did not contest the conclusions Ms Ambrus draws from her summary. Ms Baird submitted that all the tests can only be said to be considering part of the method disclosed in the MIMS document. They only consider steps 1 to 3 and not the subsequent steps.

Dr Stearne pointed out at the later hearing that the present specification refers to a disinfecting amount as one which will at least partially reduce the microorganism population and preferably will reduce the microbial burden by two log orders in four hours. All but two of the solutions referred to in Ms Ambrus’ summary of Bausch & Lomb test data achieve this. I note however that the osmolality of each of these solutions is not included in Ms Ambrus’ summary although such data has been provided in the exhibited test data. Some of the solutions in the exhibited test data include NaCl which the present specification indicates is a tonicity adjusting agent which can be used to adjust the osmolality of a solution. I also note that all of the solutions have an osmolality of less than about 600 mOsm./kg water. Because I am not aware of the nature of the different solutions, I am unable to determine whether or not the osmolality affects the activity of the antimicrobial agent.

Summary

The various declarants debate the accuracy of each other’s results. Points of disagreement include the quantities of the various compositions used, whether the compositions are exactly the same as those referred to in the MIMS document and the inconsistency of the results exhibited. Taking all this into account, it seems to me that, if there is any inhibition of antimicrobial agent activity when combined with an enzyme, it primarily occurs in relation to S.marcescens. I think that this is most clearly demonstrated in the Bausch & Lomb test results. I note that Bausch & Lomb’s declarants, in rebutting the assertions of the opponent’s declarants’ test results, invariably refer to the results associated with S.marcescens to support their argument. I think that the applicant’s invention therefore does not have any significant effect on any other organism.

In relation to osmolality, where it has been a measured parameter in the above test results, it consistently is less than 700 mOsm./kg water. This is well below the 800 mOsm./kg water level of osmolality indicated as being preferred in the present specification. The test results in evidence do not clearly establish to me that, even if the activity of the antimicrobial agent is inhibited by the enzyme, this inhibition can be reduced by decreasing the osmolality of the solution. That is not to say that those test results should do so. A number of the tests referred to above were carried out before the priority date of the present invention and as such were not necessarily directed at establishing the significance of the level of osmolality.

What is the consequence of this finding on the present specification? Certainly the present specification does not clearly indicate that the method and composition are restricted to use with S.marcescens. If the present method and composition are applied to other organisms, would the person skilled in the art be able to carry out the invention?

It seems to me that the person skilled in the art would have no difficulty in carrying out the invention (apart from the lack of clear indication in the specification of what “substantial inhibition” is). What the person skilled in the art would probably find however is that the method and composition do not particularly improve the efficacy of an antimicrobial agent against other microorganisms. That is I believe that the specification is sufficient.

NOVELTY

Although there are a number of documents particularised, the opponent’s case under this ground relies not on these documents but on the extract from the 1988 MIMS Annual (MIMS) which was not particularised but which I advised the applicant that I would inform myself of in determining this opposition. The date of publication of this document was established by the opponent to be July 1988. This date was not contested by the applicant.

MIMS discloses a number of Bausch & Lomb contact lens care products including cleaning tablets and disinfecting solutions.

It is common ground that MIMS does not refer to the osmolality of any of the solutions.

Both parties referred me to the reverse infringement test for novelty as indicated in the Federal Court decisions Werner & Co. v Bailey Aluminium 13 IPR 513 and Nicaro Holdings v Martin Engineering 16 IPR 545. In these decisions, the test for novelty is indeed indicated as being the reverse infringement test as set out by Aickin J in Meyers Taylor v Vicarr Industries (1977) CLR 228 as follows:

"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."

In Rodi Wienenberger AG v Henry Showell [1969] RPC 367 at page 391, infringement of a claim is said to occur when "each and every one of the essential integers" of that claim have been taken.

To establish lack of novelty, Allergan has to convince me that each of the essential integers of the claimed method and composition are included in the MIMS document.

The method claims

In relation to the method claims, the opponent’s argument centres around the proposition that, although MIMS discloses a method with a separate disinfecting step, it also discloses an intermediate step in which both an antimicrobial agent and a proteolytic enzyme are combined in a solution for caring for the contact lenses. The applicant’s counter argument suggests that if disinfecting occurs at the intermediate step there would be no need to have the separate disinfecting step at all. There are no clear and unmistakable directions of a simultaneous cleaning and disinfecting method.

In resolving this, I turn to the case law to which Mr Caine referred me. In particular, I note the words of Brett L J in Otto v Linford (1882) 46 L T 35 (CA) at page 44, col. 2:

“... they cannot succeed unless they show that the working of the machine is described substantially in Johnson’s specification and described so clearly that a person conversant with such things upon reading Johnson’s specification carefully would say ‘that is a description of the plaintiff’s invention’. That seems to me to be the effect of the judgement in Hill v Evans.”

In the present case, I do not think that a person reading MIMS would be able to say that it was a description of the claimed method.

I note also the words of Parker J in Flour Oxidizing Company Ltd v Carr & Co Ltd (1908) 25 RPC 428 at page 457:

"But where the question is solely a question of prior publication, it is not, in my opinion, enough to prove that an apparatus described in an earlier Specification could have been used to produce this or that result. It must also be shown that the Specification contains clear and unmistakable directions so to use it."

In the present case there are no clear and unmistakable directions in MIMS to simultaneously clean and disinfect and also to adjust the osmolality to avoid inhibition of the activity of the antimicrobial agent.

In the present case, simultaneous cleaning and disinfecting and also adjusting the osmolality to avoid inhibition of the activity of the antimicrobial agent are clearly essential integers of the claimed method. However there is no clear teaching in MIMS of either of these essential integers. I must therefore come to the conclusion that the claimed method is novel in the light of MIMS.

Mr Caine also argued that, although the method in MIMS had an extra step (the final disinfecting step), this was just a “superadded” feature. If each of the essential features of the claim have been taken there is infringement. In the present circumstances I do not think that this argument is relevant because MIMS does not specifically disclose a method for simultaneous cleaning and disinfecting. Whether or not there are further steps in the MIMS method is irrelevant to the fact that MIMS does not have clear and unmistakable directions on how to provide such a method.

However, at the later hearing, Dr Stearne and Mr Siely both pressed the point that someone who followed the directions in the MIMS document (which they suggested merely repeated instructions on the relevant products commercially available at the time) would inevitably be infringing the presently claimed method.

I was referred to General Tyre & Rubber Company v Firestone Tyre and Rubber Company Ltd [1972] RPC 457. Dr Stearne referred me to the following paragraph in that case, at 485-486:

"If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.”

Ms Baird argued the relevance of General Tyre v Firestone (supra) to the present facts by referring me to the paragraph succeeding the above quoted one viz.:

“If, on the other hand, 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 a way which would not do so, the patentee's claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented: ... A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”

Ms Baird contended that, in the present case, the MIMS document provides two alternative steps. A person carrying out such a method can either use a saline solution with the cleaning solution or a solution containing an antimicrobial agent. Ms Baird concluded that a person would at least as likely use the saline solution and thus the MIMS document contains no “clear and unmistakable directions”. The opponent argued that the above paragraph needed to be read in relation to the facts of the General Tyre V Firestone case. The MIMS document has two options but each is a separate direction. I agree. There seems to me no reason to believe that a person skilled in the art would interpret the MIMS document as disclosing two separate methods. I do not believe that the person skilled in the art would believe that there is only one method with two different optional steps. Therefore I would not dismiss the MIMS document as a relevant disclosure for anticipation purposes on this reason.

Dr Stearne and Mr Siely both argued that, although the method disclosed in the MIMS document is couched in different terms to the claimed method, a person carrying out the instructions in the MIMS document will inevitably end up with a method which would constitute an infringement of the present claims. I do not agree. I do not think that the MIMS document and the present claims which define a simultaneous cleaning and disinfecting method “approach the same device” or method. The MIMS document does not set out to achieve a method for simultaneous cleaning and disinfecting. A person carrying out the process disclosed in The MIMS document would therefore not inevitably end up with a simultaneous cleaning and disinfecting method. The person would inevitably carry out a further disinfecting step.

I find that those claims defining a method of simultaneous cleaning and disinfecting do not lack novelty in the light of the MIMS document.

The composition claims

Dr Stearne and Mr Siely argued that a person carrying out the instructions in the MIMS document will inevitably end up with a composition which would constitute an infringement of the present claims. This is so even if the person subsequently carried out the extra disinfecting step.

I have considered the test results supporting the opponent’s argument earlier. They suggest that the carrying out of the instructions in the MIMS document would result in a solution in which the osmolality was below 800 mOsm./kg water and the activity of the antimicrobial agent was not inhibited on certain microorganisms. While the applicant has challenged these results, I think that the Bausch & Lomb results to which I have referred earlier confirm this.

Although claim 17 defines a composition for simultaneously cleaning and disinfecting contact lenses and the MIMS document does not disclose simultaneous cleaning and disinfecting, nevertheless the chemical characteristics of the composition itself would be the same as those of the composition that resulted from steps 1 to 3 of the process disclosed in the MIMS document. Therefore, I am of the opinion that a person carrying out the instructions in the MIMS document would inevitably produce a composition which has all of the essential integers of claim 17.

In relation to claim 27, there is clear indication from the Ambrus test results of a pH level which falls within the claimed range (the second Ambrus declaration, paragraph 7). In any case, it is clear from the present specification that the pH of the composition has nothing really to do with the inventive concept. Therefore I believe that claim 27 also would have all of its essential integers included in a composition produced according to the MIMS document.

In relation to claims 18 to 26, I cannot find any feature which is not indicated in the MIMS document. Therefore I find that claims 18 to 26 also lack novelty.

With respect to the omnibus claim 29, the examples referred to do not use a dymed. They, instead, use other biguanide antimicrobial agents. Therefore, claim 29 does not have all of its essential integers disclosed in the MIMS document. I find that claim 29 does not lack novelty in the light of the MIMS document.

I find that claims 17 to 27 lack novelty in the light of the MIMS document.

The proposed amended claims 13 to 22 similarly would lack novelty.

OBVIOUSNESS

As section 59 of the Patents Act 1952 applies to the grounds of this opposition, the question I have to ask, in relation to obviousness, is whether the invention claimed would have been obvious to a non-inventive worker in the art who is equipped with the common general knowledge in the art in Australia at the priority date. Both parties referred me to Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd 144 CLR 253 and The Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd 148 CLR 262.

Before tackling the question of obviousness, there are two issues I have to decide viz. what was the common general knowledge in the art at the priority date of the presently claimed invention and who is the non-inventive worker in the art.

Common general knowledge

In determining the extent of the common general knowledge in this matter, I am guided by the judgement of Aickin J. in Minnesota Mining and Manufacturing Company v. Beiersdorf (Australia) Limited (supra), in which he stated:

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

The nature of common general knowledge is discussed in General Tire & Rubber Company v Firestone Tyre & Rubber Company Limited (1972) RPC 457 at 482 as follows:

"The common general knowledge imputed to such an addressee must, of course, be carefully distinguished from what in patent law is regarded as public knowledge. This distinction is well explained in Halsbury's Laws of England, Vol. 29, para. 63. As regards patent specifications it is the somewhat artificial (see per Lord Reid in the Technograph case (1971) FSR 188 at 193) concept of patent law that each and every specification, of the last 50 years, however unlikely to be looked at and in whatever language written, is part of the relevant public knowledge if it is resting anywhere in the shelves of the patent Office. On the other hand, common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee - the sort of man, good at his job, that could be found in real life."

From both of these references I deduce that common general knowledge is the background knowledge possessed by all in the trade not just the hypothetical non-inventive person. I note that the quotation from the General Tire case (supra) mentions "the sort of man, good at his job, that could be found in real life". From this I deduce that people in the art who could be said to be inventive also would possess the common general knowledge of the art. While they may possess further knowledge which is not part of the common general knowledge, this does not necessarily follow from the mere fact that they are inventive. The ability to be inventive does not necessarily come from an ability to retain vast amounts of knowledge.

Ms Baird referred me to Hood Computers Pty. Limited v Online Furniture and Weldun Engineering, 28 IPR 347 and Leader Products Pty Ltd v Allflex International Ltd (1987) AIPC 90-420 in order to persuade me that I should discount the evidence of some of the opponents' declarants because they might be classed as inventive. However, the delegates in these cases were considering the question of obviousness where it is clear from case law that this should be considered in relation to the non-inventive person skilled in the art. That is different to the present question of deciding what is the common general knowledge in the art i.e. knowledge that is common to all those skilled in the particular art.

Therefore, I am of the opinion that I should not automatically dismiss what any of the declarants allege to be part of the common general knowledge in the art merely because those declarants may be said to be inventive. In this respect, I note the delegate's comments in Braas & Co GMBH v Humes Limited, 26 IPR 273, where he comes to the view that evidence provided by "overqualified" experts may still be of high probative value in relation to the state of the common general knowledge in the art. I believe that this is equally true of experts who are said to be inventive.

However, the common general knowledge must be that knowledge which is common in the art in Australia. Ms Baird argued that the Huth declarations should be discounted entirely because there is no evidence that Mr Huth, who resides in the USA, has ever been in Australia. In this respect, Ms Baird referred me to Sumitomo Chemical Co Ltd v Rhone-Poulenc Chimie 30 IPR 591 where, at 601, the delegate disregarded the evidence of a declarant from France because there was no evidence that the declarant had ever worked in Australia.

Mr Caine submitted that Mr Huth could quite properly provide evidence on the state of the art in Australia because of his continuous and extensive dealings with Australian colleagues. In any case, the state of art in both the USA and Australia is about the same although Australian experts generally gain knowledge of recent developments by attending conferences with US colleagues.

In this respect I note paragraph 6 of the first Huth declaration where Mr Huth deals with his association with Professor Holden of the University of NSW. Mr Huth indicates that Professor Holden travelled to Allergan in the USA about once a year to discuss with Mr Huth and his colleagues their joint collaborations in contact lens care investigations. From this, Mr Huth alleges that he was very much aware of the state of the contact lens care field in Australia from the late 1970’s. In paragraph 9 of his first declaration , Mr Huth makes a similar point to Mr Caine that people in the field in Australia learnt quickly of recent developments in the USA, which might have been slightly more advanced, by conferences, scientific papers etc.

I would be more convinced by the arguments of Mr Caine and Mr Huth if there were some supporting evidence from persons skilled in the art in Australia but there is none. It seems to me that, unless people in the field in Australia suggested that it was routine to liaise with US colleagues and indeed fly to the USA yearly to discuss issues in the contact lens care field, then I cannot give much weight to this argument. The most appropriate of the opponent’s declarants, Mr Lowe, makes no mention of this. As Ms Baird pointed out to me, the opponent has provided no corroborating evidence form Professor Holden about this practice. I also note that Mr Huth dealt mainly with Professor Holden who was heading a research team. It is most likely that Mr Huth would receive information on the latest developments in the research carried out by Professor Holden’s team which may or may not equate in any way with the state of the common general knowledge across the art in Australia. As a consequence, I give no weight at all to the evidence of Mr Huth in relation to the extent of the common general knowledge in Australia.

In relation to the opponent’s other main declarants in this matter, Ms Baird argued that Mr Griffith is not a skilled worker in the field of contact lens care. He is a scientist with special interests in the structure of viruses and has a patent application dealing with fleece conditioners. Ms Baird pointed out that the only reference to contact lens care in the Griffith declaration occurs at paragraph 7 where Mr Griffith states that he has taught students on the microbiology of pharmaceutical compositions and solutions, including solutions for disinfecting contact lenses. I note that Mr Caine, in his written submissions, has indicated that the relevant skilled addressee in relation to the question of obviousness is a person who worked in the field of development and/or formulation of contact lens care products and/or persons engaged as clinical research oriented optometrists. I note that Mr Griffith who declares himself to be a senior lecturer in pharmaceutical microbiology does not fit into this category. Therefore, I find that I must disregard the evidence of Mr Griffith in relation to the extent of the common general knowledge in the art at the priority date of the present invention.

I am satisfied that Mr Lowe is an appropriate person to provide evidence in relation to the common general knowledge in the art in Australia.

In relation to the applicant’s declarants, I am satisfied that Professor Brennan is qualified to comment on the state of common general knowledge in the art in Australia.

In paragraph 32 of the first Lowe declaration, Mr Lowe summarises what he asserts to be the common general knowledge in the art at the priority date of the claims as follows:

“..it was well known in the art in Australia at that time to:
i)Clean and disinfect contact lenses to remove protein and other deposits and microbial contamination associated with normal lens wear.

ii)Remove protein deposits from contact lenses using a protease containing solution, generally on a weekly basis.
iii)Disinfect contact lenses daily, and after weekly protein removal. Disinfection was generally carried out using peroxide containing solutions or antibacterial solutions (such as solutions of the biguanide chlorhexidine, quaternary ammonium solutions etc.).
iv)Clean contact lenses of protein soils and disinfect simultaneously using peroxide/enzyme or heat/enzyme combinations.
v)Use contact lens care solutions designed for a “one step” approach (that is, where a treated lens is inserted directly into the eye following immersion in a contact lens care solution without neutralisation) at an osmolality which was about the same as that of the eye in order to avoid adverse reactions. The osmolality of tears is about 310 mOsm./kg water (about 0.9% sodium chloride) and hence such products were formulated around this osmolality.”

In response to this summary of the state of common general knowledge in the art at the priority date of the claims in suit, Professor Brennan does not specifically debate the issue of whether or not the summary reflects the common general knowledge in the art. Instead, in paragraph 56 of the first Brennan declaration, he argues:

“None of the items of knowledge referred to in sub-paragraphs (i) to (v) of paragraph 32 of the Lowe declaration (a) discloses the combination of a proteolytic enzyme with a non-oxidative antimicrobial agent, or (b) given the difference in the mode of action of oxidative and non-oxidative antimicrobial agents, suggests that such a combination could be preferred, or (c) discloses or suggests that it is necessary to formulate such a combination at an osmolality such that the antimicrobial activity of the antimicrobial agent is not substantially inhibited.”

In the second Lowe declaration, in paragraphs 6 and 7, Mr Lowe argues:

“In my opinion, at the priority date of application 628926, if a person skilled in the art of contact lens care was confronted with a reduction in bacterial killing of a solution containing a proteolytic enzyme and a non-oxidative antimicrobial agent used to simultaneously clean and disinfect contact lenses, this would have been considered to be due to:
i)an osmolality effect;
ii)pH;

iii) an inhibitory interaction between the enzyme and the non-oxidative antibacterial agent; or
iv)faulty reagents.

Osmolality would have been the very obvious candidate to adjust in any such solution (that is, decrease) given that it was well known in the field in Australia at the priority date of application number 628926 that certain antimicrobial agents, particularly biguanides and quaternary ammonium compounds, were inhibited by high salt concentrations (which is synonymous with high osmolality - see the Huth declaration made 30 August 1994 at paragraphs 11 through 16)......”

Professor Brennan in his second declaration argues that a person skilled in the art would have many more factors to consider than just the four listed above in the Lowe declaration and that the person skilled in the art would not have chosen osmolality as the first thing to look at without the benefit of knowing the present solution.

I would note here that the assertion that certain antimicrobial agents were inhibited by high salt concentrations (osmolality) is being raised as part of the common general knowledge by Mr Lowe for the first time in his second declaration. Although Mr Lowe’s first declaration refers to the proposal that antibacterial activity of biguanides is inhibited by anionic compounds, this first declaration does not include this piece of information in a list of the relevant pieces of common general knowledge to which I have referred above. I note, also, that Mr Lowe refers to the first Huth declaration in support of this point. It seems to me that it is not until Mr Lowe has read the Huth declaration, which I have disregarded as providing any evidence of the state of common general knowledge in the art in Australia, that he argues that this particular piece of information was part of the common general knowledge.

However, in the third Lowe declaration, Mr Lowe refers to certain publications to support the contention that this question of osmolality was well known in the art. He refers to page 242 of the 4th edition of Pharmaceutical Microbiology, a copy of which page is an exhibit to his first declaration. The fourth edition of this publication is indicated as being printed in 1987. The particular passage to which Mr Lowe refers discusses the antibacterial nature of chlorhexidine. The text indicates that chlorhexidine has its greatest antibacterial activity at pH 7-8 where it exists exclusively as a di-cation. This activity is reduced by anionic compounds. I note that the text refers to the linings of corks in screwtop bottle closures being a problem for chlorhexidine’s antibacterial activity. Mr Lowe, in his first declaration, refers to this publication as a standard text, and, in his third declaration, refers to this publication as an undergraduate text.

Mr Lowe also refers to an article from Supplement No. 53 of The Australian Journal of Pharmacy, Vol. 48, No 570, June 30, 1967. A copy of this article forms part of an exhibit to the second Huth declaration. The particular article deals with the problem of sterilising opthalmic solutions. The relevant passage is a paragraph appearing on the fifth page of the five and a half page article. This paragraph discusses the fact that antibacterial activity increases as a solution of benzalkonium chloride and EDTA goes from hypertonic to isotonic to hypotonic. Mr Lowe argues that this particular journal is a widely read Australian journal.

Professor Brennan disagrees that these two publications were widely known among people skilled in formulating lens care solutions.

I must say that I find it difficult to imagine that a particular piece of information on the fifth page of a five and a half page article of a supplement to a 1967 journal could of itself establish what is the background knowledge that a person skilled in this particular art would have.

The only evidence I have to suggest that the publication Pharmaceutical Microbiology is an undergraduate text is the reference to this by Mr Lowe in his third declaration. However, I note that Professor Brennan in his first declaration, at paragraph 64, discusses the “known effect of anions on the activity of antimicrobial agents”. Does this mean that Professor Brennan is conceding that the effect of anions on the activity of antimicrobial agents was part of the common general knowledge? I do not think so. This would be contrary to his comments in relation to the degree to which the two publications were known in the relevant art. It seems to me that this statement is merely acknowledging that this piece of information was publicly known.

Given the somewhat obscure reference in the Supplement No. 53 of The Australian Journal of Pharmacy, Vol. 48, No 570, June 30, 1967, the lack of any supporting evidence on the degree to which the text Pharmaceutical Microbiology could be considered to be standard in the relevant art and the fact that Mr Lowe does not refer to this alleged piece of common general knowledge until his second declaration, on balance, I am not convinced that Allergan has established that the effect of anions on the activity of antimicrobial agents was part of the general body of knowledge used by all in the trade. I therefore do not think that it has been established that this piece of information was part of the common general knowledge in Australia before the priority date of the present claims.

Taking all this into account, I believe that the relevant facets of common general knowledge in existence at the priority date of the opposed claims were:

i)Contact lenses were cleaned and disinfected to remove protein and other deposits and microbial contamination associated with normal lens wear.

ii)Protein deposits were removed from contact lenses using a protease containing solution, generally on a weekly basis.
iii)Contact lenses were disinfected daily, and after weekly protein removal. Disinfection was generally carried out using peroxide containing solutions or antibacterial solutions (such as solutions of the biguanide chlorhexidine, quaternary ammonium solutions etc.).
iv)Contact lenses were cleaned of protein soils and disinfected simultaneously using peroxide/enzyme or heat/enzyme combinations.
v)Contact lens care solutions were used which were designed for a “one step” approach (that is, where a treated lens is inserted directly into the eye following immersion in a contact lens care solution without neutralisation) at an osmolality which was about the same as that of the eye in order to avoid adverse reactions. The osmolality of tears is about 310 mOsm./kg water (about 0.9% sodium chloride) and hence such products were formulated around this osmolality.

Person skilled in the art

When determining the question of obviousness, as opposed to the question of common general knowledge, I should consider the question from the viewpoint of a non-inventive person skilled in the art in Australia. There are numerous authorities on this. Ms Baird referred me to two office decisions to which I have referred above. The difficult part of this consideration is that the person skilled in the art is a hypothetical person. This does not mean that I should dismiss the evidence of the opponent’s declarants just because they are real people. Indeed, it seems to me that, in the absence of evidence to the contrary, Mr Lowe comes very close to qualifying as such a non-inventive person skilled in the art. Mr Lowe indicates that he has had extensive research experience which seems to me to be a characteristic of the non-inventive person skilled in the present art. Therefore I believe that I should give some weight to the evidence provided by Mr Lowe with the proviso that I should stick to the common general knowledge that I have identified above.

For the reasons I have given above in relation to common general knowledge, I believe that I should place much less weight on the evidence provided by Mr Huth and Mr Griffith. This is reinforced by the fact that both of these declarants can be considered to be inventive.

In relation to Professor Brennan, there is a possibility that he may be over-qualified to be considered to be a non-inventive person skilled in the art given the extensive array of publications he has authored. However, there is no clear evidence that he is inventive. Therefore in relation to the question of obviousness, I believe that I should give equal weight to both Professor Brennan’s and Mr Lowe’s evidence.

What is the problem to be solved?

Having identified what I believe to be the common general knowledge in the art at the relevant date and the person skilled in the relevant art, I now have to determine what that person would do when equipped with this body of knowledge. It seems to me that there needs to be some motivation for the person skilled in the art to pursue a particular course of action. The courts have used a number of approaches to assign the person skilled in the art some reason for taking a particular path. For example, it is common in decisions relating to the question of obviousness to consider what the person skilled in the art would do when faced with the same problem which led to the solution claimed in the claims in suit. In Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd, (supra) at page 286, Aickin J said:

"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."

This seems to be a reasonable test to apply in the present situation. A person skilled in the art when faced with a particular problem would presumably want to solve it. In relation to the question of obviousness in relation to the Patents Act 1952, that person is non-inventive and that person can only rely on the common general knowledge in the particular art to solve the problem.

In his written submissions, Mr Caine suggests that the problem which the presently claimed invention solves is that the activity of non-oxidative antimicrobial agents is inhibited when these agents are combined in solution with proteolytic enzymes for simultaneous cleaning and disinfecting of contact lenses.

However, Mr Caine then suggests that this problem was not in fact a problem at all at the priority date of the present claims. He bases his argument on the evidence provided in the Ambrus declaration and concludes that there is no inhibition of the activity of antimicrobial agents when prior art enzyme cleaning tablets are combined with prior art commercial disinfecting solutions. It seems to me that this proposition is made with the benefit of hindsight although I can understand that the test results show that there may not be such a problem if the combination of prior art products was tested against some of the organisms. However, there is no evidence before me to suggest that tests similar to those conducted by Ms Ambrus were carried out before the priority date of the present claims in relation to the simultaneous cleaning and disinfecting of contact lenses or that such results were known to people skilled in the art. Although Ms Brady, Ms Ambrus and Ms Barnitz refer to tests carried out before the priority date of the present claims, there is no indication that any of these tests was conducted to establish whether the simultaneous cleaning and disinfecting of contact lenses was possible nor to research the relationship of the solution’s osmolality on the activity of the antimicrobial agent. It seems to me that it is easy to say that there is not a problem when the answer is known. The question I have to resolve is whether or not a person skilled in the art when faced with the problem would have bothered to test the level of osmolality at all.

In the second Brennan declaration at paragraph 35, Professor Brennan indicates what he believes the problem solved by the presently claimed invention to be viz. in a combined solution of enzyme and antimicrobial agent, the antimicrobial agent is rendered less effective for killing certain microorganisms. This is a little broader in nature than the problem suggested by Mr Caine but not markedly different. I propose to adopt the problem put forward by Mr Caine because it reflects the wording on page 3 of the present specification.

The problem to be solved is that the activity of non-oxidative antimicrobial agents is inhibited when these agents are combined in solution with proteolytic enzymes for simultaneous cleaning and disinfecting of contact lenses.

Is it obvious?

I now have to decide what the non-inventive person skilled in the art, faced with the above problem and armed only with the common general knowledge in the relevant art at the priority date of the present claims, would have done to solve the problem.

It seems to me that the person skilled in the art would initially test the combination of a non-oxidative antimicrobial agent with an enzyme to see what effect the combination had on the cleaning and disinfecting of the lenses. I think that it is highly probable that the person skilled in the art would test the effectiveness of the antimicrobial agent against a number of organisms. In doing this, I think person skilled in the art would come up with similar results to the test results provided by both parties in this opposition. It seems to me therefore that person skilled in the art would most likely find that there is no particular inhibition on the activity of antimicrobial agents in relation to most organisms when commercial products are combined in the recommended amounts. In coming to this conclusion I believe that the person skilled in the art would believe that the problem has been solved (or that there was no problem in the first place). I do not think that there is sufficient evidence before me to suggest that the person skilled in the art would have considered the osmolality of the solution when there is no inhibition of the activity of the antimicrobial agent. However, it is part of the common general knowledge of the art that the osmolality of the final solutions applied to contact lenses needs to be such as to allow the lenses to be incorporated into the eye. I believe that the person skilled in the art would therefore ensure that the solution had an osmolality level of about 310 mOsm./kg water (the osmolality of tears). It seems to me therefore that a person skilled in the art when faced with the above problem would carry out steps which would inevitably fall within the scope of the claims but for different reasons. I say this because, in considering the test results before me, there is little or no inhibition of any antimicrobial agent at osmolality levels of about 300 mOsm./kg water.

In my view, if the person skilled in the art, in trying to solve the particular problem, inevitably arrives at a solution which falls within the scope of the claimed invention even though the person skilled in the art arrives at that solution for different reasons to those of the inventor, the claimed invention is obvious. Any patent protection for the inventor’s solution would prevent the person skilled in the art from doing something which he or she would have inevitably done when faced with the problem before the priority date of the claims. In this respect, I note the words of the delegate in the unreported Patent Office decision on patent application 590428 by AB Tetra Pak and an opposition by J. Gadsden Pty Ltd, dated 6 September 1995:

“Having found that it would have been obvious to arrive at the claimed product by one route, I do not then agree with the submission made on behalf of the patent applicant that the product claimed can be considered to be not obvious for the reason that Tetra Pak had "invented" the claimed combination by solving a different problem to which the solution was not obvious. I find support for this view within the judgement in Hallen v Brabantia (supra), wherein Aldous J. said at 328:
`In my view a patent cannot be valid if it was obvious to select the features of the claim for one purpose, despite the fact that it was not obvious for another.’

[I note that this view was upheld in the Court of Appeal, Hallen Co. and Anr. v. Brabantia (U.K.) Ltd., [1991] RPC 195 at 216].”

This seems to me to be appropriate to the present circumstances. Therefore I find that the independent claims are obvious. In considering the appendant claims, I see nothing in them which does not appear to be generally known as indicated in either the present specification or the above summary of the common general knowledge in the art. As a consequence I find that all of the dependent claims are also obvious.

In relation to the omnibus claims, I believe that at least some of the examples would inevitably have been produced by a person skilled in the art in attempting to solve the above problem. For example, the use of chlorhexidine as an antimicrobial agent and the use of NaCl as a tonicity adjusting agent are part of the common general knowledge referred to earlier. Therefore, I believe that claims 28 and 29 are also obvious in that some of the examples would have inevitably been produced by the person skilled in the art. I note however that there are some examples where the osmolality is clearly less than or clearly greater than that required to achieve a level of osmolality close to that of tears. I do not believe that I could argue, on the evidence before me, that the person skilled in the art would inevitably produce a solution in which the osmolality was about 200 m0sm./kg water or less or about 400 m0sm./kg water or more. Therefore, I find that claims 28 and 29 to the extent that they include examples in which the osmolality of the solution is about 300 m0sm./kg water are also obvious.

At the first hearing, Ms Baird argued that there had been a race by the major players in the field to produce a one-step cleaning and disinfecting method and that Bausch & Lomb were the first to arrive at the finish of this race. Ms Baird argued that this clearly suggested that the present method and composition were not obvious. I do not have sufficient evidence before me to persuade me to agree with such an argument. A subsequent patent application by Alcon referred to by Ms Baird does not convince me that such a race necessarily existed. I am more convinced by the results of the tests carried out by both the opponent and the applicant in relation to the lack of inhibition of commercial antimicrobial agents in combination with proteolytic enzymes.

However, if the person skilled in the art did find that the activity of the antimicrobial agent was inhibited, it seems to me that a first step would be to increase the amount of antimicrobial agent used. While this has not been listed as part of the common general knowledge above, it seems to me to be so fundamental to any method of disinfecting that it does not need to be specifically referred to. This in effect results in a method which falls within the scope of claim 1 (see my findings in relation to section 40 matters earlier). Therefore, I find that the method of claim 1 is obvious. In relation to claim 17, I believe that the person skilled in the art would not want to increase the amount of antimicrobial agent to such an extent that it would increase osmotic value of the solution too far above the osmolality of tears i.e. about 310 mOsm./kg water. Therefore I believe that the composition of claim 17 is also obvious.

I find that all of the claims are obvious because the person skilled in the art in attempting to solve the relevant problem would arrive at a method and composition which falls within the scope of the present claims.

In relation to the proposed amended claims, I believe that they also would be obvious.

CONCLUSION

I have found that the opponent has been successful in relation to the grounds of non-compliance with section 40, lack of novelty and obviousness. I have also concluded that the proposed amendments, if allowed, would not remove these grounds of opposition.

As further amendments may remedy the above defects, I allow the applicant 60 days from the date of this decision to propose amendments to my satisfaction to overcome the above defects.

COSTS

The opponent has been successful in three of its grounds of opposition One of these grounds is lack of compliance with section 40. Some section 40 issues arose as a result of my interpretation of the specification rather than the opponent’s arguments. Any other successful section 40 issues were not particularised by the opponent. Therefore I do not think that success in the ground of lack of compliance with section 40 should persuade me to award costs to the opponent. In relation to the ground of obviousness, I have found that the claims are obvious. This is a major ground of opposition in which the opponent has been successful. On the other side of the coin, I note that part of the first hearing was not only taken up with submissions on the unparticularised section 40 matters but also submissions on the MIMS document which was also unparticularised. On the balance, given the significance of the successful ground of obviousness, I award costs in relation to the first hearing on 16 and 17 November 1995 against the applicant, Bausch & Lomb Incorporated.

In relation to the ground of lack of novelty, the MIMS document on which I have found some of the claims lack novelty was unparticularised. All evidence served between the first hearing and the second hearing was directed at the unparticularised MIMS document as was the second hearing itself. I award any costs incurred from after the first hearing on 16 and 17 November 1995 up until and including the second hearing against the opponent, Allergan, Inc.

R.W. HALLETT
Delegate of the Commissioner of Patents

Patent attorneys for the applicant : Spruson & Ferguson, Sydney
Patent attorneys for the opponent : Davies Collison Cave, Sydney

[1997] APO 42

17 September 1997