Alcon Laboratories Inc v Bausch & Lomb Incorporated

[2000] APO 11

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application  :          No. 646455 in the name of Alcon Laboratories, Inc.

Title:          Contact lens cleaning and disinfecting with combinations of polymeric quaternary ammonium compounds and enzymes.

Action: Opposition under section 59 of the Patents Act 1990 by Bausch & Lomb Incorporated

Decision:          Issued            .

Abstract

All claims were found to be entitled to claim priority from the basic document US 521218 with a priority date of 9 May 1990.  As a result, the document AU 49989/90 could only be used for considerations of novelty, not inventive step.

Due to the selection of specific complexing agents as components of the contact lens cleaning/disinfecting solutions of the invention, all claims were found to be novel and inventive.  However, the two part compositions of claims 1 to 16 were considered to define a kit of separate known components which are not for a manner of manufacture according to section 18(1)(a).

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 646455 by Alcon Laboratories, Inc. and opposition under section 59 of the Patents Act 1990 by Bausch & Lomb Incorporated.

BACKGROUND

Patent application 646455 in the name of Alcon Laboratories, Inc. (hereafter referred to as Alcon) was filed as a convention application on 8 May 1991 claiming priority from US 521218, which was filed on 9 May 1990 and US 689195, which was filed on 25 April 1991. The application was subsequently advertised as accepted on 24 February 1994.  Bausch & Lomb Incorporated (hereafter referred to as Bausch & Lomb) filed a notice of opposition on 24 May 1994 and served their statement of grounds and particulars on 24 August 1994.  Service of the evidence in support was completed on 24 January 1995.

Alcon requested leave to amend the specification on 14 June 1995 with further proposed amendments dated 11 December 1995. Subsequently, leave to amend the specification was granted but the section 104 amendments were opposed by Bausch & Lomb and the section 59 opposition proceedings deferred.

On 26 May 1997, Alcon advised of the withdrawal of the first request to amend and, at the same time, filed a new section 104 request to amend the specification. Further amendments were filed on 22 January 1998 and 26 May 1998 in response to examiner's objections. The Commissioner advised the parties of the allowance of the second request to amend on 12 January 1999 and this was advertised on 18 February 1999. Following the allowance of these amendments, the clock was restarted on the section 59 opposition and evidence in answer was completed on 12 March 1999. The opponent advised that they would not be serving evidence in reply.

The matter was heard in Canberra on Wednesday 10 November 1999.  Alcon was represented by Mr Ross McCaw SC of Counsel assisted by Mr Mark O'Donnell of F B Rice & Co and Bausch & Lomb by Mr David Yates SC of Counsel assisted by Dr Colin Bodkin of Spruson & Ferguson.

THE GROUNDS OF OPPOSITION

The grounds of opposition pursued at the hearing were as follows:

• Novelty

• Inventive step

• Manner of manufacture

THE EVIDENCE

The evidence in support comprises:

• Statutory Declaration of Noel A. Brennan, optometrist, made 23 January 1995 together with exhibits NAB-1 to NAB-37

• Statutory Declaration of John Francis McCann, patent attorney of Spruson & Ferguson, made 24 January 1995 together with exhibits JFM-1 to JFM-4

• Statutory Declaration of Catherine Sexton,librarian, made 21 December 1994

• Statutory Declaration of Robert James Thomas, librarian, made 21 December 1994

• Statutory Declaration of Lorraine Lipson, librarian, made 21 December 1994

• Statutory Declaration of Peter Cohen, librarian, made 21 December 1994

The evidence in answer comprises:

• Statutory Declaration of Barry Van Duzee, one of the inventors, made 8 February 1999 together with exhibits BVD.1 to BVD.6

• Statutory Declaration of Mark Graham Lazarus, eye specialist, made 10 March 1999 together with exhibits MGL-1 to MGL-9

THE SPECIFICATION

The specification discloses that the invention relates to improved methods and compositions for the simultaneous cleaning and disinfecting of human-worn contact lenses.  Deposits of proteins, lipids and mucopolysaccharides form on the surface of contact lenses and so lenses need both cleaning to remove these deposits and disinfecting to substantially eliminate viable microorganisms.  It is disclosed that it is known from the prior art that contact lenses may be cleaned by various means including the use of surfactants or enzymes and that lenses may be disinfected with antimicrobials such as polymeric quaternary ammonium compounds and polymeric biguanides.  Methods involving the combined use of cleaning and disinfecting agents also appear to be well known.  The specification describes three prior art methods of simultaneously cleaning and disinfecting contact lenses.  Each of these involves the use of proteolytic enzymes for cleaning with either a) a chemical disinfectant (monomeric quaternary ammonium compounds), b) heat or c) an inorganic disinfectant such as peroxides, as the disinfecting agent.

The opposed specification states that the present invention:

"involves the combined use of enzymes to clean and a very low concentration of a polymeric antimicrobial agent to disinfect.  The present invention is based on the finding that these antimicrobial agents can be effectively utilized in combination with enzymes to clean and disinfect contact lenses under certain conditions.  This finding is surprising, both in view of prior art attempts which indicate that there is mutual inhibition, possibly by binding between the enzyme and the antimicrobial agent, and in light of other, earlier observations that large excesses of one of both of the enzyme and the antimicrobial agent were required to achieve both cleaning and disinfecting."

From reading the specification as a whole it is clear that the essence of the invention is in the effective cleaning/disinfecting of contact lenses utilising low concentrations of both enzyme and antimicrobial agent.  This is achieved by the addition of complexing agents, to prevent binding between the enzyme and the antimicrobial agent in order to maintain the activity of each, and by maintaining the antimicrobial/enzyme system at an isotonic or hypotonic level to maximise antimicrobial activity.  The complexing agent is selected from citric acid, ethylenediaminetetraacetic acid, acetic acid and pharmaceutically acceptable salts thereof.

As Mr McCaw for Alcon explained, the following three criteria are essential to the invention to reduce the problems associated with the prior art:

a)        the use of a complexing agent
b)        maintaining the system at an isotonic or hypotonic level
c)        low concentrations of both enzyme and antimicrobial agent

THE CLAIMS

The specification ends with 31 claims, claims 1 to 16 defining a composition for cleaning and disinfecting a contact lens and claims 17 to 31 defining a method for simultaneously cleaning and disinfecting a contact lens.  Claims 1, 17 and 31 are the only independent claims.

1. A two part composition for forming an aqueous disinfectant/enzyme system to clean and disinfect a contact lens, comprising:
              a first component, comprising: an amount of a polymeric antimicrobial agent effective to disinfect the lens, said polymeric antimicrobial agent comprising a nitrogen-containing polymer or copolymer; and an amount of a complexing agent sufficient to provide a concentration in said system of about 0.03 to about 0.7 percent by weight/volume, said complexing agent being selected from citric acid, ethylenediaminetetraacetic acid, acetic acid and pharmaceutically acceptable salts thereof; and
              a second component, comprising an amount of an ophthalmically acceptable enzyme sufficient to provide a concentration in said system of less than or equal to about 26 proteolytic activity units per ml of solution;
              wherein said first component and said second component are kept separate from each other prior to use, and wherein the ionic strength of the aqueous disinfectant/enzyme system as at an isotonic or hypotonic level.

1. A method for simultaneously cleaning and disinfecting a contact lens by soaking the lens in an aqueous disinfectant/enzyme system, said method comprising the steps of:
              immersing the contact lens in an aqueous solution comprising: an amount of a polymeric antimicrobial agent effective to disinfect the contact lens, said polymeric antimicrobial agent comprising a nitrogen-containing polymer or copolymer; and an amount of a complexing agent sufficient to provide a concentration of about 0.03 to 0.7 percent by weight/volume in said aqueous disinfectant/enzyme system, said complexing agent being selected from citric acid, ethylenediaminetetraacetic acid, acetic acid and pharmaceutically acceptable salts thereof;
              releasing into said aqueous solution, either before or after said immersion of said contact lens, an amount of an ophthalmically acceptable enzyme sufficient to provide a concentration of less than or equal to about 26 proteolytic activity units per ml of solution, thereby forming said aqueous disinfectant/enzyme system; and
              maintaining immersion of the contact lens in said aqueous disinfectant/enzyme system to clean and disinfect said contact lens;
              wherein the ionic strength of the aqueous disinfectant/enzyme system is at an isotonic or hypotonic level.

1. A method of simultaneously cleaning and disinfecting a contact lens, which comprises:
              placing 10ml of a disinfecting solution in a container, said disinfecting solution containing 0.001 + 10% excess w/v% polyquaternium-1, 0.48 w/v% sodium chloride, 0.05 w/v% disodium edetate, 0.021 w/v% citric acid monohydrate, 0.56 w/v% sodium citrate dihydrate and an amount of purified water sufficient to make a final volume of 10ml;
              placing the lens in said disinfecting solution;
              dissolving a 50mg enzymatic cleaner tablet in said disinfecting solution to form a disinfectant/enzyme system, said tablet containing 1.38mg of pancreatin (6X), 5.95mg of citric acid, 13.135 mg of sodium bicarbonate, 0.415mg of povidone, 0.75mg of polyethylene glycol (3350) and an amount of compressible sugar sufficient to make a total weight of 50mg; and
              soaking the lens in the disinfectant/enzyme system for a period sufficient to clean and disinfect the lens.

The dependent claims add further features such as the type or concentration of antimicrobial agent and enzyme, specific tonicity values, how the enzyme is formulated or how long the lens is immersed in the solution.

DECISION

Priority date of the claims

The parties were not in agreement over the priority date of the claims.  With regard to this, Mr Yates referred me to Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1987) 15 FCR 382 at 389, Fox J (with whom Spender J agreed) stated in relation to provisional specifications:

"Where the holder of the provisional specification proceeds with a complete specification with a view to the grant of a patent, it is recognised that greater definition, as a result of further experimentation or otherwise, may be achieved before the later step is taken and the result expressed therein. Some generality of expression in the provisional specification is accepted. In language which he would not have used as a definition, but is nevertheless a guide, Lloyd-Jacob J in Imperial Chemical Industries Ltd (Clark's Application) [1969] RPC 574 at 583 said of the function of a provisional specification that it is: 'a description of the general nature of the invention, its field of application and the anticipated result.'
……………
The fact that there may be a further working out of details before the complete specification is lodged does not mean that the provisional specification can always be used as giving a priority date to something which is worked out and contained in the specification.  In particular, the selection of one compound with special qualities from a class of compounds disclosed in the provisional is not permissible for that purpose.
…………….
There is no foreshadowing in the provisional of the special advantages which the petty patent specification claims for DGBE as a carrier over the other organic solvents mentioned, xylene and cyclohexanone, or, indeed, over other glycol ethers.  The patent claim concerning DGBE is not simply a more specific application of what is claimed in the provisional specification.  It is the result of further experimentation , and can properly be regarded as involving an inventive step."

Thus, it seems that it is recognised that a complete specification may contain some development over the provisional document and still be entitled to the earlier priority date.  However, this development should not amount to a different invention (see CCOM Pty Ltd v Jiejing Pty Ltd (1994) 28 IPR 481 at 501). In F. Hoffman-La Roche & Co Aktiengesellschaft v Commissioner of Patents (1971) 123 CLR 529 at 544 Gibbs J. accepted that the opportunity for development is applicable to both provisional applications and in the case of convention applications.

If the application is not entitled to priority from the basic document, it will take the date of filing as its priority date unless the claimed subject matter was included in the specification as a result of a later amendment (section 114 and regulation 3.14).

As outlined previously, the opposed application claims priority from US 521218 filed on 9 May 1990.  Mr Yates for Bausch & Lomb submitted that the claims cannot validly claim priority from this document since, although most features of the invention were disclosed in US 521218, the document is silent in regard to the following two important features of the invention:

• The necessity for the enzyme, in solution, to provide 26 proteolytic activity units per ml

• The inclusion of acetic acid and its pharmaceutically acceptable salts in the list of appropriate complexing agents.

With regard to the enzyme, page 5 of US 521218 describes the amount of enzyme utilized in the invention.  This is described in broad terms and is said to be "an amount effective to clean the lens" which may vary depending on various factors, and on lines 19-21 "In general, one or more enzymes in an amount less than or equal to about 50 proteolytic activity units per milliliter (ml) of solution will be utilized."  A proteolytic activity unit is defined as "the amount of enzyme activity present to generate one microgram (mcg) of tyrosine per minute (mcg Tyr/min), as determined by the casein-digestion colorimetric assay" this assay being given on pages 5 to 6.  The examples in US 521218 are identical to those in the opposed specification and, as pointed out by Mr Yates, examples 3 and 4 equate to the use of pancreatin with an enzyme activity of 10.5 proteolytic activity units per ml of solution.

The amount of enzyme necessary is also described in broad terms in the opposed specification and there is a discussion of the different factors which influence this.  The amount is given on page 4/1 as "less than or equal to about 26 proteolytic activity units per milliliter (ml) of solution" and this same value is defined in claims 1 and 17.  However, I note that the value of 26 proteolytic activity units was included as a result of amendment during the course of this opposition.  Mr Yates submitted that the figure of 26 is mere choice and does not represent a valid selection.

Although the specification gives a broad disclosure of the use of an amount of enzyme effective to clean the lens, the figure of 26 proteolytic activity units per ml for the enzyme appears to me to be arbitrary.  There is nothing in the specification to indicate why the value of 26 was chosen rather than the previously disclosed value of 50.  The specification does not give any indication that values larger than 26 would not be effective, the only value being exemplified is 10.5.

In my view, the specification clearly indicates that the amount of enzyme necessary is an amount effective to clean the lens and that this is a low amount which a person skilled in the art would be able to determine without further invention.  I am satisfied that the priority document gives a real and reasonably clear disclosure of a low amount of enzyme which is effective to clean the lens.

As to the disclosure of the complexing agent, the opposed specification describes compositions comprising a complexing agent selected from citric acid, ethylenediaminetetraacetic acid (EDTA), acetic acid and pharmaceutically acceptable salts thereof.  I note that the page 8 of US 521218 describes the complexing agent as including citric acid, ethylenediaminetetraacetic acid (EDTA) and their pharmaceutically acceptable salts.  Page 3 of the description of that specification describes how problems of the prior art can be overcome by using certain chelating agents or buffering agents and on page 7 "it has been found that certain chelating agents or pharmaceutically acceptable anions or buffers can be utilized…….".  Thus, it seems to me that the list of complexing agents is not intended to be exhaustive and would include others.

The declaration by Dr Lazarus at paragraph 33 addresses this issue and states "Since acetic acid/acetate is a well known buffering and chelating agent for preparation for ophthalmic use I believe that at the filing date of the priority application I would have read the term 'complexing agent' as referring to acetic acid in addition to those specifically mentioned."  This is also confirmed by Dr Brennan at paragraph 9 of his declaration.  I thus consider this feature does not involve any inventive step over the priority document.

As a result, I find that all the claims are entitled to claim priority from US 521218 with a priority date of 9 May 1990.

Novelty

The test for determining whether an invention lacks novelty is the " reverse infringement test" as stated by Aiken J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd, (1977) CLR 228 at 235:

"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement."

Infringement of a claim occurs where "each and every one of the essential integers" of that claim have been taken, Rodi and Wienenberger AG v Henry Showell Ltd, (1969) RPC 367 at 391.

A more recent statement in relation to novelty is given in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517:

"It is well accepted that the prior art must disclose all features of the invention embodied in the patent in suit and must do so in clear, unequivocal and unmistakable terms.  The prior art must enable the notionally skilled addressee at once to perceive and understand and be able practically to apply the discovery without the necessity of making further experiments.  What ever is essential to the invention must be read out of or gleaned from the prior publications"

In assessing the teaching or disclosure of the prior art, one has to consider what the skilled addressee is being taught and what they would have done on reading the citation, General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd, (1972) RPC 457 at 485, 486:

"To anticipate the patentees 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."

Similarly, a prior disclosure will only invalidate a claim if, after having read it, the skilled addressee would, rather than could, have produced all the essential integers of the claim.  See also the following passage from C. Van Der Lely N. V. v Bamfords Ltd (1963) RPC 61:

"If…..the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but would at least be as likely to be carried out in a way that would not do so, the patentee's claim will not be anticipated."

The opposition under the ground of novelty was based on a single document.  Mr Yates submitted that all the claims of the opposed application are anticipated by AU 49989/90 in the name of Bausch & Lomb.  This was published in Australia on 30 August 1990 and has a priority date of 21 February 1989.  Since I have found above that the opposed application is entitled to a priority date of 9 May 1990 it follows that AU 49989/90 can only be used as the basis for "whole of contents" novelty.  The concept of "whole of contents" novelty in regard to an Australian patent application with an earlier priority date than the claims under consideration, finds its basis in the definition of "prior art base" in the Act.

AU 49989/90 relates to a composition and method for simultaneously cleaning and disinfecting contact lenses, said composition comprising an antimicrobial agent and a proteolytic enzyme.  The antimicrobial agents described are quaternary ammonium compounds and polymeric biguanides, which are the same as those described in the opposed specification.  The enzymes described in AU 49989/90 include such enzymes as pancreatin, papain and subtilisin, which are the enzymes specifically defined in the claims of the opposed specification.

From the submissions made at the hearing and the evidence before me it is clear that the parties are in agreement that AU 49989/90 discloses compositions comprising essentially the same antimicrobial compounds and enzymes as those described in the opposed application.  There also does not seem to be disagreement on the amount of antimicrobial agent used.  Both specifications talk in similar terms about an amount "effective to disinfect the lens" in claim 1 of the opposed specification and "a disinfecting amount" in AU 49989/90.  The typical concentrations given in each case also show considerable overlap.  There also did not seem to be disagreement that both documents describe the feature that the two components are kept separate prior to use.

However, the parties were not in agreement over three specific criteria mentioned previously as being the essence of the invention, namely the control of tonicity, the use of a complexing agent and the enzyme concentration.  I will now turn to the discussion of these three features.

Complexing agent

Independent claims 1 and 17 of the opposed application define the inclusion of a complexing agent in the first component (containing antimicrobial agent) which is selected from citric acid, EDTA, acetic acid and their pharmaceutically acceptable salts.  The concentration of this complexing agent is defined as about 0.03 to 0.7 percent by weight/volume.  This complexing agent is stated to be useful in eliminating or reducing binding between the enzyme and the antimicrobial agent.  Mr McCaw submitted that AU 49989/90 does not give a clear disclosure of either the complexing agent or its concentration

AU 49989/90 discloses on page 6 that additional components may be added to the enzyme which do not decrease its activity.  These include effervescing agents, stabilizers, buffering agents, chelating and/or sequestering agents, coloring agents, tonicity adjusting agents, surfactants and the like.  Examples of buffering agents are given on page 7 and include acetates and citrates, citric acid is given as an example of an effervescing agent on page 7 and EDTA as a preferred chelating agent on page 8.  Generally the buffering agents are said to be present in amounts from 0.01 to 2.5 percent by weight/volume and EDTA in amounts from 0.025 to 2 percent weight/volume. Page 10 line 24 to page 11 line 1 describes how the enzyme component and antimicrobial component are separate formulations with the final solution being made up by dissolving the enzyme formulation in the disinfecting solution.

Mr Yates pointed out that nothing turns on the different terms used in the two specifications for the same components.  For example, citric acid is described as an example of both a buffering agent and an effervescing agent in AU 49989/90 but is described as a complexing agent in the opposed specification.  He also observed that the opposed specification claims no special advantage for the percentage range claimed and that no selection is involved.  Further, he submitted that the skilled addressee would have understood that these complexing agents would normally be added to the antimicrobial agent, not the enzyme and directed me to paragraph 9 of Dr Brennan's declaration for support on this submission.

In my view, although AU 49989/90 discloses that additional components may be added to the solutions and that these components may include citric acid, acetates and EDTA, there is no clear direction to use these particular components rather than any other.  The list of additional agents is not exhaustive and they are said to be added to or incorporated into the enzyme, provided they do not substantially decrease the activity of the enzyme.  The examples do not include any of these particular complexing agents.  Although the skilled reader could have been led to add citric acid, EDTA, acetic acid or salts of these, I do not believe that they necessarily would chose one of those from among the large number of possible additional components.  The teaching of AU 49989/90 is that additional agents may be added to the enzyme component, but there is no teaching of adding these to the antimicrobial component or of the surprising benefit of selecting citric acid, EDTA or acetic acid.

Taking all these factors into account, I conclude that AU 49989/90 does not contain clear and unmistakable directions to include a complexing agent comprising citric acid, EDTA, acetic acid or a salt thereof.  It would seem that the choice of these complexing agents amounts to a selective advantage which was not recognised in AU 49989/90.  Since the complexing agent is an essential feature of all the claims, I must find that all the claims of the opposed specification are novel and not anticipated by AU 49989/90.

In light of this, despite the fact that the parties presented me with many submissions at the hearing in relation to the control of tonicity and the enzyme concentration, I do not need to consider these matters any further in this decision.  Since I have determined that the feature of the complexing agent is not disclosed in AU 49989/90, the claims are novel irrespective of whether or not the document also discloses the features of the control of tonicity and the particular enzyme concentration.

Although the parties only argued novelty on the basis of the one document, AU 49989/90, it would seem that the two components of the two part composition are separately known.

In the documents served in the evidence in support I find that there are a number, published prior to 9 May 1990, which exemplify compositions for disinfecting contact lenses comprising a nitrogen-containing poymeric antimicrobial and EDTA as claimed in claims 1 to 16 (see for example US 4758595, Exhibit NAB-4; GB 1432345, Exhibit NAB-7; US 4836986, Exhibit NAB-11; US 4525346, Exhibit NAB-13; US 4783488, Exhibit NAB-23; US 3639576, Exhibit NAB-24; EP 180309, Exhibit NAB-31 and US 4537746, Exhibit NAB-36).  NAB-13 also contains examples in which citrates or acetates are included.

The second component of the two part composition is an ophthalmically acceptable enzyme.  As discussed above, the parties were in agreement that such enzymes are well known and recognised as components of contact lens cleaning/disinfecting solutions.  Since the enzymes are known, any amount of them is also known.

However, none of the documents before me disclose the two components together, either in admixture or as a kit for combined use according to the inventive concept of the opposed application.  Thus, I consider all claims to be novel.

Inventive step

Mr Yates made submissions that the opposed application lacks inventive step when considering the Bausch & Lomb application AU 49989/90 in the light of common general knowledge in the art at the earliest priority date of the opposed application.  AU 49989/90 was published on 30 August 1990 which is later that the priority date of basic document US 521218.  A document which can be used for an objection of lack of novelty only on the basis of "whole of contents novelty" is not part of the prior art base for inventive step, only novelty.  Since I have found above that the opposed claims are fairly based on US 521218, I do not need to consider the issue of inventive step any further in this case.

Manner of manufacture

Section 18(1)(a) of the 1990 Act states:

"a patentable invention is an invention that, so far as claimed in any claim is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies."

The decisions of the High Court in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 32 IPR 449 and Advanced Building Systems Pty Ltd and Anor v Ramset Fasteners (Aust) Pty Ltd (1998) 152 ALR 604 confirm that section 18(1)(a) should be interpreted as retaining a threshold requirement of an invention and excluding from a "patentable" invention any claimed process, method or use which was not, on the face of the specification, proper subject matter according to traditional principles.

According to Mr Yates, claims 1 to 16 of the opposed application do not claim a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.  These claims define a two part composition or kit of two components, each of which is a known material used for the purpose for which its known properties make it suitable.  He submitted that all that has been claimed is a mere collocation, not a true combination.

Mr McCaw, however, submitted that these claims did define a true combination in which the two components were intended to be kept separate prior to use.

In National Research Development Corporation's Application (1988) AIPC 90-495, the hearing officer found that a claim to a kit for use in an assay, which comprised three known components in separate containers, did not define an aggregation of integers having a potential working relationship. In Bristol-Myers Company v L'Oreal, (1988) AIPC 90-529 the hearing officer held that as the components of the package claims could be used in other known processes, such claims were not limited to the inventive concept and thus, not patentable. However, a kit will not lack patentable subject matter if its physical construction is such that it is only capable of normal use in such a way as to realise the concept of the invention.

As discussed above, claim one clearly defines a two part composition in which the two components are kept separate prior to use.  The two components are:

a)the polymeric antimicrobial/complexing agent composition, (comprising an effective amount of antimicrobial and 0.03 to 0.7 percent by weight/volume of complexing agent selected from citric acid, EDTA, acetic acid or their salts); and

b)the enzyme in a concentration of less than or equal to 26 proteolytic activity units per ml of solution

None of the documents in the evidence before me disclose a composition containing the two components a) and b) together.  In my view, such a composition would be a patentable combination and, as I have previously found, is novel and inventive.  However, there are a number of documents which disclose the two components separately as mentioned previously in the discussion on novelty.

Claims 1 to 16, as presently drafted, do not define any means for ensuring that the two components may only be used by mixing together, such as some type of special packaging.  Thus, claims 1 to 16 define a kit, comprising two separate known components, which is not limited to the inventive concept.  Each component may, in normal use, be employed separately.  Accordingly, I find that claims 1 to 16 are not for a manner of manufacture according to section 18(1)(a).

Conclusion

I have found above that all the claims are novel and that the document AU 49989/90 cannot be used in relation to any consideration of inventive step in this matter, since all claims are entitled to claim priority from US 521218 with a priority date of 9 May 1990.  However, I have also found that claims 1 to 16 are not for a manner of manufacture according to section 18(1)(a).  Since I consider that there is patentable subject matter in the opposed application, I allow Alcon 60 days from the date of this decision to propose suitable amendments to the specification.

Costs

The opposition has succeeded on the grounds of manner of manufacture in relation to claims 1 to 16 but was not successful in relation to novelty or inventive step.  I note that the applicant amended the claims during the opposition process and Mr Yates submits that regardless of my decision, the opponent should be awarded costs up to the date of the amendments.

Since the opposition has only been partly successful, I consider that each party should bear it's own costs and so make no award of costs.

Gillian Jenkins
Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  F B Rice & Co, Melbourne

Patent attorneys for the opponent   :  Spruson & Ferguson, Sydney