Bristol-myers Company v L'OREAL

[1988] APO 26

In the Matter of the Patents Act 1952 and - In the Matter of Application NO. 537169 for a Patent by BRISTOL-MYERS COMPANY - and - In the Matter of Opposition thereto under Section 59 by L'OREAL.

 

DECISION OF A SUPERVISING EXAMINER OF PATENTS:

Background

Patent Application No. 537169, which is entitled "Hair Waving or Straightening Process and Product", was lodged on 9 February, 1982. The application which is based on a United States patent application has a priority date of 13 August, 1981. Advertisement of acceptance appeared in the Official Journal of 14 June, 1984.

L'OREAL was granted an extension of time under sub-section 59(1) and lodged a notice of opposition on 14 December, 1984. The service of evidence was completed on 14 December, 1987. On 18 December, 1986 the applicant lodged a request to amend the complete specification under section 77, which was not opposed, and allowance of this request was advertised in the Official Journal of 19 February, 1987. A further request to amend the complete specification under section 77 was lodged on 5 February, 1988.

The opposition under section 59 was set down for hearing in Melbourne on 9 February, 1988. The notice of opposition specified paragraphs (c) to (i) inclusive of sub-section 59(1) as the grounds I - 2 - of opposition; however at the hearing argument was restricted to the grounds specified in paragraphs (e), (f), (g), (h) and (i), i.e. anticipation, obviousness, manner of new manufacture and compliance with section 40. At the hearing the applicant (BRISTOL-MYERS) was represented by Mr. P.W. Jones, patent attorney of Phillips, Ormonde & Fitzpatrick, and L'OREAL was represented by Mr. J. Murray, patent attorney of Edwd. Waters & Sons.

The Specification

The specification, as amended by the request under section 77 lodged on 18 December, 1986, relates to a hair waving or straightening process which simultaneously conditions the hair to prevent tangling and leaves it in an easily combable condition which persists through several shampoos.

The specification states that cold waving or permanent waving of hair and treatments for straightening hair are essentially similar in that the hair is first treated with an agent which softens or cleaves the disulfide bonds of keratin to allow a reshaping of the hair. This is referred to as "reducing". After a usual intermediate rinse, the softened hair is set into its new shape by a subsequent step which is usually referred to as "neutralisation". In this step the effect of the reducing agent is neutralised by re-establishing the cleaved linkages. A considerable number of processes and materials are well known for the waving or straightening hair and the present invention generally relates to an improvement of all such processes.

Hair which has been exposed to a waving or straightening process is almost invariably tangled, its tactile properties deteriorate and combing is difficult. Conventionally, hair is treated to ameloriate the situation and conditioning agents are usually incorporated in the neutralising step of the waving or straightening process. Whilst the conventional conditioning agents improve the feel of hair and allow for easier combing, their beneficial effects are only transitory and are entirely lost when the hair is subsequently shampooed.

The invention is then described in similar, but less succinct terms than claim 1 which reads as follows:

"1. A process for waving or straightening hair, which comprises the steps of:

(a) contacting the hair with a composition which contains a reducing agent,

(b) rinsing the hair, and

(c) contacting the rinsed hair with a composition which contains a neutralising agent; wherein:

(i) said composition employed in step (a) contains an anionic surfactant, and

(ii) said hair is contacted with a composition containing at least one cationic polymer product (as hereinbefore defined), said contacting being carried out separately from said step (a)."

The description states that the present invention is based on the discovery that in conjunction with a process for waving or straightening hair, an insoluble complex is formed in situ on the hair when a cationic polymer is contacted with an anionic surfactant. This insoluble-complex when formed in the presence of hair has excellent conditioning characteristics and continues to condition the hair in a durable fashion.

According to the specification quaternary ammonium compounds have been widely employed for the conditioning of hair. It is also known, e.g. from US patent No. 4061150 to follow treatment by a non-polymeric cationic conditioner, with a shampooing with an anionic shampoo. However the process requires a small, rapidly diffusing quaternary amine molecule which does not result in a durable conditioning effect.

The specification also states that US patent No. 3912808 discloses the use of a particular cationic homopolymer, dimethyl diallyl ammonium chloride, in a waving or straightening composition wherein the polymer is incorporated with the reducing agent. This patent also discloses, in very general terms, the use of the specific cationic polymer in other hair treatments namely in hair colouring and hair bleaching compositions.

In accordance with the present invention the reducing agent containing composition contains the anionic surfactant, but it cannot contain the cationic polymer. This is because if the anionic surfactant and the cationic polymer are applied from the same composition, the insoluble complex would form in the composition before its application rather than in situ on the hair.

All types of reducing agents for waving or straightening can be employed in connection with the present process. Such agents generally soften the hair or otherwise cleave the disulfide bonds of the keratin in hair. Compounds customarily employed for this purpose include mercaptyl carboxylic acids, salts and esters, and alkali salts of sulfurous acid. Usually 0.5% to about 20% of the reducing agent is employed.

In the neutralisation step the disulfide keratin bonds are restored by exposure to an oxidizer such as a peroxide or a bromate. In some conventional compositions an increase of the pH during neutralisation is the prime contributing factor in re-establishing the cleaved bonds.

The specification states that the term "anionic surfactant" as used throughout the specification and the claims includes in its definition amphoteric surface active agents which become anionic under basic or near to basic conditions if the reducing and/or neutralising of hair is carried out in a composition having a basic or near to basic pH, i.e. above the pKa value of the amphoteric surfactant.

The specification then states as follows:

"The cationic polymers that are useful in accordance with the present invention have at least one positively charged nitrogen or sulfur moiety in each periodically repeating unit. The functional quality of the water insoluble durable conditioning complex that is formed on, and adheres to, the hair, which will resist the effect of several subsequent shampooings, depends on a large extent on the characteristics of the particular cationic polymer that is employed. Therefore, it is conceivable that some of these cationic polymers which have at least one positively charged nitrogen or sulfur moiety in each periodically repeating unit, will not be as effective as others. This, in fact, was observed in the case of a number of cationic polymers."

The preferred cationic polymers are homo or copolymers which contain a secondary, tertiary or quaternary nitrogen group in each periodically repeating unit.

A simple test was devised to determine the usefulness of materials for the conditioning of hair. The details of the test are described and a subjective scale of 5 values is used to define the ease of combing, i.e. the degree of conditioning of hair with the value 1 represents the combability of hair that is not conditioned at all and 5 represents the best conditioned value. If hair has a value of at least 3 after three shampooings then it is considered to have been durably conditioned.

The cationic polymer product is defined as follows:

"As used throughout the specification and the claims, the term "cationic polymer product" denotes a cationic polymer which has at least one positively charged !nitrogen or sulfur moiety in each periodically repeating unit and which can form a substantially water insoluble complex when contacted with an ionic surfactant in the presence of hair, said complex durably conditioning the hair."

I think that it is apparent that the word "ionic" in this quotation is in error for the word "anionic".

A number of different polymers were tested to determine whether they satisfied the requirements of a cationic polymer product. It was determined that it is entirely unpredictable from the structural characteristics of a polymer whether or not it will perform as a cationic polymer product. For example a dimethyl diallyl ammonium chloride homopolymer, sold under the name of MERQUAT-100 performed satisfactorily under the criteria for durable conditioning but its low molecular weight (5000) homolog did not. A polymer formed by reaction of dimethyl sulphate and a copolymer of vinyl pyrrolidine and methyl aminoethyl methacrylate sold under the name of GAFQUAT 755N also is not a cationic polymer product. The specification states that the term "cationic polymer product" is not restricted to homopolymers but also includes copolymers and the term also includes mixtures of cationic polymer products. A suitable concentration of cationic polymer product in the composition is between 6.1% to about 10%. The cationic polymer product can be used in the prewrap lotion which is used before the reducing step or it can be used in the neutralizing solution or in both. When a cationic polymer product is present in both the prewrap and neutralizing solutions, a different cationic polymer may be used in each solution.

All anionic surfactants and amphoteric detergents that were tested were suitable for the present invention and usually 0.2% to about 50% is used in the reducing lotion. The specification also describes specific examples of the present invention.

Claims 2 to 21 are all appended to claim 1, which I have quoted earlier, however for the purposes of this decision it is also necessary to refer to claim 2 as well as claims 22 to 25. These claims read as follows:

"2. The process of claim 1, wherein said cationic polymer product is a homo or copolymer containing a secondary, tertiary or quaternary nitrogen group in each periodically repeating unit.

22. A package containing a plurality of containers which comprise compositions to be employed in a process for waving or straightening of hair according to any one of claims 1 to 21, a first one of said containers containing a composition comprising a reducing agent and between 0.2% and 50% of an anionic surfactant, and second one of said containers containing a composition comprising between 0.1% and 0.25% of a cationic polymer product, and a neutralising agent which is in a third container or in said second container together with said cationic polymer product.

23. The package of claim 22, wherein the concentration of the anionic surfactant in said first container is between 0.5% and 20%, and wherein the concentration of the cationic polymer product is between 1% and 5%.

24. The package of claim 22 or 23, wherein the neutralising agent is contained in said second container together with said cationic polymer product and the package further containing a third container containing an aqueous solution of a cationic polymer product.

25. The package of any one of claims 22 to 24 wherein the package further contains instructions on how to employ the contents of the containers for waving and straightening hair."

Mr. Jones said that the value "0.25%" in claim 22 was a typographical error and the value should be "25%". I note that the value '0.25%' occurs in claim 2 as originally lodged however I also note that claim 6 as originally lodged claimed that method comprised contacting hair with "about 0.1% to about 25% of the cationic polymer product".

Evidence

I will not summarise all the evidence in respect of the present opposition because some of the evidence became irrelevant following allowance of the request made under section 77 which was lodged on 18 December, 1986.

The evidence in support of the opposition consists of statutory declarations made by Do Le Trung, Robert Owen Hellyer, Thomas Edwin Simmons and James Murray.

Mr. Murray's declaration exhibits a copy of GB patent No. 1453427 and demonstrates that this citation was available in the Patent Office library on 2 march, 1977.

Do Le Trung has been head of L'OREAL's Comparative Experiments Laboratories in France since 1983 and he declares that a number of tests described in Dr. Hellyer's declaration were carried out under his supervision. He states that he agrees with Dr. Hellyer's conclusion that a person using the process described in GB patent No. 1453427 would inevitably infringe the present claims.

Do Le Trung asserts that the criteria for the durable conditioning effect, which is described in the present specification is completely uncertain and he bases this conclusion on the tests performed in the laboratories under his control.

Dr. Hellyer, who is managing director of a company which carries out specialised technical and scientific consultancy work for the cosmetic, toiletry and pharmaceutical industry, has expertise in all the important aspects of the development and application of cosmetics and toiletries in Australia.

Dr. Hellyer's declaration discloses the results obtained when hair is treated according to a process similar to that described in GB patent No. 1453527. He considers that the results show that a durable conditioning effect is produced in this process. He concludes that the process described in the citation infringes the process defined in the present claims. Consequently he thinks that the process disclosed in GB patent No. 1453527 is a prior publication of the present process.

Schedule 4 in Dr. Hellyer's declaration summarises the results of further tests with cationic polymers which include MERQUAT 100 and GAFQUAT 755N. These results indicate that both these cationic polymers produce a durable conditioning effect whereas the present specification states that GAFQUAT 755N does not produce this effect. Dr. Hellyer declares that this indicates that the statement in the present specification regarding GAFQUAT 755A is highly confusing and leads to uncertainty as to the scope of the present claims.

Mr. Simmons, who is managing director of a company which specialises in technical consulting services to the cosmetics and toiletries industry has practical and theoretical experience with these industries in Australia dating from 1951.

Mr. Simmons says that he agrees with Dr. Hellyer's conclusion that the claims of application No. 537169 are prior published by the material disclosed in GB patent No. 1453527. He also considers that the discussion in the present specification of how to choose a suitable cationic polymer is somewhat puzzling. Moreover in the light of the results described in the schedule 4 in Dr. Hellyer's declaration, Mr. Simmons considers that little confidence can be placed in the description of the invention in the present specification. Therefore he asserts that the scope of the present claims is uncertain.

The evidence in answer consists of declarations made by Leszek January Wolfram and Dianne Atkinson.

Dr. Wolfram, who is named as one of the actual inventors in the present application is vice-president and research director of a subsidiary company of BRISTOL-MYERS in America.

Dr. Wolfram argues that GB patent No. 1453527 is not relevant to the process defined in the present claims. He points out that the citation describes a list of polymers, including quaternary products of basic polymers which are esters of acrylic acid or methacrylic acid with amino alcohols. However he asserts that the citation does not teach the selection of quaternary polymers from this list nor that a durable conditioning effect will be achieved if quaternary polymers are selected.

Dr. Wolfram points out that the tests described in schedule 4 of Dr. Hellyer's declaration were not obtained according to the test for the durable conditioning effect which is described in application No. 537169. His declaration states as follows:

"The definition of a 'durable conditioning effect' in the opposed specification requires a comparison between hair to which a conditioning composition has been applied after at least three subsequent shampooings, and hair to which no conditioning was employed after a single shampoo. In contrast to this, the test for durable conditioning effect undertaken by L'Oreal is a comparison with hair to which no conditioning was employed after three subsequent shampooings so that the percentage level of improvement achieved is obviously magnified."

Dr. Wolfram asserts that the results reported for GAFQUAT 755N in schedule 4 of Dr. Hellyer's declaration defy logic and are clearly in error.

Annexed to Dr. Wolfram's declaration is exhibit LJW-3 which describes the results of tests conducted under his direction. The tests were designed as far as possible to duplicate the tests reported in schedule 4 in Dr. Hellyer's declaration. Dr. Wolfram states that the results confirm that GAFQUAT 755N is not a cationic polymer product because it does not display a durable conditioning effect.

Dr. Atkinson, who is a lecturer in Colloid Science at Swinburne Institute of Technology in Melbourne has written several papers in the field of surface and colloid chemistry dealing with solid substrates of industrial importance.

Dr. Atkinson declares that she recognises Dr. Wolfram as an international expert in the field of keratin chemistry and she also states that she agrees with many of the arguments which Dr. Wolfram raises in his declaration.

Dr. Atkinson notes that the polymer which is used in the preferred embodiment in GB patent No. 1453527 is not a quaternary ammonium product and thus it cannot be a cationic polymer product as defined in the present specification. She considers that the reference to quaternary products of basic polymers for setting the hairstyle in the citation is consistent with the qualification that the polymers are suitable for forming a film on the hair. However she asserts that quarternisation of these basic polymers would render them unsuitable for forming a film on the hair.

The evidence in reply consists of further declarations made by pr. Hellyer and Mr. Murray and a declaration made by Lia Bronstijn.

Annexed to Lia Bronstijn's declaration is a copy of French patent No. 1225972 and a translation, which the declarant declares is a true and correct translation of the French patent. Mr. Murray's declaration establishes that French patent No. 1225972 was available from the Patent Office library in 1962.

According to Dr. Hellyer French patent No. 1225972 discloses that basic polymers of the type amino-alcohol acrylate esters give a film on hair and this film is even mare resistant if the polymer contains cationic groups. He also declares as follows:

"I recognize that there is no general disclosure in Wella of the process as claimed in the application but my opinion is that when the Wella* process is carried out with some known cationic polymers of the type disclosed by Wella, this process is encompassed by the claims of the application, and that a durable conditioning effect, as defined by Bristol-Myers, is then in fact obtained. In other words, the claims of the application are partially anticipated by Wella."

* The term "Wella" in this statement refers to GB patent No. 1453527

Dr. Hellyer also describes the data from which the results for GAFQUAT 755N were calculated in schedule 4 of his first declaration. He says that it may be that these results appear to be illogical but he states that they are facts based on experiment.

Common General Knowledge

Before considering whether the invention defined in the claims of application No. 537167 has been anticipated or is obvious, it is necessary to decide which, if any, of the documents lodged by L'OREAL are part of common general knowledge.

Mr. Jones submitted that there was no evidence to show that any of the documents lodged by the opponent were part of common general knowledge. I agree with Mr. Jones' submission with respect to the documents lodged by the opponent.

Obviousness

Mr. Jones drew my attention to the law set out in Minnesota Mining and Manufacturing Co. and 3M Australia Pty. Ltd. v. Bieirsdorf Ltd. (29 ALR 29 at pages 57 and 58), i.e. that evidence in support of the objection of obviousness has to come from common general knowledge in the art in Australia. He pointed out that this vas not the situation in the present opposition as all that the declarations lodged on behalf of L'OREAL established was what was public knowledge rather than what was common general knowledge.

I agree entirely with Mr. Jones' submissions on this matter and will say no more on it.

Anticipation

The only document I have to consider with respect to anticipation is GB patent No. 1453527, which was published in Australia before the present priority date.

The specification states that the object of the invention is a multi-stage process for the permanent waving or partial straightening of human hair. For the production of a hairstyle, it is necessary for hair to be waved and this can be effected by two different methods, either by the method of water waving or by that of permanent waving.

Claim 1 of the citation reads as follows:

"A method for the permanent waving or partial straightening of human hair, characterised in that the hair is pretreated with a washing agent containing an alkali metal or ammonium sulphite, then thoroughly moistened with an alkaline solution of a mercapto carboxylic acid salt, then wound onto open-work cylindrical hollow curlers having an external diameter of 10 to 24 mm, rinsed with water after the mercapto carboxylic acid salt has acted and the excess water removed, then oxidised with a hydrogen peroxide solution and set with a polymer, after which the hair is finally dried and removed from the curlers."

The washing agent containing an alkali metal or ammonium sulphite also contains a known anionic surfactant. The action of the mercapto carboxylic acid salt results in the known cleavage of the disulphide bridges in the hair keratin and at the same time the organic thisulphates formed due to the preceding sulphite treatment undergo cleavage. This coupled chemical process gives rise to an intensified hair-forming action.

The polymers for setting the hairstyle, according to the method, are known hair cosmetic polymers which are suitable for forming a film on the hair. The polymers are listed and include acrylic acid or methacrylic acid polymers, basic polymers of esters of these two acids with amino alcohols, salts or quaternary products of these basic polymers as well as copolymers of the listed compounds. It is possible for the hydrogen peroxide solution to be combined with the polymer solution to form a single treatment agent.

Mr. Murray submitted that there was an overlap in scope between the disclosure of GB patent No. 1453527 and claims 1 to 21 of application No. 537169 which meant that the present claims were anticipated in part by the citation. He said carrying out the process disclosed in the citation would inevitably lead to infringement of the present claims (Meyers Taylor Pty. Ltd. v. Vicarr Industries Ltd. 137 CLR 228 at page 235). Mr. Jones submitted that the claims 1 to 21 of application No. 537169 were not anticipated by the disclosures of GB patent No. 1453527 because there was not even a "signpost" to use a cationic polymer product which had a durable conditioning effect (General Tire and Rubber Co. v. Firestone Tyre and Rubber Co. Ltd. 1972 RPC 457 at page 486).

I think that the process which is described in GB patent No. 1453527, wherein a polymer may be combined with hydrogen peroxide to treat hair, is only relevant in respect of one way of performing the process defined in claim 1, i.e. the cationic polymer product is employed in step "(c)" with hydrogen peroxide used as the neutralising agent.

In my opinion the so-called coupled chemical process which is described in the citation falls within the scope of part "(a)" of the present claim 1 because the description on page 16 clearly states that the reducing lotion "usually contains one or more reducers'. However the polymer which is used in the preferred embodiment in the citation is a copolymer containing a basic polymer which is not a quaternary product.

It seems to me that a person who followed the method disclosed in GB patent No. 1453527 would not inevitably use a cationic polymer which has at least one positively charged nitrogen or sulfur moiety in each periodically repeating unit. Thus I consider that carrying out the process described in the citation does not inevitably lead to infringement of the present claims. However I agree with Mr. Murray that the scope of the present claims overlaps the disclosures of the citation.

In my view GB patent No. 1453527 broadly discloses some of the matter which falls within the scope of the present claims without disclosing a specific example that lies within the scope of the present claims. Thus the claims are in a position to be considered in terms of the law on selection. A requirement for a selection patent is the discovery that one or more members of a previously known class of products possess some special advantage for a particular purpose, which could not be predicted before the discovery was made (Beecham Group Ltd. v. Bristol Laboratories International SA 1978 RPC 521 at page 579).

It is apparent that the polymer which is used in the method described in GB patent No. 1453527 forms a film on the hair to set the hair style. This polymer may even be a quaternary product of basic polymers which are esters of acrylic acid or methacrylic acid with amino alcohols. However I consider that the citation does not teach that it is necessary to use a cationic polymer which has at least one positively charged nitrogen or sulfur moiety in each periodically repeating unit. I also think that the special advantage of the process defined in the present claims 1 to 21 is that the cationic polymer and the anionic surfactant form a complex in situ on the hair which has a durable conditioning effect on the hair. The citation, in my view, is silent with respect to this special advantage. Consequently, in my opinion, the ordinary uninventive person would be unlikely to look for a cationic polmyer to help condition the hair in the polymers for setting the hairstyle which are described in the citation (E.I. Du Pont De Nemours and Co. (Witsiepe's) Application 1982 FSR 303 at page 310). Thus I consider that the process defined in the present claims 1 to 21 is a selection from the process disclosed in GB patent No. 1453527. Therefore I am satisfied that claims 1 to 21 of application No. 537169 are not anticipated by the disclosures of the citation.

I think that a similar argument can be applied to the package defined in claims 22 to 25. Therefore the package defined in these claims is not anticipated by GB patent No. 1453527.

Manner of New Manufacture

Mr. Murray submitted that claim 22 included matter which was not a manner of new manufacture because the scope of the claim included three known containers each of which contained a known composition. Mr. Jones responded by pointing out that the package claims had been raised during examination of the application and he directed my attention to the written submissions lodged on behalf of BRISTOL-MYERS. Mr. Jones submitted that the appendancy of claim 22 to claim I meant that claim 22 was novel because the package was used in the novel process defined in claim 1.

The package which is defined in claims 22 to 25 is patentable if the pack is novel or if the package includes a novel chemical or if the package includes patentable subject matter. The fact that the claims to the package are appended to the novel process defined in claim 1, in my view, does not necessarily mean that the claims to the package are novel because the appendancy only requires that the components of the package are suitable for the process. Thus, for example, the scope of the term "cationic polymer product" in claim 22 is restricted to a cationic polymer which has a positively charged nitrogen or sulfur moeity in each periodically repeating unit and which can form a substantially water insoluble complex on hair when contacted with an anionic surfactant in the presence of hair, said complex durably conditioning the hair.

I think it is apparent that there is nothing novel about the pack defined in claims 22 to 25 and that the reducing agent, the neutralising agent, the anionic surfactant and the cationic polymer are all well known.

The composition of reducing agent and anionic surfactant as defined in claim 22, in my opinion, includes within its scope the composition which is used in the first step of the process described in GB patent No. 1453527. The composition described in Example 3 of US patent No. 3912808, which is described as prior art in the present specification, is also included within the scope of the composition of reducing agent and anionic surfactant as defined in claim 22. I think that the composition of the cationic polymer and the neutralising agent, which is defined in claims 22 and 24, includes within its scope the compositions which are described in examples 2 and 19 to 32 in US patent No. 3912808. However I have to consider whether the assembly of a container of a composition of the anionic surfactant and the reducing agent with containers of the cationic polymer and the neutralizing agent, or alternatively with a container of a composition of a cationic polymer and the reducing agent, and a container of a cationic polymer constitutes patentable subject matter.

The separate containers of compositions which are defined in claim 22 will be parts or characteristics of the novel process defined in claim 1 if there is a potential working interrelationship between them (Cobianchi's Application 1953 RPC 199 at page 200). I consider that the components of a package for use in the process for waving or straightening hair, which is defined in claim 1, will have a potential working interrelationship if the claims to the package are limited to the present inventive concept.

It seems to me that the inventive concept of the present invention is a process for waving or straightening hair which includes the in situ formation on the hair of an insoluble complex which has a durable conditioning effect. The insoluble complex is formed by treating the hair with an anionic surfactant along with the reducing agent and separately contacting the hair with a cationic polymer which has a positively charged nitrogen or sulfur moiety in each periodically repeating unit.

Turning to the package, as defined in claim 22, in which the cationic polymer and the neutralising agent are in separate containers, I note that the claim does not include a physical construction which ensures that in normal use the cationic polymer and the anionic surfactant are applied separately to the hair (Blendax-Werke's Application 1980 RPC 491 at page 506). Thus for example, the skilled person could apply the insoluble complex formed between the anionic surfactant and the cationic polymer to the hair rather than allowing the complex to form in situ on the hair. Such a process lies outside the scope of the present claim 1. I think that the skilled person is unlikely to consider mixing a composition of the reducing agent and the anionic surfactant with a composition of the cationic polymer and the neutralising agent. This is because there i# little point in simultaneously applying the reducing agent and the neutralising agent to the hair. However the package does not include a physical construction which ensures that the skilled person will normally use the containers in the same process. For example the composition of the reducing agent and the anionic surfactant could be used in the process for permanent waving or partial straightening of hair which is described in GB patent No. 1453527 and the composition of the cationic polymer and the neutralising agent could be used as a hair bleaching composition in a similar manner to that described in US patent No. 3712808. I conclude that although the components of the package defined in claim 22 are suitable for use in the novel process defined in claim 1, it is possible for the components to be used in other hair treatment processes. Thus I consider that the package which is defined in claim 22 is not limited to the present inventive concept. Moreover I think that the additional features which are defined in claims 23 and 24 do not restrict the normal use of the package to the process defined in claim 1.

Since none of the packages defined in claims 22 to 24 are limited to the present inventive concept, it follows that these claims do not define a collection of integers which have a potential working interrelationship, i.e. any more than any collection of compositions. Consequently I am satisfied that claims 22 to 24 do not define patentable subject matter.

The package defined in claim 25 consists of the package of any one of claims 22 to 24 which further contains instructions on how to employ the contents of the containers for waving or straightening hair. The High Court agreed with a comment made in an earlier case that mere writing cannot make the contents in a container a manner of new manufacture (Wellcome Foundation Ltd. v. Commissioner 30 ALR 510 at page 514). Thus I consider that claim 25 does not define patentable subject matter. Therefore I am satisfied that claims 22 to 25 do not relate to a manner of new manufacture.

Section 40

Mr. Murray submitted that the specification of application No. 537169 did not comply with section 40. Firstly, he argued that the features described at page 18, lines 24 to 27 and page 19, lines 10 to 17 were essential features of the invention and should thus be included in claim 1. Mr. Jones submitted that these are features of the preferred embodiments which, in any case, fall within the scope of the general process defined in claim 1.

I agree with Mr. Jones' submission with respect to the features described on page 18. However I think that the situation with respect to the feature described on page 19 should be clarified so that claim 1 indicates that the scope of the term "anionic surfactant' includes an amphoteric surfactant in anionic form as defined on page 5, line 28 to page 6, line 4 of the specification.

Secondly, Mr. Murray submitted that the test for the durable conditioning effect was not adequately described in the present specification. He also argued that the results reported in schedule 4 of Dr. Hellyer's declaration demonstrated that the test for the durable conditioning effect was not reproducible. Mr. Jones submitted that the test for durable conditioning effect was described in clear language in the specification. He argued that the onus was on the opponent to show that the test for the durable conditioning effect was not reproducible and L'OREAL had not done this.

The term "durable conditioning" is defined as follows:

"The term "durable conditioning" as is used throughout the specification and the claims means that after the application of the conditioning composition and the employment of a durable conditioning process, hair is easier to comb after at least three subsequent shampooings, than it is to comb when no conditioning was employed, even after a single shampoo. This defines what is meant by "durable" when we refer to "durable conditioning"."

However the specification elsewhere (page 8, lines 10 to 12) states that hair is considered to be durable conditioned if it "has a value of 3 after 3 shampooings", where the value 3 represents a conditioning improvement of approximately 50%. Thus it seems to me that the invention is not fully described because it is not certain if hair is durable conditioned if it is merely easier to comb or if there has to be a conditioning improvement of at least approximately 50%. Claim 1, because it is directly referenced to the definition of the cationic polymer product in the description which in turn includes the term "durably conditioning" is in my view therefore not clear.

I note the request which was made under section 77 on 5 February, 1988 proposes to change the definition of the term 'durable conditioning" so that it states that hair is approximately 50% easier to comb. I think that this proposed amendment would not completely overcome the conflict in the description because it is also apparent from the description on page 8, lines 9 and 10 that the conditioning improvement can be "at least 3" rather than only 3.

Some of the results reported by Dr. Hellyer for the durable conditioning effect involve a comparison with a "control" value which was measured on hair which had been shampooed three times. In my opinion these measurements do not meet the requirements for durable conditioning described in the present specification wherein the "control' value is determined on hair which has had a "single shampoo". According to Dr. Wolfram the value of the durable conditioning effect is magnified when the "control" has been shampooed three times.

Mr. Jones said that GAFQUAT 755N was the only cationic polymer which was in dispute between the parties because Dr. Hellyer found that it did produce a durable conditioning effect whilst the present specification states that it does not produce a durable effect.

In schedule 4, Dr. Hellyer reports that GAFQUAT produces a durable conditioning effect when the control value is measured on hair which has been shampooed three times. When the hair used as control has been shampooed only once Dr. Hellyer reports an even higher durable conditioning effect. In the light of these results Mr. Simmons states that little confidence can be placed on the discussion in the present specification.

In his declaration Dr. Wolfram comments on these results as follows:

"The results reported show a percentage improvement of 53.2% over control tresses washed three times with shampoo and 73.3% over control tresses washed once. I consider that such a result defies logic and is clearly in error. For these results to be correct, the conclusion is that hair washed once requires more force to comb it than hair washed three times."

In the schedule to his declaration Dr. Wolfram reports data which demonstrates that GAFQUAT does not produce a durable conditioning effect. Dr. Atkinson declares that the result reported by Dr. Hallyer is directly opposite to what she would have predicted and is therefore not logical.

Dr. Hellyer in his declaration in reply provides the data from which the results in schedule 4 were calculated. He also postulates that the reason why it is easier to comb the control hair I - 23 - after three shampoos rather than one shampoo may be due to the other treating agents being deposited on the hair and this adverse deposit is eliminated more completely after three shampoos. He also comments as follows:

"It may be that these results appear to be illogical. However, they are facts based on experiment, and the results of experiments must be admitted unless it is shown by experiment that the results were erroneous."

Mr. Jones said that even if Dr. Hellyer's results for GAFQUAT were correct, which he disputed, it only meant that BRISTOL- MYERS had given away the right to a cationic polymer product which it was entitled to use in the present process. However it seems to me, that if GAFQUAT truly does produce a durable conditioning effect then it is included within the scope of claim 1 and other consequences follow from the fact that the description states that GAFQUAT does not produce a durable conditioning effect.

According to paragraph 40.55 of the Patent Examiner's Manual a relevant question to help decide whether a claim is fairly based on the description (cf. the decision of the High Court in Hoffman La Roche AG. v. Commissioner of Patents 123 CLR 529 at page 538) reads as follows:

"Is there anything in the specification which is inconsistent with the alleged invention as claimed?"

Thus if GAFQUAT does produce a durable conditioning effect then claim 1 would be inconsistent with the description and I think that claim I would not be fairly based on the description. Consequently I have to consider whether GAFQUAT does, or does not, produce a durable conditioning effect.

The present specification states that GAFQUAT does not produce a durable conditioning effect however the evidence-in- support served on behalf of L'OREAL suggests that GAFQUAT does produce this effect. The evidence-in-answer served on behalf of BRISTOL-MYERS supports the statement in the present specification in respect of GAFQUAT. Moreover both Dr. Wolfram and Dr. Atkinson comment that the relationship between the value for hair which had been shampooed three times and hair which had been shampooed once did not accord with their experience.

It seems to me that in this situation the onus is on L'OREAL to show by experiment that the facts based on experiments by BRISTOL-MYERS are erroneous. However the evidence-in-reply served by L'OREAL does not include the results of new tests on GAFQUAT but merely reports the data used to calculate the GAFQUAT results reported in the evidence-in-support. The High Court considered that the grant of a patent should not be refused unless it has been clearly shown that the grounds of opposition have been made out (Montecatini Edison S.p.A. v. Eastman Kodak Co. 45 ALJR 593 at page 596). In my view L'OREAL has not clearly made out that GAFQUAT produces a durable condition effect. Therefore I consider that there is insufficient evidence for me to find that claim 1 is not fairly based on the description.

Earlier in this decision I pointed out that there was an error in the definition of the term "cationic polymer product" (page 8, line 27). In summary, therefore, I am satisfied that the present specification does not comply with section 40.

At the hearing Mr. Jones foreshadowed that BRISTOL-MYERS wished to amend claim 2 to make it clear that the only nitrogen group involved in compounds of the present invention contained a quaternary nitrogen atom. In this case it seems to me that the description on page 6a also requires amendment.

Summary.

I have found that the process for waving or straightening hair as defined in claims 1 to 21 of application 537169 is not anticipated and is not obvious. However I have found that claims 22 to 25 do not relate to a manner of new manufacture. I have also found that the specification does not comply with section 40. Therefore I give BRISTOL-MYERS 60 days from the date of this decision to propose amendments to overcome these defects. I award costs of this opposition against BRISTOL-MYERS.

(M. KENDALL)

Supervising Examiner of Patents

24 AUG 1988

Patent Attorney for the Applicant : Phillips, Ormonde & Fitzpatrick

Patent Attorney for the Opponent : Edwd. Waters & Sons