Lesaffre Et Cie v Burns Philip Research and Development Pty Ltd

[1999] APO 32

OFFICIAL NOTICE

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Application  :          No. 666302 in the name of Lesaffre et Cie

Title:          New Strains of Bread-making Yeast, a Process for Obtaining Same, and the Corresponding Fresh and Dry New Yeasts

Action: Opposition under section 59 of the Patents Act 1990 by Burns Philp Research and Development Pty Ltd

Decision:          Issued            .

Abstract

The nature of the technical contribution the applicant had made to the prior art knowledge was analysed to determine the essential features of the invention.  Several of the claims were found not to contain these essential features and therefore lacked fair basis.

None of the documents filed in evidence deprive any of the claims of their novelty nor has the opponent established that any of the claims lack inventive step.

Several claims defined a known goal by desiderata and therefore did not define a manner of new manufacture.

Several claims were found to be unclear because the claimed yeasts are characterised by reference to specific tests which had been inadequately described in the specification.

PATENTS ACT 1990

DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS

Re:Patent Application No. 666302 by Lesaffre et Cie and opposition under section 59 of the Patents Act 1990 by Burns Philp Research and Development Pty Ltd

BACKGROUND

Patent Application 666302 was filed on 23 April 1992 in the name of Lesaffre et Cie claiming priority from a French basic document (91-05008) filed on 23 April 1991.  The application was advertised accepted on 8 February 1996 and a notice of opposition was filed on 8 May 1996 by Burns Philp Research and Development.

The main evidence stages were completed on 8 January 1998.  An application for further evidence was filed on 29 April 1998 by the applicant and subsequently allowed.  Evidence in response to the further evidence was completed on 13 August 1998 and the matter was then set for hearing in Melbourne on 4 February 1999.  The applicant was represented by Mr Barry Hess of counsel, assisted by Ms Karen Sinclair, patent attorney of Watermark, Melbourne.  Also in attendance for Watermark was Ms Amanda Jones.  The opponent was represented by Dr Bill Pickering, assisted by Dr Jenny Petering, both patent attorneys of FB Rice and Co, Melbourne.

Proposed amendments to the specification were filed on 13 July 1998.  However, these were subsequently withdrawn by the applicant and the hearing was therefore in respect of the application as accepted.

SPECIFICATION

The specification relates to wide spectrum strains of bread making yeast which are capable of acting on both sugar-free (plain or normal) dough and highly sugared (sweet) dough.  These strains were considered desirable because they allow bakers to purchase one strain of yeast for use on both types of dough.  The specification acknowledged that wide spectrum strains were already known in the prior art (see page 1, lines 11-18) but that the yeast strains of the invention were more active on a wide range of doughs compared with prior art yeasts.

The specification ends with 47 claims, 10 of which are independent.  The opponent classified the claims into 4 distinct groups:

1. Claims to general yeast strains with particular features (claims 1-4 and 10-22);

2. Process claims to generate yeast strains (claims 5-9 and 26-42);

3. Claims to particular strains of yeast (claims 23-25 and 43-46); and

4. A claim to strains of yeast produced by a particular process (claim 47).

At the hearing, the opponent acknowledged that they were not contesting claims 23-25 and 39-46 which were limited to specific yeast strains.  Of the remaining claims, the most relevant claims to this decision are as follows:

1. Broad spectrum strains of bread-making yeast having

a high multiplication yield,
good nitrogen assimilation,
good glucose fermentation activity and
good resistance to drying,

characterised by the fact that they simultaneously have all the following enzymatic activities;

maltose-permease activity after growth of the yeast on glucose medium in the absence of maltose measured by Test T₁ as disclosed in the specification: at least 9 units,
maltase activity after growth of the yeast on glucose medium in the absence of maltose measured by Test T₂ as disclosed in the specification: at least 80 units, and
invertase activity measured by Test T₃ as disclosed in the specification: less than 10 units.

1. Process for the construction of broad spectrum strains of bread-making yeast according to one of Claims 1 to 4, characterised by the fact that:

-         parent bread-making yeast strains are selected which :

·    either belong to the group of those which have particularly remarkable properties on sugared doughs

·    or belong to the group of those which have particularly remarkable properties on normal doughs and which are not too osmosensitive

and which have in general good properties of multiplication on molasses, good mineral nitrogen assimilation and good resistance to drying

-         the strains thus selected are sporulated,

-among the haploids (segregates) thus obtained are selected those which simultaneously also show a high potential for having maximum properties on the type of baking doughs for which the parent strains do not perform and which simultaneously

·    are coloured blue when cultivated on a medium based on glucose such as the YEG medium (yeast Extract 0.5%, glucose 2%, agar 3%) in the presence of 5-bromo-4-chloro-3-indolyl-alpha-D-glucopyranoside or X alpha-glu,
show lack of a development of a pink colour in a Trumbly test,

·    have an invertase level below 10 units;

·    have the following enzymatic activities :

-maltose-permease enzymatic activity after culture on glucose: at least 3 units, and

-maltase enzymatic activity after culture on glucose: at least 40 units,

·    the high potential haploids thus selected are crossed with one another and,

·    hybrids obtained from these crossings are selected by the same tests as for the selection of the haploids and subsequently by more complete selection tests, i.e. by culture test carried out by conventional methods:

·as a function of the yield of molasses,

·as a function of nitrogen assimilation,

·as a function of the activities in Tests A₁ and A₆ as disclosed in the

·specification, and

·as a function of the resistance to drying.

1. Fresh bread-making yeast characterised by the fact that

   in Test A₁ as disclosed in the specification, it produces a release of gas of from 170 to 230 ml, over 2 hours,
   in Test A₅ as disclosed in the specification, it produces a release of gas of from 130 to 180 ml, over 2 hours, and
   in a Test A₆ as disclosed in the specification, it produces a release of gas of from 170 to 230 ml, over 2 hours.

1. Dry bread-making yeast characterised by the fact that

   in Test A'₁ as disclosed in the specification, it produces a release of gas of from 120 to 145 ml, over 2 hours,
   in Test A'₅ as disclosed in the specification, it produces a release of gas of from 95 to 130 ml, over 2 hours, and
   in a Test A'₆ as disclosed in the specification, it produces a release of gas of from 135 to 190 ml, over 2 hours.

2. Process for the construction of broad spectrum strains of bread-making yeasts according to one of claims 1-3, characterized by the fact that, if a strain has all the properties required in one of claims 1-3 but too high an invertase activity (Test T₃ as disclosed in the specification), this activity is lowered by the disruption of one of its SUC genes.

1. Strain of bread-making yeast obtained by the process according to claim 38.

The specific tests referred to in the claims are further defined in the specification and are outlined in full in the appendix to this decision.

DECISION

Fair basis

A key issue in this decision will be to determine where the invention resides and whether the claims fairly claim this invention.  In order to do this, I need to analyse the existing knowledge as it existed at the priority date and understand the technical contribution the applicant has made to this knowledge.

The specification described the production of new broad spectrum strains of yeasts and a method of producing the same.  The broadest of the claims, and where the applicant submitted the invention resided, defined yeast strains which were characterised by either:

(a)    having particular gassing rates during fermentation on doughs containing varying levels of sugar measured by specific tests (such as tests A₁, A₅ and A₆) - these rates being higher than rates achieved by prior art yeast strains (claims 10-22); or

(b)   having particular levels of enzyme activities determined by tests T₁ (which measures maltose permease), T₂ (which measures maltase) and T₃ (which measures invertase) - these levels being higher (in the case of maltase and maltose permease) and lower (in the case of invertase) than activities measured in the prior art strains (claims 1-4).

I will consider the invention as defined in each of the above paragraphs separately.  With regard to the invention as defined in paragraph (a) (claims 10-22), both sides conceded that it was known at the priority date that broad spectrum baker's yeast strains were desirable and that such strains are highly active on doughs containing a wide range of sugar concentrations.  This activity can be measured by tests (such as tests A₁, A₅ and A₆) to determine the gassing rates during fermentation - a high gassing rate over a range of sugar concentrations being indicative of a yeast's ability to operate in those conditions.  While such tests characterise a yeast strain, they do not alter the yeast strain's properties nor do they produce a new yeast strain.  Thus, whether the tests themselves are novel or inventive is not relevant to determining the novelty or inventiveness of the defined yeast strains.

It is important to note that tests such as A₁, A₅ and A₆ merely indicate a yeast strain's ability to operate in a wide range of sugar concentrations.  Given that it was known to be desirable to produce a yeast strain which was highly active in a range of conditions, it must also have been a known goal to produce a yeast strain with a high gassing rate over a range of conditions.  The claims define a specific higher level of gassing rate, but there was no suggestion of a surprising (or selective) advantage to this specific level.  Therefore, I agree with the opponent that the particular levels defined in claims 10-22 are arbitrary ones - the claims merely set higher specific levels compared with the levels previously known.  While the "bar has been raised" by these new levels, it was an obvious goal to raise the bar.

It follows that, once stripped of their excess verbiage, claims 10-22 merely define the known goal of producing a broad spectrum yeast strain with high activity over a range of sugar conditions.

With regard to the invention defined in paragraph (b) (claims 1-4), both sides agreed that it was known at the priority date that a broad spectrum baker's yeast strain would need to be:

1. adapted to the utilisation of maltose [this enabled the yeast to work effectively on plain doughs (where the main source of fermentable sugars is maltose)]; and
   
   

2. osmotolerant [this enabled a yeast strain to operate effectively in the high sugar concentrations that occur in sweet doughs].

The utilisation of maltose was known at the priority date to be inter alia dependent on the activities of the enzyme maltase permease (which facilitates entry of maltose into the cell) and maltase (which catalyses the hydrolysis of maltose into glucose).  Given this, the skilled worker would have recognised that an obvious way to improve a yeast strain's adaptation to maltose was to raise the levels of activities of the enzymes maltase and maltose permease in the yeast strain.

In addition, one factor known at the priority date to influence the level of osmotolerance in yeasts was the activity of the enzyme, invertase.  This enzyme converts sucrose outside the cell into glucose and fructose which can then be transported into the cell.  This conversion increases the osmotic pressure on the cell and, in high sugar levels, high invertase activity could damage the yeast cell.  As a result, the skilled worker would have recognised an obvious way to improve osmotolerance in a yeast strain was to lower the activity of invertase.  The applicant argued that the invertase enzyme was only one of a number of known targets for increasing osmotolerance.  However, while this may be true, there was no surprising (or selective) advantage in targeting the invertase enzyme and therefore it was as desirable as any other obvious target for increasing osmotolerance.

Tests T₁, T₂ and T₃ measure the levels of activity of maltose permease, maltase, and invertase respectively in a yeast strain.  As noted above for claims 10-22, while such tests characterise a yeast strain, they do not alter the yeast strain's properties nor do they produce a new yeast strain.  Thus, whether the tests themselves are novel or inventive is not relevant to determining the novelty or inventiveness of the defined yeast strains.

Further, the tests merely measure the activity of the enzymes maltase, maltose permease and invertase.  Given that it was known goal at the priority date to produce yeast strains which were adapted to maltose and osmotolerant, it would have also been known to produce a yeast strain with higher levels of maltase and maltose permease activity and lower levels of invertase activity.  The claims define a specific levels of such enzymes' activity, but there was no suggestion of a surprising (or selective) advantage to these levels.  Therefore, as with claims 10-22, the particular levels of activity defined in claims 1-4 are arbitrary ones - the claims merely set higher (or lower, in the case of invertase) specific levels compared with the levels previously known when it was an obvious goal to raise (or lower) these levels.

I note that the yeast strains defined in claims 1-4 also include the additional features of "high multiplication yield", "good nitrogen assimilation", "good glucose fermentation activity" and "good resistance to drying".  However, each of these additional features are, in my view, standard characteristics which would have also been considered obviously desirable in baker's yeast well before the priority date.

It follows that, once stripped of their excess verbiage, claims 1-4 merely define the known goal of producing a broad spectrum yeast strain having higher levels of maltose permease and maltase and lower levels of invertase, which strain also contains other well known desirable properties such as a high multiplication yield.  The idea of combining these obviously desirable characteristics in the one strain would be an obvious goal.

So where does the invention reside?  The applicant argued that despite extensive traditional cross breeding of yeast strains, they were unable to improve on the broad spectrum yeast strains disclosed in the prior art.  They submitted that the critical breakthrough came through a new breeding process based on a key step - the unexpected and surprising observation that it was possible to sporulate a parent strain of yeast and obtain haploids which had desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parent.  According to Brian J Clarke, who was one of the declarants for the applicant, this critical key step enabled novel strains of yeast to be produced using a single mating cycle and avoided the large number of back crossings necessary with prior art procedures.

Lord Hoffmann in Biogen v Medeva [1997] RPC 1 at page 34, considered how far an invention could extend by determining the nature of the inventive idea:

"Whenever something is done for the first time it is the result of the addition of a new idea to the existing stock of knowledge.  Sometimes it is the idea of using established techniques to do something which no one had previously thought of doing.  In that case the inventive idea will be doing the new thing.  Sometimes, it is finding a way of doing something which people had wanted to do but could not think how.  The inventive idea would be the way of achieving that goal.  In yet other cases, the many people may have a general idea of how they might achieve the goal but not know how to solve a particular problem which stands in their way.  If someone devises a way of solving the problem, his inventive step will be that solution, but not the goal itself or the general method of achieving it." (my emphasis)

Applying Lord Hoffmann's approach from Biogen v Medeva (supra) to my analysis of the prior art and the above submissions from the applicant, it seems to me that many people knew what the goal was (a broad spectrum yeast strain) and had a general idea of how they might achieve the goal (developing yeast strains with high maltase and maltose permease activities and low invertase activity or developing yeasts well adapted to maltose and osmotolerant).  There was a problem, however, achieving that goal using the standard breeding techniques.  Using a new breeding process, containing the key step of obtaining haploids which had desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parent, the applicant was able to solve this problem and generate specific broad spectrum yeast strains.  It follows that the invention resides in the new breeding method containing this key step or yeast strains when produced by that method.

The applicant submitted that they were the first to disclose yeast strains with the features defined in claims 1-4, 10-22.  Drawing an analogy with a chemical product patent, the applicant argued that they were entitled to claim this product per se rather than be limited to a particular breeding process.

However, while the applicant has shown for the first time that it was possible to develop yeast strains with the properties claimed in claims 1-4, 10-22, such yeasts were obviously desirable.  As argued by the opponent, yeast strains, defined by known desirable properties, are not "new" products.  As discussed by T. A. Blanco-White in "Patents for Inventions and the Registration of Industrial Design" [3rd edition- published by Stevens & Sons (1962)] at page 71:

"If the result is in itself new and not obvious, the inventor may - in theory, at least - claim all methods (including methods in themselves obvious) of attaining it.  But if the result is known, either in the sense that it has been attained before or in the sense that it was an obviously desirable result if it could be attained, then a claim to any method of attaining it would be too wide." (my emphasis)

In this case, the result was obviously desirable.  Further, achieving that result in one way would not enable the skilled worker to achieve the same result by any other method.  As submitted by the opponent, while the patent applicant has shown for the first time that it was possible to develop yeast strains with the properties claimed in claim 1-4, 10-22, they have only disclosed one breeding method which successfully was used to produce these strains and have not disclosed a general principle which would enable the public to produce the claimed strains other than by

that breeding method.  As noted by Lord Hoffmann in Biogen v Medeva (supra) at page 51:

"There was more than one way in which the breadth of a claim might exceed the technical contribution to the art embodied in the invention.  The patent might claim results which it did not enable, such as making a wide class of products when it enabled only one of those products and disclosed no principle which could enable others to be made.  Or it might claim every way of achieving a result when it enabled only one way and it was possible to envisage other ways of achieving that result which made no use of the invention."

In contrast, claims 23-25 and 43-46 are limited to specific exemplified strains.  A claim to a specific yeast strain defines a specific entity rather than a class of products with obviously desirable properties.  In that sense, the specific strain is a "new" product and can be claimed per se.

From the above, I conclude that the invention resides in:

(a)a new breeding process, containing the key step of obtaining haploids which had desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parent or yeast strains when produced by that method;

(b)specific exemplified yeast strains as defined in claims 23-25 and 43-46.

It follows that only claims which contain one or both of those features will be fairly based.  The broadest claims, claims 1-4, 10-22, define a wide class of yeast strains without limitation to being produced by the method defined in paragraph (a) above.  As a result, claims 1-4, 10-22 are not fairly based.

In contrast, claims 23-25, 43-46 being limited to specific exemplified strains defined in paragraph (b) above are fairly based.  Claims 39-42 in defining breeding processes using the specific exemplified strains are clearly linked to, and limited by, the invention defined in paragraph (b) above.  As a result, claims 39-42 are fairly based (as per Olin Corporation v Super Cartridge Co Pty Ltd and another (1977) 14 ALR 149 and Montecatini Edison SpA v Eastman Kodak Co (1971) 45 ALJR 593).

The remaining claims (claims 5-9, 26-38, 47) relate to breeding processes or a strain of bread-making yeast obtained by a breeding process.  With the exception of claims 38 and 47, each of these remaining claims is, directly or indirectly, appended to claim 5.  Claim 5 includes the key step that haploids are selected from the parent strains to have desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parents and this feature is carried over into each of the dependent claims.  As noted above, this critical key step was the inventive idea disclosed by the applicant.  Consequently, each of the claims appended to claim 5 includes, and is limited to, the inventive concept and so these claims are fairly based.

Claim 38 (and claim 47 dependent thereon) does not contain that key step of claim 5 and therefore does not include the inventive concept.  As a result, claims 38 and 47 are not fairly based.

Novelty and Inventive Step

The closest related art is 2 patent specifications:

(a)GB 1 590 830; and

(b)US 4 396 632

The specifications are family equivalents of each other and they also share a common inventor (Dr Annie Loiez) with the current specification.  Both documents were published before the priority date of the current specification and US 4 396 632 was cited as part of the admitted prior art in the opposed specification.

The two prior documents describe wide spectrum yeast strains with low invertase and high maltase/maltose permease activities produced through classical breeding techniques.  The opponent conceded at the hearing that the strains disclosed in the prior art did not have the levels of activity of the yeasts defined in claims 1-4, 10-22 of the current specification.  Therefore, novelty was not pursued.

Instead, the opponent argued that the prior art specifications and the common knowledge taught that higher levels of maltase and maltose permease and lower levels of invertase were known to be desirable.  Further, it was commonly known that the characteristics of broad spectrum strains of yeast could be improved by traditional genetic breeding techniques and recombinant DNA technology.  The opponent submitted that the strains defined in claims 1-4, 10-22 could be produced using traditional breeding techniques and therefore since the claims were not limited to the specific method disclosed by the applicant, the claims include strains produced by traditional breeding techniques and would not be inventive.

However, there is no evidence before me to suggest that a person skilled in the art has been able to produce the strains defined in the claims using traditional breeding techniques.  On the contrary, the applicant's evidence suggests that after 7 years using the traditional breeding techniques they were unable to produce strains with the desired properties defined in the claims.  As the applicant's evidence is based on what the skilled worker was doing (and could do) at the priority date and not based on someone's opinions or conjectures of what a skilled worker could have done (or might possibly have been able to do) using traditional breeding techniques, it is much more persuasive than the opponent's arguments.  I therefore conclude that there was an inventive step in producing the desirable yeast strains and that therefore neither of the citations deprive claims 1-4, 10-22 of their inventive step as argued by the opponent.

The opponent then argued that claims 1-4, 10-22 simply defined yeast strains by a set of obviously desirable parameters.  Referring to the decision in Raychem Corp's Patents [1998] 2 RPC 31, the opponent submitted that if a patent claim consists of no more than a product or process selected by reference to a set of obviously desirable parameters, then the selection of those parameters is obvious. However, as suggested by the applicant, the current case was different from the Raychem Corp's Patents case.  The patentee, in Raychem Corp's Patents, had done nothing more than select the obviously useful products out of the range of those which can be made with existing technology.  In the current case, the properties of the yeast defined in the claims had not been produced in the prior art (nor could they apparently be easily produced).  Therefore the properties defined in the claims were not part of existing technology.

The court also noted in Raychem Corp's Patents that where the teaching of the specification had indicated there was nothing novel by way of materials or processing had been used, this reinforced the conclusion that the patentee had done no more than select the obviously useful products out of the range that could be made using existing technology.  The current case again can be distinguished from Raychem Corp's Patents because:

1. Even if the separate properties of the yeast were individually known, the applicant's evidence show that traditional breeding techniques were unable to produce a yeast strain where these properties had been combined.
   
   

2. In contrast to the Raychem Corp's Patents specifications, the opposed specification had indicated that there was a novel step in the breeding process to produce the new yeast strains.  This step was that haploids are selected from the parent strains to have desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parents.

For these reasons, the decision in Raychem Corp's Patents does not apply to the claims of the current specification.

The opponent argued that the critical key step that haploids are selected from the parent strains to have desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parents was itself non-inventive.

Professor Dawes, in evidence in reply, had declared that it was not surprising and certainly not impossible to find haploids well adapted to maltose issuing from slow diploid strains not adapted to maltose.  However, I think his discussion is based on his knowledge of general yeast genetics rather than the knowledge known at the priority date of the genes involved in maltose utilisation and osmotolerance.  Further, his conclusions are based on an hindsight analysis of what a skilled worker could have done at the priority date rather than what the skilled worker would have "directly been led" to do (as per Olin Mathieson v Biorex [1970] RPC 157 at 187). Simplistically, it does not seem obvious to me to select haploids with a reasonable expectation of success based on a characteristic which was never present in the parent. This would be especially so given the subsequent failure of other more traditional breeding techniques and, because, as argued by the applicant, adaptation to maltose fermentation was considered a trans and dominant characteristic at the priority date. In this case, the skilled worker would have thought it highly unlikely to obtain haploids having this dominant characteristic from parent strains which did not have the trait.

The opponent then argued that the citation, GB 1 590 830 disclosed the critical key step that constituted the "surprising finding" of the applicant's invention of haploids being selected based on exhibiting desirable properties (in relation to activity on plain or sugared doughs) not possessed by the diploid parents.  In particular:

1. In example 2, haploids of quick strains (ie strains adapted to maltose) underwent a mutagen treatment with a nitrosoguanidine mutagenic agent.  The mutagenised quick strain haploids  were selected for low invertase (less than 20 units) as well as having adaptation to maltose and the selected haploids were then mated with haploids from slow strains (ie osmotolerant) to generate hybrids.  The opponent argued that this technique taught the selection of haploids based on a characteristic not found in the parent and that the technique was not excluded by the claims.
   
   

2. Two of the haploids, Ha₁ and Ha₂ disclosed in example 4 of the citation showed adaptation to maltose and osmotolerance.  Example 4 does not indicate the origins of the haploids except that it "became recognisable from examples 1-3 that a certain number of haploids were of particular interest leading to selected hybrids".  However, the opponent argued that it is clear from examples 1 to 3 of this citation that the haploids were derived from either strains adapted to maltose ("quick" strains) or osmotolerant ("slow" strains) and yet were found to have the properties of both types of strains.

I am not convinced that either example 2 or 4 provides sufficient disclosure to deprive the claims of their inventive step.  The citation did not disclose the claimed yeast strains of the opposed specification nor did it provide a clear direction which of the techniques or examples would likely produce the yeast strains of the current claims.  The applicant's evidence showed that they were unable to generate the yeast strains defined in the current claims using the breeding methods described in the citation (including using the techniques described in example 2 and using the haploids described in example 4).  Further, while the opponent has postulated that haploids Ha₁ and Ha₂ were derived from either strains adapted to maltose ("quick" strains) or osmotolerant ("slow" strains), this is not clear from the citation and therefore the citation does not provide the skilled worker with sufficient incentive to pursue this mode of research.

In my view, the key critical step represents a selection from known breeding techniques.  This step succeeded where other techniques had failed.  The technique was not obvious because a skilled worker would not expect:

• a haploid to have a characteristic not possessed by the parent in relation to activity on sugar free and sugared doughs;

• the technique to have worked where other more traditional techniques had failed; or

• the technique to enable novel strains of yeast to be produced using a single mating cycle which avoided the large number of back crossings necessary with prior art techniques.

For the opponent to then extract this method from the citation after the event and say it was obvious is clearly an ex post facto analysis.

As a result, I conclude that the opponent has not established that any of the claims lack an inventive step in light of the evidence before me.

Manner of Manufacture

(i) Known desiderata

The opponent referred to the unpublished Australian Patent Office decision in relation to patent application 592527 in the name of Takeda Chemical Industries and opposition thereto by F. Hoffmann-La Roche issued on 18 January 1996 (96 APO 3) which concluded that claiming a known goal by desiderata was not patentable subject matter.

The opponent argued that in the current case, it was an obvious goal to bring together two known desirable properties (adaptation to maltose and osmotolerance) into one strain of bakers yeast.  As a result, according to the opponent, many of the claims define yeast strains in terms of their desirable properties and hence merely claim the known mere desiderata.

As I concluded above, once the excess verbiage is removed, claims 1-4, 10-22 of the opposed specification define yeast strains in terms of the known aspirations of the art.  Therefore, claims 1-4, 10-22 define a known goal by mere desiderata and this is not patentable subject matter.

(ii) collocation of known steps

The opponent argued that claims 5-9 and 26-42 merely define nothing more than a collocation of known breeding and selection steps.  They suggested that by the applicant's own admission (eg: the Clarke Declaration) the only step in the claimed process that is alleged to be novel is the step of selecting from diploid parents which are either adapted to maltose or osmotolerant, haploid strains which are both adapted to maltose and osmotolerant.  This "novel step" was, however known, according to the opponent, because it had been disclosed in GB 1 590 830.

Regardless of the novelty of the step, I do not accept the opponent's argument.  The steps defined in the claims clearly interact together to produce a result which, while obviously desirable, had not been previously achieved.  In that sense, the steps are a patentable combination because they produce a new or improved result.

Clarity

The opponent argued that the claims in general lack clarity because a number of the terms used in the claims are vague, or do not have clear meaning to a competent microbial physiologist or geneticist.  These include:

-"high multiplication yield"
-"good nitrogen assimilation"
-"good glucose fermentation activity"
-"good resistance to drying"
-"particularly remarkable properties on sugared dough"
-"particularly remarkable properties on normal dough"
-"not too osmosensitive"
-"good properties of multiplication on molasses"
-"good mineral nitrogen assimilation"
-"high potential for having maximum properties"

According to the opponent, these phrases all describe standard characteristics which were known well before the priority date to be desirable in strains of baker's yeast.  The opponent submitted that it is difficult to give these phrases clear meanings in the context of the claims of the opposed specification because generally the claims do not define tests for measuring the characteristics, nor do they specify what levels of activity are considered to be "good" or "particularly remarkable".  As a result, the opponent argued, it would be difficult to determine with any certainty whether given strains of yeasts possess characteristics which satisfy these criteria.

The applicant argued that the terms objected to by the opponent are clear within the context of the specification and would be understood by the PSA.  In any event, clarification of many of the terms are found in the description and the examples.  For example:

1. high multiplication yield (page 26, lines 34-35, example 1, lines 8-10);

2. good nitrogen assimilation (pages 18, 20, 27);

3. good glucose fermentation activity (defined by test results achieved in tests A₁, A'₁, A₃, A'₃, A₄, A'₄, A₅, A'₅, A₆ and A'₆ which are used to measure the fermentative activity of the strains);

4. good resistance to drying (given by comparison of results in tests A before drying and in tests A' (see tables 29, 44, 46);

5. particularly remarkable properties on sugared dough (a strain which shows remarkable properties on sugared doughs is osmotolerant as defined and evaluated in the tests disclosed (ie: tests A₄, A'₄, A₅, A'₅, A₆ and A'₆, page 12, lines 3-10);

6. particularly remarkable properties on normal dough (remarkable properties on sugared doughs indicates high adaptability to utilise maltose as defined by tests A₁, see page 11, line 27 to page 12, line 2 and page 12, line 29 to page 13, line 1);

7. good properties of multiplication on molasses (defined at page 13, lines 1-3, example 5, see (i);

8. not too osmosensitive (see page 13, lines 5-20)

I do not accept that the "clarification" provided by the specification provides exact definitions for relative terms such as "good" and "high" in the claims.  It is well-established law that it is "not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of the claim by adding to those words glosses drawn form other parts of the specification" (Decor Corp v Dart Industries 13 IPR 385).

Therefore, I agree with the opponent that terms such as "high" or "good" are relative and that it is difficult to give them a precise meaning.  However, despite this, the properties being described as being "good" and "high" etc are standard properties in a yeast.  In my view, a direct consequence of that would be that a skilled worker would be aware of the normal ranges of these properties and have some understanding of what constitutes "good" or "high" within those ranges as was argued by the applicant.  This suggests that even if terminology such as "high" and "good" is imprecise, the skilled worker would still have a broad understanding of the scope of those terms in the context of the claims.  In fact, despite their stated problems with the terms, the declarants for the opponent were still able to construe the claims.

The purpose of a claim is to “define clearly and with precision the monopoly claimed so that others may know the exact boundaries of the area within which they will be trespassers.  Their primary object is to limit and not extend the monopoly” [Electric and Musical Industries Ltd v Lissen Ltd (1938) 56 RPC 23 (at p 39)]. Thus, it is possible to have imprecise words in a claim so long as the public knows where the boundary limits of the claim are. The Full Court in Leonardis v Sartas [1996] 449 FCA 1 noted that it is not inadmissible to use in a claim an imprecise word, in an appropriate context where it conveys the necessary meaning.

In the current case, the properties described as "good" and "high" were not the characterising features of the invention as claimed.  It was not necessary to precisely define them in order to understand the boundary of the claims.  The skilled worker had a broad understanding of the scope of the terms and was able to construe the claims.  Therefore, these terms were clear in the context of the claims.

The opponent also submitted that tests T₁, T'₁, T₂, T'₂ and T₃ were inadequately defined in the specification because they omitted particular innoculation details.  As a result, one of their declarants adopting three different, but equally feasible, methods of inoculation had widely different results.  According to the opponent, the results show that a person seeking to determine whether a particular yeast strain fell within the scope of the claims 1-4 could not do so with any level of confidence and therefore the skilled worker would have difficulty determining "the exact boundaries of the area within which they will be trespassers".

The applicant argued that, because of the nature of biology, there would always be experimental errors in biological tests to determine enzyme activities.  The applicant also cited Catnic Components Ltd v Hill & Smith (1982) RPC 183 as evidence that even clear terms such as "vertical" are not always precise. According to the applicant, it followed that the variation in results obtained by following tests T₁, T'₁, T₂, T'₂ and T₃ did not render the claims unclear.

In claims 1-4 as currently drafted, the levels of enzyme activities measured by tests T₁, T'₁, T₂, T'₂ and T₃ are the characterising features of the invention and therefore it is important to define the activities so that the skilled worker could understand the boundary of the claims.  I accept the applicant's argument that biological tests are not always precise.  This would be understood by the person skilled in the art and taken into consideration by them in determining the scope of the claims as happened in Catnic Components Ltd v Hill & Smith (supra).  However, the problems noted by the opponent go beyond this.  There was a wide variation in the levels measured by the different forms of tests T₁, T'₁, T₂, T'₂ and T₃ well beyond the normal experimental variation expected within this art.  It was therefore important for the skilled worker to know which form of the test was intended because, without this information, the skilled worker would not be able to determine the boundary of the claim.  As a result, claims 1-4 are not clear because the yeast strains are currently characterised by referring to tests T₁, T'₁, T₂, T'₂ and T₃ and these tests have not clearly been defined in the specification with respect to the innoculum conditions.

CONCLUSION

1. None of the documents filed in evidence deprive any of the claims of their novelty.

1. The opponent has not established that any of the claims lack inventive step.

1. Claims 1-4, 10-22 define a known goal by desiderata and do not define a manner of new manufacture.

1. Claims 1-4, 10-22, 38 and 47 are not fairly based because they do not include the essential features of the invention.

1. Claims 1-4 are not clear because the claimed yeasts are characterised by reference to tests T₁, T'₁, T₂, T'₂ and T₃ and these tests have been inadequately described in the specification.

I believe that the deficiencies I have noted above can be solved by amendment and allow the applicant 60 days in which to propose amendments.

COSTS

Costs normally follow the event and I see no reason to depart from this in this case.  Therefore,

since the opponent has been partly successful, I award costs against the applicant.

Karen Ayers
Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Watermark, Melbourne

Patent attorneys for the opponent   :  FB Rice & Co, Melbourne

Appendix

Description of Enzyme and Yeast Activity Tests

Tests T and T'

Test T₁ (maltose permease)

Test T₁ is the quantitative determination of the maltose-permease after culture on a glucose medium in the absence of maltose and is based on the protocol of R. Serrano, Eur. J. Biochem., 1977, 80, 97-102.  The specification (at page 5) describes the test as follows:

The yeasts are cultivated for 24 hours on a YEG medium (Yeast extract 0.5%, glucose 2%, agar 3%).  The yeasts are then collected and washed to produce a suspension of yeasts containing 4 to 5 mg of dry yeast substance per ml of sodium phosphate buffer 0.05 M (50 millimol), pH 6.  This suspension is incubated on a water bath at 20^oC.  A solution containing, on the one hand, non-radioactive maltose and radioactive maltose U - C¹⁴ for a final concentration of 1 M (molar) and 22 microcuries/ml (814 kiloBecquerels/ml) is prepared.  The test for incorporation (entry of maltose into the cell), which is carried out at 20^oC to keep the maltose metabolism at a low level, consists of mixing 230 microlitres of the yeast suspension with 30 microlitres of the mixture of sugars.  The speed of incorporation is estimated from the intracellular radioactivity for periods of less than or equal to 30 seconds. The maltose permease activity is expressed in nanomols of maltose entering the cell per minute and per mg of dry substance.

Test T'₁

Quantitative determination of the maltose-permease after culture on a maltose medium (Test T₁) is carried out, as indicated above, only after the yeasts have been cultivated for 24 hours on YEM medium in which the 2% of glucose are replaced by 4% of maltose.

Test T₂  (maltase)

Test T₂ is the quantitative determination of the maltase after culture on a glucose medium in the absence of maltose is carried out as follows:

The yeasts are cultivated on a YEG medium for 24 hours as for the determination of maltose-permease. The yeasts are collected and washed for preparing a suspension containing 10 to 20 milligrams of dry yeast substance per millilitre, and the yeasts are made permeable by means of chloroform by adding 0.3 ml of chloroform to 2 ml of suspension.  The whole mixture is stirred for 30 minutes at 30 C and then determined by the method of H. Halvorson and E.L. Elias, Biochem. Biophys. Acta, 1958. 30. 28,

The maltase unit is expressed in nanomols of PNP (paranitrophenol) liberated per minute and per mg of yeast solids content.

Test T'₂

Quantitative determination of the maltase after culture on a maltose medium (Test T2) is carried out as indicated above only after the yeasts have been cultivated for 24 hours on a YEM medium in which the 2% of glucose are replaced by 4% of maltose.

Test T₃ (invertase)

Test T₃ measures the level of invertase activity.  The method involves a known quantity, of the order of a few tenths of mg, of yeast solids content and of sucrose at a 0.1 molar concentration is introduced into a test tube containing a buffer medium (acetate buffer at pH 4.7) and placed in a water bath at 30 C. At the end of 5 minutes, the reaction of inversion of the sugar is stopped by addition of the reagent with sodium dinitrosalicylate by means by means of which the quantity of reducing sugars formed is determined by a colorimetric reaction.
The invertase unit is defined as the production of one micromol of reducing sugars, corresponding in the present case to a demi-micromol of invert sugar, in 5 minutes per mg of yeast solids content at 30 C and ph 4.7 without plasmolysis of the yeast.

Tests A and A'

Tests A and A' used to characterise the activity of the yeasts of the invention.  Fermentation activity is measured using the fermentation meter of Burrows and Harrison described in the "Journal of the Institute of Brewing", vol. LXV, No.1, January-February 1959.  The tests are described as follows.

Test A₁ (fresh compressed yeasts).

A weight of compressed yeast corresponding to a solids content of 160 mg is added to 20 g of flour incubated at 30 C, this yeast having been mixed with 15 ml of water containing 27 g of NaCl per litre and 4 g of SO4 (NH4)2 per litre. The components are mixed with the aid of a spatula for 40 seconds to form a paste which is placed on a water bath adjusted to 30 C. 13 minutes after the onset of mixing, the vessel containing the paste is sealed hermetically. The total quantity of gas produced is measured after 60 minutes and then after 120 minutes. This quantity is expressed in ml at 30 C and 760 mm of Hg.

For all the yeasts likely to show in 120 minutes a gas development equal to or more than 150 ml of CO₂, the amount of fermentescible (sic) sugars solely present in the flour is insufficient and is a limiting factor, so that the test is modified as indicated hereinafter: a weight of 106 mg of yeasts solids content is used instead of 160 mg and consequently, the reading of the quantity of gas produced is by convention multiplied by 1.5.

Test A'1 (dried yeasts).
Identical to Test A₁ but the 160 mg of yeast solids content which is in the form of dry active yeast are rehydrated for 15 minutes in distilled water at 38^oC prior to mixing.  40% of the volume of water of hydration employed is used for this purpose.  The remainder of water to which 405 mg of NaCl are added is then added at the end of the 15 minutes of rehydration.

Test A₃ (fresh compressed yeasts).

The test is identical to test A'1 but with the addition of 2 g of sucrose to the flour. The total quantity of gas produced is measured after 60 minutes.

Test A'₃ (dried yeasts)

Test identical to test A'₁ but with the addition of 2 g of sucrose to the flour. The total quantity of gas produced is measured after 60 minutes.

Test A₄ (fresh compressed yeasts)

Test identical to A₁ but with the addition of 5.5 g of sucrose to the flour. The total quantity of gas produced is measured after 60 minutes.

Test A'₄ (dried yeasts)

Test identical to A'₁ but with the addition of 5.5 g of sucrose to the flour. The total quantity of gas produced is measured after 60 minutes.

Test A₅ (fresh compressed yeasts)

Test identical to A₁ but with the addition of 4 g of sucrose to the flour. The total quantity of gas produced is measured after 60 minutes and 120 minutes.

Test A'₅ (dried yeasts)
Test identical to test A'₁ but with the addition of 4 g of sucrose to the flour. The total quantity of gas produced is measured after 60 minutes and 120 minutes.

Test A₆ (fresh compressed yeasts)

6.5 g of icing sugar and a weight of compressed yeast corresponding to a solids content if 320 mg are added to 25 g of flour incubated at 30^oC. This is followed by the dame procedure as in test A₁ and the total quantity of gas produced is measured after 60 minutes and 120 minutes.

Test A'₆ (dried yeasts)

Test identical as test A₆, the 320 mg of yeast solids content in the form of active dry yeast is rehydrated as in test A'1.

Tests A₉ and A₁₀ (fresh compressed yeasts)

The osmosensitivity of the strains can also be evaluated over 2 hours by adding to the flour of the A₁ test, 1g of glucose (test A₉) in one hand, and in the other hand, 1g of glucose and 3g of sorbitol (test A₁₀), and by calculating the ratio (test A₁₀)/ (test A₉).