National Starch and Chemical Investment Holding Corporation v Goodman Fielder Limited

[1998] APO 48

official notice

decision of a delegate of the commissioner of patents

Application  :          No. 649374 in the name of National Starch and Chemical Investment Holding Corporation

Title:          Low Amylopectin Starch

Action: Opposition under section 59 of the Patents Act 1990 by Goodman Fielder Limited

Decision:          Issued            .

Abstract

The claims define a high amylose starch which is characterised by the percentage of amylose and amylopectin as "determined by butanol fractionation/exclusion chromatography measurement".  It was found that the invention lay not in the starch itself but in a particular method of analysing high amylose starches and thus all claims were considered not to define the invention.  All claims were found to be not novel in the light of a single document.  The opposition failed on the grounds of inventive step, manner of manufacture and clarity.  The application was refused since it was considered that any attempt to amend the claims to define the method of the invention would contravene section 102(2).

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 649374 by National Starch and Chemical Investment Holding Corporation and opposition under section 59 of the Patents Act 1990 by Goodman Fielder Limited.

background

Patent application no. 649374 was filed on 10 August 1993 in the name of National Starch and Chemical Investment Holding Corporation ("National Starch").  The application was advertised accepted on 19 May 1994.  Notice of opposition was filed on 19 August 1994 by Goodman Fielder Limited ("Goodman Fielder") and the evidentiary stages completed by 21 February 1997.  On 9 February 1996, during the evidence stages, National Starch filed a request for leave to amend the specification.  These amendments, the subject of the request, were subsequently advertised as allowed on 7 November 1996 and incorporated into the specification.

On 6 May 1998, just prior to the date set down for the opposition hearing, Goodman Fielder served further documents on National Starch and stated its intention to make an application to serve this further evidence at the hearing.

The opposition was heard in Canberra on 11 May 1998.  National Starch was represented by Mr Barry Hess of counsel assisted by Mr Cyril Bentley, patent attorney of Griffith Hack.  Goodman Fielder was represented by Ms Julia Baird of counsel assisted by Dr Trevor Davies, patent attorney of F. B. Rice & Co.

THE GROUNDS OF OPPOSITION

The grounds of opposition identified in the statement of grounds and particulars are that the invention:
A. was published in Australia before the priority date of the claims
B. was otherwise not novel in Australia
C. was obvious and did not involve an inventive step
D. is not a manner of manufacture
E. does not comply with the requirements of section 40.

With regard to grounds A and B, the particulars specified the following:

• Australian provisional patent application PL 3894

• International patent application PCT/AU93/00389

• Maize hybrid (Zea Mays) single cross F1 (seed), code 008 deposited with the American Type Culture Collection designated ATCC 75182

At the hearing Ms Baird for the opponent made submissions relating to whole of contents novelty, inventive step, manner of manufacture and section 40 issues. Mr Hess, for National Starch, stated at the hearing that grounds B, C and D of the opposition were improperly based on the 1990 Act and appeared from the wording to be based on the 1952 Act and thus the opposition should be dismissed. However, he did present me with submissions on the issues of novelty, inventive step, manner of manufacture and section 40 issues.

I note that section 59 (b) of the 1990 Act refers to compliance with section 18(1)(a) and (b). Section 18(1)(a) states that a patentable invention is one which is "a manner of manufacture within the meaning of section 6 of the Statute of Monopolies" and thus find that ground D is quite clear and is properly based on the 1990 Act. Similarly I find that ground C, that the invention was obvious and did not involve an inventive step, to be a proper ground of opposition under the 1990 Act.

Ground A however states that the invention as claimed "was published in Australia before the priority date of those claims".  The only document relied upon for novelty purposes in the opposition is PCT/AU93/00389 (hereafter referred to as the PCT application) which was addressed at the hearing under "whole of contents" novelty and, as discussed later, was not published before the priority date of the present claims.  Ground B states that the invention "was, before the priority date of those claims, otherwise not novel in Australia".  Section 7 defines novelty and includes "whole of contents" novelty (7(1)(c)).  The PCT application is given in the particulars under the heading "A-B" and so could possibly refer to either or both of those grounds.  I believe I must apply a purposive construction to the statement of grounds and particulars (see Borden Inc. v Elkem A/S (1992) AIPC 90-893) in order that the opposition is not defeated merely on procedural grounds. I thus consider that ground B is relevant for "whole of contents" novelty.

In conclusion, I find that the opposition should not be dismissed and can proceed on the grounds of novelty, inventive step, manner of manufacture and section 40 issues. In addition, I note that the statement of grounds and particulars, which is dated 21 November 1994, refers to claims 1-15 which corresponds to all of the accepted claims. Since amendments were made during the opposition process, the present claims are dated 9 February 1996 and number 1-14. This decision is based on submissions concerning the relevant claims after amendment which are not necessarily the same as those claims specified in the statement.

THE EVIDENCE

The evidence in support consists of statutory declarations by:

• Ian Leslie Batey, Principal Research Scientist employed by CSIRO Division of Plant Industry, Grain Quality Research Laboratory, North Ryde, NSW, dated 14 August 1995 and Exhibits SA.1 and SA.2.

• Norman William Herbert Cheetham, Associate Professor at the School of Chemistry, The University of New South Wales, dated 16 August 1995 and Exhibits SA.1 and SA.2.

The evidence in answer consists of statutory declarations by :

• Teresa Capitani, employee of National Starch and Chemical Company USA, dated 16 February 1996 and Exhibits 1 and 2.

• Paul Seib, Professor of grain science, Kansas State University USA, dated 28 February 1996 and Exhibits 1 and 2.

The evidence in reply consists of statutory declarations by:

• Ian Leslie Batey dated 14 February 1997 and Exhibits ILB-1 and 2.

• Norman William Herbert Cheetham dated 19 February 1997 and Exhibits NWHC-1 to 3.

The further evidence consists of a statutory declaration by:

• Trevor John Davies, patent attorney of F B Rice  & Co, patent attorneys, dated 6 May 1998 and Exhibits TJD. 1 to 3

DECISION

Further Evidence

Ms Baird, for Goodman Fielder, made an application at the hearing to serve further evidence.  This evidence had been served on the applicant a few days before, on 6 May 1998.  The evidence consists of a statutory declaration by Dr Trevor Davies and copies of the relevant prior art documents and ATCC deposit information which were listed in the statement of grounds and particulars.  Both parties made submissions to me at the hearing regarding the admissibility of the further evidence and I have summarised their submissions below.

Ms Baird for Goodman Fielder:

• the documents were part of the statement of grounds and particulars but an oversight has occurred in actually placing the physical documents on file as evidence

• these are three interconnected documents which are the only documents referred to in the statement and specific pages have been pointed to

• there is no prejudice to the applicant in having these documents considered as it was aware of them from the statement and they were referred to in the declarations of Capitani, Seib, Cheetham and Batey

• the documents go to novelty and are important to the outcome of the opposition.

Mr Hess for National Starch

• because the documents were not part of the evidence, National Starch assumed that the opponent did not intend to rely on them in their opposition: opponents often list documents in the statement of grounds and particulars which are not proceeded with

• no explanation has been given as to why the documents were not part of the evidence until 6 May 1998, especially considering that they are the opponent's own documents

• their inclusion at this late stage results in injustice to National Starch

• the documents do not speak for themselves - there needs to be evidence to support them

• the following decisions were brought to my attention by Mr Hess

Ball Corporation v American National Can Company (Patent Office Decision, 9 January 1995, unreported), Coal Corporation of Victoria v David William Hinckley and Brian Alan Nugent (Patent Office Decision, 17 September 1993, unreported), A. C. (Wholesale) Components Pty Ltd v Rib Loc Australia Pty Ltd and Heatshield Pty Ltd (Patent Office Decision, 15 May 1995, unreported), Respironics, Inc. v Rescare Limited (Patent Office Decision, 28 December 1995, unreported) and Commonwealth Scientific and Industrial Research Organisation v Asterol International (Patent Office Decision, 22 December 1994, unreported).

Regulation 5.10(4) governs the serving of further evidence:

"The Commissioner may:
           (a) on the application of a party; and
           (b) on such reasonable terms (if any) as the Commissioner specifies;
permit the party to serve further evidence on the other party."

Regulation 5.10(5) imposes further requirements that:

"The Commissioner must not give a direction under subregulation (1) or grant an application under subregulation (2) or (4) unless the Commissioner:

(a) if he or she proposes to grant an application by a party- is reasonably satisfied that the           other party has been notified of the application; and
           (b) if he or she proposes to act on his or her own motion- ensures that the parties are        notified of the proposed action; and
           (c) in either case:
  (i) gives the parties a reasonable opportunity to make representations concerning   the application or proposed action; and
  (ii) is reasonably satisfied that a direction, an extension of time or the serving of   further evidence is appropriate in all the circumstances.

The criteria for deciding whether leave to serve further evidence should be granted was discussed in Sandoz Ltd v Fujisawa Pharmaceutical Co Ltd (1993) AIPC 91-103 and Ball Corporation v American National Can Company (supra).  These criteria are:

1. It must be shown that the evidence could not have been obtained with reasonable diligence at an earlier stage.

2. The evidence must be such that, if given, it would probably have an important influence on the result of the case.

3. The evidence must be such as is presumably to be believed, that is it must be apparently credible, though not necessarily incontrovertible.

4. Would allowance of the request to serve further evidence:
           a. cause unnecessary protraction of the opposition?
           b. result in any injustice done to the other party?

I am not convinced that, in the present case, the evidence could not have been obtained at an earlier stage.  Goodman Fielder included the documents in question in their statement of grounds and particulars dated 21 November 1994 yet these documents were not submitted as evidence until 6 May 1998.  However, the documents are likely to have a very important influence on the outcome of the case and they are certainly credible documents.  PCT/AU93/00389 is highly relevant in the opposition for novelty considerations, PL 3894 is provided to establish the priority date of the PCT document and both of these disclose maize seed designated ATCC 75182.

I do not believe that the allowance of this request will result in any unnecessary protraction of the opposition.  Both parties presented me with submissions at the hearing regarding the documents and the ground of novelty.  In addition, I invited submissions from both National Starch and Goodman Fielder subsequent to the hearing on the appropriateness of National Starch being allowed time to file evidence in response to the further evidence.  The letter from Mr Bentley dated 1 June 1998 stated that National Starch did not wish to file any further evidence.  Consequently, there will be no protraction of the opposition.

As to the consideration of injustice to National Starch, I find that although it was reasonable for it to assume that the documents given in the statement of grounds and particulars were not to be relied upon in the opposition, it was aware of them and they were referred to by the declarants in the evidence.  The documents were the only three in the statement.  This is not a large number of documents, nor does it represent a selection of documents from a large number.  National Starch have been given the opportunity to provide me with both submissions and evidence in response to the further evidence.  I am thus of the opinion that National Starch has not suffered any injustice.

Thus, although it seems that the documents in question should have been available at a much earlier stage, I find that this evidence is credible and likely to have an important influence on the outcome of the case.  I do not believe that allowing the request will cause unnecessary protraction of the opposition or result in injustice to National Starch.  In addition, it is in the public interest that a serious opposition should be dealt with on its merit rather than being shut out due to a failure in procedure.  Having considered all these issues, I believe the serving of the further evidence is appropriate in all the circumstances and will allow the further evidence to be considered.

The Specification

The specification is that as amended after acceptance.  In the introduction it states that:

"This invention relates to a low amylopectin starch having unique molecular and functional characteristics.  The starch may be obtained from a number of sources, including a novel corn breeding population comprising germplasm selections which are homozygous for the recessive amylose extender (ae) gene and into which ae modifier genes have been accumulated by recurrent selection.

High amylose starches have been known for many years.  Such starches are derived from unique breeding sources, such as high amylose corn inbreds and their hybrids, wrinkled pea cultivars, high amylose barley cultivars, and the like.  Starches obtained from these sources have been exploited commercially for their unique functional properties, such as superior film-forming ability, higher cooking temperature, higher gel strength, improved water resistance, and other properties attributed to the higher amylose content, relative to the amylopectin content, of these starches."

It is known that starch is a polysaccharide comprising a mixture of amylose and amylopectin which are organised into compact granular structures.  Amylose is a linear polymer of D-anhydroglucose units which are linked by a-1,4-D-glucosidic bonds and amylopectin a larger branched polymer of amylose chains linked by a-1,6-D-glucosidic bonds.  It appears that naturally occurring starches vary widely in their amylose content but this is generally less than one third of the total starch content.  High amylose starches, obtained by recurrent selection breeding, have been known for many years, with a 40-75% amylose content reported for commercial starches.  Starches with amylose content in excess of 70% have also been reported but the specification states that such reports have been "viewed with skepticism" since "early methods used to isolate and analyse high amylose starches were flawed".  These methods of analysis include potentiometric and colorimetric analyses and seem to give unreliable results particularly for high amylose starches.  However, it seems to be well recognised that high amylose starches have desirable properties.

In addition to amylose and amylopectin, it has been found that starch may also contain other components .  Branched starch molecules having long outer chains seem to yield an over-estimation of amylose content by potentiometric iodine analysis and the presence of lower molecular weight constituent may result in an under-estimation of the amylose content.  In addition, there are also a range of other factors which may affect the amylose content of a particular plant including the location of the kernel on the ear, growing conditions, for example drought, and growing location.

The specification on page 4 lines 6-9 states that a starch containing in excess of 75% amylose and less than 10% amylopectin "may be extracted from a novel corn breeding population having a recessive amylose extender gene.  The corn population is a genetic composite comprising germplasm selections which are homozygous for the ae gene and into which ae modifier genes have been accumulated by recurrent selection".  Further down on page 4 lines 28-30 it says that "the starch is preferably extracted in substantially pure form from the grain of a starch bearing plant having a recessive amylose extender genotype coupled with numerous amylose extender modifier genes".  Page 8 lines 26-27 say "the substantially pure starch may be extracted from the grain of any starch-bearing plant in a population which is homozygous for the ae gene."  The starch may be derived from any source although the preferred starch is derived from corn.  However it seems that the starch may comprise a blend, for example on page 7 lines 18-21 "amylose or low molecular weight amylose is added to ordinary starch (e.g. corn) to dilute the amylopectin content."

At page 4 of the specification it states that "by using more reliable measuring techniques (e.g. full starch dispersion followed by butanol fractionation and exclusion chromatography)" that a starch containing in excess of 75% amylose and less than 10% amylopectin may be obtained.  The method of the invention is butanol fractionation of the starch followed by exclusion chromatography to measure the percentage of the different components by molecular weight and is described on pages 6-7 and 11-12 of the specification.  Both butanol fractionation and exclusion chromatography are known techniques but page 11 states that "the butanol fractionation methods of Adkins and Greenwood, Carbohydrate Research, 11:217-224 (1969) and Takeda, Hizukuri and Juliano, Carbohydrate Research, 148:299-308 (1986) were modified as described below".  Part I of this modified method is a solubilization step in which granular starch is dissolved and fully dispersed.  Part II involves complexing the amylose present in the starch with butanol and then separating it from the amylopectin by centrifugation.

The amylose and amylopectin content is then determined using gel permeation chromatography (GPC) as the preferred exclusion chromatography technique which separates the starch components according to molecular weight.  Amylose shows a GPC peak of about 200,000 molecular weight and amylopectin shows a molecular weight of greater than 1,500,000.  "Low molecular weight amylose" shows a GPC peak of about 15,000.

It is quite clear to me that the starches of the application are not derived from a new plant but may be derived from any plant source having an amylose extender genotype or may be formed by blending starches to achieve the desired result.  There is certainly no adequate disclosure in the specification of a new starch.  The starch samples VJR-1, VJR-2 and VJR-3 used in the examples as the starches of the invention were obtained from a particular corn breeding program in Illinois but there is no full description of these starches or Budapest Treaty deposit information.

In addition, a starch is not affected by the technique used to measure it and can only be characterised by its component polymers.  The fact that the applicant may be using a "more reliable measuring technique" does not alter the starch itself and I reject Mr Hess's argument that a new product has been derived as a result of the testing technique.  The measuring method does not actually produce a starch and can only identify a starch which has been obtained from some other source.

Thus I must conclude that the invention does not lie in the starch itself but in a method of analysing high amylose starch, this being the modified butanol fractionation method described, including the step of full starch dispersion, followed by exclusion chromatography to measure the ratio of the different molecular weight components.

The specification ends with 14 claims.  The independent claims are as follows:

"1. A substantially pure starch extracted from a plant source having an amylose extender genotype, the starch comprising at least 75% amylose and less than 10% amylopectin determined by butanol fractionation/exclusion chromatography measurement.

6. A substantially pure starch extracted from the grain of a plant having a recessive amylose extender genotype that is associated with amylose extender modifier genes, the starch comprising at least 75% amylose and less than 10% amylopectin determined by butanol fractionation/exclusion chromatography measurement.

12. A starch composition comprising:
a) at least 75% amylose;
b) less than 10% amylopectin; and
c) 8 to 25% low molecular amylose, determined by butanol fractionation/exclusion chromatography measurement,
wherein the composition is obtained from a plant source having an amylose extender genotype and wherein low molecular amylose refers to substantially linear polymers containing approximately 30 to 250 anhydroglucose units (gel permeation chromatography peak molecular weight of about 15,000) primarily linked by a -1,4-D glucosidic bonds."

Claim 1 defines a starch in terms of its source and the proportions of amylose and amylopectin as determined by butanol fractionation/exclusion chromatography measurement.  It is quite clear to me that claim 1 defines a starch, not a method of measurement, and this starch must contain at least 75% amylose and less than 10% amylopectin.  However, it is not clear what limitation the butanol fractionation/ GPC measurement places on a claim to the starch itself.  The starch is not affected in any way by the method, the component composition being an inherent feature of starch from any specific source.  The determination method is not an essential feature of the starch yet it does enable particular starches to be identified and the values given for amylose and amylopectin content may well differ from those determined by other methods.

As I have discussed above, the inventive concept here does not lie in a starch but in the method of analysing a starch.  Claim 1 thus does not define the invention but defines a desired result, namely any high amylose, low amylopectin starch extracted from any plant source which has an amylose extender genotype.  Similarly, since all 14 claims either define a starch, a starch composition or a gel, I find that all claims do not define the invention.

Section 40 Matters

Section 40 of the Patents Act requires that "a complete specification must: describe the invention fully…". The declarations/exhibits by Batey, Cheetham, Capitani and Seib deal predominantly with the description of the butanol fractionation/exclusion chromatography measurement technique and so I will give a brief outline of their evidence.

Cheetham gives a critical assessment of examples 1-3 of the complete specification and reports results of analysis of a number of starch samples using both butanol fractionation/GPC and iodine analysis as described on pages 11-13 of the opposed application.  The starches analysed by Cheetham were HA50 and HA70, which are commercially available high amylose starches Hylon V and Hylon VII respectively and used as control samples by National Starch, and samples S4 and S6 which are high amylose starches provided to him by Goodman Fielder.  The butanol fractionation/GPC measurements were performed using varying centrifugation speeds.  Cheetham notes that samples VJR 1, 2 and 3, which were the high amylose starches described in the specification, were not available to him but expresses serious doubts that these samples contain less than 10% amylopectin.

Cheetham asserts that the butanol fractionation/GPC methods described in the opposed specification are inadequate to allow a skilled person to determine with reliability the amylose and amylopectin concentrations of a starch sample.  He identifies specific shortcomings with the described method in that there is a lack of detail in certain of the crucial steps such as amount of solvents used, centrifugation times and speed and percentage recovery of starch found.

Batey similarly undertook his own testing of a number of starch samples.  These starches were provided by Goodman Fielder and reputed to be starches with high amylose content.  They were labelled Factory 008, laboratory 008, Hybrid 136X149, Hylon 5 and Hylon 7.  The starches were subjected to butanol fractionation and the amylose and amylopectin content measured by both GPC and colorimetric iodine determination.

Batey notes that the methods given in the complete specification were incomplete and that he had to rely on his own prior experience to fill in some of the gaps.  In his conclusion he states "Further information is needed about the conditions employed before a valid comparison can be made of the provided starches with those described in the patent specification".  He also notes specific shortcomings including those mentioned by Cheetham and in addition, Batey points to the lack of description of the method used to integrate and quantify the area under the GPC peaks.

Capitani, in her declaration, disagrees with Cheetham and Batey and states "I consider that the description of the butanol fractionation/gel permeation chromatography in the Applicant's specification is adequately described to allow a person skilled in the art of starch analysis to isolate starch and to measure the amount of amylose and amylopectin".  Her exhibit 2 shows a comparison of molecular weight profiles of certain high amylose starches by GPC.

The declaration and exhibits from Seib add very little to that stated by Capitani.  Both Cheetham and Batey, in reply, address issues raised by Capitani and Seib.

Ms Baird submitted that the butanol fractionation/exclusion chromatography measurement was not fully described as evidenced by the shortcomings reported by Cheetham and Batey and that it would not be possible for a person skilled in the art, using the method as described, to reliably analyse starch samples for the percentage of amylose and amylopectin.

Both Cheetham and Batey analysed a number of starch samples according to the methods described in the opposed specification.  I have no reason to doubt that Cheetham and Batey are well qualified to perform such investigations and note that they both outlined certain shortcomings in the method as described in the specification.  Nevertheless, I agree with Mr Hess that they were able to perform the method.

National Starch, ( in the opposed application), Cheetham and Batey all report results for amylopectin content of the starches Hylon5 and Hylon 7 by the butanol fractionation/gel permeation chromatography method.  For Hylon 5; National Starch found 46.0%, Cheetham 42.2 or 33.7% depending on centrifugation speed and Batey gives 29.7%.  For Hylon 7, National Starch give 32.4%, Cheetham 26.5 or 24.4% and Batey 13.5%.  Quite clearly, three independent researchers following essentially the same method obtain different results for the amylopectin content of even commercially available starches.  However, differences in experimental techniques by independent workers will always give rise to some differences in results.  In addition, as I mentioned above, the composition of any starch can be affected by a variety of plant variables and growing conditions.

Cheetham and Batey both identify certain features of the method which, in their opinion, are crucial for the reproducibility of the method.  These include amounts of particular reagents, centrifugation speeds and times and details of the method used to integrate the GPC peaks.  I believe that these very specific details are within the routine experimentation that a skilled person would undergo to determine the optimum conditions to use.  As with all experimental procedures, it would be necessary to perform the measurement using standardised conditions and control samples in order to produce reliable results.

Thus I find that the butanol fractionation/exclusion chromatography measurement method is fully described and that the description gives enough instruction for a skilled reader to perform the method.

Ms Baird also outlined other Section 40 objections to particular terms in the claims as follows:

"butanol fractionation/exclusion chromatography measurement"

The term "butanol fractionation/exclusion chromatography measurement" appears in claims 1, 4, 6, 9 and 12 and, by appendancy, in all claims 1-14.  The opponent's objections due to this term are that the claims are not clear and not fairly based on the matter described in the specification and that the invention is not defined.

Ms Baird's written submissions state:

"(a) the claims in which the above phrase is expressly stated (claims 1, 6 and 12 (sic)) are not fairly based on the description in the body of the specification.  They
lack an essential feature of the invention regarding the measurement, namely that the method requires the first step of full starch dispersion followed by a method of butanol fractionation and exclusion chromatography defined by the inventors.  The claims are not limited to this feature as they should be;

(b) further, claims 1, 4, 6, 9 and 12 include within their scope measurement performed by any butanol fractionation and exclusion chromatography measurements whereas the description in the body of the specification is limited to a particular modification of the butanol fractionation and exclusion chromatography measurement methods known to the art;

(c) further, claims 1, 4, 6, 9 and 12 are not clear and are indefinite in that the method (as described) does not enable a relevant addressee to discern the precise metes and boundaries of that which is claimed has been invented."

As I concluded earlier, the inventive concept here is in a method of analysing high amylose starches for their amylose and amylopectin content.  This method is said on page 4 of the specification to involve full starch dispersion followed by butanol fractionation and exclusion chromatography.  I agree with Ms Baird that the step of full starch dispersion seems to be an essential step in the process (see page 6 lines 28-30 and page 11 lines 24-29 of the specification).  I also agree that the specification discloses a particular modification of the known butanol fractionation method and that this also is an essential feature of the method.  Consequently, I find that  none of the claims define the invention as they do not define the method of the invention, which is a modified butanol fractionation method including a step of full starch dispersion, followed by exclusion chromatography.

However, the term "butanol fractionation/exclusion chromatography measurement" has been found to be fully described and, in the light of the specification, the term itself is clear.  Cheetham and Batey have shown they were able to perform the method and thus found no lack of clarity with the term.

"substantially pure starch", "extracted", "stable", "effective amount"

The statement of grounds and particulars identifies the terms "substantially pure starch", "extracted", "stable" and "effective amount" in certain of the claims as rendering those claims unclear and their scope indefinite.  At the hearing, Ms Baird presented submissions regarding each of the terms.  Mr Hess asserted that "the terminology of the claims is clear to the skilled addressee" and that neither Cheetham or Batey expressed any difficulty with any of these terms.

Claims 1 and 6 each define a "substantially pure starch".  These words are also used in various places in the specification, as pointed out by Ms Baird, but no definition of the term or any percentage purity is given.  I understand a "substantially pure starch" to be one which is not 100% pure, as that would be almost impossible to achieve, but one which is pure within the practical limitations of the methods used.  If the starch was not pure it must presumably contain other plant materials such as protein, oils, fibre etc extracted with the starch.  However, I have no reason to believe that any substantial amounts of other components are present, nor has Goodman Fielder presented me with any evidence that that is the case.  Consequently, I find the term "substantially pure starch" to be clear in the present context.

Claims 1 and 6 also contain the word "extracted"in defining how the starch is obtained from the plant source.  Ms Baird's written submissions say "It is unclear what role extraction plays in the overall method of determining the amylose/ amylopectin content.  There is no assistance given in the body of the specification".  From reading the specification as a whole I do not believe that the process of extracting the starch is crucial to the working of the invention and that a person skilled in the art would be aware of the various methods used to extract starch from plant material.  Indeed, page 6 of the specification describes the starch as being preferably milled from corn kernels in commercial or pilot scale quantity and on page 11, "Starches were also obtained by milling corn kernels from the experimental corn crops described in example 1 below".  The claims do not lack clarity due to the term "extracted".

Similarly I find that the terms "stable" and "effective amount" do not lack clarity in the present claims and do not have significant bearing on the invention.  I note that neither Cheetham nor Batey expressed any difficulty with the terms and believe they would be understood by the reader in the light of the specification as a whole.

In conclusion with regard to Section 40 issues, I find that the specification fully describes a method for the analysis of high amylose starches in which starch is extracted, fully solubilized, the amylose portion separated by complexation with butanol according to the described modified method and the content of the different components determined by GPC. However, none of the claims define this invention. In addition, I find that the terms "butanol fractionation/exclusion chromatography measurement", "substantially pure starch", "extracted", "stable" and "effective amount" are all clear in the present context.

Novelty

In respect of the ground of want of novelty, Goodman Fielder indicated it wished to rely on PCT/AU93/00389 ("PCT application") filed on 30 July 1993 and claiming priority from Australian provisional application PL 3894 with priority date of 31 July 1992.  This document was published on 17 February 1994 and is thus considered for "whole of contents" novelty.  The opposed application claims priority from US application 07/937794 and a priority date of 28 August 1992.  The issue of priority dates was not raised by either party and I believe that the application is properly based on US 07/937794.

Claim 1 of the PCT application is as follows:

"1. A hybrid maize seed capable of producing a starch having an amylose content of more than 80%."

Claim 8 defines a maize starch having an amylose content of more than 80%, claims 9, 10 and 11 as starches with amylose content of more than 85%, 90.1% and 94.8% respectively.  High amylose starches are recognised as having desirable properties (see page 12).  Page 2 of the specification describes a single cross F1 hybrid maize seed which carries the ae amylose extender gene and is capable of producing grain with amylose content in excess of 80%.  Examples of parenting lines are given and the cross between male G116 and female G121, referred to as Code 008, is said to give rise to the hybrid designated ATCC 75182 which yielded grain with starch having an amylose content in excess of 80%.  The hybrid G139W x G136W is reported as having an amylose content of 95.7%.  The PCT application describes determination of the amylose content by iodine analysis (pages 5-6) and molecular weight profiling by gel permeation chromatography (pages 10-12) on starch derived from code 008 grain.  The starch components are not reported to have been analysed by the butanol fractionation/gel permeation chromatography technique of the opposed application.

The PCT application does not specifically refer to the amylopectin concentration of its starches but does acknowledge on page 1 that starch comprises both amylose and amylopectin.  The fact that certain of its starches have an amylose content of more than 90% can only mean that the amylopectin concentration is less than 10%, especially considering that starch may contain other components in addition to amylose and amylopectin such as lower molecular weight components.  These other components are not specifically referred to in the PCT application but I note that Figure 1, which is a GPC molecular weight profile of three high amylose starches, shows peaks corresponding to low molecular starches with molecular weights of around 15,000.

Tables IIA and IIB of the opposed application report amylose content for the applicants three samples VJR-1, VJR-2 and VJR-3 as determined by iodine analysis (potentiometric and colorimetric) and by the described butanol fractionation/GPC method.  I will present this data in the following table:

As can be seen from National Starch's own results, the same starch samples show different amylose (and thus also amylopectin) content depending on the chosen method of analysis.  Butanol fractionation/GPC gives higher amylose content for the same samples than does both potentiometric and colorimetric iodine analysis. However, I note that Ms Capitani refers in her declaration to the articles Starch Chemistry and Technology, 2^nd edition, Ed. Whistler et al., Academic Press, Inc (1984) and Die Starke, 26(9) pages 289-328, September 1974 "Studies on Starches of High Amylose Content", W Banks et al. which state that iodine binding measurements give an over-estimation of amylose content, especially in amylomaize (ie high amylose starches).

In considering the issue of novelty, I need to apply the reverse infringement test as set out in Meyers Taylor Pty Ltd v Vicarr Industries Ltd, (1977) CLR 228 at page 235 where Aiken J. states:

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

Thus, I have to ask myself if the PCT application would infringe the opposed application if that were valid.  Therefore I need to ask if the PCT application discloses all the essential features of the claims of the opposed application.

The PCT application does indeed disclose a starch extracted from a plant source, ie maize, having an amylose extender genotype.  It also discloses starches comprising at least 75% amylose and less than 10% amylopectin, as discussed above.  What it does not disclose is that the determination of starch content is performed using butanol fractionation/exclusion chromatography measurement.  Ms Baird submitted that "By providing that the components of the starch be measured by a technique of butanol fractionation/exclusion chromatography the claims do not thereby avoid anticipation.  This measurement technique will not avoid a finding of infringement, it does not add any characteristic or unexpected and beneficial property to the starches claimed".

Although I have found that the measurement technique does not have any effect on the starch per se, as the amylose and amylopectin content is an inherent feature of the starch, this technique is defined in the claims.  Claim1, for example, defines a starch comprising at least 75% amylose and less than 10% amylopectin which is "determined by butanol fractionation/exclusion chromatography measurement".  Because of the acknowledged unreliability of the prior art methods of starch determination, it is not possible to say with any certainty that a starch which was shown to have 75% amylose and less than 10% amylopectin by any other method would show those properties when determined by butanol fractionation/exclusion chromatography measurement.

The report by Dr Batey dated 14 August 1995 describes analysis of five starches using the described butanol fractionation/GPC method.  These starches were all obtained from Goodman Fielder, the applicant of the PCT application and the present opponent.  Samples labelled Factory 008 and Laboratory 008 gave values for amylopectin of 13.2% and 15.8% respectively.  It seems a reasonable probability that these samples correspond to the starch Code 008 described in the PCT application.  Although, as pointed out at the hearing by Mr Hess, I do not have any evidence that the starches are the same, on the balance of probabilities, I believe that they are.  It seems highly unlikely that Goodman Fielder would supply starch samples to Batey which were assigned the same nomenclature as samples in the their PCT application but which were different.  Furthermore, National Starch has not provided me with any evidence to show that the samples are not the same.

Batey also tested another hybrid starch which he stated on pages 1, 3 and 4 of his exhibit SA.2 dated 14 August 1995 to be "Hybrid 136 x 149".  This particular hybrid showed an amylopectin concentration by butanol fractionation/GPC determination of 8.6% which is certainly within the range claimed in the opposed application.  However, table III on page 4 of the exhibit refers to "Hybrid 136 x 139" and it is a hybrid with this particular nomenclature which is described in the PCT application as having a very high (95.7%) amylose content.  I do not believe that Batey used both hybrids 136 x 149 and 136 x 139 and he says that only five samples were supplied.  In his Exhibit ILB-2 dated 17 February 1997 Batey gives results of HPLC analysis of a number of starches and he refers specifically to the 136 x 139 hybrid as a low amylopectin starch.  I believe that Batey has made a clerical error in his 14 August 1995 declaration and that the hybrid which shows an amylopectin content of 8.6% is actually Hybrid 136 x 139, the one described in the PCT application.  Again, I believe that on the balance of probabilities, the starch analysed by Batey is the same as the starch Hybrid 136 x 139 described in the PCT application.

Thus, certain starches described in the PCT application as being high amylose starches have been shown by Batey to fall within the scope of the claims of the opposed application.  Although the PCT application does not disclose butanol fractionation/exclusion chromatography measurement, these same starches have been shown to inherently have the property of a certain composition when determined by this method.

Thus the PCT application would infringe the claims of the National Starch application.  Claims 1 and 6, which define a starch comprising at least 75% amylose and less than 10% amylopectin lack novelty as do claims 2 and 8 (less than 5% amylopectin) and 3 and 7 (at least 85% amylose).  Claims 4, 9 and 12 define a starch which further comprises low molecular weight amylose.  As outlined above, this feature is disclosed by Figure 1 of the PCT application.  Claims 5, 11 and 14 are to a gel and such gels of starch in water are also within the scope of the PCT application.  Claim 10 defines the feature that the starch bearing plant is Zea mays L. (maize) and this too lacks novelty as the PCT application is directed to a maize starch.  Claim 13 defines a starch composition which is a blend of two or more starch fractions and is also lacking in novelty.  Thus I find all claims not novel.

Inventive Step

As Ms Baird pointed out in her submissions, one test of obviousness or lack of inventive step is whether it would have been obvious to a non inventive worker in the field equipped with the common general knowledge in that field as at the priority date, faced with the problem confronting the inventors to have taken whatever steps might have led from the prior art to the invention.

Ms Baird pointed to passages in the description which describe the prior art which is said to disclose the beneficial properties of high amylose starches and the difficulties in measurement of the amylose and amylopectin content.  In her written submissions she stated:

"No unexpected beneficial characteristics or properties are identified.  There is no inventive step in further breeding high amylose starches without any unexpected beneficial characteristics or properties over and above the advantageous characteristics already known for high amylose starches.  Similarly, a gel of such a starch will have those known properties and it is no more than what a non inventive skilled worker in the field would expect that the higher the amylose the greater these properties, eg gel strength and stiffness"

I must agree with Mr Hess with regard to the ground of obviousness, that no attempt has been made by Goodman Fielder to establish what was the common general knowledge in Australia as at the priority date of the opposed application.  Neither of their declarants give any evidence on common general knowledge and disclosure in Goodman Fielder's own specification is not sufficient to establish what the common general knowledge was.  The PCT application is not part of the prior art base for inventive step.  I do not think Goodman Fielder have established a proper case under this ground of opposition.

Manner of Manufacture

Ms Baird submitted that the starch of claims 1 to 4 and 6 to 10, the gel of claims 5, 11 and 14 and the starch composition of claims 12 and 13 are within the known art and are thus not a manner of manufacture.  She contended that there has been no substantial exercise of the inventive faculty and there is no invention.

I agree with Mr Hess that no evidence has been tendered on this issue and that the invention as claimed is for a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.  Ms Baird's comments seem to be directed more towards the issues of novelty and inventive step which are dealt with above.  Thus I find that all claims are for a manner of manufacture within section 18(1)(a).

Conclusion

I have decided that the opposition succeeds on the grounds of novelty and that the claims do not define the invention.  All claims lack novelty when considered in the light of PCT/AU93/00389 and none of the claims were considered to define the invention.  The opposition fails on the grounds of clarity, inventive step and manner of manufacture.

I believe that the specification does describe patentable subject matter.  As I indicated earlier, this is a method of analysing high amylose starch including the steps of full starch dispersion, the described modified butanol fractionation method and followed by exclusion chromatography measurement.  Although, from the material presented during the opposition process, I am unable to comment on the novelty of this method.

However, the claims of the specification all define either a starch, a gel or a starch composition, none defining a method.  It is my view that any attempt to amend the claims to define the method of the invention would result in the amendment contravening section 102(2) since the resulting claims would not fall within the scope of the claims before amendment.  As a result, I cannot see how the problems I have identified could possibly be overcome by amendment and consequently, I must refuse the application.

Costs

Since the opposition has succeeded on the grounds that the claims lack novelty and do not define the invention, I award costs against the applicant, National Starch and Chemical Investment Holding Corporation

Gillian Jenkins

Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Griffith Hack, Melbourne

Patent attorneys for the opponent   :  F. B. Rice & Co., Sydney