Monsanto Company v Imcera Group Inc
[1994] APO 39
•8 June 1994
official notice
decision of a delegate of the commissioner of patents
Application : No. 601272 in the name of MONSANTO COMPANY
Title: Metal-Associated Somatotropins
Action: Section 104 and Section 59 opposition by IMCERA GROUP INC.
Decision: Issued .
Abstract: - Amendment not allowable; the term "metal-associated" includes both physical and chemical associations and only chemical associations were disclosed at filing.
- Claims as accepted are not novel in light of the citations raised;
- Claims (as proposed to be amended) would be novel.
patents act 1990
decision of a delegate of the commissioner of patents
Re:Patent Application No. 601272 by MONSANTO COMPANY and oppositions thereto by IMCERA GROUP INC. under section 59 of the Patents Act 1952 and section 104 of the Patents Act 1990.
background
Patent Application number 601272 by Monsanto Company ("Monsanto") was lodged on 7 April 1988 as a divisional application (under section 51 of the Patents Act (1952)) of application number 48237/85 (patent number 573904). The parent application relied on a basic U.S. application to establish a convention priority date of 4 October 1984.
The application was advertised accepted on 6 September 1990 and on 6 December 1990, the company Imcera Group Inc. ("Imcera" then known as International Minerals and Chemical Corporation) lodged a notice of opposition to the grant of the patent.
On 12 November 1991, Monsanto filed a request to amend the specification. The Commissioner granted leave to amend and published a notice to that effect (under regulation 10.5(2)) on 6 August 1992. The opponent filed a notice of opposition to the allowance of the amendments (under regulation 10.5(3)) on 9 October 1992.
The evidence for the opposition under section 59 was completed on 18 February 1993 and the evidence for the opposition under section 104 was completed on 24 August 1993.
The oppositions were heard together in Melbourne on 14 and 15 February 1994 and 3 and 4 March 1994. Dr J McL Emmerson QC assisted by Mr Bruce Wellington (from E.F. Wellington and Co (Melb)) represented the applicant and Mr J Lyons QC assisted by Mr Gary Nock and Mr Brett Connor (from Carter Smith and Beadle (Melb)) represented the opponent.
As the application was both lodged and advertised accepted before the commencement of the Patents Act 1990, the provisions of section 234(3) and regulation 23.3 of the 1990 Act are applicable - that is the opposition to the grant of the patent under section 59 is governed by the provisions of the 1952 Act and regulations. The opposition under section 104 is governed by section 104 of the Patents Act 1990 because the amendments were filed after the commencement of this Act.
The grounds of opposition were listed as sections 59(l), sub-sections (a) - (i) of the Patents Act (1952) and sections 102 (1) and (2) of the Patents Act (1990).
SPECIFICATION
The admitted prior art (pages 2-5) discloses that somatotropins have a short half-life in serum and hence a substantial dose must be administered to provide the desired biological effect over an extended time.
There are a number of general prior art methods which have been used to prolong the release of polypeptides with short half-lives. However, it is normally difficult to predict which method would achieve a prolonged effective release for a particular polypeptide because of individual differences between polypeptides.
The invention resides in realizing that a prolonged effective release of somatotropin could be achieved if the hormone was chemically associated with a non-toxic polyvalent metal.
The examples illustrate the preparation of metal-associated bovine and porcine somatotropins containing 1% zinc or copper, compositions containing those preparations and the use of those compositions for the prolonged release of somatotropins.
The specification ends with 28 claims of which claims 1, 10 - 14, 23 and 26 are independent.
Claim 1, which is the main claim, defines:
"A somatotropin chemically associated with a non-toxic polyvalent metal."
An amendment was proposed after acceptance and have been opposed by Imcera. The proposed amendments add certain extra features to each of the independent claims and alter the description to reflect these additions.
The specification, as proposed to be amended contains 24 claims of which claims 1, 8, 14, 17, 21 and 23 are independent.
The new claim 1 is the main claim in the specification as proposed to be amended. It defines:
"A metal-associated somatotropin suitable for use in a prolonged release formulation intended for parental (sic) administration to an animal by injection or implantation, comprising somatotropin and a polyvalent metal selected from the group consisting of zinc, bismuth, barium, manganese, copper and cadmium, said metal comprising up to 2% by weight of said somatotropin."
EVIDENCE
Section 59 Opposition
The evidence-in-support consists of:
a)an affidavit from James E. Seeley and 7 supporting exhibits;
b)a statutory declaration from Malcolm Roy Brandon and 2 supporting exhibits;
c)a statutory declaration from Brett Connor attesting to the publication dates in Australia of certain patent specifications;
d)a statutory declaration from Leigh Oldmeadow attesting to a publication date of a journal article.
The evidence-in-answer consists of an affidavit from M. Jerome Sabacky.
The evidence-in-reply consists of:
a)a second statutory declaration by James E. Seeley;
b)a statutory declaration from Donald G. Campbell;
c)a second statutory declaration from Malcolm Roy Brandon;
d)a statutory declaration from Allan James Robins.
Section 104 Opposition:
evidence-in-support consists of a statutory declaration from James E. Seeley;
evidence-in-answer consists of an affidavit from M. Jerome Sabacky;
evidence-in-reply is a statutory declaration from James E. Seeley.
SUBMISSIONS
Opponent's Submissions
Section 104 Opposition:
The proposed amendments to the complete specification would result in the specification claiming matter not in substance disclosed in the specification as filed. In particular:
(a)the specification as filed described a somatotropin chemically associated with a non-toxic polyvalent metal whereas the amendments describe and define a metal associated somatotropin;
(b)the specification as filed did not describe the importance of the metal being present in an amount of up to 2% by weight of the somatotropin.
The proposed amendments would result in the claims not in substance falling within the scope of the claims before amendment because the claims after amendment define a metal associated somatotropin whereas the claims before amendment define a metal chemically associated with a somatotropin.
The proposed amendments do not meet the requirements of section 40(2) and (3). These are expounded in detail in the decision below.
Section 59 Opposition
1. Novelty
a)Claims 1-28 (as accepted) are not novel because they are prior published by the Organon GB patent specification 885798 (Organon) published in Australia 29 May 1962.
b)Claims 1-13 (as accepted) are not novel in light of the citation by Reusser "Demonstration of a negative binding effect of bovine growth hormone towards potassium" Experientia XXII/5: 309-310 (1966) freely available in Australia before 1980.
c)The claims (as accepted and as proposed to be amended) were not entitled to a priority date earlier than the date of lodgement of the divisional application. There were no statutory provisions in the 1990 Patents Act which allow divisionals made under the 1952 Patents Act to claim the priority date from its parent. Even if there were statutory provisions, the claims were not fairly based on either the parent or the US basic of the parent. Therefore, the claims were not entitled to an earlier priority date based on the parent or the US basic application. As a result, the priority date for the claims is the date of lodgement of the divisional and the claims are prior published by the parent application.
d)Claims 1-24 (as proposed to be amended) are also not novel in light of Organon. Claims 1-5, 7-12, 17-22 only differ from the citation in the concentration of metal claimed. This limitation is arbitrary and confers no novelty onto the claims.
2. Obviousness
The declarations of Dr Brandon and Dr Robins establish that the Organon patent is part of the CGK in Australia in the relevant field. These provide a basis to find that there is no inventive step in the claimed invention (as accepted and as proposed to be amended).
3. Manner of Manufacture
The claims were not an invention within the meaning of the Act. The claimed invention was the mere discovery of a new use of a known product.
4. Section 40
The specification (as accepted and as proposed to be amended) has a number of section 40 deficiencies. These are outlined in detail in the decision below.
Applicant's Submissions
Section 104 Opposition
There is support in the specification for the choice of metals (i.e. zinc, bismuth, barium, manganese, copper and cadmium) and the concentration of metal (i.e. 2% by weight of somatotropin) which were both explicitly disclosed in the specification as filed. The original specification also describes the importance of the metals being present in amounts of up to about 2% by weight for reasons of prolonging release of metal-associated somatotropin and of minimizing adverse reactions at the injection site. Thus, the claimed matter was in substance disclosed.
The terms "metal-associated" and "chemically associated with a metal" are used interchangeably throughout the specification and hence the terms are equivalent in the context of the specification. As a result, the claims (as proposed to be amended) are in substance within the scope of the claims before amendment.
The specification (as proposed to be amended) meets the requirements of section 40.
Section 59 Opposition
1. Novelty
(a) Organon only discloses a physical adsorption onto an insoluble metal compound (e.g: Zn(OH)2) rather than a chemical association with a metal ion. Further, the preparation disclosed in Organon is directed to enhancing the activity of growth hormone as opposed to prolonging the release of the hormone. It can therefore be distinguished from the claims as accepted;
(b) Reusser discloses binding studies on enzymatically modified somatotropins which are not considered "somatotropins" as defined in the specification. Reusser can therefore be distinguished from the claims as accepted;
(c) Organon does not deprive any of the claims (as proposed to be amended) of their novelty. In addition to the differences noted above, The Organon patent has 2 identifiable differences from the Monsanto application (as proposed to be amended):
(i)it teaches the use of a high concentration of metal in contrast to the low concentrations of the Monsanto application;
(ii) it does not teach the removal of surplus zinc;
The metal-containing water-insoluble inorganic salts of Organon would be expected to provoke adverse tissue injection-site responses due to the inability of such water-insoluble salts to dissolve or diffuse away from the injection site. In these types of cases, the presence of the metal in amounts of less than 2% by weight will provide a substantial and advantageous reduction in injection site responses. Such an advantage will confer novelty on to the Monsanto claims (as proposed to be amended).
(d) The Reusser citation can be distinguished from the Monsanto claims (as proposed to be amended). In addition to the differences noted above, the somatotropin preparation in Reusser contains acetic acid making it unsuitable for parenteral administration;
(e) The claims were entitled to the priority date of the parent application and its US basic. The 1990 Patents Act and Regulations provides a statutory basis for a divisional application lodged under the 1952 Act to claim priority from its parent. In addition, the claims of the divisional were fairly based on the matter disclosed in the parent.
Therefore the claims were entitled to their earlier priority date and not prior published by the parent application.
2. Obviousness
(a) The invention was not shown to be obvious as there was little evidence that any of the citations formed part of the common general knowledge of the art in Australia (Minnesota Mining and Manufacturing v Beiersdorf (1980) 29 ALR 29).
(b) In addition, the Organon patent teaches that at least
10-3 mg equivalents of metal is needed and hence is teaching away from using the lower concentration claimed in the Monsanto application (as proposed to be amended). The discovery that the amount of metal associated with the growth hormone to minimize undesirable adverse site responses while providing desirably-enhanced prolonged release characteristics can be as little as 0.3% by weight is very surprising in view of the much larger amounts emphatically taught in the Organon Patent.
3. Manner of Manufacture
The application is for more than a mere use of a known substance and the claims therefore define a manner of manufacture.
4. Section 40:
The Monsanto application (as accepted and as proposed to be amended) meets all the requirements of section 40.
DECISION
SECTION 104
Allowability of amendments under section 102 (1)
Section 102(1) prohibits an amendment (not being for the purpose of correcting a clerical error or obvious mistake) which would claim matter not in substance disclosed in the specification as filed.
To assess whether an amendment includes matter not in substance disclosed, the courts have applied the same test as they use to determine whether a complete specification is fairly based on a provisional or basic specification (Merck v Sankyo 23 IPR 415).
This test comes from Hoffman la Roche v Commissioner of Patents 123 CLR 529, where the High Court used the rules outlined in Mond Nickel Company Ltd's Application [1956] RPC 189:
Is the alleged invention as claimed broadly described in the specification?
Is there anything in the specification which is inconsistent with the alleged invention as claimed?
Does the claim include as a characteristic of the invention a feature as to which the specification is wholly silent?
In the present case, the proposed amendment seeks to introduce three changes to the independent claims:
(a)restrict the claims to particular non-toxic polyvalent metals (selected from the group consisting of zinc, bismuth, barium, manganese, copper and cadmium) where the accepted specification defined any non-toxic polyvalent metal;
(b)limit the claims to a particular concentration of metal (up to 2% by weight of somatotropin) where the accepted specification defined any concentration of metal;
(c)alter the claims such that instead of defining a somatotropin chemically associated with a metal, they define a metal-associated somatotropin.
There is support for the first change in the specification as filed. Page 7, lines 6-11 of the specification as filed specifically refers to a list of metals useful in prolonged release somatotropin compositions:
"The metal is selected from the group consisting of such polyvalent metals include zinc, iron, calcium, bismuth, barium, magnesium, manganese, aluminium, copper, cobalt, nickel and cadmium"
This list includes the specific metals defined in the proposed claims and hence, the particular metals claimed are broadly described and are not features on which the specification as filed is wholly silent. There is nothing in the specification which is inconsistent with the use of the particular metals in an association with somatotropin.
The opponent admits that the specification teaches that all metals are basically equivalent and suitable for use in the somatotropin association (see James E. Seeley declaration, page 3 filed as evidence-in-support for the section 104 Opposition). The choice of certain polyvalent metals would then clearly be a mere choice amongst alternatives (Coopers Animal Health v Western Stock 15 FCR 382) and would be an allowable amendment.
It follows that the specific metals are in substance disclosed in the specification as filed.
The specification as filed also supports the second change listed above which is to limit the metal-associated somatotropin to an association containing up to 2% by weight of a non-toxic polyvalent metal. The specification as filed states on page 7, lines 19-21:
"In another preferred embodiment of the present invention, the somatotropin is chemically associated with from about 0.3% to about 2% non-toxic metal, such as zinc or copper, by weight of said somatotropin".
On page 10, lines 19-20, concentrations of metal lower than 0.3% were also mentioned.
This provides a broad disclosure for the concentration range defined in the proposed claims. The use of up to 2% metal is not inconsistent with the specification as filed which exemplifies low concentrations of metal (see page 15, lines 30-31; also page 13, line 30 - page 14, line 1) and specifically teaches the removal of excess metal. In addition, the specification as filed is not wholly silent on the particular concentration range defined.
The opponent relied on Coopers Animal Health v Western Stock 15 FCR 382 to suggest that the specification as filed did not disclose the criticality of limiting the concentration of metal and hence the amended claims were not fairly based on the specification as filed.
However, limiting the concentration of metal in the current application is not in the nature of a selection which involves a fresh inventive step beyond the disclosure of the specification as filed and hence, the current case can be distinguished from Coopers Animal Health v Western Stock (supra). There is nothing "special" about the choice of a concentration of up to 2% a point which the opponent clearly concedes in the evidence-in-support of the section 104 Opposition (page 4 of the Seeley declaration):
"This text does not disclose anything unexpected or surprising in the efficacy of somatotropin associated with the lower amounts of zinc or copper."
It follows that restricting the concentration of metal in the claims is simply a choice from a broad range of concentrations initially claimed and is an allowable amendment.
As a result, I find that the concentration of metal up to 2% in the metal-associated somatotropin is in substance disclosed in the specification as filed.
The third proposed change replaces "somatotropin chemically associated with a metal" with "metal-associated somatotropin". The plain meaning of "metal-associated" includes a metal being both chemically or physically associated. However, the applicant argued that, reading the specification as a whole, metal-associated was limited to chemically associated.
I consider that the applicant's argument is only relevant to the specification as accepted. In that specification it stated:
"We have discovered that the foregoing objectives can be realised with a somatotropin chemically associated with a non-toxic polyvalent metal.
"Said metal-associated somatotropins are ideally adapted ...."
which may, arguably, compel a dictionary limitation on the term "metal-associated" equating it to "chemically associated ..." . In that case, the terms are (arguably) used interchangeably as asserted by the applicant.
However, in the specification as proposed to be amended, any such possible dictionary limitation on the term "metal-associated" has been removed. There is no basis in the specification (as proposed to be amended) to argue that the term "metal-associated" means anything other than its ordinary meaning, which includes physical associations.
The specification as filed was wholly silent on physical associations. Hence the proposed amendment is not allowable because the proposed claims are claiming matter not in substance disclosed in the specification as filed.
In summary, the proposed amendment is not allowable under section 102(1) because they claim matter not in substance disclosed in the specification as filed. Although, there is support for the restrictions to the specific type of metal and its concentration, there is no support to alter the term "chemically associated with a metal" to "metal associated".
Allowability of amendments under section 102 (2)(a)
Section 102(2)(a) states that an amendment of a complete specification is not allowable after the complete specification has been accepted if, as a result of the amendment, a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment. Allowability of amendments under the corresponding provision in the 1952 Patents Act was considered in W.J. Voit Rubber Corps Application [1965] AOJP 1752 (at page 1754) where the court said:
"the test as to whether a proposed amendment would have the effect of causing infringement when none existed before, seems to me a perfectly reasonable one."
This test has been ratified in the High Court by the decision of AMP v Commissioner (1974) AOJP 3224.
I have already determined that "metal-associated" is a broader term than "chemically associated" because it includes physical as well as chemical associations. I believe there are clear examples which would fall outside the scope of the accepted claims but within the scope of the claims as proposed to be amended - for instance: a polyvalent metal compound physically adsorbed to somatotropin; or an elemental polyvalent metal admixed with somatotropin.
These examples would result in an infringement of the claims (as proposed to be amended) where one did not exist before. Hence the claims (as proposed to be amended) do not in substance fall within the scope of the claims and the proposed amendments are not allowable under section 102(2)(a).
Section 102(2)(b)
Under section 102(2)(b), an amendment of a complete specification is not allowable after the specification has been accepted if, as a result of the amendment, the specification would not comply with subsection 40(2) or (3). The opponent suggested that the specification (as proposed to be amended) was not valid with regard to fair basis, full description and clarity of the claims.
I have dealt with the major submissions separately below:
a)The opponent argued that the term "metal-associated" (in the claims as proposed to be amended) is not clear because the term is "uncertain or ambiguous in scope" and its limits are wholly unclear. Further the opponent suggests that the term is not fully described. I agree with these submissions. From a fair reading of the specification, the reader could not determine the nature or limits of the "association" between metal and somatotropin and would be left in doubt as to whether a given somatotropin-metal association would fall within the scope of the claims (as per Martin and Biro Swan v H. Millwood (1954) 71 RPC 458). I therefore consider that the term is not sufficiently and clearly defined nor is it fully described.
b)The opponent suggested that the proposed claims are not fairly based on the matter disclosed in the specification. In particular, the specification only discloses a somatotropin being associated with metal by the addition of metal to somatotropin to cause a precipitate but the claims are not limited to this.
I believe that the claims should be limited to a somatotropin "chemically associated" with a metal. The specification only discusses chemical associations and hence does not support claims to the full range of "metal-associated" somatotropins. As a result, claims 1-24 are not fairly based.
Having said that, I do not see that the claims should be limited to a particular type of chemical association or to a particular method of preparing a chemical associated somatotropin as suggested by the opponent. A skilled worker would recognize a number of chemical associations that somatotropin could have with a metal from their common general knowledge and be able to prepare these metal-associated somatotropins without using inventive faculty. The specification also refers to a range of chemical associations which are part of the inventive concept.
I consider that the claims need not be limited to a somatotropin metal complex formed by the addition of metal to form a precipitate. However the claims must be limited to somatotropin chemically associated with a polyvalent metal and hence the proposed claims 1-24 are not fairly based.
c)The opponent suggested that the claims of the specification did not define the invention because the invention only resided in a metal-associated somatotropin, when administered in a biocompatible oil.
The clear teaching of the current specification as a whole is that the invention is not limited to this particular form of administration. The fact that the examples only show the administration of the somatotropin preparation in a biocompatible oil is not relevant - the examples need only provide one best method of performance.
d)The opponent argued that claims 1,4-8,11-17,19-24 (as proposed to be amended) and claims 1-5, 7-28 (as accepted), include within their scope the case where no metal need be present and hence these claims do not define the invention. I do not accept this argument entirely. As pointed out by the applicant, a "metal-associated somatotropin" must, by definition, contain at least some metal. However, having said that, the specification infers that there is a minimum threshold of metal below which the object of the invention (prolonged release) will not be achieved.
Thus, page 7, lines 15 et seq, states:
"Preferably the metal is present as a water-soluble compound and in an amount sufficient to prolong the release of the somatotropin from the formulation".
Since the primary object of the invention is to prolong release of the somatotropin, it seems to me that an essential feature of the invention must be to have a sufficient amount of metal to ensure this. Any claim which omits this feature would be inconsistent with the specification and not be fairly based.
This means that claims 1-5, 7-22 of the accepted application and claims 8, 11, 12, 21-24 (as proposed to be amended), which have no minimum metal limitations, are not fairly based.
e)The opponent has argued that claim 7, as proposed to be amended, is not clear as the term "unreacted metal ions" is not clear. However, I find the claim is clear. The only reasonable construction of the claim is that all the metal ions in the somatotropin complex are reacted with the somatotropin.
f)The opponent argued that claim 17 (as proposed to be amended) and claim 23 (as accepted) were not limited to a chemical association and hence did not define the invention. The applicant counter-argued that if the 2 compounds were brought together they would chemically react and hence the "chemical association" was implicit in the claim. I do not believe that the applicant's arguments are correct. Unless the metal compound was in an environment where it could disassociate into its component ions, it will not necessarily chemically associate with the somatotropin. As a result, the claims are not limited to chemical associations and hence do not define the invention.
In conclusion, there are four section 40 deficiencies in the specification (as proposed to be amended):
a)The term "metal-associated" is not clear because the limits of the term are uncertain. Further, the nature of the association has not been explained in the specification and therefore the term is not fully described.
b)The claims must be limited to somatotropin chemically associated with a polyvalent metal and hence claims 1-24 (as proposed to be amended) are not fairly based.
c)Claims 1-5, 7-22 (of the accepted application) and claims 8, 11, 12, 21-24 (as proposed to be amended), which have no minimum metal limitations, are not fairly based.
d)Claim 17 (as proposed to be amended) and claim 23 (as accepted) do not contain implicit limitations to a chemical association and hence do not define the invention.
Discretionary power
The opponent argued that even if the amendment was allowable, the Commissioner can still apply a discretionary power not to allow the amendment. Although I have determined that the amendment is not allowable under section 102, I do not believe that the reasons for non-allowability attack the substance of the amendment (to limit the claim to a particular type and concentration of metal) and hence I believe it is also appropriate to consider whether there are any other factors that would affect the exercise of the Commissioner's discretionary powers.
Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 recently considered this issue in depth. Gummow J referred to Smith Kline and French Laboratories Ltd v Evans Medical Ltd (1989) FSR 561 where the court said:
"The discretion as to whether or not to allow amendment is a wide one and the cases illustrate some principles which are applicable to the present case. First the onus to establish that amendment should be allowed is upon the patentee and full disclosure must be made of all relevant matters. If there is a failure to disclose all the relevant matters, amendment will be refused. Secondly, amendment will be allowed provided the amendments are permitted under the Act and no circumstances arise which would lead the court to refuse the amendment. Thirdly, it is in the public interest that amendment is sought promptly. Thus, in cases where a patentee delays for an unreasonable period before seeking amendment, it will not be allowed until the patentee shows reasonable grounds for his delay. Such includes cases where a patentee believed that amendment was not necessary and had reasonable grounds for that belief. Fourthly, a patentee who seeks to obtain an unfair advantage from a patent which he knows or should have known should be amended, will not be allowed to remain. Such a case is where a patentee threatens an infringer with his unamended patent after he knows or should have known of the need to amend. Fifthly, the court is concerned with the conduct of the patentee and not with the merit of the invention".
[I note that the Full Bench of the Federal Court has recently issued their decision on an appeal to this case (Anaesthetic Supplies Pty Ltd v Rescare Ltd no NG994 issued 5 May 1994). However, the Full Bench did not consider the lower courts comments on discretionary power. These comments are consistent with Lahore et al "Patents Designs and Trademark Law" on page 778 and are still valid law.]
In my view there are no other factors relevant at this time that affect the exercise of the discretionary powers. There has been nothing in the evidence before me to show that the applicant has not shown all relevant matters nor that there was a culpable delay by the applicant in seeking amendment nor that the applicant gained any advantage in having the claims accepted in their current drafted form.
SECTION 59 OPPOSITION
Having determined that the amendment is not allowable under section 102, I have to consider the accepted specification for the purposes of the section 59 opposition. However, as I have said previously, I believe that the reasons of non-allowabilty do not affect the substance of the amendment and relevant amendments would easily overcome the problems I have noted above. As a result, I believe it is appropriate in the section 59 Opposition to discuss both the case as accepted and as proposed to be amended. The exception will be the section 40 issues for the specification as proposed to be amended which have been covered above.
Novelty
The test for determining whether an invention lacks novelty is the "reverse infringement test" as set out in Meyers Taylor Pty Ltd v Vicarr [1977] CLR 228, where Aiken J. stated:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement."
Infringement of a claim has been said to occur where "each and every one of the essential integers of that claim have been taken" (Rodi and Wienenberger AG v Henry Showell Ltd (1969) RPC 367).
Novelty of accepted claims in light of Organon
Organon discloses a preparation of a growth hormone comprising the growth hormone adsorbed onto at least one pharmaceutically acceptable water insoluble compound of the metals zinc, cobalt, nickel, aluminium, or iron in such a ratio that for each mg of the growth hormone at least 10-3 mg equivalents of the metal are present. The specific examples in Organon precipitate bovine and human growth hormone from aqueous solution by adding ZnCl2, NiCl2 or CoSO4 followed by NaOH or Na3PO4. Although porcine somatotropin is not specifically used in the examples, it would be broadly disclosed within the term "somatotropin".
This disclosure contains each of the features of accepted claims 1-3, 5, 6, 8-11, 14-17, 20-24, 26 of the Monsanto application. There are extra features defined in claims 4, 7, 12, 13, 18, 19, 25, 28, which the citation does not disclose. In order to determine whether these claims are novel, I have to consider whether the extra feature are essential to the claims.
The issue of determining essential features was discussed in Catnic Components v Hill & Smith [1982] RPC 183. The judges in that case concluded inter alia that a feature is essential to a claim if:
a)it was essential to the working of the invention or if it materially affected the way in which the invention worked; or
b) the applicant or patentee regarded the feature as essential.
The extra features in claims 4, 7, 12, 13, 18, 19, 25, 28 do not appear to be essential to the working of the invention nor do they materially affect the way the invention works. The applicant clearly did not regard them as essential because the leading claim omits them. It follows that the dependent claims have the same essential features as the citation and they too are not novel.
The applicant argued that the disclosure in Organon described a physical rather than chemical association and hence tried to distinguish the accepted claims from the citation. They suggested that zinc hydroxide and zinc phosphate (used in examples 1 and 2 of Organon) were insoluble compounds and that the association of the metal and somatotropin was a physical adsorption onto an insoluble compound.
However these arguments appear to be technically flawed. The process in examples 1 and 2 of Organon has excess zinc chloride added to an aqueous hormone preparation before excess sodium hydroxide or sodium phosphate is added to precipitate the bulk of the zinc ions. This means that zinc chloride would chemically associate with the hormone and precipitate it prior to any physical adsorption onto zinc phosphate or zinc hydroxide. The skilled worker in following the directions of Organon "would inevitably produce a result which falls within the claim" (General Tire and Rubber Co. v Firestone [1971] RPC 23). I accept that physical adsorption onto relatively insoluble zinc hydroxide is occurring as Dr Sabacky suggests in evidence-in-answer (section 104). However I believe it is in addition to a chemical association.
The applicant also argued that Organon was directed to enhancing the activity of the growth hormone and not to prolonging its activity. Organon does not specifically make such a distinction in its disclosure but even if there were such a distinction, it would not confer novelty to the accepted Monsanto claims. The claims define a particular preparation of somatotropin per se regardless of use. The fact that it may have been used for a slightly different purpose in the citation is irrelevant (see, for example, Merrell Dow Pharmaceuticals Inc. v N.H. Norton and Co. Ltd [1994] RPC 1).
As I have not accepted either of the applicant's arguments, I conclude that Organon discloses a metal chemically associated with somatotropin and a process for preparing this and therefore (having regard to the essential features noted above) deprives all of the accepted claims of their novelty.
Novelty of accepted claims in light of Reusser
Reusser discloses chemical binding studies of bovine growth hormone with the metal cations magnesium and calcium. It specifically uses concentrations of 1.2-7.3% of magnesium and 2-12% of calcium. This disclosure contains each feature of claims 1, 2, 5, 6 and 8 and deprives these claims of their novelty.
The extra features in claims 3, 4, 7, 9-13 do not appear in the main claim, are not essential to the working of the invention and do not materially affect the working of the invention. It follows that these features are inessential and cannot confer novelty to the claims in which they appear.
The applicant argued that Reusser only discloses binding studies on enzymatically modified somatotropin which are not the biologically active "somatotropins" defined by the Monsanto specification. This argument is based on the assertion that the a particular phrase in the discussion of the prior art implied that the abbreviation "BGH" refers to the full phrase "enzymatically modified bovine growth hormone" rather than simply "bovine growth hormone". The applicant then extrapolated this construction to suggest that BGH would mean "enzymatically modified growth hormone" throughout the document.
I think this is a particularly strained construction. The term "BGH" is a common abbreviation in the art for bovine growth hormone and it would seem unlikely that a skilled addressee would use the term in a more specialised way. In addition, there are a number of other indications in the citation that suggest the term is referring to the biologically active somatotropin and not a modified form of it:
The title of the paper refers to bovine growth hormone rather than "enzymatically modified bovine growth hormone";
The purpose of the paper was to induce specific conformational changes in the protein chain. For this purpose, the authors would be interested in the complete protein and not fragments of it;
The paper gives no instructions on how to prepare an enzymatically modified BGH. The skilled addressee can only assume that it was the complete hormone used in the experiments;
I conclude that the somatotropin used in the Reusser citation was the native protein and that this falls within the definition of "somatotropin" supplied in the Monsanto specification. As a result, claims 1-13 are not novel in light of Reusser.
I find that the remaining claims (claims 14-27) are novel in light of Reusser. The citation adds acetic acid to prevent precipitation of somatotropin from solution and the resultant complex would, as a result, not be suitable in parenteral release formulations. It follows that the citation does not disclose the essential features of claims 14-27 and Reusser does not deprive claims 14-27 of their novelty.
Novelty of the claims (as proposed to be amended) in light of Organon
Organon discloses a preparation of the somatotropin primarily adsorbed onto an insoluble metal compound with a minimum of 10-3 milligram equivalents of the metal present. Using some elementary schoolgirl chemistry, the minimum milligram equivalents of the different metals can be converted to percentage weights.
Organon does not specifically disclose the metals zinc, bismuth, barium, manganese, copper or cadmium in association with somatotropin in a concentration of up to 2% and therefore does not appear to disclose the features of claim 1 (or any of the independent claims which also include those features).
The opponent submitted that Organon does have all the features of claim 1 (as proposed to be amended). The opponent argued that zinc (or any of the metals claimed) would react stoichiometrically with somatotropin and if excess zinc was added to somatotropin, only a limited amount would bind with the somatotropin leaving excess zinc in solution. Thus, the addition of 3.27% zinc (the minimum concentration envisaged by Organon) would produce a precipitate with significantly less zinc (possibly under 2%) which would then fall within the scope of the claims (as proposed to be amended).
The opponent referred to the Monsanto specification to substantiate their point. In particular, page 13, lines 11-20 teaches the addition of ZnCl2 well in excess of 2% w/w Zn to produce a precipitate containing 0.3-1% zinc:
"As the addition of the ZnCl2 solution is continued, the somatotropin solution reaches first an off-white, then pearly-white colour as the stoichiometric amount of ZnCl2 is added. For instance, by adding 4 ml of 1M ZnCl2 to 400 mls of a pH 9.5 solution containing about 20 mg somatotropin per ml and 0.09M TRIS in 4.5M urea, a uniform, pearly-white zinc-somatotropin suspension will be formed. Additional ZnCl2 (e.g. up to about 10 ml of 1M ZnCl2 solution) can be added to ensure complete precipitation."
It would seem to me highly unlikely that a skilled addressee using the directions of Organon would inevitably produce a precipitate which would fall within the scope of claim 1 (as proposed to be amended). Organon does not teach that excess metal needs to be removed by washing nor does it teach that the rate of zinc addition has to be regulated to minimise the amount of zinc in the precipitate. The examples in Organon use high concentrations of zinc and add NaOH to produce an insoluble Zn(OH)2 precipitate which will further increase the amount of zinc in the precipitate.
However, even if this technical argument was correct, I do not believe that it deprives the claims (as proposed to be amended) of their novelty. The Monsanto specification teaches the importance of minimising the concentration of metal which Organon does not. As required by Hill v Evans (1862) 6 LT 90, the citation is not for the purposes of "practical utility" equal to the subsequent patent. Further, although the skilled addressee could have used the minimum concentration of metal and may have produced the claimed somatotropin preparation, there were no "clear and unmistakeable directions" in Organon for the skilled addressee to do so:
"If...the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee's claim, but which would be at least likely to be carried out in a way that would not do so, the patentee's claim will not be anticipated".
(General Tire and Rubber v Firestone [1972] RPC 457 at page 486).
In a separate submission, the opponent argued that the 2% by weight metal concentration was not an essential feature of the claims because the 2% limit:
a)was insignificant in view of, for example, the 3.27% limit (for zinc) disclosed in Organon;
b)did not significantly prevent adverse reactions in experiments by Dr Donald Campbell (submitted as evidence-in-reply);
c)was merely an arbitrary distinction which did not confer any novelty onto the claims (citing re Application by National Research Development Corporation (1992) 24 IPR 123).
I do not accept these arguments. On the first point, the 2% limit (for zinc) would appear to be very significant in light of Organon because the citation emphatically taught that at least (for example) 3.27% of zinc must be added and the examples all add much larger concentrations.
On the second point, I accept the applicants arguments which refuted it:
a)this is a question of utility which is not a ground of opposition;
b)the experiments may have been technically flawed because Dr Campbell added extra zinc in a soluble and not insoluble form and did not ensure that the concentration in the precipitate was correct by washing the precipitate or regulating the rate of addition of salt.
On the third point, I agree that the actual concentration of "2%" is an arbitrary figure but I believe that it limits the claims (as proposed to be amended) to preparations of somatotropins with low concentrations of metal. This was not contemplated in Organon and hence, the concentration limit defined in the claims (as proposed to be amended), is not merely an arbitrary distinction to avoid a prior publication.
The case can also be distinguished from Application by National Research Development Corporation (supra) because the examples in the National Research Development Corporation application were in the same range as the prior art examples and outside the range claimed. In contrast, in the Monsanto application, the examples are within the range claimed and well below the examples of Organon.
I consider that the 2% limit that appears in the claims is an essential feature of the claims and that Organon does not contain that feature. I find, as a result, that the claims (as proposed to be amended) are all novel in light of the Organon disclosure.
Novelty of the claims (as proposed to be amended) in light of Reusser
Reusser only discloses chemical binding studies of bovine growth hormone using magnesium and calcium neither of which are defined in the claims (as proposed to be amended). It follows that Reusser does not disclose all the essential features of the claims (as proposed to be amended) and hence does not deprive these of their novelty.
I also note that each claim is limited to a preparation which is suitable for parenteral administration to an animal. Reusser uses 0.05M acetic acid in order to avoid precipitation of the hormone. Such a preparation would be unsuitable for this use.
I conclude that Reusser does not deprive any of the claims (as proposed to be amended) of their novelty.
Novelty of the claims (as accepted and as proposed to be amended) in light of the Parent Application
In Mr Lyons submission, the regulations under the Patents Act 1990 do not provide for a divisional application made under the 1952 Act to maintain its divisional status under the 1990 Act.
This issue has been addressed in the recently issued office decision dated 6 June 1994 on application number 604191 by Ricardo International PLC. In this decision, the Hearing Officer discussed the priority date entitlements of a divisional application made under the 1952 Act but not finally dealt with before the commencing day of the 1990 Act:
"In Dr Emmerson's submission, the regulations under the Patents Act 1990 are so drafted that they do not give divisional status to a divisional application made under the 1952 Act but not finally dealt with before the commencing day of the 1990 Act. I note at the outset that there is no direct authority upon the point in issue.
Application 619424 was lodged prior to 30 April 1991 (the commencing day of the 1990 Act under sec 2(2)) and, consequently, is a so-called "transitional application". Chapters 23 of the Patents Act 1990 and of the regulations contain transitional and savings provisions which deal with such applications.
Before directing attention to the wording of these transitional and savings provisions, I think it is desirable to firstly discuss Dr Emmerson's submission in principle.
Broadly speaking an application made under sec 51 of the 1952 Act and finally dealt with under that Act could retain priority through to an earlier application. Corresponding benefits are of course available under the 1990 Act by virtue of sec 39. If Dr Emmerson is correct in his submission, any entitlement by a transitional application to early priority deriving from sec 51 would be lost simply because the application bridged the 1952 and 1990 Acts. I think it would be perverse to suggest that this is the legislative intent of the 1990 Act and regulations. On my understanding of the matter, the transitional and savings provisions were intended to address the need to deal fairly with transitional applications and thereby - to draw an analogy from the judgement of Lockart J in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1993) AIPC 91-025 at page 39,594 - ensure that a 1952 Act applicant is treated under the 1990 Act as if the 1952 Act had continued to operate. If this were not the case, it seems grossly anomalous that application 619424 was not entitled to have the early priority date which it would have taken under the 1952 Act preserved merely because of the passage of the 1990 Act. A similar anomaly would occur if the benefit of Convention priority rights obtained under the 1952 Act was negated simply because of the repeal of that legislation and its replacement by the 1990 Act.
An important section in Chapter 23 of the 1990 Act is sec 234. Section 234(2) provides for the case where, before the commencing day, a patent application had been lodged under the 1952 Act and a complete specification had been lodged under that Act in respect of the application, and the application had not been withdrawn or finally dealt with; and states that, subject to Chapter 23 and the regulations, the 1990 Act applies in relation to the application on and after that day (i.e. the commencing day) as if it were a complete application made under the 1990 Act.
Thus the effect of sec 234(2) is that it treats application 619424 as if it were a complete application made under the 1990 Act. However this provision does not of itself establish that the application in suit may be treated as a complete application having divisional status. Another important provision, given the background to application 619424, is reg 23.18 which provides as follows:
"23.18In the case of a claim of a specification:
(a) relating to a further application for a standard
patent or for a petty patent under section 51 of
the 1952 Act in respect of an invention disclosed
in a provisional specification under that Act;
............
the priority date is determined under section 45 of
the 1952 Act or subsection 191(8) of the Statute Law
(Miscellaneous Amendments) Act (No. 1) 1982, as the
case requires."
Thus reg 23.18 operates to maintain the priority entitlements of a further application based on a provisional specification and lodged prior to the commencing day.
However, this is not of any assistance to Orbital in the present situation. Under the 1952 Act a further application could be made by virtue of sec 51 for an invention disclosed in a provisional specification or a complete specification lodged in respect of the original or "parent" application (sec 51(1)). If the parent application was accompanied by a provisional specification then, unless the invention was also disclosed in the parent complete-after provisional specification, the further application could proceed under sec 51 only if it was lodged within 12 months of the date of lodgement of the parent (sec 51(2)).
It follows in my view that "provisional specification" in reg 23.18 means the provisional specification which originally accompanied the parent application. On this basis the claims of application 619424 are not "in respect of an invention disclosed in a provisional specification" within the meaning of reg 23.18 since parent application 26026/88 (being a national phase application) claimed priority from, but was not accompanied by, provisional specification PI 5102, i.e., provisional specification PI 5102 was, under the circumstances, treated as being analagous to a basic document in respect of a Convention application.
I think it appropriate to now turn to reg 23.14 which provides as follows:
"23.14If:
(a) a provision of the Act requires an act to be done
under that or another particular provision of the
Act; and
(b) the act was done under a corresponding provision
of the 1952 Act;
that act is taken to have been done under the
provision of this Act referred to in paragraph (a)."
In APM Ltd v CIL Inc (1981) 148 CLR 554 the High Court of Australia held that the provisions of sec 160(2) of the Patents Act 1952 were applicable to sec 141(1) of the 1952 Act for making Convention applications. In doing so the court addressed the question of whether sec 141(1) involved what sec 160(2) described as "an act or step in relation to an application for a patent ... required to be done or taken", and took the view (page 556 refers) that "the very first act by way of application for a patent will itself be an act or step in relation to an application within the meaning of s. 160(2)".
It is clear from this decision (see also Kimberly-Clarke Ltd v Commissioner of Patents and Minnesota Mining and Manufacturing Company 13 IPR 569) that the concept of what constitutes an "act" under the provisions of sec 160(2) of the 1952 Act should be interpreted broadly. I see no reason why this broad interpretation should not similarly apply to the provisions of reg 23.14 of the 1990 Act, despite the obvious different wording. In this regard it is relevant to observe that although reg 23.14 does not specifically refer to an act which is "in relation to an application for a patent", I cannot find any clear indication elsewhere in the Act or regulations which excludes such an act from the operation of reg 23.14 (compare with, for example, the effect of sec 235(2) on the operation of sec 235(1)).
Section 39 is the section of the 1990 Act which provides for divisional applications. Section 39(1) entitles a person who has already made a complete application to make a further application for a standard patent or a petty patent for an invention disclosed in the specification filed in respect of the original or "parent" application. Thus sec 39(1) essentially maintains the provisions of sec 51(1) of the 1952 Act regarding divisional applications. As a consequence of the view taken by the High Court in APM v CIL (supra), I am of the opinion that the making of such further application constitutes an "act" within the meaning of reg 23.14.
It may be argued that sec 39 does not require an act to be done. The Federal Court in Scaniainventor v Commissioner of Patents 36 ALR 101 came to the conclusion that "required" in the context of sec 160(2) meant "requisite" or "needed" in order to secure an advantage or avoid a disadvantage. In sec 39 (and also sec 51) an applicant may secure the advantage of an entitlement to the earlier priority date of the parent application. Unlike the statutory provisions considered by the courts in the above-cited cases, reg 23.14 is not specifically concerned with an act which is required to be done "within a certain time". However, to the extent that sec 39 confers a benefit or right only as a result of the doing of an act, viz. making a further application for an invention disclosed in the parent application, I think this act may aptly be described as "required" by sec 39.
Taking account of the various issues raised above, I can not agree with the result contended for by Dr Emmerson and, consequently, I find that Orbital application 619424 is entitled to prima facie divisional status under the 1990 Act. The priority date of the claims of the Orbital application is accordingly governed by reg 3.12(1)(c)."
I agree with the analysis and adopt the conclusions of the Hearing Officer. Consequently I find that application 601272 can be considered a divisional application under section 39 of the 1990 Act and is therefore entitled to claim priority from its parent application under regulation 3.12(1)(c) of that Act.
In a separate submission, Mr Lyons suggested (using Coopers Animal Health v Western Stock (supra) as an authority) that the claims of the specification were not fairly based on the basic or the parent specifications. Hence the claims were only entitled to claim priority from the date of filing of the divisional application and, as a result, the claims were prior published by the parent application which was published before the date of filing of the divisional.
However, as I have said previously, I do not believe that Coopers Animal Health v Western Stock (supra) applies in the present case because it involved a selection.
The appropriate test for determining whether a claim was "in substance disclosed" in the basic specification is the same as fair basis and comes from Hoffman la Roche v Commissioner of Patents 123 CLR 529, where the High Court used the rules expounded in Mond Nickel Company Ltd's Application [1956] RPC 189.
There appears to be ample support throughout both the basic and parent specifications for the claims as accepted, including 8 claims in the basic specification and 9 claims in the parent application which specifically define a somatotropin chemically associated with a metal or a process to produce this complex. The matter defined in the accepted claims of the Monsanto specification has therefore been broadly described in the specification. Further, the specification is not inconsistent with nor wholly silent on this matter.
With regard to whether the claims (as proposed to be amended) are fairly based on the parent and basic applications, I have to consider whether the three changes to the independent claims have been in substance disclosed. These changes are:
(a)restrict the claims to particular non-toxic polyvalent metals (selected from the group consisting of zinc, bismuth, barium, manganese, copper and cadmium) where the accepted specification defined any non-toxic polyvalent metal;
(b)limit the claims to a particular concentration of metal (up to 2% by weight of somatotropin) where the accepted specification defined any concentration of metal;
(c)alter the claims such that instead of defining a somatotropin chemically associated with a metal, they define a metal-associated somatotropin.
Support for the first change (restricting to a specific type of metal) can be found in both the parent application (page 9, lines 13-16) and the basic application (page 8, lines 12-15).
There is less support in the basic and parent applications for the second change noted above (to restrict the concentration of non-toxic polyvalent metal claimed (up to 2%)) than there is in the specification as filed. The basic and parent applications mention "2%" but only in relation to zinc (see pages 9, lines 11-13 of the basic application; pages 10, lines 15-17 of the parent application). However, the specifications, in claiming somatotropins chemically associated with a metal broadly define somatotropins chemically associated with metal of any concentration (including 2%). The 2% concentration of any non-toxic polyvalent metal is therefore implicitly broadly disclosed and the specification is not wholly silent on this feature. Further, the feature is not inconsistent with the basic or parent applications. The teaching of both is to use a low concentration of metal, the examples all use a concentration within the 2% range claimed. Therefore, the applications provide sufficient support for the amendment to restrict the concentration of metal claimed.
With regard to the third proposed change (to include a metal-associated somatotropin), I have previously concluded (under section 102(1)) that this feature was not in substance disclosed in the specification as filed. The descriptions in the parent and basic specifications are similar to the description in the current Monsanto specification in this aspect and hence, the amended claims are not fairly based on the basic or parent specification.
Technically, this could lead to a prior publication of the amended claims by the published parent application. However, in this case, the term "metal-associated" suggests two forms of the invention - somatotropin chemically-associated with a metal and somatotropin physically associated with a metal. The former is disclosed in the basic and parent applications while the latter is not. Under, sub-section 43(3) (Patents Act 1990), the two forms will have different priority dates. The chemically associated form of the invention is entitled to the priority dates of the parent and basic application and cannot be prior published by those documents. The physical form has the date of filing of the statement of proposed amendments as its earliest priority date (subsection 114(1) and subregulation 3.14(b) (Patents Act 1990)) but was not disclosed in the parent or basic applications and is not prior published by them.
I find that neither the parent or basic application provides support for the term "metal-associated" somatotropin. However, despite this, neither application prior publishes the claims (as proposed to be amended) by virtue of sub-section 43(3) (Patents Act 1990).
Obviousness
Under the 1952 Act, the determination of obviousness depends on the common general knowledge in the field of the invention in Australia at the priority date (see the judgement of Aiken J. in Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd 144 CLR 253). The test for obviousness is whether the invention would have been obvious to a non-inventive skilled worker in the art having regard to their common general knowledge.
Thus, the first step in determining whether a claim is obvious is to establish the common general knowledge of the non-inventive worker in the art. The opponent has attempted to show (in evidence from Malcolm Roy Brandon and Allan James Robins) that the Organon patent is common general knowledge. However I have found this evidence unconvincing for a number of reasons:
a)Allan James Robins was not involved in growth hormone research and did not search the patent literature in this area (nor become "aware" of Organon) until after the relevant priority date of the current application. He is not in a position to comment on the common general knowledge of the skilled worker at the relevant time nor are his opinions directed to the relevant date;
b)The evidence has also failed to prove that Malcolm Roy Brandon was a person skilled in the art at the relevant time. His first declaration states that at the relevant priority date he was "supervising a large group of scientists researching many areas in Animal Biotechnology including the production of panels of monoclonal antibodies for sheep and cattle" but does not disclose a particular interest in growth hormones. I do not accept Mr Lyons submission that "many areas" necessarily encompasses the field of growth hormones nor his argument that a broad interest in such a complex and diverse field as "animal biotechnology" is sufficient to demonstrate that Malcolm Roy Brandon was a person skilled in the art at the relevant time;
c)The circumstances in which Malcolm Roy Brandon became "aware" of the Organon patent were not disclosed in his declarations and hence it is unclear whether the non-inventive person skilled in the art would also have searched the patent literature at the relevant date and have known about the citation. The declaration implies that academics searched the patent literature since 1979 as the first point of publication of work in the biotechnology field. It would seem unlikely (at least prima facie) that they would be interested in a patent application from December 1958 as a first publication.
In my opinion, the opponent has not established that Organon was part of the common general knowledge of the non-inventive person skilled in the art. There is also no evidence that Reusser was part of the common general knowledge.
Hence the citations are not relevant to consider for inventive step.
Manner of Manufacture
Using the decisions in W.R. Grace and Co. v AsahiKasei Kabushiki Kaisha (1993) 25 IPR 481 and N.V. Philips Gloeilampenfabrieken and Philips Lighting Pty Ltd v MirabellaInternational Pty Ltd (1993) 117 ALR 79, the opponent submitted that the claims were not an invention within the meaning of the Act.
The opponent argued that the claimed invention was the mere discovery of a new use of a known substance and cited the following passage from B.A.'s Application (1915) 32 RPC 348 (quoted with approval in Commissioner of Patents v Microcell (1959) 102 CLR 232):
"I regard it as one of the well-established principles of patent law that when once a substance is known, its characteristics and its constituents well-defined, you cannot patent the use of that for a purpose which was hitherto unknown".
The opponent has not provided any evidence from expert witnesses to support their argument although there is some basis for it in the admitted prior art (see in particular page 5, lines 20-31) where aqueous suspensions of metal salts or complexes of polypeptides (specifically gonadotropin and insulin) have been used for prolonged release.
However, the specification also states (page 3, lines 11-16) that:
"Since each polypeptide is different, e.g. in its three-dimensional structure and it interaction with other substances, the feasibility of achieving a prolonged effective release with a high loading of polypeptide in a suitable vehicle is impossible to predict or demonstrate theoretically."
This suggests that the art is unpredictable and that the skilled addressee could not predict whether a complex between a particular polypeptide (in this case somatotropin) and a polyvalent metal would have prolonged release. In other words, the properties of a polyvalent metal were not so "known" that a polyvalent metal would have been known at the relevant priority date to be suitable in a prolonged release composition with somatotropin. This is distinguishable from Commissioner v Microcell (supra) where the court found that the properties of synthetic resinous plastics reinforced with mineral fibres were "well-known" and hence their use in a known article was not inventive.
The evidence does not establish the Monsanto application lacks patentable subject matter and therefore I find that this ground of objection has not been made out.
Section 40 (specification as accepted)
Most of the issues on section 40 were common to both the section 104 and section 59 Oppositions and I have chosen to deal with these issues under section 104 rather than here.
The remaining issue with regard to the accepted application is that the term "chemically associated" in the claims is not clear because the term is "uncertain or ambiguous in scope" and its limits are wholly unclear.
According to the "Condensed Chemical Dictionary" (ninth edition) published by Van Nostrand Reinhold Company, New York, (1977), an "association" is:
"A reversible chemical combination due to any of the weaker classes of chemical bonding forces".
However, the term is clearly used more broadly than this in the specification. For example, page 9, lines 25-30 of the specification as accepted states:
"Some or all of the metal may be associated in a salt of the somatotropin, occluded within folds, crystals or amorphous shapes of the somatotropin or associated as a cation bridge between at least two somatotropin molecules".
From this, the reader must construe the term "chemically-associated" broadly to include a somatotropin bound to a metal with either a strong or weak chemical bond.
The opponent used the above quotation to suggest that the phrase "occluded within folds, crystals or amorphous shapes of the somatotropin" implied that physical associations were included within the term "chemically associated" making the limits of that term unclear. However, I do not consider that the above phrase in context implies that the association between metal and the somatotropin is anything other than chemical. The phrase appears in a paragraph which discusses how much metal could bind to somatotropin. This will be determined by the number of active sites available for binding. The physical folding of the somatotropin will obviously affect the accessibility of the active sites to the metal binding. In context, the phrase is not referring to the nature of the binding but to the location of the binding and to factors which affect the number of metal binding sites.
I believe that the specification as a whole suggests that the association between metal and somatotropin is chemical. Although the term "chemically associated" is to be construed broadly in the specification, the skilled addressee would still readily recognize a limit to the types of chemical associations that somatotropin could have with a metal and be able to produce the associations claimed without using inventive ingenuity.
I also consider that the reader would not be left in doubt as to whether a given somatotropin-metal association would fall within the scope of the claims (as per Martin and Biro Swan v H. Millwood (1954) 71 RPC 458). I therefore consider that the term is clear.
In my view, the term "chemically associated" is also sufficiently described. The skilled addressee can understand the term and comprehend the nature of the association. From his or her common general knowledge, the skilled addressee would know how to associate the metal with the somatotropin.
Similarly, the terms "complex" and "reaction product" would all be readily understood by the skilled addressee and are not uncertain or ambiguous in scope.
SUMMARY
I conclude that the oppositions succeed in part under both section 59 and 104. In particular, I find that:
section 104
a) The amendment is not allowable under sections 102(1) and 102(2)(a). The term "metal-associated" includes both physical and chemical associations and as a result the incorporation of the term in the claims defines matter not in substance disclosed at filing and results in the claims being in substance broader than the accepted claims.
b) The amendment is also not allowable under section 102(2)(b) because there are section 40 deficiencies in the specification (as proposed to be amended):
Claims 1-24 (as proposed to be amended) are not clear and the specification is not fully described with regard to the term "metal-associated". The limits of the term are uncertain and the nature of the association has not been explained in the specification;
Claims 1-24 (as proposed to be amended) are not fairly based. The claims must be limited to somatotropin chemically associated with a polyvalent metal;
Claims 8, 11, 12, 21-24 (as proposed to be amended) are not fairly based because they do not contain minimum metal limitations.
Claim 17 (as proposed to be amended) does not contain an implicit limitation to a chemical association and hence does not define the invention.
Section 59
Novelty
a)None of the accepted claims are novel in light of Organon;
b)Claims 1-13 (as accepted) are not novel in light of Reusser;
c)All of the claims (as proposed to be amended) are novel in light of both of the citations raised;
d)The claims (as accepted and as proposed to be amended) are not prior published by the parent specification;
Obviousness and Manner of Manufacture
a)The opponent has not established that the citations are common general knowledge and hence has not proven a lack of inventive step under the 1952 Act.
b)The evidence has not established that the application is for no more than a mere use of a known substance.
Section 40
a)Claims 1-5, 7-22 (as accepted) are not fairly based because they do not contain minimum metal limitations.
b)Claim 23 (as accepted) does not contain an implicit limitations to a chemical association and hence does not define the invention.
I believe that the problems raised can be solved by appropriate amendments and the applicant should be given an opportunity to amend the specification.
I therefore allow the applicant 60 days from the date of this decision to propose relevant amendments.
COSTS
In actions before the Commissioner, costs normally follow the event. I see no reason to depart from this practice and award costs against the applicant.
Karen Ayers
Delegate of the Commissioner of Patents
Patent attorneys for the applicant : E.F. Wellington and Co (Melb)
Patent attorneys for the opponent : Carter Smith and Beadle (Melb)
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