Frank D'Amelio and Graeme a. Close v Australian All Natural Pty. Ltd
[2003] APO 25
•27 June 2003
OFFICIAL NOTICE
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Application : No. 734644 in the name of FRANK D'AMELIO and GRAEME A. CLOSE
Title: Centipeda Plant Extract
Action: Opposition under Section 59 of the Patents Act 1990 by AUSTRALIAN ALL NATURAL PTY. LTD.
Decision: Issued 27 June 2003.
Abstract
The claimed invention was directed to a topical composition comprising an aqueous alcoholic extract from the plant Centipeda cunninghamii combined with a carrier which is not water or aqueous ethanol alone, to the use of the extract in the preparation of a topical composition and to a method of treatment comprising the topical administration of the composition.
The opposition was unsuccessful on all grounds, the only grounds relied on at the hearing being lack of novelty and lack of inventive step.
None of the 4 documents relied upon by the opponent for lack of novelty disclosed all the essential features of the topical composition. Similarly the declaratory evidence failed to establish lack of novelty. Thus the claims were novel.
The opponent failed to establish that the invention was obvious to a person skilled in the art in the light of the common general knowledge alone. The most relevant prior art documents taught away from formulating an aqueous alcoholic extract of plant material into a topical composition with the expectation of producing a useful result. Thus the claims had an inventive step.
Costs were awarded against the opponent.
PATENTS ACT 1990
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Re:Patent Application No. 734644 by FRANK D'AMELIO and GRAEME A. CLOSE and Opposition thereto by AUSTRALIAN ALL NATURAL PTY. LTD.
BACKGROUND
Patent application 56477/98 was filed as PCT application PCT/AU98/00031 with international filing date 22 January 1998. It claims priority from Australian provisional applications PO 4803, filed on 28 January 1997, and PP 0220, filed on 6 November 1997. The application was advertised accepted on 21 June 2001 with serial number 734644.
Australian All Natural Pty. Ltd. filed a notice of opposition on 24 July 2001. Evidence-in-support was filed on 24 April 2002 following the grant of one extension of time. While a further extension of time to 24 May 2002 to complete the evidence was granted, no further evidence was filed. Evidence-in-answer was due on 24 August 2002 and an extension of time of three months was granted. However on 22 November 2002 the applicants advised that no evidence-in-answer was to be served.
The matter was set for hearing in Melbourne on 15 May 2003. At the hearing Mr John Slattery, patent attorney of Davies Collison Cave, represented the applicants and Mr Michael Kraemer, patent attorney of Sandercock & Cowie & Associates, represented the opponent.
STATEMENT OF GROUNDS AND PARTICULARS
A statement of grounds and particulars was served on 24 October 2001 accompanied by 4 documents to which I shall refer later. The statement alleged that the applicants were not entitled to the grant of the patent, and that the invention as claimed was not a manner of manufacture, had been published before the priority date in the 4 documents and did not involve an inventive step. At the hearing Mr Kraemer indicated that the opponent no longer wished to rely on the first 2 grounds and that the opposition was only in respect of the grounds of novelty and inventive step.
THE SPECIFICATION
The invention relates to a topical composition comprising an aqueous alcoholic extract from the plant Centipeda cunninghamii combined with a carrier which is not water or aqueous ethanol alone. The specification acknowledges that C. cunninghamii is a plant species that has been known and used by the Aboriginal people for many generations in the treatment and prevention of many ailments. C cunninghamii is commonly known by a variety of names including sneezeweed and old man weed. Traditionally it has been used by the Aboriginal people as a tea, which has either been taken orally or used directly on the skin. The implication is that the traditional use was as an aqueous extract of the plant.
The inventors discovered that an aqueous alcoholic extract of the plant combined with various carriers was useful for the treatment of many types of medical conditions as well as for cosmetic applications. The specification at page 2 defines the term "aqueous alcoholic extract" as "an extract prepared by extraction of plant material from a plant of the genus Centipeda with an aqueous alcoholic solvent." The extract can be prepared from part or all of the plant using various extraction methods. A preferred extract was obtained by extraction of dried plant material with aqueous ethanol comprising 30% ethanol/70% water.
The accepted specification comprises 18 claims of which 3, claims 1, 9 and 13, are independent. Claim 1 is directed to a composition per se, claim 9 is a "Swiss style" use claim which recites the composition in the same terms as claim 1, and claim 13 is a method of treatment claim comprising the topical administration of a composition recited in the same terms as claim 1. Claim 1 reads as follows:
1. A topical composition for the treatment of a human or other animal, comprising an aqueous alcoholic extract from the plant Centipeda cunninghamii, combined with a cosmetically acceptable, topical carrier or diluent, said extract being an extract of plant material with aqueous ethanol in the range of from 10% ethanol/90% water to 95% ethanol/5% water, and said carrier or diluent not being water or aqueous ethanol alone.
EVIDENCE
The evidence-in-support comprises a declaration by Terence Dowel, Managing Director of Nature's Organics Pty. Ltd., and one exhibit comprising 2 photographs of the label on a jar of cream, and a declaration by Michael Herman Kraemer, patent attorney, and one exhibit comprising pages 10 and 11 of US patent 6025347.
In addition 4 documents were served on the applicant with a document accompanying the statement of grounds and particulars but these documents were not served formally as part of the evidence-in-support. At the hearing Mr Kraemer indicated that these documents were intended to form part of the evidence and apologised for his lack of familiarity with the correct procedure. Mr Slattery, for the applicant, did not object to the admission of these documents into the evidence and consequently I will have regard to them in making my decision. These documents are:
1. Patent application AU-A-32649/84 in the name of Robert A. Egan, published 7 March, 1985
2. Page 57 of the 19 April, 1993 edition of Woman's Day
3. A report written by Matthew Corkhill and released by Northern Metropolitan College of T.A.F.E. at Parkville (NMIT) entitled "An investigation into the growth and active constituents of Centipeda cunninghamii"
4. Pages 785-786 of the Australian Journal of Pharmacy, Volume 67, released in August, 1986. See Pharmacists Report section.
Further submissions
10. On 30 May 2003 the Commissioner received a letter from Mr Kraemer seeking to have some further material considered in relation to issues that had been raised at the hearing. I advised Mr Kraemer by letter that:
" You were provided with the opportunity to make full submissions at the hearing and you did not seek leave at that time to present any further evidence or make further submissions. There is a general presumption that parties make all their submissions during the hearing since there must be some finality to the litigation. Consequently the Commissioner will exercise her delegation to re-open proceedings only in exceptional circumstances."
11. Since I had not issued my decision at that time I indicated that I would initially make my decision based on the evidence, other materials and submissions presented at the hearing. I would then review the material in Mr Kraemer's letter, and if it appeared that it would materially affect the substance of my decision the opponent would be given the opportunity to seek leave to serve further evidence under Regulation 5.10(4). Mr Kraemer advised by letter dated 6 June 2003 that the opponent did not intend to seek leave to serve further evidence.
SUBMISSIONS
12. The thrust of Mr Kraemer's submissions on behalf of the opponent was that the Dowel declaration demonstrated the prior preparation of the alcoholic extraction of the plant material and this was subsequently made up into an ointment. Furthermore there was nothing inventive in adding a "splash of alcohol" to a known process of water extraction and the invention had no merit.
13. Mr Slattery for the applicant submitted that the opponent had failed to meet the onus to show that the grant was clearly bad through either their evidence or their submissions. The Dowel declaration did not establish that an alcoholic extract had been formulated into a topical composition. In addition the opponent had failed to establish the common general knowledge or that a skilled person would be led to try an aqueous alcoholic extract in a topical composition.
14. I shall refer to the submissions further in my decision below.
DECISION
Novelty
15. The test for lack of novelty is the "reverse infringement" test as set out in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235. For a claim to be found lacking in novelty each and every one of the essential integers of the claim must be disclosed in a single prior art document. Therefore initially I will consider each of the 4 documents filed in evidence to ascertain whether any one of them discloses all the following features which I regard as essential to all of the claims:
· A composition comprising an aqueous alcoholic extract from the plant C cunninghamii
· And a carrier or diluent which is not water or aqueous ethanol alone
· The extract is with ethanol in the range of from 10% ethanol/90% water to 95% ethanol/5% water
· The composition is to be applied topically
16. I will then consider the material in the declaratory evidence.
17. The Egan patent discloses a composition to promote the growth of human scalp hair. The composition includes an extract from the plant C cunninghamii. At page 3 lines 1-3 the extract is described as being prepared "by infusing at least a part of the plant into a quantity of liquid carrier". The only mention of a suitable liquid carrier is water. There is no mention of an aqueous alcoholic extract. The composition is to be taken orally or it can be in the form of an ointment. The ointment consists of the crushed plant suspended in an "unctuous carrier" which may be any suitable oil or fat. The patent does not disclose the use of an aqueous alcoholic extract in a topical composition and therefore I conclude that the claims are novel in the light of the Egan patent. Mr Kraemer did not dispute Mr Slattery's submission in relation to this patent, indicating that the document had been provided to show that the incorporation of the plant material into topical creams was already known at the priority date of the opposed application.
18. The Woman's Day article describes a range of skin and hair products made from C cunninghamii combined with essential oils. The only mention of the use of a plant extract is in the first column where there is a reference to boiling the plant. In the absence of any other information I can conclude only that this is a reference to boiling in water. There are certainly no "clear and unmistakable directions" (General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd, (1972) RPC 457 at pages 485, 486) to use an aqueous/alcoholic extract. Therefore I conclude that the claims are novel in the light of the Woman's Day article.
19. In relation to the Corkhill document Mr Slattery submitted that there was no evidence of the publication date or even that the document was publicly available. In response Mr Kraemer indicated that Mr Corkhill had been working at the TAFE in 1991 and had left there in 1992, although he was unable to provide evidence that the document was available from 1991. I note that the document refers to "production and sourcing of the plant material started in October 1994" so prima facie the document was not available until at least late 1994. Initially I will assume that the document was publicly available before the priority date.
20. The Corkhill document indicates that C cunninghamii has been reported to possess a number of medicinal properties and refers to the use of decoctions of the plant. It refers to the solvent extraction of the dried plant material with methanol, with the resultant sludge being subsequently extracted into hexane, dried and then chloroform was added. This resulted in 3 extracts, from hexane, chloroform and methanol. The document subsequently indicates that a limited amount of work was carried out on the hexane extract but no work was carried out on the chloroform or methanol extracts. The document nowhere discloses a topical composition containing an aqueous/alcoholic extract and a carrier. Therefore I conclude that, irrespective of whether or not the Corkhill document was publicly available before the priority date, it fails to disclose all the essential integers of the claims and hence the claims are novel in the light of this document.
21. The Wiesner article (Australian Journal of Pharmacy) reports on a study by various people to substantiate the reputed medicinal properties of C cunninghamii. The pharmacist's report is the most relevant because it describes the alcoholic extraction of the plant material in various forms. Powdered leaves, seeds and dried components of whole plants were each placed in jars to which either alcohol 90%, alcohol 60% or pure water were added. The jars were all subjected to standing and gentle shaking over a 3 week period. The resulting solutions were then tested for activity by being applied to a nutritious medium with Penicillium mould actively growing on it. I agree with Mr Slattery's submission that the Wiesner article does not contain a disclosure of a topical composition of the aqueous alcoholic extract as claimed in claim 1, or of the use of the extract as claimed in claim 9, sufficient to destroy the novelty of those claims. Nor does it contain any disclosure of a method of treatment by topical administration of a composition as claimed in claim 13. Consequently the claims are novel in the light of the Wiesner article.
22. I will now consider the declaratory evidence in relation to novelty. Mr Kraemer submitted that the Dowel declaration provided a complete account of the aqueous alcoholic extraction of the plant material which was subsequently made up into the composition as claimed in the opposed application. However Mr Slattery considered that the declaration failed to provide the necessary level of substantiation required to establish lack of novelty. In paragraph 8 of his declaration Mr Dowel describes how Robert Egan enlisted his help to prepare extracts of C cunninghamii and he explains further in paragraph 9:
"I…..changed his procedure by the introduction of an added ethanol/propylene glycol component. This component was added once the hot water extraction was finished and before separation of the liquor from the solids. I regard the use of organic C1-5 alcohols as routine in these types of extractions. In Mr Egan's extractions the colour of the extract was pale brown using hot water. The addition of alcohol turned the liquor deeper brown. I suspected that the active principle was probably a mix of water-soluble and alcohol-soluble alkaloids. Mr Egan had useful results already from aqueous extraction prior to my move to alcohol addition. When my initial extractions showed colour deepening, alchohol/water extraction became the preferred procedure for him from 1988 onwards."
23. In paragraph 11 Mr Dowel recites claim 1 of the opposed application and states:
"I conclude the aqueous alcoholic extract referred to must be the same as I prepared in 1988 and 1989. The carriers referred to in Claim 6 seem to be ordinary materials which appear in skin formulations. I see nothing new in any materials listed in Claim 6. They are standard base materials for topical creams that have been standard practice for many years."
24. In Mr Slattery's submission the Dowel declaration provides insufficient detail as to how the extract was prepared, of when it was prepared or how it was subsequently used. In Mr Kraemer's view a manufacturing chemist would understand, from the information in the declaration, how to prepare the extract which could then be made into a topical cream.
25. If I accept Mr Kraemer's view that the declaration does provide sufficient detail as to how to prepare the extract, and that the extract is in fact the same as that used in the topical composition of the claims, and accepting Mr Dowel's recollection that the extraction was performed "about Christmas 1988" (paragraph 10), there is no evidence to show that Mr Dowel's work was made publicly available. Nor is there any evidence to support Mr Dowel's assertion that Mr Egan used the extract in his topical products. Mr Kraemer referred me to the exhibit to Mr Dowel's declaration as evidence that the extract was incorporated into a product on the market. However that exhibit merely shows 2 views of a jar of cream and the only decipherable words on those views are "AUSTRALIAN OLD MAN WEED" and" An emollient for dry and chaffed skin". I note that paragraph 8 of the Dowel declaration implies that the cream in the jar is made from an aqueous extract.
26. Furthermore it seems to me that, even if Mr Dowel had published the results of his extraction work, while a manufacturing chemist could have produced a topical composition from the extract, there are no clear and unmistakable directions to show that a chemist would have produced a topical composition (Canadian General Electric Co., Ltd v Fada Radio Ltd, (1930) 47 RPC 69 at page 90). Consequently I conclude that the Dowel declaration is insufficient to establish the lack of novelty of the claims.
27. Mr Kraemer's declaration merely asserts, in paragraphs 3 and 4, that claims 9 and 11 are not novel in the light of the Egan patent and the Wiesner article, both of which I have dealt with above.
28. Therefore I find that all the claims are novel.
Inventive step
29. Under sections 7(2) and (3) an invention is taken to involve an inventive step when compared to the prior art base unless it would have been obvious to a person skilled in the art, in the light of common general knowledge considered either alone or together with a single document.
30. Mr Slattery submitted that the opponent had failed to establish the common general knowledge. In addition none of the documents relied on by the opponent would lead a notional research group to try the invention as claimed in the expectation that they would get the desired result, as set out in Olin Mathieson v Biorex (1970) RPC 157 at page 187. Mr Kraemer submitted that Mr Dowel was eminently placed to express the common general knowledge. He pointed out that the specification itself admitted that the carriers were well known in the art. The specification contained no indication of the difficulties overcome or the advantages of using the extraction method and hence, in his submission, a research group would be led to try the invention. Consequently, in Mr Kraemer's view, the claims lacked an inventive step and the invention lacked merit.
31. While Mr Dowel does not refer specifically to the concept of common general knowledge in his declaration, he makes some statements in paragraphs 6 and 7 which purport to show that solvent extraction of plant materials is well known:
"(6)…..The concept of assisting solvent extraction of the active principles of plant materials by the addition of monohydric and dihydric alcohols, such as ethanol, methanol and glycol is routine and has been known since alchemists noticed that natural substances which resisted solution in water dissolved more readily in wine.
(7) As a working manufacturing chemist I am able to state that I and others used to this field would know about the effectiveness of various organic solvents and likely solubilities of plant materials and the methods of recovering active matter."
32. Apart from his reference above to being a "working manufacturing chemist" the only other indication of Mr Dowel's background and qualifications appears in paragraph 2 where he states:
"(2) I began my working life in 1961 in the pharmaceutical/chemical industry and was interested early on in my career in natural remedies and their extraction. I have been able to specialise in the past 20 years and I am known throughout Victoria for my specific knowledge about extractive processes."
33. While I am inclined to agree with Mr Slattery that Mr Dowel has not adequately established his credentials to make the statements in relation to the common general knowledge, I have some sympathy for Mr Kraemer's submission that solvent extraction is not "rocket science" and therefore that a person of Mr Dowel's experience could provide evidence as to the common general knowledge. Having said this I do not consider that Mr Dowel's declaration contains sufficient detail to clearly establish what was the common general knowledge at the priority date of the claims such that the claims could be shown to lack an inventive step in the light of that knowledge alone. For example Mr Dowel indicates that solvent extraction "is routine" but he does not indicate to whom it would be routine or that it would be routine to incorporate an aqueous alcoholic extract of the plant material into a topical composition
34. I note that Mr Kraemer's declaration purports to establish that the carriers used in the compositions are common general knowledge and he states in paragraph 2:
"…..The common general knowledge would at least include publications in the library of the Melbourne College of Natural Medicine."
35. Mr Kraemer describes himself as a patent attorney who has prosecuted pharmaceutical patent applications. I consider that this is insufficient to establish that he is a person skilled in the art and hence he is not qualified to make statements concerning the common general knowledge. However I note that the specification admits at page 5 that the use of the carriers is well known in the art. Furthermore the specification acknowledges at page 1 that C cunninghamii is well known in the treatment and prevention of many ailments. Therefore I accept that the properties of the plant material and the use of the carriers in the formulation of topical compositions are part of the common general knowledge.
36. In order to establish lack of inventive step the opponent must show not only what is the common general knowledge but also that the invention is obvious to a skilled person in the light of that knowledge. Therefore the opponent must show that it was obvious to make the aqueous alcoholic extract of C cunninghamii into the topical compositions of the claims. Even if I accept that alcoholic extraction of the plant material is part of the common general knowledge, I am not convinced that it would be obvious to a person skilled in the art to include such extracts in a topical composition. Therefore I consider the claims to have an inventive step based solely on the common general knowledge.
37. However I must also consider the effect of the common general knowledge considered together with a single document. Of the documents put in evidence by the opponent, the only ones that disclose alcoholic extraction of plant material are, as I have indicated above in my discussion on novelty, the Corkhill and Wiesner documents.
38. The Corkhill document merely discloses the testing of hexane, chloroform and methanol extracts to try to ascertain the composition of the active constituents. In my view this would not necessarily lead a research group to try to formulate a topical composition from the extracts, and in any event the opponent has failed to establish the publication date of this document.
39. The Wiesner document does disclose aqueous/alcoholic extracts of C cunninghamii and so I must consider whether the notional research group would be led to using these extracts in a topical composition with the expectation of a getting a useful result. The document describes how, in order to test the claims that the plant material had therapeutic properties, the alcoholic solutions were applied to a nutritious medium with Penicillium mould actively growing on it. Since the alcohol limited the growth of the mould the conclusion at the end of page 797 was that "it would be difficult to determine whether any components extracted from the plant material possessed any inherent anti-bacterial activity." The overall conclusion was that the results were "inconsistent and unreliable" and further studies would be necessary.
40. In my view a research group, reading the Wiesner document would not be led to try to formulate the aqueous/alchoholic extracts into a topical composition with the expectation that it would get a useful result. Therefore the opponent has not convinced me that a person skilled in the art would be led to prepare a topical composition from these extracts.
41. The other documents which I must consider are the Egan patent and the Woman's Day article. Both of these disclose aqueous extracts. In paragraph 9 of Mr Dowel's declaration he refers to certain differences between the aqueous and the alcoholic extracts:
"(9)…In Mr Egan's extractions the colour of the extract was pale brown using hot water. The addition of alcohol turned the liquor deeper brown. I suspected that the active principle was probably a mix of water-soluble and alcohol-soluble alkaloids."
42. This indicates to me that the aqueous alcoholic extracts probably have a different composition from those extracts obtained by using water alone. The Wiesner document supports this conclusion. At page 786 the products of the various extractions are described. Saponins are described as being present in the highest concentrations where water alone was used to extract the plant material, whereas alkaloids "are extracted usually from mixtures of alcohol and water" and "volatile oils, resinous material, fixed fats and oils" are described as being present when 90% ethanol was used to extract the plant material.
43. If the composition of the products extracted varies according to whether the extract was obtained by aqueous extraction or by aqueous alcoholic extraction, then I do not consider that it would be obvious to a person skilled in the art to substitute the aqueous extracts for alcoholic extracts in a topical composition with the expectation of getting a desired result . Consequently I consider the claims do have an inventive step in the light of the common general knowledge considered together with a single document.
44. Therefore I find that, on the evidence before me, the ground of lack of inventive step fails.
Further submissions
45. I indicated earlier in my decision that I would consider the material in Mr Kraemer's letter of 29 May 2003 once I had made my decision. I will do this now even though Mr Kraemer has indicated his client will not be seeking leave to serve further evidence.
46. Mr Kraemer's letter refers to 3 issues, namely some further information purportedly from Mr Dowel about the extraction process, an assertion that "Bob Egan made the extract into ointment" and details of the wording on the jar of cream pictured in the exhibit to Mr Dowel's declaration. I indicated in my consideration of novelty that I based my decision on the proposition that the Dowel declaration contained sufficient detail of the extraction process. The assertion that the alcoholic extract was made into an ointment is not supported by any evidence. The details of the wording on the jar merely indicate who manufactured the product. Therefore the further material provided by Mr Kraemer does not affect my decision.
CONCLUSION
47. I have found that all the claims are novel and inventive in the light of the evidence and submissions presented by the opponent and consequently the opposition is unsuccessful. I direct the application may be sealed after twenty-eight (28) days from the date of this decision. If the Commissioner of Patents is served with a notice of appeal from this decision before that time, I direct that sealing not occur until the appeal has been decided or discontinued.
COSTS
48. The opponent has been unsuccessful on all grounds of the opposition. The Commissioner's usual practice in such a situation is for costs to follow the event. Both parties' submissions were consistent with this approach. Therefore I award costs against the opponent, Australian All Natural Pty. Ltd.
Janet Werner
Deputy Commissioner of Patents
Patent attorneys for the applicant : Davies Collison Cave
Patent attorneys for the opponent : Sandercock & Cowie & Associates
0
1
0