Gary Cox v Abbott Laboratories - [2015] APO 84

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Gary Cox v Abbott Laboratories [2015] APO 84

Patent Application: 2006306366 and 2011218634

Title:Infant formulas containing docosahexaenoic acid and lutein

Patent Applicant:  Abbott Laboratories
Opponent:  Gary Cox
Delegate:  Keith Wagg
Decision Date:  7 December 2015
Hearing Date:  13 and 14 of May 2015 in Canberra, with further evidence and submissions completed on 26 August 2015

Catchwords: PATENTS – opposition to grant of parent and divisional – claims are clear – lutein refers to a specific carotenoid and does not include zeaxanthin – infant formula on a ready to feed basis – calculation of concentration of lutein in powdered formula disclosed in prior art not within the scope of claims when calculated on a ready to feed basis – claims are novel – common general knowledge – totality of the claimed invention involves an inventive step over the common general knowledge – when the common general knowledge is combined with the cited prior art it has not been established that the person skilled in the art would be directly led as a matter of course to the claimed invention – inutility not established – insufficiency not established – claims are fairly based.

Representation: Patent applicant: Katrina Howard, SC instructed by Shahnaz Irani of Spruson and Ferguson
Opponent: Julian Cooke of Counsel instructed by Linda Kennaugh of Wrays, Gary Cox also appeared.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006306366 and 2011218634

Title:Infant formulas containing docosahexaenoic acid and lutein

Patent Applicant: Abbott Laboratories
Date of Decision: 7 December 2015
DECISION
I allow the amendment to the Statement of Grounds and Particulars.
The opposition fails on all grounds. Subject to appeal, I direct 2006306366 and 2011218634 to proceed to grant.
Costs are awarded against Gary Cox.
REASONS FOR DECISION
Background

Patent application number 2006306366 (‘366) in the name of Abbott Laboratories (the applicant) was advertised as accepted by the Commissioner on 12 May 2011. A subsequent patent application, 2011218634 (‘634), was filed on 29 August 2011 with the patent request claiming divisional status from ‘366. On 12 August 2011 a notice of opposition to the grant of ‘366 was filed by Gary Cox (the opponent). On 20 June 2013 the ‘634 application was advertised as accepted by the Commissioner and a notice of opposition filed by the Gary Cox on 20 September 2013. Both of the oppositions were heard together.
The request for examination for both of these applications was filed prior to 15 April 2013. As a consequence, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent applications. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. I also note that any subsequent reference to the Patents Act relates to the Patents Act1990, prior to amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
Standard of proof
The onus of proof in this opposition proceeding rests with the opponent, who must demonstrate that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 at [67]; 50 IPR 305; Commissioner of Patents v Sherman [2008] FCAFC 182 at [18]; 79 IPR 426).
The specifications
The ‘366 and ‘634 specifications both relate to infant formulas containing docosahexaenoic acid (DHA) and lutein. The ‘366 specification ends with 19 claims and 1 Figure with claims 1, and 11 being independent product claims. Claims 13-16 are method claims involving administration of the product of claims 1-12. Claim 17 is an independent claim to the use of a series of ingredients for the manufacture of an infant formula. Claims 18 and 19 claim the use of the infant formula of claims 1-12.
The ‘634 specification ends with 20 claims and 2 Figures with claims 1, and 11 being independent product claims. The descriptions of both applications are largely identical.
What is the invention as described
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139]:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."
The background to the invention
Both specifications relate to infant formulas. On page 1 of both specifications the technical field is provided. This is:
“The present invention relates to infant formulas containing select combinations of docosahexaenoic acid and lutein for promoting retinal health and vision development in infants”.
It is also stated in the background of the invention (page 1) that both arachidonic acid and DHA had previously been identified in human breast milk and subsequently added to infant formulas.
Lutein has also been identified in human breast milk and although infant formulas may contain some inherent lutein at low concentrations from natural oils commonly used in infant formula, the specifications state that lutein is not added as an isolated ingredient (page 1). The specification notes that dietary lutein may provide individuals with eye benefits. The extension of this benefit to breast milk was, however, said to be speculation.
DHA was known to be susceptible to oxidation in the eye and lutein, which concentrates in the retina, is inherently an antioxidant (page 2). Therefore the two compounds are believed to work in combination in the retina and are beneficial.
The aim of the invention
The aim of the invention can be gleaned from both specifications. It is to provide an infant formula which promotes retinal health and vision development in infants, including reducing the risk of retinopathy of prematurity in infants, and protecting against the damaging effects of excessive natural or artificial light on the infants’ eyes (page 2).
The nature of the invention
In order to achieve the aim of the invention the specifications state that lutein concentrations must be higher than that found in human breast milk. This is because the lutein in formulas is less bioavailable than that in human breast milk (page 2). This is clear from page 2a which states:
“It has now been found that infant formulas should be prepared with lutein concentrations of at least 50 mcg/litre if they are to produce the same plasma lutein concentrations found in breast fed infants, even though human breast milk itself typically contains no more than about 30 mcg/litre of lutein. It has also been found, consequently, that the weight ratio of lutein (mcg) to DHA (mg) in the infant formula should range from about 1:2 to about 10:1. It is believed that the combination of lutein and docosahexaenoic acid are particularly useful in promoting retinal health and vision development in infants, provided that sufficient quantities of each are designed into the infant formula as described herein.”
The person skilled in the art (PSA)
It is well established that many of the issues in an opposition are answered by reference to the person skilled in the art:
"He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious."
(Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70])
However, they are an artificial construct that is used as a tool of analysis, and there is a danger in trying to identify them as an actual person or persons:
"The notional person is not an avatar for expert witnesses whose testimony is accepted by the court. It is a pale shadow of a real person – a tool of analysis which guides the court in determining, by reference to expert and other evidence, whether an invention as claimed does not involve an inventive step."
AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]
Our understanding of the person skilled in the art is based on evidence from persons with knowledge of the art as to the things that they know and do, and what they understand to be commonly known and done. The weighting and evaluating of this evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
In this case the person skilled in the art would include infant formula formulators with a focus on retinal health and eye development.
The Claims
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification".
Claim 1 of ‘366 reads:
“An infant formula comprising fat, protein, carbohydrate, vitamins, and minerals, including docosahexaenoic acid and, on a ready-to-feed basis, at least about 75 mcg/litre of lutein, wherein the weight ratio of lutein (mcg) to docosahexaenoic acid (mg) is from about 1:2 to about 10:1 and the formula is free of egg phospholipids.”
Claims 2-10 are dependent on claim 1 and claim the infant formula but further define the amount of lutein (75-230 mcg; 200 mcg), the ratio (1.5:1 to about 10:1; 2:1 to about 5:1); the caloric density (20 to 30 kcal/fluid ounce); the source of the lutein is defined in claim 7; claim 8 claims the formula as a powder and claim 9 as a liquid and claim 10 states that the lutein is 25% by weight added lutein.
Claim 11 is an independent claim to an infant formula on a ready-to-feed basis with specified ranges of carbohydrate, fat, protein and lutein (100-200 mcg/litre). The amount of DHA is not specified but the ratio of lutein to DHA is 2:1 to about 5:1 and the formula is free of egg phospholipids. Claim 12 is dependent on claim 11 but specifies the source of the lutein.
Claims 13 to 16 are claims to methods involving the administration of the formula of any one of claims 1-12. The methods are to reduce the risk of retinopathy of prematurity in preterm infants (claims 13 and 14) with the range of lutein provided per day specified. Claims 15-16 are methods to promote retinal health and vision development to an infant in need thereof, with a specified amount of lutein.
Claim 17 is an independent Swiss style claim to the use of the ingredients in amounts identical to claim 11, in the manufacture of an infant formula on a ready to feed basis.
Claims 18 and 19 are to the use of an infant formula to provide a specified range of lutein for reducing the risk of retinopathy of prematurity in preterm infants and for promoting retinal health and vision development in an infant.
Claim 1 of ‘634 reads as follows:
“An infant formula comprising fat, protein, carbohydrate, vitamins, minerals, and, on a ready-to-feed basis, at least about 50 mcg/litre of lutein and from about 72 to about 360 mg/litre of docosahexaenoic acid, wherein the ratio of lutein (mcg) to docosahexaenoic acid (mg) is from about 1:2 to about 10:1, and wherein the formula is free of egg phospholipids.”
Claims 2-10 are dependent on claim 1 and claim the infant formula but further define the concentration range of lutein (70 mcg to about 1150 mcg), the concentration of DHA (72 mg to 144 mg/litre), the ratio (1.5:1 to about 10:1; 2:1 to about 5:1); the caloric density (20 to 30 kcal/fluid ounce); claim 7 claims the formula as a powder and claim 8 as a liquid and claim 9 states that the lutein is 25% by weight added lutein; the source of the lutein is defined in claim 10.
Claim 11 is an independent claims identical to claim 1 but with a maximum concentration of DHA being about 130 mg/litre. Claim 12-20 are dependent on claim 11 with the same limitations as claims 2-10.
Construction of Claim 1 of ‘366
The claim relates to an infant formula. These are used to replace breast milk for various reasons and have been made from cow milk or soy products (Sinn #1 at 24). They are typically sold as a powder and made up to liquid by the end user (Sinn #1 at 25-26). It was not disputed that at the priority date these would typically comprise fat, protein, carbohydrate, vitamins and minerals.
The infant formula claimed contains docoashexaenoic acid (DHA). This is an omega-3 fatty acid typically obtained from fish oils (Sinn #1 at 33) and was included in infant formula at the priority date (Sinn #1 at 34) and would be known to the PSA.
The claim then follows with the statement “and, on a ready-to-feed basis, at least about 75 mcg/litre”.
“On a ready-to-feed basis” followed by a concentration means that the concentration is measured when the formula is made up to a liquid actually given to the infant (Sinn #1 at 71-73).
Therefore at least about 75 mcg/litre of lutein is the concentration of lutein in the formula when fed to the infant.
Lutein is a carotenoid with a defined chemical structure. It is also defined at paragraph [0026]. There was some contention that it might include other compounds, namely zeaxanthin. Zeaxanthin is named separately in claim 7. The meaning of lutein is discussed below in clarity; however, the claim is expressly defining the amount of lutein not lutein and zeaxanthin.
The concentration of lutein is preceded by the term “at least about”. Sinn construes this as greater than about 75 mcg/litre lutein (Sinn #1 at 78). The opponent found this unclear and it is discussed below under clarity.
The next feature of the claim is the ratio of lutein to docosahexaenoic acid. This indexes the amount of lutein to the amount of DHA and vice versa (Sinn #1 at 79). Sinn notes that the lutein is expressed in mcg and the DHA in mg so for that for 1 mcg lutein there is 0.1 to 2 mg DHA (Sinn #1 79-80).
Finally the formula is free of egg phospholipids.
Parameteritis
The opponent argued that the amount of lutein and the ratio should be treated as parametritis.
Parameteritis was discussed by Laddie J in Raychem Corp’s Patents [1998] RPC 31. At page 37, he defines the concept:
“This is the practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art. Sometimes it includes reference to parameters measured on test equipment which did not exist at the time of the prior art. The attraction of this to a patentee is that it may be impossible to prove now that the prior art inevitably exhibited the parameters and therefore it is impossible for an opponent to prove anticipation. Even if that is what has happened here, it does not alter the task of the court. It must decide whether the opponent has proved anticipation or some other statutory ground of invalidity. Parametritis may make the court’s task more difficult, but at the end of the day the test of invalidity must be the same, whatever the form of the claims.”
At page 46, he refers to the parameter (the S/D volume ratio) that is used in the claims as:
“essentially arbitrary and has little technical significance. The selection of a group of compositions by reference to such a parameter does not involve any inventive step. Although it may not be obvious, in the common use of that word, to limit a claim by reference to this particular meaningless and arbitrary parameter, that has nothing to do with patentability. Patents are not given for skill in inventing technically meaningless parameters.”
It is clear that parameteritis is not objectionable per se. However, it may give rise to grounds of opposition, depending on the merits of the case. In Australia there have been several cases where the issue has arisen, and they provide useful understanding. In Williams Advanced Materials Inc v Target Technology Co LLC [2004] FCA 1405 at [48], 63 IPR 645 at 654, Bennett J considered claims to an optical storage medium having a reflective layer including a silver – palladium alloy. Her Honour noted that the parameters were selected without a purpose:
“there is nothing in the specification that suggests that the proportions or the ranges of the metals in the alloys are in any way part of the invention, other than the mere reference to them. It is a case of ‘parameteritis’.”
Her Honour then found that certain of the claims were not novel.
In Austal Ships Pty Ltd v Stena Rederi Aktiebolag [2005] FCA 805 at [108], 66 IPR 420 at 437, Bennett J referred to the Williams case, and distinguished it because:
“there is reference in the patent specification and evidence which supports the fact that the parameters have been carefully chosen, are part of the invention and are related to a claimed advantage as part of the combination of the design”.
The critical question is whether or not the parameters have been chosen to achieve a technical effect, or whether they are an arbitrary convenience. The amount of lutein was tested by the plasma study on page 27. It showed that in infants fed formula with lutein at 32.6 mcg/L, the plasma concentration of lutein was the same as the control but an infant fed formula with 52.6 mcg/L of lutein would have significantly higher plasma concentrations. The claims reflect this.
The specification also tells me that DHA is readily oxidised in the retina and lutein is an antioxidant. As the lutein helps prevent the oxidation of DHA it is clear that the ratio of these two compounds has a technical effect.
I therefore find that the parameters in the claims have a technical effect and are not to be dismissed as parameteritis.
The opposition
At the hearing the opponent sought to amend statements of grounds and particulars to reflect the current case. The grounds included the following:
1.and 2. Not a Manner of Manufacture
3.Lack of Novelty
4.Lack of Inventive Step
5.Claims Lack Utility
6.Invention Not Fully Described
7.Claims Not Clear
8.Claims Not Fairly Based
These grounds existed in the first statement and the amendments focused largely on the particulars. Given this I see no reason not to allow the amendment. Therefore the amendments to the statements are allowed.
The parties relied upon evidence by several declarants and it was agreed that evidence from either case could be used interchangeably with the other. As the same declarants were used for both cases it is logical to number them in order of date and continue the numbering from one case to the other. The opponent has used this system on page two of the submissions for the substantive hearing for both cases.
Evidence in Support of the opposition consists of:
1.Declarations by Dr Linda Kennaugh (Kennaugh #1 and #2 for ‘366 and ‘634 respectively)
2.Declarations by Professor Frederick Khachik (Khachik #1 and #3 for ‘366 and ‘634 respectively)
3.Declarations by Professor Robert Gibson (Gibson #1 and #3 for ‘366 and ‘634 respectively).
Evidence in Answer consists of:
1.Declarations by Dr John Sinn (Sinn #1; #2; #3 and #4; #5 #6 for ‘366 and ‘634 respectively).
Evidence in Reply consists of:
1.Declarations by Professor Frederick Khachik (Khachik #2 and #4 for ‘366 and ‘634 respectively)
2.Declarations by Professor Robert Gibson (Gibson #2 and #4 for ‘366 and ‘634 respectively).
Further evidence

At the hearing there was some discussion on documents which the opponent alleged deprived both applications of novelty. These documents are discussed below. On day two of the hearing the applicant sought to table some further material in relation to this. It was decided that they would have the opportunity to file further evidence to clarify the disclosure in one document. The opponent also sought to file further evidence in relation to another document. Further evidence is available under r 5.10 for ‘366, if the nature of the information is likely, if not certain, to change the outcome of the opposition in a significant way it can be brought in under r 5.23 for ‘634.
This resulted in a round of further evidence consisting of:
1.A declaration by Professor Frederick Khachik (Khachik #5)
2.A declaration by Daniel S Albrecht (Albrecht #1).
with responding evidence consisting of:
3.A declaration by Professor Robert Gibson (Gibson #5)
4.A declaration by Professor Frederick Khachik (Khachik #6).
The applicant did not file responding evidence.
Submissions were received in relation to the further evidence.
Clarity
It is a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim" (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).
The opponent has alleged that the claims lack clarity in three ways, the first being that they allege the term “lutein” is unclear.
This arises because in the evidence in Khachik #1 he considers it to include combinations of lutein and zeaxanthin (at 146 to 152).
Evidence by Sinn and by Gibson (Sinn #1 60 to 68 and Gibson #1 207 to 213 and 267 to 275) indicates that they do not construe lutein to include zeaxanthin. The opponent believes this conflict results in a lack of clarity.
Lutein is defined at paragraph [0026] of the application. It does say that it includes “related structures”, however, this is to be read in context. The structure provided on [0026] shows lutein has a double bond in a different position to zeaxanthin (Khachik #1 at 44). They are different compounds.
Furthermore, claim 8 of ‘366 and claim 10 of ‘634 both mention lutein and zeaxanthin. If the drafter had intended the term lutein to include zeaxanthin they would not have mentioned it separately in these claims.
The opponent has not established that the term lutein is unclear.
The opponent then alleges that “a combination of free lutein and zeaxanthin from a single source” is unclear. A single source of these two compounds is consistent with there being a source of lutein being from an extraction of Marigold which would also include zeaxanthin. As the claims are focused on a formula comprising a concentration of lutein, this wording merely recognises that sources are available that also include zeaxanthin. I do not find the evidence supports that this is unclear.
The use of the terms “at least about” are also considered to be unclear by the opponent. Khachik finds this ambiguous in Khachik #1 at 160. However, the other declarants did not have any issue construing these terms in the claims (Sinn #1 page 15). Furthermore, Khachik is later able to comment on whether the prior art falls within the scope of these claims without difficulty.
On weighing these considerations I do not find this term to be unclear.
Conclusion on Clarity
The opponent has not established that the claims lack clarity.
Novelty
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art base. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19 at [20]; 137 CLR 228 at 235:
"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".
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486).
US 2003/0228392 A1 (Zimmer)
Zimmer was published on 11 December 2003 and is titled “Infant Formula Compositions Containing Lutein and Zeaxanthin”.
Disclosure of Zimmer and ‘366
Zimmer relates to infant formulas with added lutein and zeaxanthin (title and abstract). The document recognises that these carotenoids are found in the retina of the human eye (at [0003]). The document goes on to state that:
“Lutein and zeaxanthin may protect the retina from damage by acting as antioxidants or filtering out damaging wavelengths of blue light.”
Zimmer also discusses that both lutein and zeaxanthin are present in human breast milk and states (at [0016]):
“The use of lutein and zeaxanthin in the present amounts closely resembles the amounts of such compounds found in human breast milk on a worldwide basis.”
Zimmer only contains one example, example 1 at [0022]. This uses 25 mcg of lutein and zeaxanthin. As the claims of both ‘366 and ‘634 require a specific concentration of lutein, it is important to look at the source of the lutein used.
Zimmer states at [0014] that:
“…lutein and zeaxathin may be obtained by extraction from marigolds or other xanthophylls-rich sources, derived and enriched xanthophyll sources. A suitable form of lutein and zeaxanthin useful in the present invention is available commercially as “Lutein 5% TG” from Roche vitamins, Inc., Parsippany, N.J.).”
The amounts of lutein and zeaxanthin added is also stated at paragraph [0015]:
“The infant formula composition of the present invention may comprise lutein and zeaxanthin in an amount of about 6 to about 230 mcg/Litre. Preferably the present formula compositions contain about 15 to about 44 mcg/Litre, more preferably about 20 to about 30 mcg[/]litre and most preferably, about 25 mcg/Litre of lutein and zeaxanthin.”
This disclosure is clearing telling the PSA the amount of lutein and zeaxanthin together and not the lutein per se. This is supported by Sinn #2 at paragraphs 18-22 and 71 and the passage directly following that quoted above which states:
“The amounts of lutein and zeaxanthin disclosed herein refer to combined amounts of the compounds lutein and zeaxanthin and not these compounds individually. Therefore, as long as the formulations contain the total amount of lutein and zeaxanthin set forth herein, the amounts of the individual components is not critical.”
The opponent alleged that the range of 6-230 mcg/Litre as outlined above would fall within the scope of the present claims for both applications.
The opponent relied on evidence by both Khachik and Gibson in arguing this. Both declarants refer to the range of lutein/zeaxanthin being between 6 and 230 mcg/Litre (see Khachik#1 and #2 at paragraphs 60-61 and Gibson #1 and #2 at paragraphs 94-96).
In Sinn #2 the declarant notes at 25-27 that while there was a large range (6 – 230 mcg/Litre), Zimmer presents the breast milk study( at [0017]), which shows a range of lutein and zeaxanthin from 15-44 mcg/L. The declarant also provides an average for the breast milk study which is 26 mcg/L. He also notes that the amount used in example 1 of Zimmer is very close to this average, i.e. 25 mcg/Litre. Khachik #3 at paragraph 64 agrees.
Khachik outlines in Khachik #6 at 22 that:
“Zimmer refers to the use of Lutein 5% TG product. I was aware that product contained 94-97 % free lutein and 3% to 6% free zeaxanthin. Therefore the amount of free lutein in 230 mcg/litre of lutein and zeaxanthin using Lutein 5% TG product this was approximately 216.2 to 223.1 mcg/litre of free lutein.”
The opponent relies on the person skilled in the art selecting the higher ranges of lutein and zeaxanthin disclosed in Zimmer. In Khachik #6 the reason for choosing this is given:
“In paragraph [0015], Zimmer states that lutein and zeaxanthin should be present in infant formula from 6 to 230mcg/litre. Based upon my knowledge before October, I would have used amounts of lutein/zeaxanthin approaching the upper end of the range specified and claimed in Zimmer i.e. 230 mcg/litre. I would have selected such amounts since I knew that: (i) lutein was not toxic (i.e. I had previously given adults milligram quantities of lutein), (ii) I had already established and published in 1997 that the more lutein that is present in a nutritional source the greater the lutein level will be in the plasma and hence the eye and (iii) I had shown Lutein was safe in my 2003 to 2005 monkey studies.”
The opponent concludes in his submissions of 17 August 2015 that:
“By the skilled addressee carrying out the directions contained in Zimmer at the priority date it will inevitably have resulted in an infant formula within the claims of the application.”
If, in carrying out the invention in the prior art there is an inevitable consequence that the person skilled in the art does something that falls within the scope of the claims, then the claim would lack novelty (Novozymes A/S v Danisco A/S [2013] FCAFC 6 at 145).
It appears that Khachik has stated that he would have chosen to use an amount of lutein at the higher end of the range provided in Zimmer. However, the example in Zimmer does not use an amount within the scope of the claims (25 mcg/litre). Sinn (in Sinn #2) has clearly read the disclosure of Zimmer in context and has pointed out that the breast milk studies in Zimmer show a range lower than that claimed. Zimmer also provides preferable ranges and a most preferable amount (at [0015]). While Khachik believes he personally would have used a larger amount of lutein than what is said to be preferable in Zimmer, I find that the inevitable consequence of following the teaching of Zimmer would be to use the “most preferable” amount of lutein, i.e. 25 mcg/litre.
Although Khachik has outlined what he would do personally on reading Zimmer, Sinn has informed me of the clear and unmistakable directions in Zimmer. These clear and unmistakable directions are the most preferable amount, the amount used in the example and the average of the breast milk study. On following the clear and unmistakable directions the PSA would not do something within the scope of the opposed claims.
In order to satisfy novelty, each feature of the claim must be contained in the prior art. Because I have found that the amount of lutein used in Zimmer is not within the scope of the claims I do not have to decide whether or not the amount of DHA used in Zimmer falls within the scope of the claims.
I therefore find that Zimmer does not anticipate any claim in either ‘366 or ‘634.
US 2005/0208179 (Albrecht)
Albrecht was published on 22 September 2005, which is before the priority date of the current applications−which is 26 October 2005.
Albrecht is titled “Nutritional Formula Containing Select Carotenoid Combinations”. The opponent alleges that examples 2 and 3 of Albrecht anticipate the claims of both ‘366 and ‘634.
Albrecht discloses that many formulas, including infant formulas, contain a variety of polyunsaturated chain fatty acids, including DHA ([0004]). Albrecht also acknowledges high concentrations of DHA are added to infant formula for optimal eye and cognitive development ([0006]). However, the polyunsaturated chain fatty acids are susceptible to oxidation ([0006]) and carotenoids, including lutein, can be added as antioxidants ([0009]).
Example 2 of Albrecht makes a Powder Soy Formula for infants at [0080]. It contains DHA-containing oil (40% DHA) 0.381 kg and lutein solution (5.0% active) 0.003 kg. The carotenoid content from ingredients, ppm by weight of total lipids, is given for lutein and this value is 1.2 ppm.
Example 3 of Albrecht makes a Powder Milk-based infant formula at [0089]. It contains lutein solution (20% active) at 0.000939 kg and DHA-containing oil (40% DHA) at 0.49 kg. Again the carotenoid content from all ingredients is given in ppm by weight of total lipids at 1.6 ppm.
It was noted in the hearing that this was a powdered preparation and in order to determine whether this disclosure falls within the scope of the claim it would require calculation of the formula in a ready-to-feed basis. I do not consider a powder to be ready to feed.
The declarations by Khachik and Gibson did not provide the amount in mcg/litre when made up in a ready-to-feed preparation but instead drew conclusions based on the amounts per kilogram. This issue was addressed in the further evidence.
The applicant presented two sets of calculations for determining the lutein and DHA content of examples 2 and 3 of Albrecht in further evidence. The first uses the amounts given in percentages of the weight in kg when made up using 131 g of powder to make a litre of ready to feed formula. The second calculation uses the amount of lutein in ppm of the total lipids when made up using the caloric density as given in Albrecht#1 at page 5 paragraph 16.
The results of these methods are from calculation 1 that there would be 43.23 mcg/Litre of lutein and 43.97 mg DHA/Litre in the ready to feed formula based on the amounts used in example 2 and this would give a ratio of lutein to DHA at 0.98:1. This is not within the scope of the claims.
The second set of examples shows that between 30 and 60 % of the formula can be fat and then given that 1.2 ppm of the total fat is lutein the range would be 26.4 to 65.64 mcg/litre. In example 2 there would be 47.6 mcg/litre lutein in the made up formula and 48.4 mg DHA. In example 3, using the caloric density method there would be 54.2 mcg/litre lutein and 56.6 mg DHA/L. This is again not within the scope of the claims.
Khachik criticised these calculations saying that they did not take into account what he called “inherent Lutein”. If inherent lutein was present this might not be taken into account using the calculation method 1. However, calculation 2 uses the amount of lutein in ppm as the carotenoid content from all ingredients in ppm. Therefore the carotenoid content of all ingredients would include “inherent” lutein. I do not accept that there would be additional inherent lutein.
Both Khachik and Gibson present further calculations that rely on the fat content being 60% and the caloric density being 810 kcal from a range given. This is choosing the highest content of fat and highest caloric density. Albrecht has calculated caloric density based on the ingredients in the example as being 677 kcal.
The question to ask is whether following the clear and unmistakable directions of Albrecht would the inevitably result in a formula within the scope of the claims. Albrecht’s calculations are based on following the examples 2 and 3 and not choosing the top fat content and caloric density possible. I therefore accept the method used by Albrecht.
For these reasons the disclosure of the Albrecht document does not provide clear and unmistakable directions to produce an infant formula within the scope of the claims.

100. Therefore Albrecht does not anticipate either ‘366 or ‘634.
US 6,811,801 B2 (Nguyen)
101. Nguyen was published on 2 November 2004 and is titled “Methods and Compositions For Brightening the Color of Thermally Processed Nutritionals”. It discloses that lutein can be added to brighten the colour of nutritional formulas. Example III in column 17 illustrates the preparation of a ready-to-feed infant formula containing the brightening agent lutein. The amount of lutein is expressed as 11.5 kg of lutein (20%) which I am told equates to 210 mcg/Litre.
102. The document states in column 10 lines 10-11:
“The nutritional formulas will contain suitable carbohydrates, lipids and proteins.”

103. It then goes on to say at lines 20-29:
“Suitable lipids include, but are not limited to, coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, cottonseed oil, fish oil, palm kernel oil, menhaden oil, soybean oil, lecithin, lipid sources of arachidonic acid and docosahexaenoic acid, and mixtures thereof. Lipid sources of arachidonic acid and docosahexaenoic acid include, but are not limited to, marine oil, egg yolk oil, and fungal or algal oil.”

104. The opponent submitted that the person skilled in the art would read this as adding lutein to a formula which already contains DHA (see page 51 of their submissions in chief on ‘366). However, none of the examples of Nguyen utilise a lipid source of arachidonic acid and DHA and while the above passage mentions lipid sources of these could be added, I do not agree that this is clear and unmistakable directions to add DHA in the specified amounts and ratio to lutein as claimed.
105. Therefore Nguyen does not anticipate either ‘366 or ‘634.
Conclusion on novelty
106. I find that in view of the evidence presented this ground of opposition fails and that ‘366 and ‘634 are novel over Zimmer, Albrecht and Nguyen.
Inventive step
107. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (subsection 7(3)).
108. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12 at [45]; 148 CLR 262 at 286 Aickin J stated:
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."

109. The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 approved this approach.
110. In the present case the art relates to the formulation of infant formulas. These are formulated specifically for retinal health and development. The problem relates to the production of formulas for that purpose.
The common general knowledge (CGK)
111. The common general knowledge was defined by Aickin J in Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 292 as:
"The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge."

112. The opponent alleged that the claims of both applications lacked an inventive step in view of the common general knowledge as it existed before the priority date.

113. In order to decide this ground I will look at what has been presented as common general knowledge and then ask the question if, based on what could be considered common general knowledge, would the person skilled in the art have been directly led as a matter of routine to the claimed invention.
The cited patents as part of the CGK
114. The opponent submitted that:
“The evidence shows that by the claimed priority date each of Professors Givson and Khachik were in the habit of searching patents if they wanted to identify or locate information for developing something within the purview of their research activities.”

115. The applicant has disagreed with this view and said it is not correct and pointed me to paragraph 41 of Khachik #1 where he says:
“I also keep up to date with all of the literature on carotenoids that relate to my area of interest. This is now achieved by the use of various search engines. Prior to the development of the internet I received regular lists of the most recent publications concerning carotenoids from the National Agricultural Library. Those lists were generated using keywords (i.e. Carotenoids AND synthesis, isolation, Characterisation, Bioavailability, Metabolism and Supplementation studies) that I set for the librarians.”

116. This does not mention patents, however, Gibson makes the following statement in Gibson #1:
“In addition to conducting searches of the scientific literature, occasionally I was sent copies of patents for my interest. The patents generally concerned infant nutrition that had been located by my colleagues. Also, in my searching if I came across a patent that was in the field of infant nutrition I would occasionally access the patent to consider its content.”

117. Gibson may have occasionally accessed patents, but it does not appear that Khachik would have. There is no evidence to support that these patents were accessed and or widely known in the field. It has not been established that patents would have been part of the background knowledge and experience of the person skilled in the art.
118. In view of this, I do not consider that Zimmer, Albrecht and Nguyen have been established as common general knowledge.
DHA as CGK
119. It was not disputed that DHA was added to infant formulas before the priority and that it was part of the CGK (applicant’s submissions at 116). Sinn #1 at 29 discusses the FSANZ’s standard 2.9.1 (JS-5). It is considered that the FSANZ standard would be CGK as it is an Australian government food safety department that sets the Australian standards. It does include DHA in the fats added at page 11-12.
120. It was, however, disputed that it was CGK that DHA could be used to promote retinal health and vision development in infants.
121. The opponent argued that:
“DHA was included in commercially available infant formulas for its known retinal health and vision development benefits.”

122. Evidence provided by Gibson (Gibson #1 at 50-57 and Gibson #3 at 51-58) discusses that DHA supplementation to infant formulas was known and he mentions a study on primates. In this study primates fed diets poor in DHA had low levels of tissue DHA and poor visual function.
123. Gibson states that (Gibson #1 at 55):
“The motivation for including DHA in infant formula is based on a study conducted in the early 1960’s on primates. Primates that were raised on n-3 polyunsaturated fatty acid deficient diets had low tissue levels of DHA and poor visual function. Subsequent studies have shown that pre-term infants fed formulas that contained no DHA had lower brain DHA levels than infants fed breast milk containing DHA. The outcomes of these randomized clinical trials are that pre-term infants benefit from a supply of dietary LCPUFA such as DHA. The benefit to term infants is less understood.”

124. He then concludes that:
“as at 26 October 2006 DHA in LCPUFA supplemented infant formula fed to term infants had not been conclusively shown to have any effects on visual acuity.”

125. Dr Sinn acknowledges that DHA was added to infant formula to help with brain development. He does not associate this addition with retinal health and visual function before the priority date. He makes the following statements (in Sinn #1 at 34 and 35)
“As of October 2005, DHA was known additive for infant formula, with DHA being identified as having benefits in infant brain development.”

126. He continues with:
“As of October 2005, I can see no reason why an infant formula formulator would consider altering their existing infant formula to change the level of DHA in their existing formulations.”

127. It appears clear that the addition of DHA to infant formula was done because of studies like those discussed by Gibson. However, the exact role in retinal health is not common general knowledge. The primate studies appear to focus on n-3 polyunsaturated fatty acids supplementation in general and LCPUFA supplementation in general may have been associated with visual acuity.
Lutein as CGK
128. The next feature in the claims in both applications is lutein. The applicant stated that:
“It is hotly disputed that it was CGK before the priority date that lutein was added to infant formulas.”

129. They used evidence from Sinn to support their argument. Sinn stated that he was not aware that lutein had useful benefits (Sinn #1 at 40) and that the FSANZ standard 2.9.1 (JS-5) did not include it. Sinn noted that the FSANZ Standard 2.9.1 was amended in 2009 to include lutein i.e. after the priority date.
130. Gibson states (in Gibson #1 at 70) that:
“I am not aware of any nutritional supplement studies or evidence to suggest that retinopathy may be prevented by nutritional supplements such as lutein.”

131. He then discusses a conference in 2006 in Gibson #1 at 73 which focused on the release of infant formula that contained lutein. This later release of a formula does not establish to me that lutein was common general knowledge before the priority date.
132. He noted at 74:
“I am aware that lutein had been shown prior to 26 October 2005 to provide antioxidant protection to DHA in the eye in adult humans. I can think of no reason why lutein would not do the same thing in infants, but this remains to be proven by properly designed scientific tests.”

133. In Gibson #2 he acknowledges the FSANZ guidelines at 34 and that there may not have been formula in Australia with lutein added before the priority date.
134. Khachik had published studies on lutein as an antioxidant in human and monkey retinas (Khachik #1 at 33).
135. He notes a study he conducted on human breast milk and identified 34 carotenoids, including lutein as the most abundant in concentrations of 21 mcg/L to 33 mcg/L.
136. Khachik then turns to the document Jewell et al. (2004) “A comparison of lutein and zeaxanthin concentrations in formula and human milk samples from Northern Ireland mothers” Eur. J. Clin. Nutr., 58:90-97 (Jewell), which shows a wide variation of lutein in human breast milk and compares them to infant formulas.
137. Jewell notes that the antioxidant properties of carotenoids may be important protective factors in the retinal pigment epithelium of new born infants.
138. The applicant has pointed out that Jewell has not been established as common general knowledge in Australia in their submissions and notes that while some of the formulas in Jewell do have high concentrations of lutein, this lutein comes from egg yolk. I note that egg phospholipids are excluded from the claims. This is also acknowledged by Khachik (in Khachik #1 at 101).
139. Khachik then makes a further statement that:
“Thus, as early as 1997 I had reported that lutein and zeaxanthin should be included in infant formula to closely resemble their distribution in plasma. Accordingly, I am of the view that I had already described lutein fortified human fortified formulas well before 2005.”

140. I do not see any evidence which shows that it was common general knowledge to add lutein at the concentrations as claimed in a formula free of egg phospholipids.
141. Jewell does not teach that lutein is less bioavailable in formula than breast milk and therefore the amount of lutein in formula should be increased as the current specifications show.
142. It is clear that the amount of lutein is important and, while its levels vary in breast milk, its addition must be at a particular level to achieve the benefits to the retina. There is nothing in the evidence which establishes this as common general knowledge.
Lutein/DHA ratio
143. The opponent stated in his submissions at paragraph 266 that:
“the person skilled in the art would be directly led as a matter of course to try infant formulas within the broad weight/concentration ranges of lutein and by doing so would have been directly led as a matter of course to an infant formula within the claimed lutein/DHA ratio.”

144. The lutein prevents the DHA from being oxidised and in order to achieve this they must be present in the ratios as claimed. It has not been shown that this ratio formed part of the common general knowledge. However, the direction to do this has not been established in the evidence, nor have the steps which the skilled person would have taken to achieve this.
Conclusion on CGK
145. Therefore the evidence does not establish that all of the features of the claims were common general knowledge and furthermore it has not been established that the person skilled in the art would be directly led as a matter of routine from the common general knowledge to the totality of the claims.
Section 7(3) Inventive step
146. The opponent alleged that both specifications do not involve an inventive step when either of the documents Zimmer, Albrecht or Nguyen is combined with the common general knowledge.
147. In order for a document to be considered prejudicial to inventive step it must be established that the document will be ascertained, understood and regarded as relevant.
148. The opponent submitted that:
“The evidence shows that by the claimed priority date each of Professors Gibson and Khachik were in the habit of searching patents if they wanted to identify or locate information for developing something within the purview of their research activities.”

149. The applicant has disagreed with this view and said it is not correct and pointed me to paragraph 41 of Khachik #1 where he says:
“I also keep up to date with all of the literature on carotenoids that relate to my area of interest. This is now achieved by the use of various search engines. Prior to the development of the internet I received regular lists of the most recent publications concerning carotenoids from the National Agricultural Library. Those lists were generated using keywords (i.e. Carotenoids AND synthesis, isolation, Characterisation, Bioavailability, Metabolism and Supplementation studies) that I set for the librarians.”

150. This does not mention patents, however, Gibson makes the following statement in Gibson #1:
“In addition to conducting searches of the scientific literature, occasionally I was sent copies of patents for my interest. The patents generally concerned infant nutrition that had been located by my colleagues. Also, in my searching if I came across a patent that was in the field of infant nutrition I would occasionally access the patent to consider its content.”

151. It appears from the above statements that conducting patent searches was routine, and they would probably read a patent concerning their work if they came across it (Gibson). I believe that in formulating a new infant formula utilising search engines (Khachik) and being sent patents of interest (Gibson), patent documents would have been ascertained. The applicant has stated that both Albrecht and Nguyen would not be regarded as relevant as they are not concerned with retinal health and vision development but address stability and colour.
152. Although Albrecht is more generally to do with colour and stability, Albrecht discusses eye development at [0006]. I therefore believe it would be regarded as relevant.
153. Zimmer discusses lutein and zeaxanthin as antioxidants that may protect the retina from damage ([0003]). I therefore consider Zimmer would be regarded as relevant.
154. Nguyen is a document which uses lutein for brightening the colour and appeal of infant formula and makes no mention of eyes or the retinal development. A formulator would appreciate these benefits but would not regard it as relevant to the problem. For the sake of completeness, however, I will consider this document briefly.
Inventive step: Zimmer and CGK
155. As outlined above for novelty, Zimmer states that infant formula may comprise lutein and zeaxanthin in an amount of about 6 to about 230 mcg/Litre. However, the example only uses 25 mcg of lutein and zeaxanthin and this is said to be the most preferable amount to use ([0015]).
156. In order for the person skilled in the art to arrive at the current claims they would have to use the common general knowledge to increase the amount of lutein in the formula to be within the scope of the claims and in a ratio to DHA.
157. Lutein was known to be present in breast milk and this is shown in Zimmer at [0017]. The average of this was calculated by Sinn (Sinn # 2 at 26) and is 26 mcg/L with a range of 15 to 44 mcg/L.
158. The current applications differ in that they realise that the amount of lutein in formula needs to be increased above that typically found in breast milk. This is because it is less bioavailable in formula than breast milk. It also needs to be present in a ratio to DHA. I can find nothing in the evidence that establishes this was common general knowledge. The steps that the person skilled in the art would need to take as a matter of course to arrive at the current claims have not been laid out.
159. Therefore, in view of the evidence, both applications possess an inventive step over Zimmer and the common general knowledge.
Inventive step: Albrecht and CGK
160. Albrecht differs from the claims in the amount of lutein used in the formulas and also in the ratio of lutein to DHA. This difference has been outlined above for novelty.
161. Albrecht recognises a relationship between DHA and lutein at [0009] and teaches that carotenoids, such as lutein, can be used to stop oxidation. However, this is in the context of stability and colour performance and does not extend that relationship to retinal health.
162. The current specification discusses that increasing the amount of lutein in formula is required because of the difference in bioavailability between a formula and breast milk.
163. There is nothing from the common general knowledge or in Albrecht that would lead the person skilled in the art to increase lutein and come to the ratio of lutein to DHA as claimed to achieve the benefits to retinal health.
Inventive step: Nguyen and CGK
164. Nguyen discusses lutein as a brightening agent for infant formulas (see example III). There is mention of DHA sources in terms of lipids that could be added. There is no teaching in Nguyen or the common general knowledge which would direct the person skilled in the art to the claimed concentrations of lutein and the ratio of lutein to DHA. Similarly there is no evidence that outlines the steps that would lead the person to these claims and produce a formula for retinal health.
Conclusion on inventive step

165. The current specification identifies that lutein must be added to infant formulas at a higher concentration than the equivalent amount in breast milk in order to obtain the same plasma levels of lutein as infants fed breast milk. Lutein has a relationship to DHA and together they improve retinal health. In order to achieve this benefit the amount of lutein to DHA present in a formula must be within a specifically claimed ratio. The evidence has not established that the person skilled in the art would be directly led to the totality of the features of the claims as a matter of course either by common general knowledge or when it is combined with the patent documents.
166. This ground of opposition fails.
Utility
167. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be useful. The issue of utility was considered by the Full Court of the Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228. Emmett J at 247 [81] stated:
"A claim is bad if it covers means that will not produce the desired result, even if a skilled person would know which means to avoid. That is to say, everything that is within the scope of a claim must be useful, otherwise the claim will fail for inutility."

168. The opponent has argued that the lutein concentration of 50 mcg/L fails to meet the promise of the invention (see paragraph 61 of the submissions). The opponent focuses on the experiment shown in the table on page 27 of both applications where an amount of 52.6 mcg/L in infant formula is:
“ only marginally greater than 50% of the plasma lutein concentrations found in breast-fed infants receiving no more than 30 mcg/L of lutein.”

169. The applicant has argued that the specification does not promise 50 mcg/L will achieve the same concentrations as breast milk.
170. Looking at the plasma study on page 27 it appears that the amount of lutein in breast milk varied greatly however, breast milk gave the highest plasma lutein, 5.88 +/- 0.77 at 56 days. Formula L2, which contained 52.6 mcg/L gave plasma lutein at 3.25 +/- 0.26 at 56 days. The controls and formula L1 (which had 32.6 mcg/L lutein) gave plasma lutein as 2.17 +/- 0.12 and 2.21+/- 0.16.
171. I note that the breast milk in this table varied from 6.5-107.8 mcg/L of lutein and is not representative of breast-fed infants receiving no more than 30 mcg/L of lutein.
172. It appears that 52.6 mcg/L gave a plasma lutein concentration at 56 days that was significantly higher than the controls or 32.6 mcg/L formula. While this was not identical to breast milk, the breast milk in the study varied.
173. This study showed there was no difference in plasma lutein between a formula with 32.6 mcg/L and the control, however, when the formula contained 52.6 mcg/L lutein the plasma lutein was seen to increase. It showed that above 52.6 mcg/L was needed to increase plasma levels of lutein.
174. It therefore clear to me that at concentrations of 52.6 mcg/L lutein, plasma lutein would be increased beyond that of controls. This does not establish that a concentration of 50 mcg/L would not work and does not establish that the claims fail to meet the promise of the invention.
175. I therefore find that this ground of opposition fails.
Manner of manufacture
176. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. This requirement has been discussed many times by the courts, and the opponent has relied on it in three ways.
177. Firstly, the opponent claims that the infant formula is the use of known material in the manufacture of known articles for a purpose which that material’s known properties make it suitable (I.1 in their submissions). They cite the Full Federal Court in Astrazeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [383]:
“…the majority in NV Philips clearly held that the requirement of inventiveness will not be satisfied where the claims are for nothing more than the use of known materials in the manufacture of known articles for a purpose for which that material’s known properties make it suitable.”

178. Secondly, the opponent claims the features of the claims amount to mere analogous use and they cite Microcell v Commissioner of Patents (1953) 102 CLR 232:
“It is not an inventive idea for which a monopoly can be claimed to take a substance which is known and used for the making of various articles, and make out of it an article for which its known properties make it suitable, although it has not in fact been used to make that article before.”

179. Thirdly, the opponent alleges that the claims are a mere collocation and have cited Smith & Nephew Pty Ltd v Wake Forest University Health Sciences [2009] FCAFC 142 at [16]:
“A mere collocation of parts, each performing its own separate function, is not patentable. However, a claim may validly combine a number of elements which interact with each other to produce a new result or product.”

180. In this regard I have found above for novelty and inventive step and that it was not established common general knowledge to add lutein to breast milk in the concentrations as claimed or in the ratio to DHA as claimed. These are not arbitrary parameters as they both work together to promote retinal health and vision development.
181. I find that both applications possess a manner of manufacture.
Fair basis
182. It is a requirement of subsection 40(3) of the Act that the claims must be fairly based on the matter described in the specification. The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 at [69], 217 CLR 274 at 300 approved the words of Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95:
"the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification".

183. The opponent has argued that because the sources of lutein used include some zeaxanthin consequently there is no clear and reasonable disclosure of an infant formula containing lutein alone. However, the claims do not require the formula to be free of zeaxanthin but merely require knowledge of the concentration of lutein specifically. In this regard there is a real and reasonably clear disclosure; the concentration of lutein is given.
184. It is further argued that claim 10 of ‘366 lacks fair basis because there is no example of a formula wherein the lutein comprises at least 25% by weight of added lutein. This would require the lutein to be 75% inherent lutein. This range is identified in the consistory clause and the person skilled in the art would understand this. Fair basis does not limit the claims to the specific examples, lutein is added to the formulas and they can include some inherent lutein. I therefore find this claim to be fairly based.
185. This ground of opposition fails.
Sufficiency
186. It is a requirement of subsection 40(2) of the Act that the specification must describe the invention fully. The High Court in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8 at [25]; 207 CLR 1 at 17 explained this requirement as:
"The question is, will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?"

187. The opponent has argued that the claims lack sufficiency because the lutein is not usually available in a single source and is usually present with some zeaxanthin.
188. The claims to not require that there be no zeaxanthin present, but merely require the concentration of lutein to be known. This can be measured and has been done in the prior art documents cited as well. There is no evidence that suggests this could not be achieved.
189. This ground of opposition fails.
Conclusion
190. The opposition fails on all grounds.
191. Subject to appeal, I direct that ‘366 and ‘634 proceed to grant.
Costs
192. The parties submitted that costs should follow the event. I see no reason to depart from that result. The opposition has been unsuccessful. Costs are awarded against the opponent.
Keith Wagg
Delegate of the Commissioner of Patents