BioVax Limited v Equilume Limited
[2020] APO 27
•15 June 2020
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
BioVax Limited v Equilume Limited [2020] APO 27
Patent Application: 2016231515
Title:An apparatus and method for inhibiting melatonin synthesis in a horse
Patent Applicant: Equilume Limited
Opponent: BioVax Limited
Delegate: Dr A. Lim
Decision Date: 15 June 2020
Hearing Date: 22 April 2020, via video conference
Catchwords: PATENTS – section 59 – opposition to the grant of a patent – non-compliance with the grounds of clarity, novelty and inventive step not established – claims 11, 21 and dependent claims include subject matter that does not properly reflect the key features of the applicant’s invention – opportunity to amend – costs awarded against the opponent
Representation: Patent attorney for the applicant: Mr Mark O’Donnell from Madderns Pty Ltd
Counsel for the applicant: Mr Benjamin Fitzpatrick
Patent attorney for the opponent: Ms Helen Bellchambers from AJ Park
Counsel for the opponent: Ms Clare Cunliffe
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2016231515
Title:An apparatus and method for inhibiting melatonin synthesis in a horse
Patent Applicant: Equilume Limited
Date of Decision: 15 June 2020
DECISION
The opponent has not established a case that a ground of opposition to the grant of a standard patent exists. However, I have identified that claims 11 and 21 and dependent claims include subject matter that does not properly reflect the key features of the applicant’s invention.
I allow Equilume Limited two months from the date of this decision to propose amendments. Where no amendments are proposed within this period, or where amendments are proposed and once amendments have been allowed, I will consider whether the patent application should be re-examined.
Costs according to Schedule 8 are awarded against BioVax Limited.
REASONS FOR DECISION
Patent application number 2016231515 (the opposed application) was filed on 21 September 2016 as a divisional application from 2012264964 (the parent application). The parent application was subsequently converted to innovation patent application number 2012101968. The opposed application ultimately claims priority from Irish application S2011/0245 filed on 27 May 2011 (priority date). The applicant of the opposed application is Equilume Limited (Equilume).
The opposed application was examined and advertised accepted by the Commissioner on 17 May 2018. The application was subsequently opposed under section 59 of the Patents Act 1990 (the Act) by BioVax Limited (BioVax). BioVax served a notice of opposition on 17 August 2018 and filed a statement of grounds and particulars (SGP) on 19 November 2018.
A hearing was held on 22 April 2020 by video conference to decide the opposition. Equilume was represented by Mr Benjamin Fitzpatrick, counsel, and Mr Mark O’Donnell from Madderns Pty Ltd. BioVax was represented by Ms Clare Cunliffe, counsel, and Ms Helen Bellchambers, patent attorney from AJ Park.
1 The opposition
The grounds of opposition pressed at the hearing were:
·lack of clarity,
·lack of novelty, and
·lack of inventive step.
The evidence is summarised in the table below.
Evidence Declarant Exhibits Date Reference In Support Claude Aguergaray CA 1-9 19 February 2019 Aguergaray #1 William Richard Allen WRA 1-4 18 February 2019 Allen #1 Edward Squires ES 1-2 15 February 2019 Squires #1 In Answer Jason Andrew Gerard JAG 1-3 21 May 2019 Gerard Barbara Anne Murphy BAM 1-3 08 May 2019 Murphy Simon James Robinson SJR 1-5 23 May 2019 Robinson[1] In Reply Claude Aguergaray CA-10 30 July 2019 Aguergaray #2 William Richard Allen None 29 July 2019 Allen #2 Edward Squires None 30 July 2019 Squires #2 [1] Original and substitute copies of the declaration and exhibits of Simon James Robinson were filed on 24 May and 27 May 2019, respectively. At the hearing, I confirmed with the applicant’s representatives that the content of the original and substitute copies is the same and the only difference is that the reproduction of the substitute copies is clearer.
The opposed application was filed on 21 September 2016. As a consequence, the amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 apply to the present application. This includes subsection 60(3A) of the Act which states:
(3A) If the Commissioner is satisfied, on the balance of probabilities, that a ground of opposition to the grant of the standard patent exists, the Commissioner may refuse the application.
The standard of proof that applies to the present opposition is the balance of probabilities, and BioVax carries the onus of proof.
2 Regulation 5.23
After the period for evidence in reply was completed, Equilume requested under regulation 5.23 that the Commissioner consult further declarations and exhibits from Simon James Robinson and Jason Andrew Gerard.[2] A delegate of the Commissioner considered the request and subsequent correspondence from Equilume and was of the view that the additional material was not likely to be crucial to my decision and therefore invoking regulation 5.23 was contrary to the public interest and contrary to the balance of convenience of the parties.[3] The delegate considered that it was not appropriate to accede to the regulation 5.23 request.
[2] Letters from Equilume dated 18 September 2019 and 08 October 2019.
[3] Letters from IP Australia dated 02 October 2019 and 17 October 2019.
3 The specification
The specification relates to an apparatus and method for inhibiting melatonin synthesis in seasonally breeding animals, such as a horse.[4] In particular, the specification relates to advancing the onset of a mare’s breeding season relative to the universal birthday of many horse breeds.[5] The specification has 22 claims. Claims 1, 11 and 21 are independent claims. The claim set is reproduced in Annex A of this decision.
[4] The specification at page 1, lines 1-5.
[5] The specification at page 1, lines 1-19.
3.1 Principles of construction
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd:
“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.”[6]
[6] [2013] FCA 214 at [139]; 100 IPR 451.
3.2 The background to the invention
The specification describes that photoperiod signals are the primary regulators of reproduction in seasonally breeding animals.[7] The production of melatonin by the pineal gland is described to be confined to the night-time hours and inhibited by light. Melatonin therefore acts as a decoder of seasonal day-length in seasonally breeding animals.[8] As the days get longer in the spring, the duration of melatonin production is reduced and the inhibitory action of melatonin on a mare’s reproductive activity lifts consequently.[9]
[7] The specification at page 1, lines 9-10.
[8] The specification at page 1, lines 10-12.
[9] The specification at page 1, lines 13-14.
The universal birthday for many horse breeds is 1st January in the Northern Hemisphere.[10] Since horses normally foal later in the year, there is a demand for early foals in order to produce yearlings and two-year old racehorses to meet industry timelines for sales and racing schedules.[11]
[10] The specification at page 1, lines 14-16; Robinson at [13]; Allen#1 at [3.5].
[11] The specification at page 1, lines 17-18.
The specification describes that exposure of thoroughbred breeding mares to lengthened hours of light for at least 8-10 weeks is a standard industry practice in order to advance the reproductively active period of a mare’s circa-annual reproductive cycle.[12] The specification also describes that the only known solution is to leave the stable lighting on over housed mares, and that the literature reports that a 100 Watt light bulb in a 12 feet by 12 feet stall burning for 16 hours a day provides sufficient light for this purpose.[13]
[12] The specification at page 1, lines 20-23.
[13] The specification at page 2, lines 27-30.
The method of maintaining mares indoors under lights is labour and energy intensive as mares must remain indoors and require feeding, bedding and labour associated with their upkeep during this time.[14]
[14] The specification at page 1, lines 25-28.
The specification also notes that research studies indicate that administration of artificial light to mares can shorten the gestation period and increase the birth weight of foals.[15]
[15] The specification at page 2, lines 14-25.
3.3 The aim of the invention
The specification states that the present invention aims to provide a cost-effective device and method for inhibiting melatonin synthesis in a horse.[16]
[16] The specification at page 3, lines 10-11.
3.4 The invention as described in the specification
The summary of the invention discloses that the invention relates to a light-based method,[17] a device[18] and a system[19] for inducing physiological change in a horse or other animal. The physiological change is selected from the group consisting of: advancing the breeding season of the horse or other animal, shortening the gestational length, increasing the birth weight, mitigating the effects of jet-lag, and advancing the shedding of a winter coat.[20]
[17] The specification at page 3, lines 12-22.
[18] The specification at page 5, lines 1-12.
[19] The specification at page 5, lines 13-25.
[20] ibid.
The method involves shining low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity from 10-100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change. The blue light is provided for a period such that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24-hour period.[21]
[21] The specification at page 3, lines 12-22.
The device and system for inducing physiological change is operable to shine low intensity blue light from an artificial blue light source in which the artificial blue light source provides blue light with intensity from 10-100 lux into just one eye of a horse or other animal. The device and system includes a control that is operable to turn on the artificial blue light source and to leave the light source on so that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24-hour period.[22]
[22] The specification at page 5, lines 1-25.
The specification describes that blue light is directed into only a single eye of the horse or other animal at any given time.[23]
[23] The specification at page 5, lines 26-27.
The specification describes the basis of the invention as:
“the recognition that the photic pathways involved in circadian, neuroendocrine and neurobehavioural responses in the retina are independent of those that convert light signals to neural signals for the visual system.”[24]
[24] The specification at page 5a, lines 1-4.
The specification explains that:
“Melanopsin is the photopigment mediating these non-visual responses in conjunction with rod and cone cells and is found in a novel set of photoreceptors called intrinsically photosensitive retinal ganglion cells (ipRGCs). The action spectra for these photoreceptors show peak sensitivities in the short-wavelength region of the visible spectrum and studies conducted in mice and humans indicate a peak sensitivity range between 459nm and 484nm.”[25]
[25] The specification at page 5a, lines 4-9.
The specification then states:
“Since, for horses, we are most interested in the circadian and neuroendocrine signals that reach the SCN (the part of the brain regulating biological rhythms), we chose a suitable wavelength range that has shown to be effective in other species and likely to be effective in horses, as we have shown. The light chosen is not light for vision, but light to stimulate the SCN.”[26]
[26] The specification at page 5a, lines 9-14.
The specification describes the advantages of the invention are that mobile timed lighting can be provided to horses or other animals while they remain in their natural outdoor pasture environment. As a consequence, an advanced reproductive breeding season for animals can be facilitated without the need to house the animals indoors and permits a highly cost-effective means for reducing gestation length and/or increased birth weights.[27]
[27] The specification at page 5a, lines 15-21.
Description of the preferred embodiment
The specification describes a horse’s face mask fitted with an artificial blue light source to provide blue light with an intensity of 10-100 lux into just one eye of the horse as the preferred embodiment.[28] Drawings of the face mask fitted with a an LED (light-emitting diode) emitting blue light (item 26. Figure 2) that is controlled by a power supply (item 30, Figure 3) have been reproduced in Annex B of this decision.
[28] The specification at pages 6-8; Figures 1-3.
The face mask is described to comprise a fabric base (item 10, Figure 1) having ear openings (item 12, Figure 1), eye openings (item 14, Figure 1) and fasteners (item 16, Figure 1) for fastening the mask behind the horse’s neck. One of the eye openings is fitted with a blinker (item 18, Figure 2) which comprises a rigid cup (item 20, Figure 2) having a diffusively reflective internal concave surface 22. The cup is fixed to a semi-rigid annular base (item 24, Figure 2) and the annular base is fitted around the eye opening.
The LED 26 emitting blue light is mounted on the blinker 18 at the junction of the cup and base (Figure 2). The LED 26 is positioned to shine blue light onto the reflective surface 22, from where it is diffused into the horse’s cornea. The reflecting surface is white so that it does not significantly filter the blue light.[29]
[29] The specification at page 6, line 28 to page 7, line 2.
The specification describes that the construction of the mask is such that the horse is exposed to diffuse light that provides much less distraction than a light directly pointed at the eye.[30] The specification describes that the behaviour of the horses remained normal and they continued to feed or rest during the time they were exposed to the blue light.[31]
[30] The specification at page 7, lines 4-5.
[31] The specification at page 7, lines 6-7.
The specification describes that it is important that the blue light is administered to a single eye as this will not impede the natural behaviour of horses maintained outdoors at night whereas light administered to both eyes might impede vision and movement.[32]
[32] The specification at page 7, lines 11-13.
The power supply (item 30, Figure 3) is described to have a battery compartment (item 34, Figure 3) and a switch (item 36, Figure 3). Switching the power supply on and off can be done manually or the power supply can include an automatic time to turn the LED on and off at pre-selected times.[33]
[33] The specification at page 7, lines 21-25.
The specification describes that in variations of the preferred embodiment, diffuse light can be directed towards the horse’s eye without being reflected from a surface, for example by providing the LED with a diffusing lens surface.[34] The diffusing lens surface may be in the form of a covering lens surface such as a transparent glue.[35]
[34] The specification at page 8, lines 1-4.
[35] The specification at page 8, line 5.
The specification describes that the LED 26 emits blue light with a peak wavelength at 468 nm and that 10-50 lux of such light directed at a single eye can inhibit the production of melatonin in the horse to daytime levels.[36]
[36] The specification at page 9, lines 10-12.
The specification describes that the invention may be implemented using blue light in general but preferably having a peak wavelength from 440 to 490 nm and most preferably having a peak wavelength from 459 to 484 nm.[37]
[37] The specification at page 9, lines 19-21.
The lux levels of blue light are described to be very low, preferably 10-100 lux, and most preferably 10-50 lux, compared to natural daylight which provides anywhere from 1000-10,000 lux of light, depending on cloud cover.[38]
[38] The specification at page 9, lines 13-14 and lines 21-22.
In another variant of the preferred embodiment, the LED 26 can be a white light emitting LED, and the internal surface 22 of the cup 20 could be fabricated as a diffusively reflecting blue filter, either by providing a white diffusively reflecting surface with a separate transparent filter in front of it, or by making the internal surface itself of a blue diffusively reflecting material.[39]
[39] The specification at page 11, lines 6-11.
The specification describes a regime of administering blue light each day for at least 6 weeks, and more preferably for 6-8 weeks from about 1st December for advancing the breeding season of mares.[40] The blue light is described to be turned on before dusk and remains on so that the mares receive a combined total of at least about 16 hours of natural daylight and blue light each day.[41] The specification states that overlapping periods of daylight and blue light do not count double in the total.[42]
[40] The specification at page 9, lines 28-29. I consider the skilled person would understand the date, 1st December, applies to the breeding season of mares in the Northern Hemisphere. See section “Technical background that forms part of the common general knowledge”.
[41] The specification at page 9, line 29 to page 10, line 2.
[42] The specification at page 10, lines 1-2.
Preliminary results are described to show that the administration of blue light using the above-mentioned regime can be at least as effective as maintaining animals indoors under barn lighting to advance the breeding season of mares.[43]
[43] The specification at page 10, lines 4-6.
The specification states that horses have a circadian rhythm and genes which undergo a 24-h profile that is regulated by the light/dark cycle.[44] Jet-lag, which is a consequence of a misalignment of internal rhythms of physiology and a new light/dark cycle following abrupt changes in time zones, is described to be an issue for horses.[45]
[44] The specification at page 10, lines 15-17.
[45] The specification at page 10, lines 9-12 and line 20.
In order to mitigate the effects of jet-lag for a horse, the specification recommends that dusk and dawn be delayed or advanced, respectively, in selected daily increments (10, 30 or 60 minutes) by providing, prior to travel, blue light using the horse mask described above.[46] The blue light is administered for a duration of time such that the animal is synchronised to the light/dark cycle of the destination.[47] Generally, the specification suggests advancing the light cycle by a maximum of one hour per day when flying east and delayed by one hour per day when flying west.[48] The number of days of light therapy should correspond roughly to the number of time-zones crossed.[49]
[46] The specification at page 10, lines 25-28.
[47] The specification at page 10, lines 28-29.
[48] The specification at page 10, line 29 to page 11, line 1.
[49] The specification at page 11, lines 1-2.
The specification also describes that use of the present invention advances the shedding of a horse’s winter coat and reduces the costs associated with either manually or accelerating shedding via housing under artificial light.[50]
[50] The specification at page 12, lines 28-30.
3.5 The field of the invention and the problem addressed
Having regard to the background of the invention in the context of the whole specification, I consider the field of the invention to be inducing physiological changes in seasonally breeding animals, especially horses, including advancing the breeding season of these animals.
As previously discussed, the specification describes the current method of maintaining mares indoors under lights during the winter months to advance their reproductively active period as labour intensive and costly. In broad terms, I consider the problem addressed by the opposed application as improving control over inducing physiological changes in seasonally breeding animals, especially horses. More specifically, I consider the problem addressed as more efficiently advancing a mare’s breeding season relative to the universal birthday of many horse breeds.
3.6 The person skilled in the art
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.”[51]
[51] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70]; 177 ALR 231.
However, the person skilled in the art is 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.”[52]
[52] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]; 89 ALJR 798.
An 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 qualifications of the expert witnesses, relevant to the present opposition, are summarised below.
Professor Edward L. Squires is currently an adjunct professor at the Gluck Equine Research Centre at the University of Kentucky. He was a Professor in the Department of Biomedical Sciences at Colorado State University for 33 years.[53] Professor Squires has published extensively in refereed journals and text books and is an editor of the text Equine Reproduction (Second Edition).[54] He has been the editor of the Journal of Equine Veterinary Science for the past 13 years and chairman and host of the International symposium on Equine Reproduction.[55] Professor Squires is also a co-author of a prior art document, D1, relied on in this opposition.[56]
[53] Squires #1 at [1]-[2].
[54] Squires #1 at [3].
[55] Squires #1 at [4].
[56] D1 is a journal article by V. Shabpareh, E.L. Squires, V.M. Cook and Roger Cole entitled ‘An alternative artificial lighting regime to hasten onset of the breeding season in mares’, Equine Practice, Vol. 14, pages 24-27, 1992.
Professor William Richard (Twink) Allen founded the Thoroughbred Breeders Association’s Equine Fertility Unit at the Animal Research Station (ARS) in Cambridge, England. He spent 18 years at the ARS undertaking basic and applied research into various aspects of equine reproductive physiology. He continued to research into various aspects of thoroughbred breeding until his retirement in 2007. Since retirement he has continued to conduct research on equine reproduction.[57]
[57] Allen #1 at [1].
Dr Aguergaray is a specialist in the area of photophysics.[58]
[58] Aguergaray #1 at [2.3]-[2.4].
Dr Simon James Robinson is a registered veterinary scientist and a specialist working with the Victorian Equine Group (VEG). The VEG operates the Victorian Equine Reproduction Centre which is a specialist reproduction centre set up to facilitate assisted equine reproduction. Dr Robinson’s veterinarian duties with VEG include mare fertility evaluations, and management of mares for breeding. Dr Robinson has provided advice and assistance to horse breeders, most notably breeders of thoroughbred horses, in how to use light-based methods for advancing the reproductive season of mares.[59]
[59] Robinson at [5]-[6].
Mr Jason Andrew Gerard is an electronic engineer with extensive experience in the lighting industry.[60]
[60] Gerard at [1].
Dr Barbara Anne Murphy is a co-inventor of the opposed application. In 2013, Dr Murphy was a lecturer in equine science at University College Dublin, Republic of Ireland and was the founder of the applicant, Equilume.[61]
[61] Murphy at [1], Exhibit BAM-2.
Equilume submitted that the relevant addressee would be a veterinary scientist knowledgeable in inducing physiological changes in animals (particularly horses) or a person involved in, or having a professional interest in, the induction of physiological changes in animals, and particularly in equine reproduction.[62] Equilume also submitted that Dr Aguergaray’s speciality is in laser physics and he has no experience in the field of inducing physiological changes in seasonally breeding animals, especially horses, including inducing changes in the breeding cycle[63] While Equilume accepts that Dr Aguergaray could give evidence as to the inherent properties of light, or its ability to be measured, Equilume submits it is impermissible to assimilate his knowledge into the knowledge of the notional skilled person in the field at the priority date.[64]
[62] The applicant’s written submissions, dated 15 April 2020, at [52].
[63] The applicant’s written submissions, dated 15 April 2020, at [54], [151].
[64] ibid.
Equilume referred me to Minnesota Mining & Manufacturing Company v Tyco Electronics Pty Ltd (3M v Tyco) where the Full Court noted:
“The team approach is, of course, designed to solve a problem which requires the joint efforts of experts in more than one field. Such an approach must involve interaction between or amongst the experts so that common general knowledge can be shared. In this case the evidence did not deal with the way in which this process might have occurred….. Unfortunately, this hiatus in the evidence relates to the point at which any inventive step occurred.”[65]
[65] [2002] FCAFC 315 at [91].
Equilume submitted that while it accepts that the notional skilled person may be a team of skilled persons,[66] BioVax has:
[66] The applicant’s written submissions, dated 15 April 2020, at [55].
“adduced no evidence to suggest that, faced with the problem at the priority date, an assembled team would include a specialist in laser physics (or any other light source) or that there would be a sharing of knowledge between persons with experience in equine reproduction and laser physics.”[67]
[67] The applicant’s written submissions, dated 15 April 2020, at [57].
I have considered Equilume’s submissions regarding how the skilled person is to be identified and characterised,[68] and Equilume’s characterisation of the nature of the evidence of BioVax’s expert witnesses. [69] It appears to me that Equilime’s concerns are mostly regarding the nature of the evidence—Equilume submitted some of the statements of BioVax’s expert witnesses are either assertions without proper explanation or tainted with the benefit of hindsight. The expert witnesses of BioVax have made statements in evidence regarding how they would modify the cited prior art to arrive at the claimed invention of the opposed application. In some instances, BioVax’s expert witness also made statements regarding the obviousness of the claimed invention.
[68] The applicant’s written submissions, dated 15 April 2020, at [50], citing Aktiebolaget Hassle v Alphapharm P/L (2002) 212 CLR 411 at [153].
[69] The applicant’s written submissions, dated 15 April 2020, at [136], [141], [142], [152], [165], [184]-[208].
Where expert witnesses have provided reasoning to substantiate their statements made in evidence, this reasoning is more likely to assist me in weighing the evidence. Statements made without proper support or explanation are likely to be of less assistance. As will become evident, several questions regarding the properties and measurement of light need to be addressed to understand the invention of the opposed application. The evidence of the lighting experts regarding the properties and measurement of light is therefore valuable. I consider all the declarants mentioned above are in a position to provide evidence as to what the person skilled in the art knew and would have done. The weighing and evaluating of the evidence to decide the characteristics of the person skilled in the art is part of the normal work of a delegate of the Commissioner.
3.7 Technical background that forms part of the common general knowledge
Before construing the claims it is helpful to review what was already known in the art before the priority date, 27 May 2011, about the reproductive physiology of seasonally breeding animals, particularly that of a female horse or mare.
Common general knowledge (CGK) is the background knowledge and experience available to all those working in the relevant art:
“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.”[70]
[70] Minnesota Mining and Manufacturing Co v Beiersdorf (Aust) Ltd [1980] HCA 9 at [115]; 144 CLR 253 at page 292.
The onset of the reproductive season of seasonally breeding animals, such as a horse, is known to be regulated by the duration of light in a day.[71] The term “photoperiod” is used in the art to refer to the duration of light in a day.[72] As day-length increases after late winter, mares steadily progress towards their reproductive season which commences naturally in early spring (that is, about the 1st of April in the Northern Hemisphere and about the 1st of October in the Southern Hemisphere).[73] The timing of the reproductive season in horses means that a mare which becomes pregnant during this period will usually foal in the period of March to August (in the Northern Hemisphere).[74]
[71] Robinson at [11]; Allen #1 at [4.1].
[72] ibid.
[73] Robinson at [11].
[74] Robinson at [13].
Since the standardised birthday for horses in the Northern Hemisphere is the 1st January (or 1st August in the Southern Hemisphere), and this date governs the “age” of horses, for example, age-restricted thoroughbred horse racing — races for two year old horses — and yearling sales, it is known that horse breeders desire that foals are born as early as possible after, but not before 1st January of the next year. [75] This is so that foals are more developed relative to later born foals of the “same age”.[76]
[75] Robinson at [13]; Allen #1 at [3.4]-[3.7].
[76] Robinson at [13]; Allen#1 at [3.7].
The effect of the duration of light in a day on the reproductive cycling in mares is known to involve the inhibition, by light, of melatonin synthesis.[77] The reduced level of melatonin leads to an increase in secretion of gonadotropin-releasing hormone which, in turn, drives reproductive cycling in mares.[78]
[77] Robinson at [12]; Allen #1 at [4.4].
[78] Robinson at [12]; Allen #1 at [4.4]-[4.6].
For many years, horse breeders have used artificial light to bring forward the reproductive season of mares in order to achieve early foaling.[79] Starting typically at the beginning of December (or mid to late June for the Southern Hemisphere) and lasting for a period of 2 to 3 months, this has generally involved bringing the mares into barns or stables overnight and leaving the lights turned on until 10.00 or 11.00pm each night (that is, to provide an artificially increased day-length).[80] This ensures that the mares receive around 16 hours of light in every 24 hours, as they would on a summer day.[81] A 16-hour period per day is a typical length of extended photoperiod used in standard light-based methods and also referred in the opposed application.[82]
[79] Robinson at [14]; Allen #1 at [5.1], [5.6]-[5.7].
[80] Robinson at [14]; Allen #1 [5.3], [5.6]-[5.7].
[81] Allen #1 at [5.3].
[82] Robinson at [36]; the specification at page 2, lines 27-30.
Professor Allen states that the artificial light is provided by a 150 Watt light bulb placed 4 feet above the mare in a 12 foot by 12 foot box.[83] Dr Robinson acknowledges that the method of using a 100 Watt light bulb in a 12 foot by 12 foot stall described in the specification is a standard method of providing artificial lighting to mares.[84] I consider that the use of a light bulb of at least 100 Watt and placed above mares in a 12 foot by 12 foot stall is known in the art to provide sufficient light to mares to hasten their reproductive season.
[83] Allen #1 at [5.7].
[84] Robinson at [36]; the specification at page 2, lines 27-30.
The administration of artificial light during the winter and early spring months is also known to stimulate the mare to shed its winter coat earlier than normal since this process is also controlled by the photoperiod.[85]
[85] Allen # 1 at [5.5]; Robinson at [30].
The method of maintaining mares indoors under lights during the winter months is known to be labour intensive and expensive due to energy costs, managing the movement of horses and the daily cleaning of their housing.[86]
[86] Robinson [14]; Allen #1 at [5.8].
I will now discuss what was known before the priority date about the properties of light in general and generally how light is measured.
Light is an electromagnetic radiation of a particular range of wavelengths within the electromagnetic spectrum, and visible light is a small fraction of the electromagnetic spectrum.[87] The colour of visible light depends on its wavelength. Light colour in the transition between purple and blue has a wavelength of 425 nm, light having a cyan colour has a wavelength of 490 nm and light having a green colour has a wavelength range of 500-550 nm.[88] I consider the skilled person understands the wavelength of light that appears blue in colour has a range between 425 nm and 490 nm.
[87] Aguergaray # 1 at [3.1].
[88] Aguergaray #1 at [3.3].
White light is a combination of light of different wavelengths in the range 450-800 nm, that is, white light will always contain at least some amount of red, green, and blue light.[89]
[89] Aguergaray # 1 at [3.4].
Incandescent light bulbs contain a filament that heats up and produces light. The light produced by an incandescent bulb can be varied by changing the size of the filament, the temperature at which it operates, or by changing the material used to make the filament. These variables affect spectrum of light produced by the bulb.[90]
[90] Aguergaray #1 at [4.3].
Light is measured with two main sets of units: radiometric units, which measures absolute light power at all wavelengths, and photometric units, which accounts for the sensitivity of the human eye to different wavelengths of light. Photometric units are therefore concerned with the light’s interaction with the human eye. [91]
[91] Aguergaray #1 at [5.1].
Dr Aguergaray explains lux is a photometric unit which is a measure of the intensity of illumination on a surface. One lux is equal to one lumen per square metre. Lumen is a unit of luminous flux, or the measure of the total quantity of visible light emitted by a source. [92] The difference between lumen and lux is that the lux accounts for the area over which the luminous flux is spread. A flux of 1000 lumens, concentrated into an area of one square metre, lights up that square metre with an illuminance of 1000 lux. The same 1000 lumens, spread over ten square metres, produce a dimmer illuminance of only 100 lux. [93]
[92] Aguergaray #1 at [5.4].
[93] Aguergaray #1 at [5.5].
Lux is a measurement of the intensity of all the sub-components of the light (red, blue, green, etc). If a light bulb is too bright to look at directly, putting on a red filter, such that only the red components will make it through the filter into a person’s eyes, can allow a person to look at the bulb. This is because the red components are only a portion of the initial white light and therefore have a lower intensity.[94]
[94] Aguergaray #1 at [5.7].
The human eye is not equally sensitive to all wavelengths of visible light. The eye, for example, responds much more strongly to green light than to red, so a green source will have greater luminous flux than a red source with the same radiant flux. Photometry attempts to account for this by weighting the measured power at each wavelength with a factor that represent how sensitive the eye is at that wavelength. Photometric units, including lumens and lux, incorporate this weighting factor.[95]
[95] Aguergaray #1 at [5.8].
Mr Gerard stated that at the priority date of the opposed application, the measurement of lux values could easily be obtained with reasonable accuracy using a lux meter.[96]
[96] Gerard at [11].
Dr Aguergaray stated:
“It is possible to determine the intensity of the blue light component of a white light using a spectral filter. The filter blocks out the other colours, and the intensity of the remaining blue light can then be measured. However, practically speaking, it would be difficult to measure the intensity of light having wavelengths within the specific ranges identified in the claims ie, 440-490 nm and 459-484 nm. These would require a custom filter. Custom filters are also expensive (several thousand US dollars each). Furthermore, filters are never perfect. The measured intensity would therefore be overstated as there would be some light with wavelengths above and below of the specified range.”[97]
[97] Aguergaray #1 at [10.10].
The evidence of Mr Gerard and Dr Aguergaray tells me that the skilled person would understand how to measure the lux value of light. Dr Aguergaray’s evidence tells me that the skilled person would understand how to measure the lux value of white light including the sub-components of light (red, blue, green, etc).
3.7 The invention as claimed
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd. (Lundbeck):
“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”[98]
[98] [2009] FCAFC 70 at [118] – [120]; 81 IPR 228.
Claim 1
Claim 1 is the first independent claim of the present application. It reads:
“A light-based method of inducing physiological change, the method comprising the step of shining low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change, the physiological change selected from the group: advancing the breeding season of the horse or other animal; shortening the gestational length; increasing the birth weight; mitigating the effects of jet-lag; and advancing the shedding of a winter coat; wherein the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.”
What does claim 1 define?
Reading the words of the claim in the context in which they appear, claim 1 is directed to a method of inducing physiological change in a horse or other animal comprising shining low intensity blue light into just one eye of a horse or other animal to cause a substantial suppression of melatonin production sufficient to induce physiological change. The physiological change is selected from the group consisting of advancing the breeding season of the horse or other animal, shortening the gestational length, increasing the birth weight, mitigating the effects of jet-lag; and advancing the shedding of a winter coat.
I will now consider the meaning of several terms in claim 1.
“the step of shining low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light”
A question here is whether the artificial blue light source provides blue light only or whether the artificial blue light source provides light that may appear in a colour other than blue, provided the light source emits blue light. As I discussed above, the specification describes the preferred embodiment with a LED emitting blue light.[99] In another embodiment of the invention, the artificial blue light source is a white light emitting LED, and the internal surface of the cup of the blinker is fabricated as a diffusively reflecting blue filter, either by providing a white diffusively reflecting surface with a separate transparent filter in front of it, or by making the internal surface itself of a blue diffusively reflecting material.[100]
[99] The specification at pages 6-8; Figures 1-3.
[100] The specification at page 11, lines 6-11.
As discussed above, Dr Aguergaray states that white light is a combination of light of different wavelengths in the range 450-800 nm.[101] He also states that white artificial light will always contain at least some amount of light in the red, green and blue spectral regions.[102]
[101] Aguergaray #1 at [3.4].
[102] Aguergaray #1 at [4.1].
I consider that the skilled person would understand that the artificial blue light source includes a light source that provides blue light only and a light source that provides light that may appear in a colour other than blue, provided the light source emits blue light. In other words, I consider that the skilled person would understand that a white light source, such as a white light LED that includes wavelengths of blue light in its emission, would fall within the scope of an artificial blue light source.
“artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal”
A possible question here is whether the specified intensity, of from 10 lux to 100 lux, refers to the intensity of the blue light component of the light or the intensity of all the light emitted by the artificial blue light source.
A natural reading of the words of the claim in the context in which they appear indicates to me that it is the blue light emitted by the light source that has an intensity of from 10 lux to 100 lux. To the extent that there may be any ambiguity, this can be resolved by reference to the specification. As discussed previously, the specification describes the lux level of the blue light to be very low compared to natural light, and preferably 10-100 lux.[103] The LED 26 of preferred embodiment is described to emit blue light having an intensity of 10-50 lux and the blue light at this intensity found to inhibit the production of melatonin in the horse to day-time levels.[104]
[103] The specification at page 9, lines 21-22.
[104] The specification at page 9, lines 10-17.
I consider that the skilled person would understand that it is the blue light component emitted by the artificial blue light source that has an intensity of from 10 lux to 100 lux.
As discussed previously, when the artificial blue light source is a white light source, the evidence establishes that the skilled person would understand how to measure the lux value of the blue light component of white light. Therefore, I consider that the skilled person would understand the intensity of light in terms of the lux values which fall within the scope of the claim.
“causing a substantial suppression of melatonin production sufficient to induce physiological change”
Reading the words in the context in which they appear in claim 1, the result of shining blue light with an intensity of 10 lux to 100 lux into just one eye of a horse or other animal is a substantial suppression of the amount of melatonin produced in the animal which is sufficient to induce one or more of the physiological changes recited in the claim and discussed above. As previously discussed, the invention is based upon the recognition that photic pathways are involved in circadian and neuroendocrine responses in horses and other animals and these pathways regulate biological rhythms. The inventors have chosen wavelengths of the blue spectral region of light with specific intensities to inhibit melatonin production and thereby cause a physiological change to occur in the animal.
I consider that the skilled person would understand the terms to be the result of shining blue light with an intensity of 10 lux to 100 lux into just one eye of a horse or other animal.
“the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period”
Reading the words in the context in which they appear in claim 1, the horse or animal would receive a combined total of at least about 16 hours of natural daylight and artificial blue light each day.
Claim 2
Claim 2 reads:
“The method of claim 1 in which the light source provides only blue light in the range 440nm-490 nm.”
I interpret the plain meaning of the terms of claim 2 to mean that the artificial blue light source used in the method is limited to a light source that emits only blue light in the range 440 nm-490 nm.
Claim 3
Claim 3 reads:
“The method of claim 1 or 2 in which the light source provides only blue light in the range 459nm-484nm.”
I interpret the plain meaning of the terms of claim 3 to mean that the artificial blue light source used in the method is limited to a light source that emits only blue light in the range 459 nm-484 nm.
Claim 11
Claim 11, another independent claim, reads:
“A device for inducing physiological change that is operable to shine low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change, the physiological change selected from the group: advancing the breeding season of the horse or other animal; shortening the gestational length; increasing the birth weight; mitigating the effects of jet-lag; and advancing the shedding of a winter coat; wherein the device includes the artificial blue light source and a control which is operable to turn on the artificial blue light source and to leave the light source on, so that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.”
“A device for inducing physiological change”
One definition the Macquarie dictionary provides for the preposition “for” is “suit the purposes or needs of”.[105] Therefore, I interpret the plain meaning of the words of claim 11 to be directed to a device that is suitable for inducing one or more of the recited physiological changes in a horse or other animal but is not limited to the specified purpose.
[105] Macquarie Dictionary online.
“that is operable to shine low intensity blue light from an artificial blue light source”
The word “operable” means “capable of being operated, used or put into practice”.[106] Therefore, I interpret that the device of claim 11 can be operated to shine low intensity blue light in a manner specified by the claim but not limited to the specified manner.
“the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux”
Reading the words in the context in which they appear in the claim, I interpret the design of the artificial blue light source is such that the light source emits blue light with an intensity of from 10 lux to 100 lux when the device is turned on. For the same reasons as I discussed above for claim 1, the skilled person would understand that the artificial blue light source includes a light source that provides blue light only and a light source that provides light that may appear in a colour other than blue, provided the light source emits blue light. As previously discussed, the skilled person would understand how to measure the lux value of the blue light component of white light and therefore would understand the intensity of light in terms of the lux values which fall within the scope of the claim.
“the device includes the artificial blue light source and a control which is operable to turn on the artificial blue light source and to leave the light source on, so that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.”
A plain meaning of the words of the claim indicates that the device has an artificial blue light source and a control which can be operated to turn on the light source. The artificial blue light source can be left on so that the horse or other animal receives a combined total of at least about 16 hours of natural daylight and artificial blue light each day.
What does the scope of claim 11 include?
[106] ibid.
100. Adopting an interpretation of the words of claim 11 I have just discussed, claim 11 includes within its scope a light bulb, such as a white LED or a blue LED, that can be turned on and off by a control such as a switch. The only limitation of the light bulb is that it emits blue light with an intensity of from 10 lux to 100 lux when the light bulb is turned on. The light bulb can be operated to shine low intensity blue light with the specified intensity in into just one eye of the horse or other animal to induce a physiological change but is not limited to use in this manner.
101. At the oral hearing I raised this interpretation with the applicant.
“provides blue light…..into just one eye of a horse or other animal”
102. The applicant submitted that the terms “provides blue light…into just one eye of a horse or other animal” place some limitations on the device to provide blue light into just one eye of a horse or other animal. If there are limitations to the device, I am unclear what these limitations are. The words of claim 11 do not recite any features which tell me how the device is configured such that low intensity blue light is shone into just one eye of the animal. An interpretation which reads an ambiguity into the claim is not necessary. I consider a more natural reading of the words of the claim is that the device is capable of being operated to shine low intensity blue light from an artificial blue light source into just one eye of a horse or other animal but is not limited to operation in this manner. Therefore, I consider that a light bulb controlled by a switch, such as a white LED or a blue LED, that emits blue light with an intensity of from 10 lux to 100 lux when the switch is turned on falls within the scope of claim 11.
103. As a consequence of this interpretation, I made observations at the oral hearing that claim 11 could possibly lack support and lack novelty. I acknowledged that the ground of support is not being relied upon by the opponent. However, in deciding a case, it is open to the Commissioner to take into account any ground on which the grant of a standard patent may be opposed, whether relied on by the opponent or not.[107]
[107] Patents Act 1990, subsection 60(3).
104. The applicant submitted that it is their intention that claim 11 be directed to a device that is placed on the head of a horse. The applicant intended that the key features of the device include a light source that shines artificial blue light with an intensity of 10 lux to 100 lux into just one eye of a horse or other seasonally breeding animal to induce a physiological change. The physiological changes are those which I have previously discussed.
105. The applicant also submitted that where the claims might encompass subject matter that is unintended and do not properly reflect the key features which were intended, the applicant would be open to making amendments to address my concerns. The applicant suggested, for example, claim 11 could be amended to “A harness device for inducing physiological change….”.
106. It is clear claim 11 in its current form does not reflect the applicant’s intention. I understood the applicant’s submissions to be an indication that they would likely amend claim 11 as the claim encompasses subject matter that does not properly reflect the key features of the invention.
107. As the scope of any claim depends on the exact words and the context in which they appear, I consider that the choice of words proposed for an amended claim is best left to the applicant. However, I consider that a claim that includes within its scope simply a light bulb and a switch where the light bulb emits blue light with an intensity of from 10 lux to 100 lux when turned on does not properly reflect the key features of the applicant’s invention. A sensible direction to exclude unintended subject matter could be for the words of the claim to place a limitation on the environment in which the device is used so that when the device is operated artificial blue light with an intensity of 10 lux to 100 lux is shone into just one eye of a horse or other animal to induce the recited physiological change. The applicant’s suggested wording reciting a harness device would be proceeding in the appropriate direction, but, by itself would likely not go far enough. This because it is unclear to me how simply reciting a harness device in the preamble without any other amendments to the words of the claim would limit the harness device to one which when the artificial blue light source is operated would shine blue light with an intensity of 10 lux to 100 lux into just one eye of a horse or other animal.
108. Given that the applicant has helpfully provided me with an indication that they would likely amend claim 11 to limit the device to one that reflects the key features of their invention, it is not necessary for me to make a formal finding on claim 11 in regard to the ground of support. I understood that the applicant’s intention to properly reflect the key features of their invention extends to all claims including claim 21. Therefore, I will not make a formal finding in regard to the ground of support for any claims. I will give the applicant an opportunity to amend the claims. Where no amendments are proposed within the time period provided, or where amendments are proposed and once amendments have been allowed, I will consider whether the opposed application should be re-examined.
Claim 12
109. Claim 12 reads:
“The device of claim 11 in which the light source provides only blue light in the range 440nm-490nm.”
110. I interpret the plain meaning of the terms of claim 12 to mean that the artificial blue light source of the device is limited to a light source that emits only blue light in the range 440 nm-490 nm.
Claim 13
111. Claim 13 reads:
“The device of claim 12 in which the light source provides only blue light in the range 459nm-484nm.”
112. I interpret the plain meaning of the terms of claim 13 to mean that the artificial blue light source of the device is limited to a light source that emits only blue light in the range 459 nm-484 nm.
Claim 20
113. Claim 20 reads:
“The device of any one of claims 11 to 18, in which the artificial blue light source includes a white light LED.”
114. I interpret the plain meaning of the terms of claim 20 to indicate that the artificial blue light source of the device is limited to a white light LED that emits blue light and intensity the blue light is within a range of from 10 lux to 100 lux. For example, the intensity of blue light of the device of claim 20 when appended to claim 14 is between 10 to 50 lux.
Claim 21
115. Claim 21, another independent claim, reads:
“System including a control and a device for inducing physiological change, the device operable to shine low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change, the physiological change selected from the group: advancing the breeding season of the horse or other animal; shortening the gestational length; increasing the birth weight; mitigating the effects of jet-lag; and advancing the shedding of a winter coat; wherein the device includes the artificial blue light source, the control is in connection with the device, and the control is operable to turn on the artificial blue light source and to leave the light source on, so that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.”
“System including a control and a device”
116. I interpret the plain meaning of the words to indicate that the system has a control and a device.
“System…for inducing physiological change, the device operable to shine low intensity blue light”
117. For a similar reasons as I explained above for claim 11, I interpret claim 21 to be directed to a system that is suitable for inducing one or more of the recited physiological changes in a horse or other animal but is not limited to the specified purpose. I also interpret the device of the system of claim 21 can be operated to shine low intensity blue light in a manner specified by the claim but not limited to the specified manner.
“the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux”
118. For the same reasons as I discussed above for claim 1, the skilled person would understand that the artificial blue light source includes a light source that provides blue light only and a light source that provides light that may appear in a colour other than blue, provided the light source emits blue light. As previously discussed, the skilled person would understand how to measure the lux value of the blue light component of white light and therefore would understand the intensity of light in terms of the lux values which fall within the scope of the claim.
“the device includes the artificial blue light source, the control is in connection with the device, and the control is operable to turn on the artificial blue light source”
119. I interpret the plain meaning of the words to indicate that the device of the system has an artificial blue light source and the artificial blue light source is connected to a control which can be operated to turn the light source on and off.
120. Equilume’s expert suggested that the control and device of the system of claim 21 are distinct elements. [108] In contrast, the control is part of the device of claim 11.[109] At the oral hearing BioVax submitted that there is no reason for the control and device of claim 21 to be physically separated elements. I agree. In any case, nothing turns on the difference in interpretation.
[108] Robinson at [40].
[109] ibid.
121. I consider there is no material difference in the scope of claims 11 and 21. In both claims the control must be connected to the artificial blue light source for the light source to be turned on and off.
122. I therefore interpret the scope of claim 21 to include simply a light bulb that emits blue light with an intensity of from 10 lux to 100 lux, such as a white LED or a blue LED of the appropriate power, that can be turned on and off by a switch. Consequently, I make the same observations for claim 21 as I have for claim 11 above—a claim that includes within its scope simply a light bulb that emits blue light with an intensity of from 10 lux to 100 lux connected to a switch does not accurately reflect the applicant’s intention as it does not properly reflect the key features of the applicant’s invention. The applicant is given an opportunity to amend the claims.
Claim 22
123. Claim 22 reads:
“The system of claim 21, in which the artificial blue light source includes a white light LED.”
124. I interpret the plain meaning of the terms of claim 22 to indicate that the artificial blue light source of the device is limited to a white light LED that emits blue light and the intensity of the blue light is from 10 lux to 100 lux.
4 Clarity
125. It is a requirement of subsection 40(3) of the Act that the claims must be clear. A claim will lack clarity if a third party could not ascertain whether or not a proposed action would fall within the ambit of the claim.[110]
[110] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59.
126. In written submissions BioVax alleged that claims 1, 11 and 21 and dependent claims 4-9, 14-18, 20 and 22 (especially claims 20 and 22) lack clarity.[111] At the oral hearing BioVax submitted that they were only pressing that it is unclear whether the light intensity specified in mentioned claims is the intensity of all the light put out by the light source, or just the intensity of the blue light component of the light. This is particularly when the artificial blue light source is a white light source.
[111] The opponent’s written submissions, dated 06 April 2020, at [125].
127. I have construed the claims as discussed above and do not consider that any of the claims lack clarity.
128. The opponent has not established that there is a lack of clarity.
5 Novelty
129. 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. 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.
130. 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.:
“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…”[112]
[112] [1977] HCA 19 at [20]; 137 CLR 228 at 235.
131. This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed.[113]
[113] Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] 91 ALR 513 at 517; 16 IPR 545.
132. Australian courts have often identified the principles of the UK Court of Appeal in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited[114] (the General Tire case) as the criteria for determining anticipation by a prior publication. Most relevantly, to anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented.
[114] [1972] RPC 457 at 485 – 486.
133. The disclosure necessary to support the ground of lack of novelty has also variously been described as “planting the flag” (ICI Chemicals & Polymers Ltd. v The Lubrizol Corporation Inc[115]), “the accuracy of a sniper, not the firing of a 12 gauge shotgun” (Apotex Pty Ltd. v Sanofi-Aventis[116]) or “what a prior art document teaches” as distinct from “what might be ‘included’ or ‘encompassed in’ a prior art document” (Sanofi-Aventis Australia Pty Ltd. v Apotex Pty Ltd. (No 3)[117]). These various descriptions of the disclosure necessary to support lack of novelty emphasise that there is a degree of specificity that is required.
[115] [2000] FCA 1349 at [51]; 106 FCR 214, citing the General Tire case at [485]-[486].
[116] [2008] FCA 1194; 78 IPR 485 at [91].
[117] [2011] FCA 846; 92 IPR 320 at [180].
134. Before analysing the disclosure of the citations, it is worthwhile considering the subject of anticipation by inevitable outcome. The principles for this subject have also been develop from the General Tire case where the court stated:
“If the prior inventor's publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee's claim if carried out after the grant of the patentee's patent, the patentee's claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor's publication will inevitably result in something being made or done which, if the patentee's patent were valid, would constitute an infringement of the patentee's claim, this circumstance demonstrates that the patentee's claim has in fact been anticipated.”[118]
[118] [1972] RPC 457 at 485 – 486.
135. The principles regarding anticipation by inevitable outcome in the General Tire case were accepted as stating the law in Australia in Lundbeck.[119] The plurality in AstraZeneca AB v Apotex Pty Ltd noted that the sufficiency of the disclosure given by a prior art document can be assessed by considering whether, in following that disclosure, the claim under challenge would inevitably be infringed.[120]
[119] [2009] FCAFC 70 at [182].
[120] [2014] FCAFC 99 at [296].
136. BioVax relies on a journal article by V. Shabpareh, E.L. Squires, V.M. Cook and Roger Cole entitled ‘An alternative artificial lighting regime to hasten onset of the breeding season in mares’, Equine Practice, Vol. 14, pages 24-27, 1992 (herein referred to as the Shabpareh paper or D1) to allege lack of novelty.[121]
[121] V. Shabpareh, E.L. Squires and V.M. Cook are named on the journal article as researchers from the Animal Reproduction and Biotechnology Laboratory, Colorado State University, Colorado. Roger Cole is named as a researcher from the Department of Psychiatry, University of California, California. I understand the research to be done in the United States of America and therefore in the Northern Hemisphere.
Shabpareh paper (D1)
137. D1 was published in February 1992 and therefore is part of the prior art base.
138. D1, co-authored by Professor Squires, reports that a total of 48 mares were used to test the effects of three different lighting regimes on time to ovulation. Mares were disclosed to be exposed daily to a total of 16 hours of light. Two groups were fitted with light-emitting blinkers: one group on both eyes and one group on one eye only. One group, the control group, was exposed to overhead incandescent lighting. The results were reported to suggest that the response in hastening ovulation was similar in all three groups, and that blinker-lighting could be a viable lighting regime alternative.[122]
[122] D1 at page 24, abstract.
139. The lights on the blinkers are disclosed as battery-powered and time-controlled.[123]. Importantly, D1 does not disclose the type of light bulb that is used on the blinkers or the wavelengths of the light emitted. I will discuss these points in more detail in due course.
[123] D1 at page 24, left-hand column.
140. D1 discloses that 48 mares considered to be in winter anoestrus were randomly assigned to one of three artificial lighting regimes:
a.24 mares (the control group) were exposed to an overhead incandescent bulb supplying between 90 and 200 lux (average 135 lux) depending on location within the pen, beginning at dusk and continuing until a total of 16 hours of light was provided;
b.12 mares (two-eyed group) were exposed to artificial light provided by battery-operated lights mounted in two flexible plastic eyepieces of a hood for a total of 16 hours of photoperiod (natural plus artificial); and
c.12 mares (one-eyed group) were exposed to artificial light provided from only one eyepiece of the hood for a total of 16 hours of light.[124]
[124] D1 at page 24, right-hand column.
141. The hoods are disclosed to be constructed of nylon mesh with Velcro under the jaw. A pack worn around the neck contained rechargeable batteries and a light timer. The lights were programmed to come on prior to dusk and go off when a total of 16 hours of light was acquired. The timers were adjusted weekly to account for natural changes in day-length such that a fixed photoperiod of 16 hours could be provided. All mares were exposed to lights beginning December 11 and continuing until April 1. D1 discloses that the lights in the blinkers delivered approximately 130 lux per eyepiece.[125]
[125] D1 at page 24 right-hand column to page 25, left-hand column.
142. D1 discloses that the interval to oestrus and ovulation from December 11 was similar for all treatment regimes. The mean date to ovulation was the last week in February for all three groups. The number of mares ovulating by April 1 was 20 of 24 (83%) for the control group, 10 of 11 (91%) for the two-eyed group and 8 of 12 (67%) for the one-eyed group. All mares but one control mare ovulated by May 1.[126] The authors noted that the mean date of first ovulation in 248 nonlactating unlit mares was May 20, nearly 3 months later than for lighted mares in the study of D1.[127]
[126] D1 at page 26, left-hand column, page 27, Table 1.
[127] D1 at page 26, right-hand column.
143. The authors concluded that the response was similar for mares exposed to incandescent overhead lighting as those exposed to illumination in one eye or two eyes. However, the authors noted that since the percentage of mares ovulating by March 31 was lowest in the one-eyed treatment, further studies are needed to evaluate this treatment.[128]
[128] D1 at page 26, bottom left-hand column to top right-hand column.
144. The authors also concluded that the method of illuminating mares with timer-controlled lights in blinkers would appear to be a viable alternative to the standard lighting regimes.[129] They noted that this may have the advantage of allowing mares to remain in pasture but still receive artificial illumination, although further studies are needed to correct technical problems—there being a need to identify timers that are less sensitive to severe cold temperatures, batteries that keep their charge for longer than one week and more durable material for hoods.[130]
[129] D1 at page 26, right-hand column.
[130] D1 at page 27, left-hand column.
145. BioVax submitted that although the light in the blinker of D1 is not described, Dr Aguergaray understands from the reference to recharging the batteries and the date of publication that the artificial light was a small lightbulb.[131] BioVax referred to the statement of Professor Squires, a co-author of D1, made in evidence that the blinkers of D1 used a small incandescent bulb.[132] BioVax therefore submitted that the blinkers of D1 used an incandescent light source, this light source emitted light of 130 lux and some portion of the light would have consisted of blue light, probably in the range of 10-100 lux.[133] BioVax therefore submitted that claims 1, 4, 5, 6, 7, 8, 11, 15, 16, 17, 18 and 21 of the opposed application are not novel in light of D1.[134]
[131] The opponent’s written submissions, dated 06 April 2020, at [68] citing Aguergaray #1 at [7.3].
[132] The opponent’s written submissions, dated 06 April 2020, at [68] citing Squires #1 at [6.3].
[133] The opponent’s written submissions, dated 06 April 2020, at [71] citing Aguergaray #1 at [11.2].
[134] The opponent’s written submissions, dated 06 April 2020, at [69].
146. I note that while Professor Squires has stated that the blinkers of D1 used a small incandescent bulb, for the purposes of assessing novelty under the Act, I am to compare the claimed invention to the prior art base—in this case disclosure of the prior art, D1, itself. I am not to supplement the disclosure of D1 with the recollection of Professor Squires, even if that recollection is accurate. In any event, Professor Squires’ evidence does not mention the wavelengths emitted by the incandescent bulb or the wattage of the light bulb.
147. Dr Aguergaray stated that D1 makes no mention of the wavelengths of the light used in either the control group of the experimental groups. He also stated that the incandescent bulb used in the control was probably a yellow-white colour, the artificial light used in the hood was probably similar, and the yellow-white light would be made up of at least red light, green light and blue light.[135]
[135] Aguergaray #1 at [7.7].
148. Dr Aguergaray also stated:
“The incandescent bulb used in D1 would have contained a blue light component. Without being able to measure the light source, it is not possible to provide a definitive lux value for the blue light component in D1. The most accurate answer I can give is that the intensity of the blue light component would be less than 130 lux. However, it is likely that the intensity of the blue light component would be between 10-100 lux, assuming a standard yellow-white incandescent bulb was used in D1.”[136]
[136] Aguergaray #1 at [11.2].
149. Mr Gerard stated that D1 does not reveal what kind of light source was used in the hoods, but he expected that a low wattage incandescent light source, such as a torch bulb would have been used.[137] He also cited an article by Maclsaac et al., ‘Basic physics of the incandescent lamp (lightbulb)’, in The Physics Teacher, Vol. 37, pages 520-525, December 1999—Exhibit JAG-3 filed in evidence—which showed that for an incandescent light bulb, the radiation falls off very steeply progressing from the red, to the green, to blue wavelengths. Mr Gerard quoted the article by Maclsaac et al. which says:
“…incandescent filaments are quite inefficient for visible light production, and their light is quite reddish-yellow. Low temperature filaments (2500 to 2700K) are particularly rich in red spectral energy and tend to bring out red in skin complexions, making people appear healthier. Higher temperature filaments (2800 to 2900K) are relatively richer in blue wavelengths, and are paradoxically caller ‘cooler’ lights in the color sense”.[138]
[137] Gerard at [14].
[138] Gerard at [16]; quote from the article by Maclsaac et al. at pages 520-521.
150. Mr Gerard then stated:
“Thus, as the Wattage falls, the filament temperature falls (ie the temperature is 2900K for a 150 W bulb, and 2800K is a 60 W bulb) and, accordingly, the light from a small form-factor, low wattage incandescent light source such as a torch bulb (eg 0.25W to 0.5W), which is what I expect was used in the hoods of the Shabpareh paper, would have been particularly rich in red spectral energy and particularly poor in blue spectral energy. In conclusion, it is not at all clear what the specific lux level would have been for the blue light component of the white light used in the Shabpareh paper, however it would have been variable and very low, most likely less than 10 lux even when all of the blue light wavelengths are considered collectively. For the narrower wavelength range of 459nm - 484nm specified in claim 3, the total lux level of those wavelengths in the white light used in the Shabpareh paper would have been even less.”[139]
[139] Gerard at [16].
151. Both Dr Aguergaray and Mr Gerard clearly acknowledged that the type of light in the blinker of D1 (Shapareh paper) is not disclosed and their statements were made on an assumption that the light in the blinker of D1 is an incandescent light bulb. As I discussed earlier, I am to assess novelty based on the disclosure of D1 itself. Even if the light in the blinker of D1 is an incandescent light bulb, the most accurate response Dr Aguergaray could give was that the intensity of the blue light component would be less than 130 lux, likely between 10-100 lux. Mr Gerard’s response was that he expected such an incandescent light bulb would provide less than 10 lux of blue light. I consider that the evidence does not establish that the incandescent light bulb would inevitably emit blue light with an intensity of from 10 lux to 100 lux.
152. D1 does not provide any disclosure, and certainly not a clear and unmistakable direction, of the use of an artificial blue light source that provides blue light with an intensity of from 10 lux to 100 lux.
153. At the oral hearing, Equilume and BioVax both made submissions regarding whether, or not it is necessary for D1 to disclose the claim feature of “causing a substantial suppression of melatonin production sufficient to induce physiological change”. Equilume submitted that D1 does not even mention melatonin.[140] BioVax submitted that the mentioned words of the claim explain the mode of action of the light and, for the purposes of anticipation by inherency, it is not necessary for D1 to disclose what the light is doing because it is well known that light affects the production of melatonin. BioVax referred me to the deliberations of judges on the “association feature” in Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd. (No 2).[141] I understand BioVax’s submissions to be that the knowledge of how the light is affecting melatonin production is not a limiting feature of the claim.
[140] The applicant’s written submissions, dated 15 April 2020, at [89].
[141] [2016] FCAFC 111.
154. I note that D1 does not disclose anything regarding melatonin. I have previously discussed that D1 does not disclose the type of light source used on the blinkers or the wavelengths of the light emitted. It follows that even if the light of the blinkers of D1 caused a substantial suppression of melatonin production sufficient to induce physiological change in the mares, it cannot be apparent that this was an inevitable result of shining 10 to 100 lux of any blue light component of the light of D1 into an eye of the horse.
Conclusion on novelty
155. I conclude that it has not been established that claim 1 or any other claim of the opposed application lacks novelty in light of D1.
6 Inventive step
156. 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:
For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).
157. Subsection (3) prescribes the information that may be considered as:
The information for the purposes of subsection (2) is:
(a) any single piece of prior art information; or
(b) a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
158. Once the CGK and relevant information have been identified, 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 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.”[142]
[142] [1981] HCA 12 at [45]; 148 CLR 262 at 286.
159. An expectation of success is not an additional requirement over and above matters of routine:
“It is difficult to think of a case where an expectation that an experiment might well succeed is not implicit in the characterisation of steps as routine and to be tried as a matter of course.”[143]
[143] Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft [2014] FCAFC 73 (Generic Health); 314 ALR 91 at [71].
160. A frequently applied test for obviousness is the “Cripps question” re-stated by the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd. (Aktiebolaget Hassle), being whether the person skilled in the relevant art would “ directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce a useful alternative”.[144] The Cripps question and the matter of routine approach are alternative ways of analysing obviousness.[145]
[144] [2002] HCA 59 at [53]; 212 CLR 411 at 433, referring to Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187-188.
[145] Generic Health at [71].
161. Where the invention comprises a combination of integers, the question is whether the combination, not the individual integers, is obvious: “the selection of the integers out of ‘perhaps many possibilities’…must be shown…to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.”.[146]
[146] Aktiebolaget Hassle at [41].
162. The High Court in Aktiebolaget Hassle also noted that information cannot be treated as part of the CGK unless there is “evidence of its general acceptance and assimilation” by persons skilled in the art.[147]
[147] Aktiebolaget Hassle at [31].
163. Regarding the undesirability of analysis by hindsight, the Full Court of the Federal Court (Sheppard J in agreement with Lockhart CJ and Wilcox J) warned:
“Questions of obviousness are frequently difficult because it is very easy to fall into the trap of using hindsight. Once an innovation which is useful comes onto the market, there is an inclination not only for lawyers but also for those in the relevant industry to treat it as the norm and as something which might have been easily thought of by any reasonably competent worker in the industry.”[148]
[148] Elconnex Pty Ltd v Gerard Industries Pty Ltd (1992) 25 IPR 173, at 193-194.
6.1 Obviousness in light CGK considered alone
164. At the oral hearing, BioVax stated that they were no longer pressing that the content of D1 was part of the CGK and, consequently, no longer pressing that the claims of the opposed application were obvious in light of CGK alone. Instead, BioVax pleaded D1, and two other citations, are part of the prior art base under subsection 7(3) and that the claims of the opposed application are obvious in light of the cited prior art considered together with CGK.
165. Therefore, I will not consider BioVax’s written submissions regarding obviousness in light of CGK alone. In any event, as I will discuss later in my decision, the evidence does not establish it was part of the CGK at the priority date, 27 May 2011, that providing blue light with intensity of from 10 lux to 100 lux was effective in inhibiting melatonin production to induce a physiological change in a horse.
6.2 Obviousness in light of citations considered together with CGK
166. BioVax relies on the following three citations to allege lack of inventive step:
1.V. Shabpareh, E.L. Squires, V.M. Cook and Roger Cole entitled ‘An alternative artificial lighting regime to hasten onset of the breeding season in mares’, Equine Practice, Vol. 14, pages 24-27, 1992 (D1);
2.US 7,678,140 (D3); and
3.US 20080170476 (D5)
Shabpareh paper (D1)
167. BioVax submitted that it was obvious in light of D1 to use a blue LED of 90 lux or less.[149] In written submissions, BioVax argue:
“Professor Squires explained that if he was undertaking his work in 2011, he would use an LED (which was smaller and more energy-efficient),102 use a more modern battery to improve performance,103 use a blue light rather than a bright white light (which would be better tolerated),104 and use a better timer and more durable hood material.105 Professor Aguergaray explains that he would also use an LED,106 and put an opaque cover over the light source to make the device more comfortable for the horse.107 Professor Allen also suggested use of an LED, and a lighter, cheaper mask.108
The opponent submits a skilled team would opt for a single blinker, using a blue LED rather than an incandescent lamp (which would be more tolerable but also conserve energy).109 They would consult on the appropriate Lux and design a light which was most likely to be effective without being intrusive – which would result in a blinker with a Lux closer to 90 than 200, and possibly even lower than that.”[150]
[149] The opponent’s written submissions, dated 06 April 2020, at [104]-[110].
[150] The opponent’s written submissions, dated 06 April 2020, at [108]-[109] citing Squires #1 at [8.2]-[8.5], Aguergaray #1 at [7.9]-[7.10], Allen #1 at [6.14]. [7.12.1].
168. At the oral hearing BioVax also submitted that it was obvious to replace the incandescent lamp in the blinkers of D1 with a white LED.
169. BioVax’s arguments regarding obviousness in light of D1 are based on the propositions that the CGK included:
“[e]xposure to light, even low intensity light, has an effect on melatonin production.”[151]
and
“[l]ight having wavelength of 440-490 nm ie, blue light, is the most effective for inhibiting melatonin synthesis. The photoreceptors mediating melatonin synthesis are most sensitive to blue light”.[152]
[151] At the oral hearing BioVax referred me to the Statement of grounds and particulars (SGP), dated 19 November 2018, at [3.3.4].
[152] SGP, dated 19 November 2018, at [3.3.7].
170. I will first discuss BioVax’s submissions regarding obviousness to use a blue LED in light of D1. Professor Squires stated:
“I would also use a blue light in the mask. Blue light was not commonly used in human treatments in the 1990s, but by 2011 it was known for this purpose. I would make this change because I consider the horse would tolerate the blue light better than a bright white light.”[153]
[153] Squires #1 at [8.4].
171. Equilume submitted:
“It is not clear what ‘purpose’ Professor Squires is referring but, notably, he makes no mention of ‘inhibiting melatonin synthesis’ (either in this paragraph or anywhere else in the declaration), let alone indicate that he knew of the efficacy of blue light for inhibiting melatonin synthesis.”[154]
and
“Consistent with this, in reply Dr Squires states that, in May 2011, ‘while I knew that white light would work in such a mask, not knowing much about blue light, I would have had some reservations’.”[155]
and
“Furthermore, Professor Squires relies, without hesitation, on some (unidentified) use of blue light in humans to support an assertion that blue light would be effective in a horse. As noted by Dr Robinson85, humans are not seasonal breeders, so it seems unlikely that Professor Squires would have so definitely switched to a blue light source to improve the hood of D-1 based on such knowledge. It is also noteworthy that, in his reply evidence, Professor Squires relies on the need to consider potential differences of ‘horse physiology’.”[156]
[154] The applicant’s written submissions, dated 15 April 2020, at [185].
[155] The applicant’s written submissions, dated 15 April 2020, at [186], citing Squires #2 at [14].
[156] The applicant’s written submissions, dated 15 April 2020, at [187], citing Robinson at [69], Squires #2 at [23].
172. I have reviewed the evidence of Professor Squire and consider that it was not clear to him, at the priority date, that blue light was effective in inhibiting melatonin and thereby advanced the breeding season of mares.
173. Professor Allen stated:
“…, I consider that it is not inventive to use a blue light in a horse mask as disclosed in D1. … There is nothing to show that low intensity blue light supresses melatonin to the same degree as the more conventional higher intensity white light. However, it makes sense to use a lower intensity light to conserve power, and a low intensity blue light would be practical and comfortable for the horse to wear while run out at night.”[157]
[157] Allen #1 at [7.12.1].
174. Professor Allen’s evidence indicates to me that it was not clear to him that low intensity blue light was effective in inhibiting melatonin and thereby advanced the breeding season of mares.
175. I consider Professor Squires’ and Professor Allen’s evidence to indicate they were not aware, at the priority date, that low intensity blue light was effective in inhibiting melatonin to a induce physiological change in mares including advancing their breeding season. Without this knowledge, it is not clear to me why they would readily replace an incandescent lamp of D1, assuming this was the type of light source of the blinkers, with a low intensity blue light. I consider the opponent’s submissions in regard to conserving power, energy efficiency and comfort of the horse are not sufficient reasons to make the suggested replacement if the skilled person does not know that use of low intensity blue light would be effective in inhibiting melatonin production such that the physiological changes in mares, including advancing their breeding season, would be achieved.
176. Dr Robinson’s evidence is that the explanation for using blue light disclosed on page 5a of the opposed application was new to him when he first read the opposed application, let alone in May 2011, and this knowledge “does not, and did not form part of the armoury of knowledge held by someone involved in, or having an interest in, equine reproduction.”[158] Dr Robinson also stated that the use of low intensity blue light of 10 lux to 100 lux to cause a substantial suppression of melatonin production sufficient to induce a physiological change was not part of the CGK of a veterinary scientist or someone involved in, or having an interest in, equine production in May 2011.[159]
[158] Robinson at [27].
[159] Robinson at [55].
177. The opponent has not established that it was part of the CGK, at the priority date, that providing low intensity blue light was effective in inhibiting melatonin production to induce a physiological change in mares including advancing their breeding season. I consider that the opponent has certainly not established it was part of the CGK that providing blue light with an intensity of from 10 lux to 100 lux was effective in inhibiting melatonin production to induce a physiological change in mares.
178. I will now discuss BioVax’s submissions that it was obvious to use a white LED—which would emit light of various wavelengths including blue light—in the blinker of D1. BioVax referred me to Professor Allen’s statements regarding the effectiveness of low intensity light to bring mares into oestrus:
“There has been some debate amongst those knowledgeable in the science on how much light is needed to effectively hasten an anoestrous mare through the transitional phase and into full oestrous cyclicity. In fact, the light does not have to be particularly bright or intense. I have observed myself that the amount of light produced by street lights along the road by the paddock where mares were kept overnight was enough to bring them into oestrus.”[160]
[160] Allen# 1 at [5.9].
179. Professor Allen’s observations about the sufficiency of street lights along the road by a paddock to bring mares into oestrus and the effectiveness of light which is not particularly intense do not indicate to me that this knowledge was part of the background knowledge used and known by persons skilled in the art. Additionally, I consider his statement that there is debate amongst those knowledgeable in the science of hastening the onset of a mare’s oestrous cycle to be a strong inference that it was not clear to the skilled person at the priority date what intensity of light is needed to advance a mare’s reproductive cycle.
180. Professor Allen’s evidence does not establish that it was part of the CGK that exposing mares to low intensity light has an effect on melatonin production and thereby advances a mare’s reproductive cycle. I also consider that the lux level of blue light included in the street lights Professor Allen observed cannot be inferred from his evidence.
181. BioVax submitted that it was known by 2011 that a light with relatively low intensity of 90 lux would have been effective to induce a physiological change in mares.[161] In support of this proposition, BioVax cited Professor Squires’ evidence regarding the research that resulted in publication of D1:
“The intensity of the light was selected based on the light a horse would have received during conventional treatment ie, standing in a stall under a light bulb. As stated in our paper, horses receiving conventional treatment were used as a control group. Horses in the control group were exposed to light with an intensity between 90-200 Lux (average 135 Lux), depending upon their location in the pen. We chose to use a light intensity of 130 Lux in our device as it was close to the average Lux received by the control group. However, I expect that we could have used a light bulb with an intensity between 90-200 Lux and still seen an effect on the mares.”[162]
[161] The opponent’s written submissions, dated 06 April 2020, at [18(b)] citing Squires #1 at [6.4] and [5.9]. I note there is no [5.9] in Professor Squires’ first declaration.
[162] Squires #1 at [6.4].
182. Professor Squires’ statement of his expectation that use of a light bulb with an intensity between 90-200 lux would advance a mare’s reproductive cycle indicates to me that this was his own knowledge rather than part of the background knowledge used and known by persons skilled in the art. Since Professor Squires’ statement was made in the context of his research, I consider that his knowledge of the efficacy of light intensity of 90 lux to induce a physiological change in mares was not generally accepted and assimilated by the skilled person. I also consider that the lux level of blue light included in the light of 90 lux intensity, which Professor Squires refers to, cannot be inferred.
183. BioVax submitted at the oral hearing that because Dr Robinson’s evidence on CGK[163] did not exclude the item in paragraph 3.3.4 of the SGP—this being, exposure to light, even low intensity light, has an effect on melatonin production—Dr Robinson concedes that this was part of the CGK. I disagree. I also note the opponent, BioVax, bears the onus of establishing that a ground of opposition to the grant of a standard patent exists.
[163] Robinson at [51].
184. BioVax’s submitted that all their expert witnesses stated they would use an LED in the blinkers of D1 if they were to improve upon the horse hood in 2011[164] BioVax submitted it was known in 2011 that LEDs were smaller and more energy efficient.[165]
[164] Squires #1 at [8.2], Aguergaray #1 at [7.9], Allen #1 at [6.14].
[165] The opponent’s written submissions, dated 06 April 2020, at 18(d), citing Squires #1 at [8.2] and Aguergaray #1 at [7.9].
185. Dr Aguergaray’s evidence was that because of the advantages of LEDs—including energy and cost efficiencies, longer lifetime, smaller size for use in portable devices and requirement of less battery power—LEDs had replaced incandescent bulbs in many devices by 2011.
186. Mr Gerard stated:
“I believe that 27 May 2011 was during a period where LED lights started to gain popularity in a variety of lighting applications, including outside lighting.”[166]
[166] Gerard at [17].
187. Even if LEDs were known in May 2011, the evidence does not establish that the skilled person would as a matter of routine replace the light of the blinker of D1 with a specific type of LED—one which emits blue light with an intensity of from 10 lux to 100 lux, be it a white LED or blue LED. As the type of light used in the blinker of D1 and the wavelengths of light emitted are not disclosed, I consider the power requirement of the LED which would serve as a replacement would be unclear to the skilled person. Furthermore, I have previously concluded that it was not part of the CGK that providing low intensity blue light was effective in inhibiting melatonin production to induce a physiological change in mares. It follows it cannot be a matter of routine for the skilled person to choose an LED that emits blue light with an intensity of from 10 lux to 100 lux.
188. The opponent has not established that any of the claims of the opposed application lacks an inventive step in light of D1 considered together with the CGK.
US 7,678,140 (D3)
189. D3 relates to the use of light therapy to regulate various hormone systems in mammals, particularly humans, which involve melatonin production. The disorders disclosed to be treated include circadian disruption, sleep disorders and menstrual cycle disorders.[167] D3 discloses that light with wavelengths in the range of 446-477 nm was most efficient for supressing melatonin production in humans.[168] Light with wavelengths in the range 425-505 nm is disclosed to regulate various hormonal systems in mammals.[169]
[167] D3, column 8.
[168] D3, column 4.
[169] D3, column 8.
190. D3 does not disclose the use of light having wavelengths in the blue light range with an intensity of from 10 lux to 100 lux. I have previously concluded that it was not part of the CGK at the priority date that providing blue light with an intensity of from 10 lux to 100 lux was effective in inhibiting melatonin production to induce a physiological change in mares.
191. The opponent has not established that any of the claims of the opposed application lacks an inventive step in light of D3 considered together with the CGK.
US 2008/0170476 (D5)
192. D5 relates to a light-emitting device to awaken an animal and supress melatonin secretion.[170] D5 explains that one practical application of the role of melatonin in controlling seasonal reproduction is its use to artificially manipulate cycles of seasonal breeders.[171] D5 discloses a preferred method is to use light of wavelengths 450-460 nm,[172] this being wavelengths in the blue light range. The use of light of an intensity from 0-4000 lux is disclosed.[173] The device for providing light is disclosed to be a face-covering device or mask.[174] The light used in the device is disclosed to include an LED.[175]
[170] D5, abstract.
[171] D5, page 1, [0014].
[172] D5, page 2, [0018].
[173] D5, page 4, [0056].
[174] D5, page 3, [0041]; Figures 3 and 4.
[175] D5, page 2, [0021].
193. D5 does not disclose the use of light having wavelengths in the blue light range with an intensity of from 10 lux to 100 lux. I have previously concluded that it was not part of the CGK at the priority date that providing blue light with an intensity of from 10 lux to 100 lux was effective in inhibiting melatonin production to induce a physiological change in mares.
194. The opponent has not established that any of the claims of the opposed application lacks an inventive step in light of D5 considered together with the CGK.
Conclusion on inventive step
195. I conclude that the opponent has not established that any of the claims of the opposed application lacks an inventive step in light the cited prior art considered together with CGK.
7 Conclusion
196. The opponent not established that any of the claims fail to comply with the grounds of clarity, novelty and inventive step.
197. However, I have identified that each of claims 11 and 21 includes within its scope simply a light bulb that emits blue light with an intensity of from 10 lux to 100 lux where the light bulb is turned on and off by a switch. This does not properly reflect the key features of the applicant’s invention. The observation applies to any of the dependent claims having a scope that does not properly reflect the key features of the applicant’s invention. These matters need to be resolved before the opposed application proceeds to grant.
198. Equilume indicated that they would be open to making amendments to address the concerns I have identified. Therefore, I allow a period of two months from the date of this decision in which to proposed amendments. Where no amendments are proposed within this period, or where amendments are proposed and once amendments have been allowed, I will consider whether the opposed application should be re-examined.
8 Costs
199. The opponent has not made out a case that a ground of opposition to the grant of a standard patent exists. Costs according to Schedule 8 are awarded against BioVax.
Dr A. Lim
Delegate of the Commissioner of PatentsAnnex A: The claims of the opposed specification
1. A light-based method of inducing physiological change, the method comprising the step of shining low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change, the physiological change selected from the group: advancing the breeding season of the horse or other animal; shortening the gestational length; increasing the birth weight; mitigating the effects of jet-lag; and advancing the shedding of a winter coat; wherein the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.
2. The method of claim 1 in which the light source provides only blue light in the range 440nm -490nm.
3. The method of claim 1 or 2 in which the light source provides only blue light in the range 459nm -484nm.
4. The method of any one of the preceding claims in which the light source provides blue light with intensity of between 10 - 50 lux.
5. The method of any one of the preceding claims in which the light source is turned on before dusk.
6. The method of any one of the preceding claims further comprising the step of keeping the horse or other animal outdoors whilst the low intensity light is shone in the just one eye of the horse or other animal.
7. The method of any one of the preceding claims further comprising the step of keeping the horse or other animal in outside pasture for at least 6 weeks in the two or three months preceding the start of the horse or other animal's breeding season.
8. The method of any one of the preceding claims in which the horse or other animal is a horse.
9. The method of any one of the preceding claims in which the artificial light source is used from approximately 1 December for a period of approximately 6 weeks.
10. The method of any one of the preceding claims in which the artificial light source produces only low intensity blue light.
11. A device for inducing physiological change that is operable to shine low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change, the physiological change selected from the group: advancing the breeding season of the horse or other animal; shortening the gestational length; increasing the birth weight; mitigating the effects of jet-lag; and advancing the shedding of a winter coat; wherein the device includes the artificial blue light source and a control which is operable to turn on the artificial blue light source and to leave the light source on, so that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.
12. The device of claim 11 in which the light source provides only blue light in the range 440nm -490nm.
13. The device of claim 12 in which the light source provides only blue light in the range 459nm -484nm.
14. The device of any one of claims 11 to 13 in which the light source provides blue light with intensity of between 10 - 50 lux.
15. The device of any one of claims 11 to 14 which is weatherproof so that the device is capable of being used on a horse or other animal that is kept outdoors whilst the low intensity light is shone in the just one eye of the horse or other animal.
16. The device of any one of claims 11 to 15 when used on a horse or other animal that is kept in outside pasture for at least 6 weeks in the two or three months preceding the start of the horse or other animal's breeding season.
17. The device of any one of claims 11 to 16 implemented as part of a harness including a blinker that covers the eye into which low intensity blue light is shone.
18. The device of claim 17 in which the harness fits around the head of the horse or other animal and is designed to be weatherproof so that it is operable outdoors over a period of at least 6 weeks.
19. The device of any one of claims 11 to 18 in which the artificial light source produces only low intensity blue light.
20. The device of any one of claims 11 to 18, in which the artificial blue light source includes a white light LED.
21. System including a control and a device for inducing physiological change, the device operable to shine low intensity blue light from an artificial blue light source, in which the artificial blue light source provides blue light with intensity of from 10 lux to 100 lux into just one eye of a horse or other animal, causing a substantial suppression of melatonin production sufficient to induce physiological change, the physiological change selected from the group: advancing the breeding season of the horse or other animal; shortening the gestational length; increasing the birth weight; mitigating the effects of jet-lag; and advancing the shedding of a winter coat; wherein the device includes the artificial blue light source, the control is in connection with the device, and the control is operable to turn on the artificial blue light source and to leave the light source on, so that the horse or other animal receives a combined total of natural and low intensity blue light of at least approximately 16 hours during each 24 hour period.
22. The system of claim 21, in which the artificial blue light source includes a white light LED.
Annex B: Figures 1-3 of the opposed application
Figure 1
Figure 2
Figure 3
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