Transcend Medical, Inc. v Glaukos Corporation
[2015] APO 73
•9 November 2015
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Transcend Medical, Inc. v Glaukos Corporation [2015] APO 73
Patent Application: 2006336598
Title:Glaucoma Treatment Device
Patent Applicant: Transcend Medical, Inc.
Opponent: Glaukos Corporation
Delegate: Ed Knock
Decision Date: 9 November 2015
Hearing Date: 25 August 2015, in Canberra
Catchwords: PATENTS - opposition to grant - system for installing a shunt within an eye to relieve intraocular pressure - claiming by result - broadest claim limited by preferred features - whether full description, clarity and fair basis - whether claims novel in light of cited prior publications - citations not combinable - whether claims involve inventive step in light of the citations - all bar one document would not have been ascertained - other citation does not point to the present invention - opposition fails on all grounds.
Representation: Patent applicant: Christian Dimitriadis SC, instructed by Robert Finzi of Pizzeys, Canberra
Opponent:Trevor Davies, assisted by Tony Shaw, of Allens, Sydney
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2006336598
Title:Glaucoma Treatment Device
Patent Applicant: Transcend Medical, Inc.
Date of Decision: 9 November 2015
DECISION
Opposition dismissed. Unless the opponent appeals within 28 days of the date of this decision, I direct that the application proceed to grant. Costs awarded against the opponent Glaukos Corporation.
REASONS FOR DECISION
Background
1. Application 2006336598 was filed by Transcend Medical Inc. (Transcend) under the provisions of the Patent Cooperation Treaty, on 22 December 2006, as application PCT/US2006/049234. It claimed priority from three US patent filings, the earliest filing being on 17 January 2006. International publication of the PCT application took place on
2 August 2007, the application being accorded the International Publication Number
WO 2007/087061. The application did not undergo international preliminary examination under the PCT, and instead an International Preliminary Report on Patentability (Chapter I) (IPRPI) was issued on 22 July 2008. The application entered the national phase in Australia on 8 July 2008, and it was allocated Australian application number 2006336598. The application was advertised accepted on 10 October 2013.2. A notice of opposition to application 2006336598 was filed on 10 January 2014 by Glaukos Corporation (Glaukos), followed by a statement of grounds and particulars on 10 April 2014. This was subsequently amended to add an eighth citation document to the seven which had been cited in the original statement. The evidence in support of the opposition was completed on 10 September 2014, and the other evidentiary stages were duly completed on
11 February 2015 without need of extension.
3. The opposition was heard on 25 August 2015 in Canberra. The applicant Transcend was represented by Mr Christian Dimitriadis SC, and the opponent Glaukos was represented by Mr Trevor Davies, patent attorney.
The specification
4. The invention relates to a system for treating the eye disease known as glaucoma. Glaucoma is the build-up of pressure within the eye due to an excess of the eye’s aqueous humour. If left untreated it will result in damage to the optic nerve, and eventually blindness. Treatment strategies focus on reducing the intraocular pressure (IOP) back to normal levels.
5. Usual procedure is to initially try drug treatments to reduce the pressure. As observed in the specification, unfortunately drug treatments can cause adverse side effects and often fail to adequately control IOP, often due to patients being lackadaisical in following proper drug treatment regimens. When drug treatment is ineffective, surgical procedures are often the recourse.
6. Those surgical procedures commonly involve draining aqueous humour from the anterior chamber of the eye in order to lower the pressure within the eye. A typical way of doing this is to implant a shunt within the eye, enabling excess aqueous humour to drain away to some desired location. The desired location might be directly to the surface of the eye, or might be to some interim position within the eye. This draining away of excess aqueous humour is something a healthy eye will do as part of its natural functioning, and is enabled by a sieve-like structure known as the trabecular meshwork which is situated at the corner of the iris and the wall of the eye. After passing through the trabecular meshwork, the aqueous humour, by one way or another, finds its way into the ocular veins, and thence out of the eye via the blood circulatory system. It is when the trabecular network becomes clogged (for instance, as a result of ageing) that an undesirable pressure build-up can occur. The source of the additional aqueous humour which has led to the excess arises from another natural function of the eye, namely, the continuous production of aqueous humour by the ciliary body, which is the part of the eye that contains the muscles which change the focal length of the eye’s lens. Thus, in a normal healthy eye there is a natural flushing of aqueous humour into and out of the eye. Surgical procedures to relieve pressure within the eye therefore seek to facilitate this flushing in circumstances where the natural drainage processes have become dysfunctional.
7. The present invention relates to a system for enabling the removal of aqueous humour from the anterior chamber of the eye. It involves the use of a shunt to provide a fluid pathway from the anterior chamber to the suprachoroidal space. The choroid is the vascular layer of the eye, and is a thin layer located between the innermost layer of the eye, which is the retina, and the outermost layer of the eye, which is the sclera or, more colloquially, the white of the eye. In places the choroid is only loosely attached to the sclera, and forms what is referred to as the suprachoroidal space. In normal configuration this suprachoroidal space constitutes what some authorities refer to as a “virtual space”, but if penetrated by liquid or by something solid (such as a surgical device) it can be transformed into a real space.
8. The following drawing is from the present application, and is a representation of the forward portion of an eye, showing its basic components, with AC being the anterior chamber, PC the posterior chamber, I the iris, L the lens, CB the ciliary body, S the sclera and R the retina:
The next drawing is also from the present application, and is a detail from the first drawing. It shows the location of the inventive shunt (105) having a proximal end (110) and distal end (120). The shunt (105) and its position within the eye are central to the present invention.
9. The specification as filed comprised 134 claims directed to, variously, a method of inserting the shunt, the shunt per se, and a system comprising a shunt plus a delivery device. The delivery device is, in effect, a hand-held surgical tool for inserting the shunt into its ultimate location between the anterior chamber and the suprachoroidal space. In the course of examination the claims were amended so as to comprise just one independent claim that is directed to a system, and thirteen dependent claims.
10. Independent claim 1 is of the combination type, being a combination of an ocular implant and a delivery system. It reads as follows:
An ocular implant system, comprising:
an ocular implant comprising:
a tube, the tube having a proximal region having at least one ingress, a distal region having at least one egress, and an internal lumen formed by an annular wall;
wherein the tube has a length adapted to be positioned in the eye such that the at least one ingress to the internal lumen opens into the anterior chamber of the eye when the tube is positioned in the eye in a deployed location such that the at least one ingress is outside the ciliary body and posterior of an inner surface of the cornea and the at least one egress from the internal lumen communicates with the suprachoroidal space when the tube is positioned in the eye in the deployed location so as to provide aqueous pressure regulation by draining aqueous humor from the anterior chamber towards the suprachoroidal space via the internal lumen, wherein the at least one egress includes at least one opening in the distal region of the tube;
wherein the tube includes a first region of increased radial wall thickness and a plurality of regions of decreased radial wall thickness distal of the first region of increased radial wall thickness so as to form alternating raised and lowered cylindrical surfaces extending around the annular wall of the tube along at least a portion of the length of the tube; and
a delivery instrument comprising:
a handle component having an actuator;
a tubular deployment structure fixedly coupled to the handle component; and
an elongated member comprising:
a proximal end operatively coupled to the handle component via the actuator and surrounded by the tubular deployment structure, wherein actuation of the actuator retracts the elongated member in a proximal direction relative to the handle component and the tubular deployment structure; and
a blunt distal end that facilitates blunt dissection to the deployed location; and
a diameter and cross-sectional shape configured to insert through the internal lumen of the tube such that the ocular implant is removably coupled to t he elongated member,
wherein the elongated member is configured to introduce the ocular implant into the anterior chamber through a self-sealing corneal incision, advance the ocular implant through the anterior chamber, bluntly dissect at least a portion of the ciliary body from the sclera at a location proximate a scleral spur to form a dissected tissue plane between the ciliary body and the sclera, advance the ocular implant toward the suprachoroidal space through the dissected tissue plane, and retract in the proximal direction upon actuation of the actuator to uncouple from the ocular implant while the ocular implant remains substantially fixed in place relative to the deployed location.
Grounds of opposition
11. The grounds of opposition are ones coming under subsections 59(b) and 59(c) of the Patents Act 1990, in particular, firstly, that the invention as claimed is not a patentable invention as it does not comply with subsection 18(1)(b) (that is, the claimed invention is not novel and does not involve an inventive step), and, secondly, that the specification filed in respect of the complete application does not comply with subsections 40(2) and 40(3).
12. The particulars for the ground of novelty initially cited seven prior art patent documents. The statement of grounds and particulars was later amended to include a non-patent document. These eight documents, designated D1 – D8, are:
D1: WO 2005/046782 entitled 'Ocular pressure regulation' in the name of Minas Theodore Coroneo filed on 12 November 2004 and published on 26 May 2005.
D2: US 2005/0266047 entitled 'Injectable glaucoma implants with multiple openings' in the names of Hosheng Tu, Jason Artof and David Haffner filed on 18 March 2005 and published on 1 December 2005.
D3: US 6544249 entitled 'Biological microfistula tube and implantation method and apparatus' in the names of Dao-Yi Yu and William Huxley Morgan filed on
28 November 1997 and published on 8 April 2003.D4: US 6186974 entitled 'Device for use in the eye' in the names of Bruce Duncan Samuel Allan, Andrew Victor Graham Muir and Stephen Alister Jones filed
12 January 1998 and published on 13 February 2001.D5: US 2004/0015140 entitled 'Uveoscleral drainage device' in the name of Milton B Shields filed on 21 July 2003 and published on 22 January 2004.
D6: WO 1996/020742 entitled 'Improve eye implant and relief for glaucoma' in the name of Vernon G Wong filed on 6 January 1995 and published on 11 July 1996.
D7: US 5741292 entitled 'Punctum dilating and plug inserting instrument with push-button plug release' in the name of Richard Mendius filed on 28 April 1997 and published on 21 April 1998.
D8: Schocket, S.S. (1986) Transactions of the American Ophthalmological Society
volume LXXXIV, pp743 – 798.
13. The particulars for inventive step also relied on these documents when considered in light of the common general knowledge in the art. That knowledge was said to include that in order to treat glaucoma:
“shunt-type stenting devices can be used to permit and/or enhance aqueous outflow from the eye's anterior chamber toward existing outflow pathways, including by placing an object or foreign body into a cyclodialysis cleft in order to maintain its patency. Ophthalmic shunts and applicators to deliver ophthalmic shunts were well known in the art before the priority date of the Opposed Application.”
14. In regard to section 40, the statement of grounds and particulars alleges non-compliance with part (a) of subsection 40(2) (failure to describe the best method of performing the invention) and with subsection 40(3) (lack of fair basis and clarity).
Evidence in support
15. The evidence in support consists of the eight prior art documents listed above, as well as statutory declarations by Dr Ilesh Patel, Dr Colin Clement and Mr Craig Andrews. Dr Patel is a consultant ophthalmic surgeon who has practiced both in Australia and overseas, and he discusses the background of the invention before proceeding to compare the prior art documents against the claims and make some observations on the clarity of the claims. Dr Clement is likewise a consultant ophthalmic surgeon, and his statutory declaration is similarly formulated to that of Dr Patel. Craig Andrews is a design consultant with qualifications in industrial design and product design, and has both local and overseas experience. He has had significant involvement in the design of medical products and surgical equipment. All three declarants are currently working in Australia.
Evidence in answer
16.The evidence in answer consists of statutory declarations by Dr Anne Jen-Wan Lee, Professor Jonathan Crowston and Professor Robert Stamper. Dr Lee is an ophthalmologist and Glaucoma Subspecialist who has trained both in Australia and overseas, and is currently working in Sydney. She provides background information on glaucoma, and assesses the prior art documents contained in the evidence in support against the claims. Professor Crowston is a Professor of Ophthalmology at the University of Melbourne who has trained both in Australia and overseas before emigrating to Australia in 2006, where he has worked ever since. In like manner to Dr Lee, he outlines the environment of the current invention and discusses the prior art documents cited in this matter. Professor Stamper is Professor of Clinical Ophthalmology at the Department of Ophthalmology, University of California, San Francisco (UCSF). He practiced as an ophthalmologist from 1973 to 1998 before joining UCSF. He specialises in glaucoma and cataract surgery. His declaration is along similar lines to that of Professor Crowston and Dr Lee.
Evidence in reply
17.The evidence in reply consists of (second) declarations by Dr Patel, Dr Clement and Mr Andrews providing comment on a selection of points contained in the evidence in answer.
18.I note that all the declarants in this matter appear to be independent.
19.The evidence will be given more detailed analysis, where appropriate, at later stages of this decision.
Submissions
20.In both its written submissions and at the hearing the opponent Glaukos indicated that it only wished to rely on four of the eight prior art documents in evidence, namely D1 – D3, and D7. Glaukos’s main challenge to the validity of the invention appears to be based on lack of novelty in light of, firstly, D1 read in conjunction with D7, and, secondly, D2. Glaukos asserted that reading D1 together with D7 was permissible under part (b) of subsection 7(1) of the Patents Act 1990 because the person skilled in the art (PSA) would treat them as a single source of information. This was based on there being a direct and unambiguous reference in D1 to the document D7.
21.Mr Davies commenced at the hearing by discussing the invention to which the present application is directed, observing that it is well-known to relieve IOP by moving aqueous humour from the anterior chamber to other parts of the eye, including the suprachoroidal space. He then stated his perception of the attributes of the PSA, including whether the PSA would be aware of patenting activity in the field of the present invention. He thought that the applicant’s approach to this was too restricted, and did not take into account the importance of patents to the regulatory processes. He noted patents are an integral part of the development of new technologies, and that Professor Stamper had listed in his CV two patents for which he was the inventor. He also observed that Patent Offices treat specifications as prior art.
22.In relation to novelty, Mr Davies acknowledged that D1 itself did not disclose every feature of the claimed invention, and that all the integers of claim 1 were essential. D2, however, was “far closer to the claimed invention”, and Mr Davies conducted a detailed analysis of D2 against claim 1. D3 did not feature in the opponent’s submissions at the hearing.
23.In relation to inventive step, and the requirement in the Patents Act 1990 that the prior art information had to be able to be “ascertained, understood and regarded as relevant”, Mr Davies disputed assertions from the applicant in its written submissions that the lack of commercial success of the prior art was a factor to be considered in relation to this.
24.In relation to the clarity of the claims, apart from an appendency issue which I will address later in this decision, Mr Davies only made specific mention of the way that the different radial wall thicknesses of the tube had been defined, as possibly lacking clarity.
25.Mr Dimitriadis in his submissions at the hearing firstly contradicted the opponent’s assertion that D1 and D7 could be combined in the way the opponent wished to do, and drew attention to alleged deficiencies in D2 and D3 as novelty-depriving citations.
26.As to the common general knowledge in the art, Mr Dimitriadis noted that there was nothing commercially available in this area, and he cited Professor Stamper’s declaration as support for the contention that the broad approach of the invention whereby the technique of cyclodialysis was employed to relieve IOP in the anterior chamber had been tried but discarded.
27.On whether the prior art documents D1 - D7 in evidence would have been ascertained, understood and regarded as relevant, Mr Dimitriadis drew attention to the general lack of expert evidence in this matter that would go to justifying this conclusion. He observed that only Mr Andrews, who is a designer in the field of the invention, said that he would have searched patent literature, although even he had not said that he would have actually found the documents. In regard to this issue, Mr Davies later pointed out that Mr Andrews had been the inventor of twelve patented inventions. But in any case, according to Mr Dimitriadis, Mr Andrews was not in the position of the PSA. Moreover, even if D1 - D7 could have been ascertained, understood and regarded as relevant, the applicant maintained that the invention would still involve an inventive step in light of these pieces of information.
28.As to D8, which was the only one of the prior art documents in evidence which the applicant conceded would have been ascertained and understood - though not regarded as relevant - Mr Dimitriardis argued that this disclosure, even when considered with the common general knowledge, did not lead to the present invention.
29.Both parties made brief submissions regarding section 40 issues and costs. I will traverse the parties’ submissions in greater detail, where necessary to do so, later in my decision.
Applicable law
30. As a consequence of the Intellectual Property Legislation Amendment (Raising the Bar) Act 2012 (“the Amendment Act”), there are substantial changes to the Patents Act 1990. The date of effect of those changes was 15 April 2013. The application of the Amendment Act depends on the date of the request for examination. The applicant filed its request for examination on 10 November 2010. Consequently the Patents Act 1990 as in force immediately before 15 April 2013 applies in the present case.
31. Section 18 of the Patents Act 1990 relates to patentable inventions. Relevant parts of subsection (1) appear below.
(1) Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a)is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b)when compared with the prior art base as it existed before the priority date of that claim:
(i)is novel; and
(ii)involves an inventive step; and
(c)is useful; and
(d)was not secretly used in the patent area …
Evidentiary principles
32.In proceedings such as these before the Commissioner the onus rests with the opponent to clearly establish its case in reaching a conclusion on any issue, and the standard of proof required is the civil standard of proof on the balance of probabilities (see, for example, Dunlop Holding's Ltd.'s Application [1979] RPC 523). A tribunal is entitled to act on any material which is "logically probative" (T. A. Miller Ltd. v The Minister for Housing and Local Government and Another (1968) 1 WLR 992). In F. Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283 Emmett J found that in opposition proceedings the Court (and ergo the Commissioner of Patents as a tribunal) should be "clearly satisfied that the patent, if granted, would not be valid". Where questions of fact such as obviousness and existence of invention are involved, "the grant should not be refused unless it has been clearly shown that the grounds of opposition have been clearly made out" (Montecatini v Eastman Kodak (1971) 45 ALJR 593).
33. This was in essence the approach argued by the applicant, citing Aspirating IP Ltd v Vision Systems Ltd (2010) 88 IPR 52 at [33], in which Besanko J summarised the effect of the authorities as follows:
“It is well established that an opposition will be upheld only where it is practically certain that the patent, if granted, would be invalid (Commissioner of Patents v Microcell Ltd [1959] HCA 71; (1958) 102 CLR 232 at 244-245; Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742; (1999) 92 FCR 106 at 112 [17]). Other formulations of the relevant test have been used, but they are to similar effect: Austal Ships v Stena RederiAktiebolag [2005] FCA 805; (2005) 66 IPR 420 (‘Austal Ships’) at 422 [6] per Bennett J and Commissioner of Patents v Sherman at 399 [18] ‘clearly satisfied’; F Hoffman-La Roche AG v New Zealand Biolabs Inc (‘F Hoffman-La Roche AG’) [2000] FCA 283; (2000) 99 FCR 56 at 70 [67] per Emmett J ‘appear clear to the Court’; Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning v Commissioner of Patents [1971] HCA 7; (1971) 124 CLR 654 at 664 per Gibbs J (as he then was) ‘unless it clearly appears’”.
34. The applicant also cited the following statement by Bennett J in Austal Ships v Stena Rederi Aktiebolag (2005) 66 IPR 420 at [35] regarding expert evidence:
“I can accept that a lower standard may apply to proof of evidence such as whether a document has been published or, indeed, whether a prior art vessel was well-known. I do not accept that it properly applies to the factual question that itself is the test for obviousness or lack of inventive step. Where the factual question is itself the legal test, as set out in s 7(3) of the Act, it seems to me that it should be determined at the higher standard. That means that where there are two opposing expert views that are conclusive on obviousness, both presented bona fide by witnesses of accepted expertise, unless one set of views can be rejected on proper grounds, the legal burden to establish a ground of opposition is not discharged; the court cannot be practically certain that obviousness or lack of inventive step is established.”
35.I understand the opponent to be accepting of this approach, and I will proceed accordingly.
36.Finally, for completeness it is worth noting that the construction of documents is always ultimately the responsibility of the hearing officer, and moreover, in particular, novelty is basically a question of construction. To quote from Blanco White, Fifth Edition, 4-105:
"The question whether a claim has novelty over what is disclosed in an earlier document is primarily one of construction of the two documents, once the court has been put by evidence of the state of the art into the position of a skilled reader of them. For this purpose the earlier document must be construed in the usual manner, but as of its own date; that is to say, its meaning must be the meaning it bore at the date when it was written. Just as in the case of infringement, however, the further question, whether or not what the prior document ought to be regarded as disclosing is or is not substantially within the claim, is a question of fact."
Person skilled in the art (PSA)
37. The PSA for any given specification is the addressee of the specification and is the hypothetical non-inventive skilled workman in the field in Australia before the priority date (Minnesota Mining and Manufacturing Co and 3M Australia Pty Ltd v Beiersdorf (Aust) Ltd [1980] 144 CLR 253, Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at 610, Populinv HB Nominees Pty Ltd (1982) 41 ALR 471 at 476, Fisher & Paykel Healthcare Pty Ltd v Avion Engineering Pty Ltd (1991) 103 ALR 239 at 254, 260, Décor Corp Pty Ltd v Dart Industries Inc (1988) 13 IPR 385 at 397). The PSA may be a team of people from different disciplines - see, for example, Root Quality Pty Ltd v Root Control Technologies Pty Ltd
49 IPR 225, American Cyanamid v Ethicon Ltd (1979) RPC 215 and Sunbeam Corp v Morphy-Richards (Aust) Pty Ltd (1961) ALJR 212.38. Mr Davies cited more-recent case law to the same effect: in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] 212 CLR 411; 56 IPR 129 at [148] - [154], the PSA in the context of pharmaceutical formulations was discussed as follows:
“In the area of pharmaceutical development, the hypothesised formulator will ordinarily have postgraduate qualifications in science, just as in other fields it has been acknowledged that skilled formulators will be ‘trained engineers and scientists, who are well versed in the periodical literature of their subjects.’”
39. As well, in VIP Plastic v BMW Plastics [2011] FCA 660 at [23] it was stated that the PSA should be a person “with practical knowledge and experience” in the subject matter of the invention.
40. Mr Davies went on to say:
“Since opposed application concerns devices and methods for the treatment of glaucoma the opponent submits that the person skilled in the art would include a member being familiar with developing medical devices. As medical devices are not developed solely by surgeons or other medically qualified persons the Opponent submits that the skilled person for the Opposed Application is a team of people including an ophthalmic surgeon and a medical device designer. The relevant person skilled in the art is a hypothetical, non-inventive worker in the relevant field of technology in Australia, who is equipped with the common general knowledge in the art as at the priority date.”
41. The applicant’s view was that the PSA in the present case was limited to someone with a medical degree and particular expertise and experience in relation to ophthalmology and the treatment of glaucoma, in effect all of the declarants in this matter except for Mr Andrews, who, as a medical device designer, was the odd man out. I tend to agree with the opponent rather than the applicant on this point, instead viewing the hypothetical PSA as being a team of an ophthalmologist and a medical designer such as Mr Andrews. Clearly the ophthalmologist plays a primary role in the present invention in terms of locating the shunt within an eye (including determining its length). However a medical designer would also play a crucial role in so far as he or she would have to design a shunt with appropriate flow characteristics, anchoring capability and made out of suitable materials fit for function.
Construction of the specification and section 40
42.In Décor Industries Inc (supra), Sheppard J reviewed the authorities and set out ten principles of construction:
1.The claims define the invention which is the subject of the patent. These must be construed according to their terms upon ordinary principles. Any purely verbal or grammatical question that can be answered according to ordinary rules for the construction of written documents is to be resolved accordingly.
2.It is not legitimate to confine the scope of the claims by reference to limitations which may be found in the body of the specification but are not expressly or by proper inference reproduced in the claims themselves. To put it another way, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim by adding to those words glosses drawn from other parts of the specification.
3.Nevertheless, in approaching the task of construction, one must read the specification as a whole.
4.In some cases the meaning of the words used in the claims may be qualified or defined by what is said in the body of the specification.
5.If a claim be clear, it is not to be made obscure because obscurities can be found in particular sentences in other parts of the document. But if an expression is not clear or is ambiguous, it is permissible to resort to the body of the specification to define or clarify the meaning of words used in the claim.
6.A patent specification should be given a purposive construction rather than a purely literal one.
7.In construing the specification, the court is not construing a written instrument operating inter partes, but a public instrument which must define a monopoly in such a way that it is not reasonably capable of being misunderstood.
8.The body, apart from the preamble, is there to instruct those skilled in the art concerned in the carrying out of the invention; provided it is comprehensible to, and does not mislead, a skilled reader, the language used is seldom of importance.
9.Nevertheless, the claims, since they define the monopoly, will be scrutinised with as much care as is used in construing other documents defining a legal right.
10.If it is impossible to ascertain what the invention is from a fair reading of the specification as a whole, it will be invalid. But the specification must be construed in the light of the common knowledge in the art before the priority date.
43. Further guidance on issues of construction of patent specifications relevant to the present matter is provided by the following “other principles of construction” cited by Hely J in Flexible Steel Lacing Co v Beltreco Ltd [2000] FCA 890; 49 IPR 331:
· It is permissible for an invention to be described in a way which involves matters of degree. Lack of precise definition in claims is not fatal to their validity, so long as they provide a workable standard suitable to the intended use: Stanway Oyster Cylinders at 585; Minnesota Mining at 274. The consideration is whether, on any reasonable view, the claim has meaning (Elconnex Pty Ltd v Gerard Industries Pty Ltd (1991) 32 FCR 491 at 512-513, Tye-Sil Corp Ltd v Diversified Products Corp (1991) 20 IPR 574 at 585). In determining this, the expressions in question must be understood in a practical, commonsense manner (Nesbit Evans Group Australia Pty Ltd v Impro Ltd (1997) 39 IPR 56 at 95, Martin Engineering Co v Trison Holdings Pty Ltd (1989) 14 IPR 330 at 338). Absurd constructions should be avoided (Stanway Oyster Cylinders at 582-583) and mere technicalities should not defeat the grant of protection (Tye-Sil at 585).
· As a general rule, the terms of a specification should be accorded their ordinary English meaning: Electric & Musical Industries at 41, Elconnex at 512-513, Interlego at 478, Minnesota Mining at 270.
· Evidence can be given by experts on the meaning which those skilled in the art would give to technical or scientific terms and phrases and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning: Sartas No 1 v Koukourou at 485-486, N V Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1993) 26 IPR 513 at 531-532, Leonardis v Sartas No 1 Pty Ltd (1996) 67 FCR 126 at 137-138, Patent Gesellschaft AG v Saudi Livestock Transport and Trading Co (1996) 33 IPR 426 at 455.
· However, the construction of the specification is for the Court, not for the expert witness. Insofar as a view expressed by an expert depends upon a reading of the patent, it cannot carry the day unless the Court reads the patent in the same way: Allsop Inc v Bintang Ltd [1989] FCA 297; (1989) 15 IPR 686, 697. See also Glaverbel SA v British Coal Corporation [1994] RPC 443 at 486, Sartas No 1 v Koukourou at 485-486, Patent Gesellschaft at 455.
Full description
44. The opponent contended that, because there was no teaching or description of how to perform blunt dissection of the ciliary body from the sclera, as recited in claim 1, there was a failure to describe the invention fully, including the best method of performing the invention. I do not agree. The expression “blunt dissection” is a widely-used term of art, and I accept the evidence from the applicant’s experts that there was sufficient information contained in the specification to enable the addressee of the specification to carry out the invention without any difficulty. The opponent also argued that there was a lack of clarity in claim 1 arising from the way this feature was defined in the claim, but on the basis of all of the available evidence and my reading of the specification, that manner of definition would appear to achieve a “workable standard suitable to the intended use” (Stanway Oyster Cylinders, supra) and create no substantial uncertainty in the mind of a potential infringer.
Clarity
45. In relation to clarity, Lord Russell in EMI v Lissen (1939) 56 RPC at 39 stated:
"It is the function of a claim to define clearly and with precision the monopoly claimed, so that others may know the exact boundaries of the area within which they will be trespassers."
46. The first instance of non-clarity raised by the opponent was in the way claim 1 defined the length of the tube to be positioned in the eye. This was as follows:
wherein the tube has a length adapted to be positioned in the eye such that the at least one ingress to the internal lumen opens into the anterior chamber of the eye when the tube is positioned in the eye in a deployed location such that the at least one ingress is outside the ciliary body and posterior of an inner surface of the cornea and the at least one egress from the internal lumen communicates with the suprachoroidal space when the tube is positioned in the eye in the deployed location so as to provide aqueous pressure regulation by draining aqueous humor from the anterior chamber towards the suprachoroidal space via the internal lumen.
47.In its written submissions the opponent states that “It is unclear from the description as to how the tube is actually adapted to fit between the anterior chamber of the eye and the suprachoroidal space.” Putting aside the fact that it is the clarity of the claim that is pertinent rather than the description, and the fact that the word “fit” does not appear in claim 1, it is apparent that the passage complained of by the opponent is an attempt to define the length of the tube by result, that is, by its function. That is usually a permissible approach from a clarity perspective, and I believe it to be so here. I can see no reason why the addressee of the specification would not be aware of a range of values required for the tube to cater for variations of the size of eyes and variations of size and location of components of eyes (although noting Dr Clement’s evidence that “eye morphology is fairly consistent between patients”) and thus be able to attribute a precise scope to the passage in question.
48.The opponent has also challenged the “succinctness” of this passage. In doing so, the opponent has managed to come up with a fairly good summary of it, namely “wherein the tube has a length to fit between the anterior chamber of the eye and the suprachoroidal space of the eye”. This would indicate that the opponent has not found it all that difficult to attribute a scope and meaning to the passage. As to whether this passage is lacking in succinctness, it is a generally-held principle that applicants should have the freedom to define their monopoly in words of their choosing, provided the claims achieve a requisite level of clarity. Succinctness normally only becomes an issue where there is a multiplicity of independent claims of overlapping scope. I do not perceive there to be any lack of succinctness with regard to this passage.
49.The next instance of non-clarity raised by the opponent was in respect to the following passage in claim 1:
wherein the elongated member is configured to introduce the ocular implant into the anterior chamber through a self-sealing corneal incision, advance the ocular implant through the anterior chamber, bluntly dissect at least a portion of the ciliary body from the sclera at a location proximate a scleral spur to form a dissected tissue plane between the ciliary body and the sclera, advance the ocular implant toward the suprachoroidal space through the dissected tissue plane, and retract in the proximal direction upon actuation of the actuator to uncouple from the ocular implant while the ocular implant remains substantially fixed in place relative to the deployed location.
50. The opponent says of this feature that “it is unclear from the description as to how the elongated member is actually configured to be used in such a method of delivery.” Once again this is definition by function. It speaks of the capability of the elongated member to advance the ocular implant to its ultimate destination by bluntly dissecting its way to the position within the eye as defined in the claim, uncouple from the ocular implant, and retract in the proximal direction upon actuation of the actuator. It occurs to me that, once again, the addressee of the specification and potential infringer would have no significant difficulty in identifying if a particular contrivance had these capabilities.
51. Claim 1 was also said to lack “succinctness” with regard to this passage as well. For the reasons expressed earlier in regard to a purported lack of succinctness, I do not accept that this is the case here either.
52. The opponent also contended that the feature of claim 1:
wherein the tube includes a first region of increased radial wall thickness and a plurality of regions of decreased radial wall thickness distal of the first region of increased radial wall thickness so as to form alternating raised and lowered cylindrical surfaces extending around the annular wall of the tube along at least a portion of the length of the tube
which is used to anchor the shunt in place in the eye (and hereinafter referred to as “the anchoring feature”), was not clear, based on the difficulty that two of the opponent’s declarants – Dr Clement and Dr Patel – had in determining the meaning of this feature because, as Dr Clement put it, “the feature is not clearly defined in the description”. I think that what Dr Clement was concerned about was that there is no particular embodiment/drawing which shows every element defined in the above passage, which seems more about fair basis than clarity. However, I note that at pages 40 and 41, the specification says as follows:
In another embodiment, shown in Figure 30, one or more sleeves 3405 are positioned over the outer surface of the shunt 105. The sleeves 3405 can be interspersed at various locations along the length of the shunt 105. In the embodiment of Figure 30, a first sleeve 3405 is located on a distal region of the shunt 105 and a second sleeve 3405 is located on a proximal region of the shunt 105. More than two sleeves can be positioned on the shunt…
As an alternative or in addition to sleeves that are positioned over the shunt, the outer surface of the shunt can include grooves that are machined or molded into the outer surface. The grooves can be a series of annular grooves... The grooves function to form alternating raised and lowered surfaces on the shunt…
53. Thus there is a disclosure of an increased radial wall thickness (a sleeve) located at the proximal end of the tube and a separate disclosure of regions of decreased radial wall thickness (grooves) located elsewhere on the annular wall of the tube, and the teaching of the specification (as, for example, in the above passage) is such that all permutations of the referred to grooves and sleeves are contemplated. Clearly also, if sleeve 3405 is located at the proximal region of the shunt 105 (as envisaged by the above passage) and in addition there are grooves in the shunt (as also envisaged by the above passage), by deduction these will be distal of the shunt. Therefore I do not see any fair basis issue arising with respect to this feature. And as for Dr Patel’s concerns, the basis of his difficulty of comprehension is not apparent.
54. Returning to the issue of clarity, I agree that if the feature in question is considered phrase by phrase, there are points at which it could be considered unclear. For example, the relative expressions “increased” and “decreased” initially appear to lack any frame of reference. Nevertheless, if the passage is read as a whole it is then clear that the frame of reference is the external surface of the basic annular tube structure. Overall, the claim is clear in respect to this feature.
55. Other purported items of non-clarity relate to terms used in the claims which were expressed slightly different from corresponding terminology used in the description. I am satisfied that the addressee of the specification would not have been misled by these imprecisions.
56. Finally, the opponent drew attention to the fact that although claim 6 is appended to “any one of the preceding claims”, only claims 4 and 5 provide any antecedence for the feature “the series of annular grooves on the tube” which is referred to in claim 6. To my mind this does not involve any lack of clarity, since “any one of the preceding claims” could only sensibly be construed as applying to those claims which provide an antecedent for “the series of annular grooves on the tube”, that is, claims 4 and 5. To the extent that “any one of the preceding claims” could at first glance be seen to encompass something wider than that, upon reflection that choice of words would be taken to fall within the ambit of an “obvious mistake”.
Fair basis
57. The test for fair basis accepted in LockwoodSecurity Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58 at [69] and [98] - [99] as being relevant to the consideration of fair basis is:
·whether there is a real and reasonably clear disclosure of the claimed invention in the specification [from Société Des Usines Chimiques Rhône-Poulenc v Commissioner of Patents [1958] HCA 27; (1958) 100 CLR 5 and cited with approval in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79] or
·whether the claims travel beyond the subject matter of the invention described in the specification [Olin v Super Cartridge [1977] HCA 23; (1977) 180 CLR 236].
58. An essential feature of an invention cannot be used for the determination of fair basis. In Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (supra), the High Court stated:
“The comparison which s40(3) calls for is not analogous to that between a claim and an alleged anticipation or infringement. It is wrong to employ ‘an over meticulous verbal analysis’. It is wrong to seek to isolate in the body of the specification ‘essential integers’ or ‘essential features’ of an alleged invention and to ask whether they correspond with the essential integers of the claim in question.”
59. The aspects of the claims in respect of which the opponent asserts that the claims are lacking in fair basis have already been the subject of tacit consideration in the course of dealing with full description and clarity. Only two of those aspects raised by the opponent warrant further attention under the heading of fair basis.
60. Firstly, in its written submissions the opponent states:
“Claim 1 of the Opposed Application is not fairly based on the description as there is no definition in the description of the feature 'wherein the tube includes a first region of increased radial wall thickness and a plurality of regions of decreased radial wall thickness distal of the first region of increased radial wall thickness so as to form alternating raised and lowered cylindrical surfaces extending around the annular wall of the tube along at least a portion of the length of the tube'.”
61. As I have already discussed at [52], above, I believe there to be a satisfactory basis for this feature in the description.
62. Secondly, in its written submissions the opponent states:
“Claim 1 is not fairly based on the description as there is no support for carrying out blunt dissection of the ciliary body from the sclera. In particular there is no disclosure or support to the feature 'bluntly dissect at least a portion of the ciliary body from the sclera at a location proximate a scleral spur…'. There is only teaching and support in the description for passing the shunt through the scleral spur of the eye into the suprachoroidal space.”
63. In response, the applicant has drawn attention to this passage at page 27 of the specification:
In general, the shunt is implanted using the delivery system by accessing the scleral spur to create a low profile dissection in the tissue plane between the choroid and the sclera. The shunt is then secured in the eye so that it provides communication between the anterior chamber and the suprachoroidal space.
And I note also this passage at page 18 of the specification:
In one embodiment, the applier travels along a pathway that is toward the scleral spur such that the applier crosses through the scleral spur on the way to the suprachoroidal space.
And this from page 18 also:
The applier 525 can have an atraumatic or blunt distal tip such that it serves as a component for coupling to the shunt, or performing blunt dissection, rather than as a cutting component.
64. These three passages in sum provide a disclosure of the location and effect of the blunt dissection of the ciliary body from the sclera which is defined by claim 1.
Novelty
65. The test for determining whether the invention lacks novelty is the "reverse infringement test" as set out in Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235 where Aickin J stated:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask whether the alleged anticipation would, if the patent were valid, constitute an infringement."
66. Infringement occurs when "each and every one of the essential features" of the claim has been disclosed by the alleged anticipation (Rodi and Wienenberger AG v Henry Showell Ltd [1969] RPC 367 at 391). Furthermore, as stated in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486, in order to meet this requirement, the prior art must:
"contain clear and unmistakeable directions to do what the patentee claims to have invented … A signpost, however clear, upon the road to the Applicant's invention will not suffice. The prior inventor must clearly be shown to have planted his flag at the precise destination before the patentee.”
67. For anticipation to occur, the disclosure in the prior art document must be sufficient to 'enable' the skilled person to produce the invention, with nothing remaining to be ascertained and no additional inventive input required. Recently, in Samsung Electronics Co Ltd v Apple Inc. (2011) 286 ALR 257, the Full Court of the Federal Court of Australia (at [127]) reiterated the fundamental principle stated in Hill v Evans 1A IPR 1 at 7
“that the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent”.
68. As the present invention is a combination invention (that is, an ocular implant and a delivery system), the decision in Britax Childcare Pty Ltd v Infa-Secure Pty Ltd (No 4) [2015] FCA 651 has relevance. In that decision Middleton J addressed the anticipation of a claimed combination as follows:
“where the nature of the invention claimed comprises a combination of features (as in this proceeding), in order to properly anticipate the invention, the prior art must disclose all of the essential integers together in that combination. As Lockhart J said in Nicaro Holdings Pty Ltd v Martin Engineering Co [1990] FCA 40; (1990) 91 ALR 513 at 517:
‘In the case of combination patents cross-references in one specification which has some of the elements of a combination patent to another specification which has other elements do not disclose the combination. The essential point is that it is the combination which must be disclosed in the case of a combination patent.’”
69. At the hearing the opponent indicated that it only wished to rely on D1 plus D7 (when considered as a single source of information), D2 (alone) and D3 (alone) as rendering the present claims not novel. A preliminary issue to be determined is whether D7 can actually be considered as a single source of information with D1. The answer is: only to some extent. The cross-reference in D1, page 10, is in the following terms:
The shunt may be inserted into a paracentesis port, or one or more ports, using, for example, a punctum plug inserting instrument such as described in US Patent No. 5,741,292 [D7].
70. Generally speaking, this constitutes an incorporation of the disclosure of D7 into D1. However, as has been noted by the applicant, there are two distinctly different embodiments of the invention described in D1, only one of which is relevant to the present invention. The relevant embodiment so far as this matter is concerned relates to a shunt between the anterior chamber and the suprachoroidal space. The embodiment which is referred to in the passage quoted above relates to a shunt extending from the anterior chamber to the surface of the eye at the cornea. D7 discloses an instrument specifically designed to insert a plug into a tiny hole at the surface of the eye known as the lacrimal punctum, which is located at the upper and lower lid margins and drains the tears away through ducts for proper circulation. As such, it is clearly functionally unsuitable and unrelated to the insertion of a shunt into the suprachoroidal space, and there is no suggestion in D1 that it is otherwise. It follows that the reading of D1 and D7 in the particular manner urged by the opponent is not permissible.
71. Considering now D1 – D3 and D7 as individual disclosures, as has been previously mentioned, at the hearing Mr Davies conceded that D1 does not disclose all the features of claim 1, and that all of those features are essential. In particular, I note that the opponent’s written submissions concede, correctly in my view, that D1 does not disclose the anchoring feature of the shunt. The shunt described in D1 which goes from the anterior chamber to the suprachoroidal space is tubular with a hollow lumen, has a plate attached to it and optionally has a valve in the lumen. Otherwise, it is unembellished. For a delivery instrument, D1 proposes using a cannula with, optionally, a plunger mechanism, and also using a cannula prior to insertion of the shunt to create a cyclodialysis in the location where the shunt is to be inserted. As such, the D1 delivery instrument lacks many of the features of the delivery instrument defined in claim 1 (hence the opponent’s desire to enlarge the disclosure of D1 with D7). I also note that there is nothing in the evidence which runs counter to this analysis of D1 compared with present claim 1, although the assertions from the opponent’s declarants of lack of clarity and fair basis of the anchoring feature were perhaps predicated upon sidestepping this feature. It follows that the claims of the present application are novel in light of D1.
72. D2 is a US Patent Application Publication which discloses literally dozens of shunts of many shapes and sizes, and also discloses several forms of delivery instrument. Regarding the presently claimed system, D2 appears to have three major shortcomings as an anticipation.
73. Firstly, the shunts are configured to extend between the anterior chamber of the eye and Schlemm’s canal, rather than between the anterior chamber and the suprachoroidal space. Referring to the drawings previously shown at [8], above, Schlemm’s canal is a relatively small aperture in the outer layer of the eye, roughly in the area where the sclera, cornea, and iris come close to intersecting. As such, a shunt having a length making it suitable for this purpose would appear to be required to be considerably shorter than one required for the purposes of the present invention. Mr Davies sought to expand the disclosure of D2 to have the shunt extending to the suprachoroidal space by drawing attention to the fact that [0252] of D2 referred to the stent extending into the “vascular choroid”. However, I accept Mr Dimitriadis’ submission that the choroid and the suprachoroidal space are distinctly different entities, as is apparent from the figures 43 and 44 of the drawings to which reference is made in [0252]. In accepting this difference in length due to an intended positioning of the shunt within the eye as distinguishing the present invention from D2, I am cognizant that this feature is only defined in the claim in terms of a capability. Despite this, it does impose a real limitation upon the scope of the claim, albeit perhaps not a greatly restrictive one, compared with other shunts used for treating glaucoma but positioned differently within the eye.
74. Secondly, the specific anchoring feature defined in claim 1 does not appear to be disclosed in D2. Although Mr Davies drew my attention to several examples in D2 of shunts which he submitted did fall within the present definition, his arguments in that regard seemed to be based on a construction of the anchoring means of claim 1 as being merely a plurality of regions of decreased radial wall thickness, and disregard the feature of the tube including a first region of increased radial wall thickness. The first shunt raised by Mr Davies was that shown in Figure 52A of D2. In that drawing the shunts are shown as having a perpendicular flange at their proximal end and a 45° flange at the distal end. These appear as flanges in the drawings, and are described as flanges in the description. Because these flanges are depicted in the drawings with a thickness, Mr Davies sought to characterize these as “alternating raised and lowered cylindrical surfaces extending around the annular wall of the tube along at least a portion of the length of the tube”, as per present claim 1. Clearly the disclosed structure can only be considered to involve a single region of decreased radial thickness, but in any case this characterization constitutes such a strained construction of the document in question (D2) as to fail the requirement of clear and unmistakeable directions. The next shunt invoked by Mr Davies was that described in Figure 54A. It is basically the same as that shown in 52A, and attracts similar findings. The only difference between the respective embodiments is that in Figure 54A the proximal side of the distal flange is perpendicular to the longitudinal axis of the shunt instead of being at 45°. Next was Figure 58, which resembles Figure 54A except that the proximal side of the distal flange is arcuate, giving what is referred to in the specification as a “mushroom-shape”. Lastly came Figure 61, which has something of a pointy-nosed bullet-like appearance, with multiple regions of decreased radial thickness proximal of the pointy-nose of the shunt. This embodiment probably goes closest to the claimed structure of all the prior art ocular implants in evidence, but appears to lack anything which could be said to be a “first region of increased radial thickness”. Mr Dimitriadis submitted that it also lacked an egress at a distal region, which I think is true, and I would also question whether it could be properly said to comprise an internal lumen, and fall within the meaning of a “tube”. Figure 61 only appears to show a shunt with a cavity towards its proximal end providing ingress for aqueous humour through its base, and egress through a number of “pores” in the circumferential sidewall of the shunt adjacent to the cavity. Once again, this would appear to fall short of being clear and unmistakeable directions to the present invention.
75. Thirdly, D2 lacks any explicit reference to the delivery instrument being capable of blunt dissection, or of being capable of being utilised for blunt dissection in the manner defined in claim 1. The applicant saw this as a point of distinction between its delivery instrument and that disclosed by D2. In their submissions the opponent was only able to point to one embodiment in D2 (Figure 29) which it said utilized blunt dissection. “Blunt dissection”, according to Dr Clement, “simply refers to the use of an instrument to separate tissue layers without the need for an incision”. However, the embodiment described with reference to Figure 29 does appear to involve creating incisions. It occurs to me that conceptually “blunt dissection” is of such a nature that a wide range of instruments of various shapes and sizes could be used to perform it, and that disclosure of blunt dissection could occur without actually employing that phrase. However, this would require expert evidence to substantiate, and that expert evidence is lacking in the present matter. As a consequence I must regard “blunt dissection” as comprising a novelty-conferring distinction between the present claims and D2.
76. With regard to D3, this patent is directed towards a biocompatible, soluble tube for forming a drainage canal at locations within the human body generally, but with particular applicability to the eye. While a number of positions for the shunt to be located within the eye are exemplified, none of these involve the suprachoroidal space. Moreover, apart from being sharpened at the distal end and having thicker walls at the proximal end, the shunt of D3 is otherwise lacking in structural embellishments, and clearly would not infringe the shunt defined by present claim 1. Furthermore, as regards the delivery instrument defined by the present claims, the opponent appeared in its written submissions to concede that D3 failed to define some of the integers of the delivery instrument, such as a handle component having an actuator and blunt dissection capabilities. It is somewhat difficult to make a comparison between the delivery instrument of D3 and that claimed in present claim 1, since the present arrangement is a hand-operated device, whereas D3, according to the specification at column 6, line 56, in use:
105. I take Mr Davies’ point that Professor Stamper’s comments in this area seem at first glance to be a little at odds with evidence of his inventive activity (and, by the way, might also be seen to impact on his capacity to comment on the general level of knowledge and skill of the PSA), but, as observed by Mr Dimitriadis, the patenting process occurs downstream of the inventing stage, and there is not necessarily a great deal of interplay between the two, particularly in so far as the main participants in the process are concerned. I note also that similar weaknesses would also apply to Mr Andrews’ evidence because of his evident inventiveness.
106. As to Mr Andrews, as I have stated already, I disagree with Mr Dimitriadis that he would not be a PSA, but believe he would only be so when teamed with an expert person working in the ophthalmological field. However, notwithstanding this, as previously mentioned at [27], above, there are weaknesses in Mr Andrews’ evidence, as Mr Dimitriadis observed:
“...he merely asserts in bald terms that D1 to D7 would have been found and regarded as relevant, without providing any supporting evidence or reasoning. There is no suggestion that he actually located these documents as part of the exercise of preparing his evidence or otherwise, or that he located similar patent documents as part of any similar exercise he actually performed before the priority date. There is no evidence of any literature search that could or would have been conducted by the skilled person so as to locate the documents in addressing a particular problem. It is well-established that the requirements of ascertainment and relevance in s 7(3) are to be considered not at large, but rather by reference to the particular problem being addressed by the skilled person before the priority date. The opponent’s evidence simply fails to address this.”
107. The upshot is that I have formed the view that the evidence does not adequately establish that D1 – D7 could be reasonably expected to have been ascertained by the PSA in seeking to solve the problem solved by the invention. Thus I find that D1 – D7 do not fulfil the requirements of subsection 7(3) of the Patents Act 1990, and therefore are not capable of depriving the present claims of an inventive step.
108. The applicant concedes - appropriately in my view - that D8 would have been ascertained (and, presumably, understood), given its publication by the American Ophthalmological Society and availability on PubMed. However, the applicant disputes that it would have been considered relevant because it is a review of the ACTSEB procedure, and as such is conceptually removed from the present procedure, which relates to the suprachoroidal space. I do not agree. I see the problem addressed by the present invention as being a more general one of draining aqueous humour from the anterior chamber, which is what is addressed by the ACTSEB procedure, and thus D8 is relevant to the present invention.
109. However, as to whether the information in D8, when considered together with the common general knowledge in the art, is such as to render the present invention obvious, I think that something considerably less than the requisite “practical certainty” attaches to that. As already noted at [83], above, in relation to novelty, D8 fails to disclose many of the details of the shunt which is defined in the claim, and fails to disclose any form of delivery instrument whatsoever. Furthermore, when the common general knowledge set down in [93], above, is considered together with D8, the result still falls a long way short of delivering all the features of claim 1. To my mind the absence of some of those features from D8 and from the common general knowledge means that it cannot be said that the PSA would be directly led to try them in the expectation that they may well prove a success in devising an effective system for draining aqueous humour. It follows that the claimed invention is non-obvious, and that claims 1 – 14 involve an inventive step over D8.
110. Accordingly I find that the evidence in this matter does not establish that the claimed invention does not involve an inventive step.
Conclusion
111. The opposition fails on all the grounds which were relied on. I therefore dismiss the opposition.
112. Unless the Commissioner is served with a notice of appeal within 28 days of the date of this decision, I direct that the application proceed to grant.
Costs
113. In proceedings such as these it is usually the case that costs follow the event. I see no reason to vary that approach on this occasion. I therefore award costs against Glaukos Corporation.
E J Knock
Delegate of the Commissioner of Patents
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