RKW Se v Berry Film Products Company, Inc
[2021] APO 49
•02 December 2021
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
RKW SE v Berry Film Products Company, Inc. [2021] APO 49
Patent Application: 2015259236
Title:Breathable and microporous thin thermoplastic film
Patent Applicant: Berry Film Products Company, Inc.
Opponent: RKW SE
Delegate: Cathy Douglas
Decision Date: 02 December 2021
Hearing Date: 14 September 2021
Catchwords: PATENTS – section 59 – regulation 5.23 - novelty - prior use – inevitable result – lack of novelty not established – inventive step – lack of inventive step not established – opposition unsuccessful on all grounds
Representation: Counsel for the applicant: Craig Smith
Patent attorney for the applicant: Ramon Tozer and Dario Buso, Davies Collison Cave
Solicitor for the opponent: Mr Philip Kerr and Ms Jodi Bewicke, Quinn Emanuel Urquhart & Sullivan
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2015259236
Title:Breathable and microporous thin thermoplastic film
Patent Applicant: Berry Film Products Company, Inc.
Date of Decision: 02 December 2021
DECISION
The opposition is unsuccessful. None of the grounds of opposition were made out.
Subject to any appeal, I direct that the opposed application should proceed to grant.
I award costs against the applicant according to Schedule 8 of the Regulations up to the date the amendments dated 11 June 2020 were allowed, 6 October 2020, and from 6 October 2020 I award costs against the opponent according to Schedule 8 of the Regulations.
REASONS FOR DECISION
Clopay Plastic Products Company Inc filed patent application 2015259236 (the application) as an international application under the Patent Cooperation Treaty (PCT) on 13 May 2015, claiming priority from three US applications, the earliest being 13 May 2014. Due to a company name change, the application is now proceeding in the name of Berry Film Products Company, Inc (the applicant). The application was advertised accepted on 23 May 2019.
RKW SE (the opponent) filed a Notice of Opposition under section 59 of the Patents Act 1990 (the Act) on 23 August 2019. A statement of grounds and particulars was filed on 22 November 2019. Subsequently a request to amend the statement of grounds and particulars was filed on 24 February 2020, and this request was allowed on 13 March 2020. The amended statement identifies the following grounds: Lack of novelty and inventive step, lack of utility, lack of clear enough and complete enough disclosure, lack of support and lack of clarity.
The evidence filed during the evidentiary periods is summarised in the table below. The table notes that that the fifth declaration of Robert Koplin is the redacted version; this replaced the original version following a letter of a Delegate of the Commissioner dated 8 September 2020 declining to invoke the provisions of Regulation 4.3(2)(b) of the Patents Regulations to make certain annexures attached to the original version not open to public inspection. The opponent therefore filed a redacted version and requested that the original be made unavailable and not open to public inspection. On 15 October 2020 the Deputy Commissioner directed that pursuant to Regulation 4.3(2)(b) the original declaration and Annexures A, H and I are not open to public inspection. This direction was made on the basis that the confidential exhibits were not available to the parties in this opposition.
Furthermore, I note that the Direction of a Delegate of the Commissioner dated 16 November 2020 resulted in some of the evidence in reply being removed from consideration as the Delegate considered it was not properly in reply to the evidence in answer. This material is as follows:
a.paragraphs [15] to [21], [30], [33] to [36] and [41] to [50] of the second declaration by Mr Arrigo D. Jezzi dated 27 July 2020 (Jezzi 2), as well as Annexure B; and
b.paragraphs [12], [15], [17] and the last sentence of paragraph [18] from the fifth declaration by Mr Robert Koplin dated 27 July 2020 (Koplin 5) as well as Annexure B.
Evidence Declarant Exhibits Date of declaration Reference In Support Carlos Richer CR-1 to CR-5 17/2/20 Richer 1 Arrigo D. Jezzi AJ-1 to AJ-8 18/2/20 Jezzi 1 Robert Koplin A to D 17/2/20 Koplin 1 Robert Koplin A & B 17/2/20 Koplin 2 Robert Koplin RK-1 and RK-2 19/2/20 Koplin 3 Robert Koplin Exhibit RK-3 20/2/20 Koplin 4 In Answer Naveen Singh NKS-1 to NKS-5
25/5/20 Singh 1 In Reply Arrigo D. Jezzi A to D (excluding material removed by direction of 16/11/2020) 27/7/2020 Jezzi 2 Carlos Richer A to C 27/7/2020 Richer 2 Robert Koplin B, C, D, E, F, G, J, K, L (excluding material removed by direction of 16/11/2020) 27/7/2020 Koplin 5 -redacted version filed 22/9/20205 Regulation 5.23 Evidence
Following a request by the opponent, a Delegate of the Commissioner issued a direction on 5 January 2021 that paragraphs [18] to [21] of the declaration by Arrigo D. Jezzi dated 27 July 2020 (Jezzi 2) is to be considered pursuant to Regulation 5.23 for the purpose of deciding the opposition. This direction also provided the applicant the opportunity to file evidence and/or submissions in response to these paragraphs. The applicant filed “responsive evidence” to the Regulation 5:23 material on 5 March 2021 as follows:
Declarant Exhibits Date of declaration Reference Naveen Singh NKS-6 – NKS-8 1 March 2021 Singh 2
After foreshadowing on 12 March 2021 that it would request the Commissioner consider additional evidence, on 8 July 2021 the opponent filed the following declaration.
Declarant Exhibits Date of declaration Reference Arrigo D. Jezzi 28 June 2021 Jezzi 3
In a letter to the parties dated 10 September 2021, I confirmed that the matters relating to the outstanding Regulation 5.23 request would be decided as a part of the hearing and substantive opposition.
The hearing was held on 14 September 2021 by video conference. At the hearing, the following grounds were pressed:
a.Lack of novelty in view of two instances of prior use, and in view of US 2005/0248051 (the 051 patent);
b.Lack of inventive step in view of US 4929303 (the 303 patent).
Regulation 5.23
Regulation 5.23 of the Patents Regulations provides as follows:
(1)For the purposes of deciding an opposition, the Commissioner may consult a document that:
(a) is relevant to the opposition; and
(b) has not been filed under this Chapter; and
(c) is available in the Patent Office.
(2) If the Commissioner proposes to rely on the document, the Commissioner must give the parties:
(a) notice of the Commissioner’s intention to do so; and
(b) a copy of, or access to, the document; and
(c) an opportunity to give evidence or make representations about the document.
Noting that Regulation 5.23 is a discretionary provision, the delegate in Reflex InstrumentsAsia Pacific Pty Ltd v Minnovare Limited[1] listed a number of factors relevant to whether this regulation should be invoked:
a)the circumstances leading up to the evidence not being filed earlier;
b)what the evidence shows and whether the information is likely to be crucial to the delegate’s decision;
c)the public interest; and
d)the balance of convenience of the parties if the information is considered
I will consider each of these factors, whilst keeping in mind that a weighty consideration, as stated in Merial Limited v Bayer Intellectual Property GmbH ,[2] is whether the information is likely, if not certain, to change the outcome of the opposition in a significant way.
[1] [2017] APO 8 at [52].
[2] [2015] APO 16 at [24].
The second declaration of Dr Singh is dated 1 March 2021, and I accept that a period of several months to prepare and file the responsive declaration, Jezzi 3, dated 28 June 2021 does not represent an unreasonable time on the part of the opponent. I also note the opponent’s submission that it is in the public interest that all relevant evidence is considered by the delegate. However, this matter has already been significantly delayed, and the inconvenience of considering further evidence at this stage weighs against these considerations.
Most significantly, though, I note that the opponent’s submissions make only three references to the Jezzi 3 declaration - Jezzi 3 at [9]-[11], [12]-[15] and at [28]-[32].[3] I have considered the parts of the declaration that have not been referred to in the submissions and have not identified any crucial piece of evidence that would impact my decision in these paragraphs. I consider that the balance of the declaration (the parts not referred to in the submissions) would not change the outcome of the opposition in a significant way. However, I will consider the paragraphs referred to specifically in the opponent’s submission in more detail below.
[3] Oppponent submissions [15], [53].
Paragraph [9] repeats part of the Table already in evidence in Jezzi 2. Mr Jezzi then makes an assumption about tear values. No test data is presented in support.
Paragraphs [10] and [11] express Mr Jezzi’s view about how the skilled person might vary the process of the 303 patent and what the outcome might be. The paragraphs indicate that the skilled person would need run a trial and evaluate the outcome of variations to the stretching process. No evidence is provided to substantiate the stated claim that “the probability of generating a film with the properties in claim 1 would be very high”. On the contrary, there is a suggestion that further changes might be required to “optimise any parameters that need adjustment.” In my view, though I acknowledge Mr Jezzi’s opinion that the probability is high that a film would have the properties of claim 1, these paragraphs suggest that there are still significant questions around the properties that would be generated by adjustments, and as such, they do not provide me with clear evidence of what the expectation of the skilled person would be after considering the disclosed process and potential changes to it.
Paragraph [12] states Mr Jezzi’s opinion about the possible breathability and tear properties of a film of the 303 patent altered by further stretching. No test data is presented in support.
Paragraph [13] discusses comparability of several standard test procedures. Unless tests have actually been done on a modified film of the 303 patent, I do not find this material of relevance.
Paragraphs [14]-[15] discuss the Middlesworth patent, which is not pressed as part of the opponent’s case.
Paragraphs [28]-[32] restate Mr Jezzi’s view already stated in Jezzi 2 [21], and in my view these paragraphs add only minor details to the reasons Mr Jezzi has already provided which he says would motivate the skilled person to alter the process of the 303 patent.
Taking into account these observations about the cited paragraphs, I do not consider that they provide information that is crucial to my decision; they are not likely to change the outcome of the opposition in a significant way. In these circumstances the public interest is not served by consideration of this evidence. On balance, I decline to invoke Regulation 5.23 regarding all Jezzi 3.
Onus and Standard of Proof
The application was filed on 13 May 2015. Consequently, substantive amendments of the Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act2012 apply to the application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. Notably it is the Opponent who bears the onus of proving their case to the requisite standard during opposition proceedings.
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.”[4]
The hypothetical skilled person works in the field with which the invention is connected and is a non-inventive person or team likely to have a practical interest in the subject matter of the invention.[5]
[4] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980 at [70].
[5] Ibid at [70]-[72].
The specification relates to a breathable thin thermoplastic film used as an outer layer for a personal care item such as a diaper. The description states that it is desirable that thermoplastic films used in personal care items are as thin as possible whilst maintaining the other necessary properties of the film. Reasons given are cost, comfort, conservation of resources and minimising waste. The skilled person in this case will therefore have knowledge of thermoplastic films made from polymers such as polyethylene and polypropylene, and interest and experience in the manufacture processes and apparatus for forming and testing such films. The opponent has filed evidence from three experts.
Mr Koplin is the Head of the Center of Competence, Breathable Film and Multicolour printing at the firm RKW SE that is the opponent in the present matter. He has been employed by RKW SE as Product Manager Hygiene Films since 1 July 2011.[6]
[6] Koplin 1 [1]-[2].
Mr Jezzi holds a Bachelor of Chemical Engineering and has worked in the paper, non-woven and absorbent care industry for over 35 years. In particular, he has been involved with the development and use of breathable and non-breathable films as back-sheets in disposable products since 1983 and was extensively involved in the development and commercialization of breathable films when he worked for Clopay Plastics Products Company between 2000 and 2006. Since retirement in 2006, he opened a consultancy focusing on products and processes used in the disposable absorbent industry. He is an inventor listed on several patents in the field.
Mr Richer holds a Bachelor of in Chemical Engineering and a Master’s degree in Mechanical Engineering. He has worked in the diaper industry since 1982 and has more than 35 years manufacturing experience in this field. He started his own company to provide consulting services to the disposable diaper industry in 2005.
The applicant has filed evidence from one expert, Dr Singh. Dr Singh holds a Bachelor of Polymer Engineering and Technology, and a Master’s degree and PhD in Polymer Science and Engineering. He has worked in a range of polymer fields, particularly in extrusion technology. Between 2014 and 2017 he worked as the Principal Scientist for Clopay Plastic Products in the area of breathable films and laminates. He is listed as an inventor on several patents.
All the expert witnesses appear suitable to provide information as to the knowledge of the person skilled in the art. Where there is conflicting evidence, I will decide which evidence should be given greater weight.
The specification
Amendments to the specification
A first set of voluntary amendments to the specification were filed on 8 April 2020 and allowed on 27 August 2020. Further voluntary amendments to the specification were filed on 11 June 2020 and were allowed on 6 October 2020.
Background
The description indicates that the necessary properties of a film intended for diaper use include being liquid impervious, breathability, bonding ability, and sufficient physical strength for processing. Stretching the film after extrusion in the machine direction (MD) is known to form a highly oriented thin gauge film but may result in reduced qualities such as reduced cross-directional (CD) tensile strength.[7]
[7] Description [0002]-[0004].
Other problems identified in the prior art methods of forming films by a cast process are “draw resonance” which results in uneven film thickness, and the formation of holes in the film. These problems increase with production speed, and the consequent slowing of production results in increased cost.[8]
Disclosure of the invention
[8] Description [0005].
The description states that the invention addresses these deficiencies by providing a breathable film that exhibits higher tear strengths than would be expected for comparative films of similar thickness. That is, the films show an improved ratio of tear strength to thickness. The film comprises polyethylene or polypropylene having a basis weight less than or equal to 15gsm, a ratio of MD load at break to the CD load at break of from 1 to 10, and specific water vapour transmission rate and tear strength as specified in claim 1.[9]
[9] Description [0007]-[0008A].
The invention also relates to a process for making the film comprising extruding a molten web onto a first chill roller and advancing the film through a series of rollers, wherein the film is stretched in the machine at a temperature that is high enough to prevent detrimental MD orientation, yet below the melting point of the polymer. The process is outlined with reference to Figure 1 showing the specific temperature and velocity requirements of the various stages of the process, and notably includes a dedicated machine direction orientation (MDO) section.[10]
[10] Description [0008], [0008D], [0068]-[0069], [0071]-[0072], Figure 1.
The description defines several key terms. In particular, the tear strength is the ease with which the film can be torn, and the water vapour transmission rate is a measure of film breathability.
The ratio of the MD to the CD load at break is described as an “important and inventive” aspect of the invention and is described as a measure of the improved balance between these properties, achieved by reducing machine direction orientation by the described new process.[11] The description indicates that to make the films careful control of the temperature of the rollers is required to allow stretching without significant MD orientation, and that the temperatures are higher than in previous MDO processes.[12] The amount of MDO is said to correlate to the properties of the film, in particular, improved CD properties and an improved balance of CD and MD tensile strengths.[13]
[11] Description [0057].
[12] Description [0071]-[0072].
[13] Description [0078].
The description concludes with Examples 1-11; example 1 details the method of manufacture and reports the properties of the manufactured film. Data collected from the films made by a similar method, examples 2-11, is presented in Table 1.[14] The reported properties measured are within the ranges claimed in claim 1. Notably, the basis weights of the films produced in the examples range from 8.6 to 12.6 gsm, and the MD/CD ratios (based on the reported MD and CD loads at break) range from about 1.4 to 5.8.
The claims
[14] Description page 18.
The specification concludes with 21 claims. Claims 1, 13, 20 and 21 are independent. The opponent confirmed at the hearing that only the validity of claim 1 is contested. Notably, the amendments filed on 11 June 2020 limited the scope of the claims to films having the ratio of MD/CD in the range from 1 to 10. Claim 1 is reproduced below.
1. A breathable, thermoplastic film comprising polyethylene or polypropylene, the
breathable, thermoplastic film having a basis weight less than or equal to 15 gsm and a water vapor transmission rate of at least 500 grams H2O/24-hour/m2; wherein said film has a ratio of the MD load at break to the CD load at break of from 1 to 10, and at least one of a machine direction notched Elmendorf tear strength of at least 5 g or a machine-direction notched trapezoidal tear strength of at least 15 g.Construction
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd:[15]
“…the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear. Words used in a specification are to be given the meaning which the person skilled in the art would attach to them, having regard to his or her own general knowledge and to what is disclosed in the body of the specification … This applies to words used in the claims. … the construction of a specification, including the claims, is ultimately a question of law …
…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 ...”
[15] [2009] FCAFC 70; 81 IPR 228 at [118]- [120].
Middleton J provided a useful summary of relevant principles in Eli Lilly and Co Ltd v Apotex Pty Ltd:[16]
·a patent is a public instrument which must, if it is to be statutorily valid, define a monopoly which is not reasonably capable of being misunderstood;
·the Court, when reading the entire patent specification, must place itself in the position of a person who is skilled in the relevant art, given their general knowledge, and the common general knowledge and the state of the art that existed before the priority date of the patent;
·the words used in a specification, including the claims, are to be construed from this standpoint in a “common sense” and not abstract manner;
·what is disclosed in the body of the specification will also assist the skilled person in the art to understand the claims, bearing in mind that a patent is a unilateral document and the patentee has chosen particular words to describe the invention;
·the claims define the monopoly claimed by the patent;
·terms which are unclear in the claims may be defined or clarified by reference to the body of the specification;
·language which has no positive meaning in the claims may become clear when the specification is used as a “dictionary” for the jargon in the claims; and
·that said, given the special function of the claims, it is impermissible to read into a claim an additional integer, or otherwise vary the scope of the claim by reference to the body of the specification.
[16] [2013] FCA 214 at [143]; 100 IPR 451 at 482.
The cautions provided by Middleton J on several occasions are also helpful.
“…the use the [decision maker] can make of the body of a specification will vary from case to case. As Apotex submitted, there is a fine line between using the specification to construe the claim, and using the specification in such a way that adds an impermissible gloss to the claims.”[17]
“Above all, the [decision maker] should approach the task of patent construction with a generous measure of common sense.”[18]
[17] Eli Lilly and Co Ltd v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [144].
[18] Ranbaxy Laboratories Ltd v AstraZeneca AB [2013] FCA 368; (2013) 101 IPR 11 at [108].
It is possible for the description to set up a “dictionary” for the claims, but it must be clear that this is the case, as stated by Lord Reid in Minerals Separation North America Corporation v Noranda Mines Ltd.
“Their Lordships do not doubt that it is possible for a patentee to make his own dictionary in this way. If he has put something in the earlier part of the specification which plainly tells the reader that for the purpose of the specification he is using a particular word with a meaning which he sets out, then the reader knows that when he comes to the claims he must read that word as having that meaning. But this is an awkward method of drafting ... and it is in all cases incumbent on a patentee who chooses to adopt this method to make his intention plain to those who read the specification."[19]
Breathable Thermoplastic Film
[19] (1952) 69 RPC 81 at page 94.
Mr Richer explains that a breathable thermoplastic film is one that allows passage of gases without allowing passage of liquids. Breathability is measured in terms of water vapour transmission rate (WVTR).[20] This is uncontested.
Comprising polyethylene or polypropylene
[20] Richer 1 [3.21].
Mr Jezzi states that it would be possible to make breathable films with 100% of either polyethylene or polypropylene.[21] However, he does not expect that any polyethylene or polypropylene based composition would provide the results required by claim 1.[22] Dr Singh considers that it was common practice at the priority date to define thermoplastic films in terms of relevant properties rather than specific formulations.[23]
[21] Jezzi 1 [3.62.6].
[22] Jezzi 1 [3.62.10].
[23] Singh 1 [98].
The experts do not comment on the use of the term “comprising”. I consider that “comprising polyethylene or polypropylene” means that the film contains at least one of these polymers in any proportion, but may also contain other components, provided that the film meets the limitations of the parameters stated in the claim. This construction is not inconsistent with Mr Jezzi’s statement. Also, even though lower limits for the amounts of polyethylene or polypropylene are not specified in the claim, this is consistent with Dr Singh’s statement that it is the properties of the film that define it rather than the formulation.
Basis Weight
Mr Richer states that basis weight is determined by dividing the gram weight of a film by the area of the film in square meters. It is thus measured in units of g/m2 or gsm.[24] Dr Singh further notes that basis weight is a measure of the film’s density and is not dependant exclusively on the physical thickness of the film.[25]
[24] Richer 1 [3.13].
[25] Singh 1 [20].
In claim 1, the basis weight is “less than or equal to 15gsm”. The use of a specific numeric value for the upper limit, in my view, invites a construction limited to the precise value recited. The word “about” has not been used to suggest that any slight variations are within the scope. I therefore consider that to fall within the scope, the basis weight may be 15 gsm but not more than that.
Water vapor transmission rate
Mr Richer further explains that WTVR represents the amount of water vaper that can pass a specific area over a 24-hour period. Environment conditions related to temperature and relative humidity are defined for each test as well as how the sample is collected. Most equipment measures several small samples at the same time and then provides the user with an average. The result is typically given as grams of water vapor per m2 over 24 hours (g.H2O/24-hour/m2). There are several standards for determining WVTR. Generally, Mr Richer states he uses the ASTM-E96- 2000 standard.[26]
MD load at break; CD load at break
[26] Richer 1 [3.23]-[3.24].
Mr Richer explains that MD load at break represents the maximum load that a specific width of the film can stand before it breaks while the film is held in the same direction of winding. He states that there are several ASTM methods in the literature for measuring this parameter. He also states that CD load at break is similar to machine direction load at break, except the film is tested in the tensile tester perpendicular to the direction the roll of film was wound.[27]
notched Elmendorf tear strength; notched trapezoidal tear strength
[27] Richer 1 [3.46]-[3.49].
Mr Richer explains that Elmendorf tear strength is a measure of the force needed to tear a film. It uses a pendulum like device with different weights to measure if the film will tear. He states that notched trapezoidal tear strength is another measure of the force needed to tear the film.[28]
[28] Richer 1 [3.50]-[3.53].
Dr Singh comments as follows:
“Conventionally, mere reference to "MD Elmendorf Tear" values would be taken to be reference to unnotched tear values, which are indicative of the inherent tear propagation resistance of the film. If the values were "notched" tear strength values, it would be common practice to specify it in the text (or at least refer to a test standard that inherently measures "notched" tear strength values).”[29]
Use of standard test methods
[29] Singh 1 [161].
Regarding the above-mentioned parameters, Dr Singh confirms that he agrees with Mr Richer’s definitions. However, he adds that the actual value of each of those parameters is significantly test-dependent, and he states that there are several test methods one could adopt to measure any one of those parameters. He explains that each test procedure would dictate specific sets or ranges of test parameters, and, as a result, each test would return a value of a given parameter that may vary greatly depending on the specific test conditions and procedure that was used.[30] He states:
“…it is almost meaningless to refer to any value of those parameters without reference to the test method used to measure it, and to the specific test parameters adopted within those suggested by the test method. It is also meaningless to compare values of any of those parameters across different samples unless the samples have been tested in accordance with the same test method and using the same test parameters adopted within those suggested by the test method.”[31]
[30] Singh 1 [37]-[38].
[31] Singh 1 [39]-[40].
In reviewing Dr Singh’s comments about test methods, Mr Jezzi states of the test methods mentioned, “…the only one that has the greatest range of values in its determination and methodology is MTVR. The other three tests mentioned by Dr Singh are relatively standard and well understood….”[32]
[32] Jezzi 2 [11].
I understand Mr Jezzi’s reference to MTVR to mean WTVR; he uses the latter in his previous declaration.[33] He goes on in the same paragraph to mention the following two tests that are accepted in the industry for this parameter: ASTM E96E and MOCON.
[33] Jezzi 1 [3.62.14].
Dr Singh notes that when measuring the tensile strength of films, the test speed is significant as polymers respond differently to loads applied at different speeds. He states:
“… because the deformation of thermoplastics is time-dependent, careful control of test strain rate is critical. A slower test allows more time for deformation and thus alters the stress-strain curve and lowers the tensile strength. Remarkably, the tensile behaviour of polymers can range from brittle to ductile by merely changing the testing speed.”[34]
He substantiates these statements by referring to an extract from ASTM standard D882-02, which places emphasis on the need to carefully control the test speed, and also upon temperature and humidity control.[35]
Use of parameters in the description
[34] Singh 1 [128], Annexure NKS-4.
[35] Singh 1 [129]-[132], Annexure NKS-5.
In the present description, the parameters referred to in the claims are defined as follows.
“‘Tear strength’ or ‘tear force’ reflects the ease or difficulty by which the film can be torn, and is expressed in units of grams. Herein, tear strength may be measured by the Elmendorf notched tear test, ASTM D-1922, incorporated herein by reference and/or by the Trapezoid tear test (‘trap test’), as described herein or according to ASTM D-5587. The test may be performed with either a notched or an unnotched film and in either the CD or MD direction.”[36]
“'Tensile strength," means the load required to induce a break ("load at break") in the film in either the CD or the MD. Tensile strength is expressed in units of N/cm or equivalent units thereof, and is determined by ASTM method D822-02, using the following parameters: Sample Direction = MD x CD; Sample size = 1 inch width x 6 inch length; Test speed = 20 in/min; Grip distance = 2 inch. Grip size = 3 inch wide rubber faced grips evenly gripping sample.”[37]
“‘WVTR’ means ‘water vapor transmission rate’ ...WVTR is expressed in units of g H2O/24 hours/m2 or equivalent units thereof, and may be measured according to ASTM method D-6701-01.”[38]
[36] Description [0052].
[37] Description [0053].
[38] Description [0054].
Regarding tensile strength, I note the use of definite language, that it “…is determined by ASTM method D822-02..”. By comparison, tear strength “…may be measured by the Elmendorf notched tear test, ASTM D-1922, and WVTR “…may be measured according to ASTM method D-6701-01.” The use of the word “may” often suggests that the action following is optional. However, I note that both Mr Jezzi and Dr Singh agree that at least for measuring WVTR, the choice of test used significantly impacts the values obtained, so I think it is unlikely that the word “may” in this context is intended to mean an optional action. I further note that the section of the description containing the references to these tests is preceded by the phrase “As used herein:” suggesting that the following meanings are to be given throughout the document. This strongly indicates to me that the section is a dictionary. I therefore construe the parameters in the claims to refer to values obtained when the specific tests outlined in paragraphs [0052]-[0054] are applied.
Claim 1 therefore defines a breathable, thermoplastic film having at least some polyethylene or polypropylene, having a basis weight less than or equal to 15 gsm (but not more than 15gsm), that also satisfies the following parameters:
·Water vapor transmission rate of at least 500 grams H2O/24-hour/m2 measured according to ASTM method D-6701-01;
·ratio of the MD load at break to the CD load at break of from 1 to 10 determined by ASTM method D822-02, using the following parameters: Sample Direction = MD x CD; Sample size = 1 inch width x 6 inch length; Test speed = 20 in/min; Grip distance = 2 inch. Grip size = 3 inch wide rubber faced grips evenly gripping sample; and
·at least one of a machine direction notched Elmendorf tear strength of at least 5 g or a machine-direction notched trapezoidal tear strength of at least 15 g, measured by the Elmendorf notched tear test, ASTM D-1922, or by the Trapezoid tear test (‘trap test’), according to ASTM D-5587.
Novelty
Section 7 of the Patents Act specifies the prior art base for the consideration of novelty.
“(1) For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;...”
The tests for lack of novelty are well established, as indicated in the decision in AstraZeneca AB v Apotex Pty Ltd (AstraZeneca):[39]
“The touchstone for determining whether a prior publication, such as the 471 patent, anticipates a claimed invention, is stated in General Tire at 485 to 486:
When the prior inventor’s publication and the patentee’s claim have respectively been construed by the Court in the light of all properly admissible evidence … the question whether the patentee’s claim is new … falls to be decided as a question of fact. 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 publications 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.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented … a signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.”
[39][2014] FCAFC 99 at [293].
The court also stated:
“Sufficiency of disclosure is a cardinal anterior requirement in the analysis of whether a prior art document anticipates a claimed invention. It is only after the stage of assessing the sufficiency of disclosure – which involves a determination about whether a prior document has “planted the flag” as opposed to having provided merely “a signpost, however clear, upon the road” or, perhaps, something less – that the notion of reverse infringement comes into play as the final and resolving step of the required analysis… It is not the first step of the required analysis; nor is it the only step.”[40]
[40] Ibid at [302].
Jessup J comments as follows in Novozymes A/S v Danisco A/S:[41]
“Although General Tire is part of Australian jurisprudence in the relevant area, it must be accommodated to the terms of s 7(1) of the Patents Act, upon which everything depends. That is to say, the inevitability of outcome to which General Tire refers must be such as would arise from recourse to the information referred to in the section. At the expense of repetition, it is here useful to remind ourselves of what the Court of Appeal said in that case ([1972] RPC at 485-486):
… 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. [Emphasis added]
This proposition is explicitly hypothetical. It is concerned not with what has happened or with what could have happened, but with what would have happened if the directions were carried out. As such, the proposition is in complete harmony with s 7(1), and with every other presently relevant aspect of the jurisprudence in this area. It is not the doing of it, nor even the ability to do it, that amounts to anticipation: it is the content of the information. If the information contains directions which, if carried out, would constitute an infringement of the patent in suit, the invention under the latter is not novel.”[42]
[41] Novozymes A/S v Danisco A/S [2013] FCAFC 6; (2013) 99 IPR 417.
[42] Ibid at [177].
He then elaborates on the case before him.
“In my view, the General Tire approach, if taken at all, may be taken only with respect to the whole of any claim asserted to have been anticipated. The “precise destination” at which the flag must have been planted is one which includes every integer of the claim. The approach cannot, in my view, be taken for some integers only, leaving others to be dealt with by reference to the understanding of the skilled addressee. In the present context, what this means is that, to the extent that the appellants’ case is based on General Tire, it is not sufficient that they be able to point to passages in the Novo patent from which it would appear to the skilled addressee that inactivation was contemplated or intended by the earlier inventors. It is necessary that they show that, if Example 20 were worked as directed, it would inevitably, as a matter of hard fact, have involved inactivation of the enzyme (to the standard set up under Claims 1 and 7 of the patent in suit as identified by the primary Judge) at the baking stage.”[43]
Authorities on Prior Use
[43] Ibid at [187].
In relation to lack of novelty by prior use, regarding whether information can be considered “publicly available” before the priority date, the court in Insta Image Pty Ltd v KD Kanopy Australasia Pty Ltd noted the following principles.[44]
“• The information must have been made available to at least one member of the public who, in that capacity, was free, in law and equity, to make use of it (PLG Research Ltd v Ardon International Ltd [1993] FSR 197 at 226 per Aldous J cited in Jupiters at [141]). (This test of communication to a member of the public who is free in law or equity to use the information as he or she pleases had been enunciated by the English Court of Appeal as early as 1887 in Humpherson v Syer (1887) 4 RPC 407 at 413 per Bowen LJ.)
• It is immaterial whether or not the invention has become known to many people or a few people (Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd (1961) 180 CLR 98 at 111 per Windeyer J). As long as it was made available to persons as members of the public, the number of those persons is not relevant. Availability to one or two people as members of the public is sufficient in the absence of any associated obligation of confidentiality (Fomento Industrial S.A. v Mentmore Manufacturing Co Ltd [1956] RPC 87 at 99–100; Re Bristol-Myers Co’s Application [1969] RPC 146 at 155 per Parker LJ).
• The question is not whether access to an invented product was actually availed of but whether the product was made available to the public without restraint at law or in equity (Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31 (Merck) at [98]–[103]).
• In order to be “available”, information said to destroy novelty must be of a kind that would disclose to a person skilled in the relevant art all of the essential features or integers of the invention (cf RD Werner & Co Inc v Bailey Aluminium Products Pty Ltd (1989) 25 FCR 565 at 593–594).
• In order to be “available”, information said to destroy novelty must “enable” the notional person skilled in the art at once to perceive, to understand, and to be able practically to apply the discovery, without the need to carry out further experiments in order to arrive at that point (Stanway Oyster at 581–582).”
[44] [2008] FCAFC 139 at [124].
The court in Damorgold Pty Ltd v JAI Products Pty Ltd[45] considered the question of enabling disclosure in prior use cases.
“As noted by Dr Bodkin (at 3790), the test for anticipation by use is no less stringent than the test for anticipation in a published document and also requires enabling disclosure of the claimed invention. Further, information made publicly available by the doing of an act must be such as to enable a person skilled in the relevant art to put the claimed invention into practice if it is to amount to an anticipation of a patent claim… It is not necessary in this case to discuss what may constitute sufficient disclosure to be enabling, as the facts are clear: no person was permitted to examine the roller blind to ascertain the integers of the invention or how it worked.
The act of giving the encased mechanism to another person did not constitute an enabling disclosure. It constituted what was described as ‘uninformative use’ (Merrell Dow) and is not sufficient to constitute an anticipation….
In order to destroy novelty, the information must enable the notional person skilled in the art at once to perceive, to understand and to be able practically to apply the discovery without the need to carry out further experiments (Insta Image at [124] citing Stanway Oyster Cylinders Pty Ltd v Marks (1996) 66 FCR 577 at 581-582). Mere observation in the absence of direct evidence of what could be gleaned from such observation does not discharge the onus to establish an enabling disclosure (Insta Image at [125]). In Insta Image, the evidence established that people looked in detail at the way the product, a canopy, was structured and put together and that simple visual inspection was an adequate means of giving the person skilled in the art an understanding of the invention (Insta Image at [146]), whereas in Jupiters, mere observation would not disclose the necessary features, and in the absence of direct evidence from a person skilled in the art of what could be gleaned from such observation, the Full Court was not prepared to conclude that it was sufficient to constitute an anticipation (Jupiters at [147]).”
[45] [2015] FCAFC 31 at [54]-[57].
In Aspirating IP Limited v Vision Systems Limited, Besanko J stated that “the correct principle is that a prior public use must be strictly proved and evidence which is not corroborated must be scrutinised with care…”[46]
[46] [2010] FCA 1061 (30 September 2010) at [200].
Consideration - Lack of novelty by prior use
The opponent’s case for lack of novelty by prior use, as I understand it, is in two parts. Firstly, the opponent submits that they manufactured a film falling within the scope of claim 1, which was made publicly available by its sale to Proctor & Gamble before the priority date of 13 May 2014. Secondly, they submit that the film was publicly available by virtue of its use as a diaper backsheet which was displayed at a trade show in April 2014.[47]
[47] Opposition submissions [33], [36].
With respect to the first part of the opponent’s case, Mr Koplin states that RKW provided test data to Proctor & Gamble from a product run of the RKW GOC2P 15 GSM film conducted in October 2013, stating that the date on the upper right of the table of data, 27 September 2013, was the date that the sampling plan was issued to him.[48] The table is presented as Annexure A. This table is unreadable.
[48] Koplin 1 [3]-[4].
With respect to the second part of the case, Mr Koplin further states that diapers incorporating the RKW GOC2P 15 GSM film were displayed at a Trade Show in April 2014. He states that this particular film has the properties shown in the table dated 27 September 2013 and provided as Annexure B.[49] This annexure is also unreadable, but presumably is the same as the table in Annexure A. Later, in his fifth declaration, Mr Koplin provided another reproduction of that table as Annexure E, stating that “with regard to Dr Singh’s comments as to the legibility of Annexure A of my first declaration, I refer to Annexure E to this declaration.” [50] Annexure E is also dated 27 September 2013. From Mr Koplin’s statement and from this date I conclude that Annexure E is a reproduction of the table previously provided as Annexures A and B, and that Annexure E is not a table of values derived from later testing of a film extracted from one of the displayed diapers.
[49] Koplin 2 [3]-[5], [10].
[50] Koplin 5 [39].
When considering Annexure E, I note the heading reading “RKW Petersaurach 15 gsm GOC2+”. Purchase orders provided as Annexures B and C to Mr Koplin’s first declaration also have the identifier “GOC2P 15gsm” in the product description, and a letter with Proctor & Gamble letterhead (Annexure D, Koplin 1) confirms delivery before the priority date of the previously mentioned purchase orders, specifying the same purchase order numbers as found in Annexures B and C. I am reasonably satisfied that a product film having the specifications indicated in Annexure E was delivered to Proctor & Gamble before the priority date.
Neither party has commented as to whether P&G were free in law and equity to do as they pleased with the film supplied. However, for the reasons discussed below, I consider that the fundamental requirement that a disclosure must be enabling has not been established, and therefore I do not find it necessary to consider this point. I also do not find it necessary to address the arguments presented about whether or not the properties of the film that was the subject of quality testing as shown in Annexure E disclosed a film within the scope of claim 1.
Enabling disclosure
The authorities state that the disclosure relied upon in a prior use case must be enabling; the information must enable the notional person skilled in the art at once to perceive, to understand and to be able practically to apply the discovery without the need to carry out further experiments. I do not consider that the opponent has made out that skilled person, even when provided information about the physical properties of the film, would have been enabled to “practically apply” that information “without the need to carry out further experiments”.
The opponent acknowledges the requirement for the disclosure to be enabling in the submissions, stating that the product must be “made available to the public in circumstances where the composition of the product could be determined by routine means and the product could then be reproduced without undue burden.”[51] The opponent submissions also reference Inexa Industsria Extractora CA v Omniactive Health Technologies Ltd[52](Inexa). In that decision, the delegate quoted a passage from the Lundbeck v Alphapharm,[53] which is particularly relevant to chemical cases:
“Indeed, when the prior art is a product, the product itself, though dumb, may be enabling if it is “available to the public” and a person skilled in the art can discover its composition or internal structure and reproduce it without undue burden.”
[51] Opponent submissions [41].
[52] Inexa Industsria Extractora CA v Omniactive Health Technologies Ltd (2012) 99 IPR 168; [2012] APO 128.
[53] [2009] FCAFC 70 at [187].
In the Inexa decision, the delegate recognised the two parts of this question – whether the product was available to the public in a manner that would enable its composition to be determined by routine means, and whether the skilled person could reproduce it without undue burden. Also in this decision, I note that the delegate had before him evidence that showed that the skilled person would also be able to reproduce the result without undue burden. [54]
[54] Inexa at [78].
In the present case of a film having a list of properties supplied to a purchaser, it is not enough simply for the properties of the purchased film to be known. To satisfy the tests, it must be able to be reproduced from that list of properties, and the onus is on the opponent to establish this. However, I cannot see any evidence provided by the opponent to indicate that this is the case. There is no indication that the film was or could be reverse engineered from test data. The opponent merely states “a member of the public could have taken the material and tested it to create a film with the properties of Claim 1”,[55] without referring me to any evidence of how the skilled person would go about a reverse engineering process.
[55] Opponent submission [37].
I have reviewed the expert’s statements for evidence as to how a skilled person would go about reproducing this film. Mr Richer comments that films having less than 15 gsm were known before the priority date,[56] but does not identify the properties of such films[57] when he responds to Dr Singh’s comments that simply stretching a breathable film to a target basis weight does not enable a required strength to be achieved.[58]
[56] Richer 1 [3.15].
[57] Richer 2 [8].
[58] Singh 1 [28].
Mr Jezzi states that to form a film, “you start out by what you are trying to achieve.” He then lists the factors that would be considered to make such a film and goes on to discuss the effect of the process parameters on the properties.[59] He states:
“MDO draw ratios are fairly well understood with regards to % CaCO3 and breathability as well as tensile strengths and their respective ratios. I believe most good film product developers will have a good feel for what they need to do with the process to accentuate certain film properties.”[60]
[59] Jezzi 1 [3.37].
[60] Jezzi 1 [3.41].
Whilst these statements indicate that the skilled person may be able to manipulate particular film properties, I consider they fall short of providing a basis to conclude that when provided with the specific combination of target film properties such as those provided in product specifications or determined by analysis, the skilled person would be able to manufacture that film by routine means.
Mr Jezzi further states that he has supervised “the reverse engineering of diapers and the separation of the backsheet from the diaper…”[61] However, his comments following this statement relate to the method of separating and analysing the backsheet, and do not appear to extend re-making the backsheet based upon the properties determined in the analysis. He refers to obtaining an “accurate analysis”[62] but does not explain whether or how he went on to produce a replicated film from that analysis.
[61] Jezz1 2 [53].
[62] Jezzi 2 [55].
The problem of reproduction without undue burden is exacerbated when considering the second alleged prior use based upon the disclosure of the diaper containing the film at a trade show, since the film has first to be removed from the rest of the diaper for analysis, introducing further possibilities for error when determining the film properties, such that the determined properties may fall outside the scope of the claims, even before the reverse engineering of the film is attempted.
Mr Koplin states that the RKW exhibition diapers incorporate the RKW GOC2P 15 GSM film.[63] He also states it is possible if care is taken to dissect the components of a diaper to analyse the properties of the component film without changing those properties.[64] He confirms that he conducted such a test, and states that “When I conducted the test, all of the values I derived were within 10% of the original values.” [65]
[63] Koplin 2 [5].
[64] Koplin 2 [13].
[65] Koplin 5 [39].
However, it does not appear that the values Mr Koplin actually derived are present in the opponent’s evidence, and the opponent didn’t point to any actual values in their submissions. I understand Mr Koplin’s statement that his derived values were “within 10% of the original values” is referring to his derived values being within 10% of the originally tested values of the film shown in the Annexure E table. As previously stated, I understand the Annexure E table as being a repeat of the tables of Annexures A and B (the “original values”), not the values he produced by re-testing the film. I also understand “within 10%” means plus or minus 10% as in the opponent’s submission.[66]
[66] Opponent submission [37].
When considering Annexure E, I note that the testing of the original film has been conducted on multiple samples from different sample positions on a roll of film. The test data demonstrates, according to the opponent, that the film had a basis weight in the range of 14gsm -15.4 gsm,[67] depending on position of the sample being analysed. Therefore, if Mr Koplin’s re-testing of the film after removal from the diaper produced a plus 10% result this would equate to a basis weight of over 15 gsm for even for the lowest thickness reported, 14gsm (14+1.4=15.4). However, neither Mr Koplin’s evidence, not the opponent’s submission, account for this possibility; the opponent merely states “his results were +/-10%. That is, the exact properties of Claim 1” without providing the actual values obtained.
[67] Opponent submission [33].
I cannot accept that “the exact properties of claim 1” are demonstrated when the error margins allow for the properties of the tested film alleged as the prior use falling outside the scope of the claimed basis weight. On this point alone I consider that the second part of the opponent’s case for prior use, based on the disclosure of the diaper, fails. Furthermore, my previous comments regarding the lack of evidence as to whether the film can be reproduced without undue burden, going to the issue of whether the disclosure is enabling, apply equally to a set of film properties determined from analysis of a dissected diaper.
I note here that the question of whether the alleged prior use represents an enabling disclosure is separate from the question of whether present claim 1 is enabled by the description of the application. The former is a question of what the experts say regarding the abilities of the skilled person and the common general knowledge; the latter is a question of what the skilled person is enabled to do by the disclosure of the present specification. As I have previously commented, the present description details a new production method for making films having the properties of claim 1 and there is no evidence to suggest that this method cannot be used to produce films across substantially the whole claim scope.
For the above reasons, I do not consider the evidence supports a conclusion that the disclosure of a film having a set of properties determined from a data sheet or from analytical methods would be able to be reproduced from that data alone by the skilled person without undue burden. I do not consider that the opponent has demonstrated on the balance of probabilities that either the supply of a film having a set of properties to Proctor & Gamble, or the film displayed as a part of a diaper at a particular trade show makes available to the public a film as claimed in claim 1. The opponent has not made out the case for lack of novelty based on prior use.
Lack of novelty by inevitable result
The document pressed by the opponent under this ground is US 2005/0248051 (the 051 patent). The opponent submits that Mr. Koplin has demonstrated in Koplin 3 that he has previously followed the directions in the 051 patent and in doing so has produced two polymer films containing at least the properties of claim 1 of the application.
“It is therefore clear that each of the films produced by Mr. Koplin had each of the defined
characteristics of the product of Claim 1 of the Opposed Application. This shows that a person skilled in the art following the instructions in, and disclosure of, Cancio et al. ‘051 before the Priority Date of the Opposed Application could, and would, have made a product that fell within Claim 1 of the Opposed Application. Claim 1 of the Opposed Application has been anticipated and, consistent with the principles set out in of General Tyre, therefore lacks novelty.”[68][68] Opponent submissions [39].
Koplin 3 refers to the reproduction of Example 1 of the 051 patent; Koplin 4 discusses the reproduction of Example 4 but was not mentioned in the submissions. I asked the opponent at the hearing if they wished to rely on Example 4 as a part of their case. After some discussion, the opponent agreed that they did wish to press the argument in respect of Example 4, and that the case argued from Example 1 also applied to Example 4. The applicant submitted at the hearing that the case for lack of novelty by inevitable result argued from Example 4 was not made out for similar reasons as for Example 1.
In his third and fourth declarations Mr Koplin describes the procedure he used to produce films from the instructions given in the 051 patent. He states that he produced two polymer films with basis weight less than 15 gsm in accordance with Example 1 of the 051 patent and produced three series of films in accordance with Example 4. In both third and fourth declarations, he states that he took care to match the formulations given in the examples as closely as possible, noting that “minor deviations in the composition (<1%) will not have a significant effect on the properties…”.[69] Mr Koplin gives details of the process steps in similar paragraphs in both declarations.
“The blend was then filled into a drum and thoroughly mixed with a drum hoop mixer and filled into the feeding hopper of a pilot-scale Collin extrusion line. The extruder fed the melt to a slot die that cast the film onto a water-cooled chill-roll.”[70]
Following this, Mr Koplin states that the web was conveyed to an MDO stretching apparatus with a series of rolls, “the speed of which can be adjusted freely to meet the process conditions”.[71]
[69] Koplin 3 [10]; Koplin 4 [17].
[70] Koplin 3 [11]; Koplin 4 [18].
[71] Koplin 3 [12]; Koplin 4 [19].
Regarding the production process disclosed in the 051 patent, Dr Singh notes several differences between the process conducted by Mr Koplin and the process set out in the 051 patent. He states that the stretching procedure performed by Mr Koplin uses a different roller set-up. [72] Dr Singh expects this would change the mechanical properties of the film.[73] Mr Koplin responds that Dr Singh has not provided supporting data of the expected changes. He also states that the 051 patent “does not state that such aspects influence the mechanical properties of the film”. [74] This suggests to me that Mr Koplin acknowledges differences in his process compared to that of the 051 patent.
[72] Singh 1 [215 b], [232].
[73] Singh 1 [232 a ii].
[74] Koplin 5 [57].
Another difference pointed out by Dr Singh is that the 051 patent uses a strictly controlled roll gap x, which is stated at [0006] of the 051 patent to be “critical”. Both Examples 1 and 4 report that a particular roll gap was used in Tables 1 and 6. Dr Singh says he cannot find a corresponding gap in Mr Koplin’s system.[75] Mr Koplin does not respond to this comment in his responding fifth declaration.
[75] Singh 1 [232 c].
Furthermore, regarding the films that were produced by Mr Koplin upon following the Example 1 directions, I note Mr Koplin states in his third declaration that he changed the gauge of the primary web thickness disclosed in Example 1.[76] He confirms this in his fifth declaration where he agrees with Dr Singh that Example 1 does not produce films with basis weight less than 15gsm, but states that “a person in the art using their common general knowledge could reduce the basis weight beyond the range that is disclosed.”[77] This indicates to me that following Example 1 as directed does not inevitably produce a film with the claimed thickness.
[76] Koplin 3 [13].
[77] Koplin 5 [44].
The films produced in Example 4 include films of 15 and 13.9 gsm, according to Table 6. In Mr Koplin’s reproduction of this example, he also achieves films of a basis weight less than 15gsm.[78] Mr Koplin tests these films for breathability and tensile strength (ratio of MD/CD) using the same tests specified in the description of the application. However, he does not specify the standard he uses to measure the MD notched trapezoidal tear strength.[79] This latter point is noted by Dr Singh,[80] and Mr Koplin does not respond to the criticism in his subsequent declaration.
[78] Koplin 4 [22]-[24].
[79] Koplin 4 [21].
[80] Singh 1 [239].
There also appear to be differences in the precursor compositions used to make the films in Mr Koplin’s method as compared to Example 4 of the 051 patent. Dr Singh says that Mr Koplin has used a blown film as opposed to the cast film used in Example 4, which appeared to result in the need to use a reduced speed for the first metal roll.[81] He also notes that Mr Koplin has used significantly more additive for the B layer, even though by his own admission the differences should be <1%.[82] Mr Koplin does not respond to either of these criticisms about the type of film used or the amount of additive. The opponent’s submissions do not address these deficiencies
[81] Singh 1 [231a].
[82] Singh 1 [231e].
The lack of response to the points raised by Dr Singh are important, given that the onus is upon the opponent to make out their case. In a case for lack of novelty by inevitable result, according to the Novozymes decision, what must be shown is that if the prior art examples were worked as directed, it would inevitably, as a matter of hard fact, produce the film as claimed. I am not satisfied that the examples were worked as directed. Furthermore, I do not consider that the opponent has discharged their onus to demonstrate that in following the directions of either Example 1 or Example 4 contained within the context of the 051 patent, the skilled person would inevitably arrive at a film within the parameters of claim 1. The case for lack of novelty by inevitable result is not made out.
Inventive step
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 (subsection 7(3)).
In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd[83] (Wellcome) 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."
[83] [1981] HCA 12 at [45]; (1981) 1A IPR 268 at 281.
In Aktiebolaget Hassle v Alphapharm Pty Ltd (Alphapharm)[84] the High Court endorsed the use of the reformulated "Cripps question":
"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and the facts … directly be led as a matter of course to try [the invention as claimed] in the expectation that it might well produce a useful alternative…”[85]
[84] [2002] HCA 59; (2002) 56 IPR 129.
[85] Ibid at [53].
Further elaboration is found in the Full Federal Court’s decision Generic Health Pty Ltd v Bayer Pharma Aktiengesellschaft (Generic Health):
“We do not think that the plurality in Alphapharm were saying that the reformulated Cripps question was the test to be applied in every case. Rather, it is a formulation of the test which will be of assistance in cases, particularly those of a similar nature to Alphapharm. The plurality did not reject as an alternative expression of the test the question whether experiments were of a routine character to be tried as a matter of course (The Wellcome Foundation Limited v VR Laboratories (Aust) Proprietary Limited [1981] HCA 12; (1981) 148 CLR 262, at 280281, 286, per Aickin J). We do not think there is a divide here in terms of whether an expectation of success is relevant between a test which refers to routine steps to be tried as a matter of course and the reformulated Cripps question. 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.”[86]
Common general knowledge
[86] [2014] FCAFC 73 at [71].
What is meant by common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·standard texts and handbooks;
·standard English dictionaries;
·technical dictionaries relevant to the field;
·magazines and other publications specific to the field.”[87]
[87] [1999] FCA 345; 45 IPR 577 at [112].
The common general knowledge must be established by evidence as stated by Emmett J in Dynamite v Aruze:
“It is necessary to establish common general knowledge by appropriate evidence. Evidence that consists of generalised and sweeping statements of opinion or recollection, unsupported by secondary materials such as text books, trade journals and technical publications, should be treated with caution and given little weight.”[88]
[88] [2013] FCA 163 at [104].
Mr Jezzi states that historically, the diaper industry has been driving to lower basis weight films as a cost reduction practice.[89] He considers that the basis weight is ultimately determined by the MDO draw ratio, and that the MDO process “has been around for decades.”[90]
[89] Jezzi 1 [3.3].
[90] Jezzi 1 [3.25]-[3.26].
He notes that film strength is a requirement of backsheet production to enable the film to withstand printing and lamination. He states that “In both these cases, machine direction strength orientation is key…” and also that “The machine direction orientation process has always been known to provide a very monodirectional property for films that are stretched in this manner.”[91]
[91] Jezzi 1 [3.9]-[3.10].
Regarding the properties of films, Mr Jezzi states that in his experience, the major property changes are formulation based.[92] When asked whether it was easy or difficult to predict the resultant properties of the film if you changed the parameters of the process, he stated the following:
“Yes. For instance, MDO draw ratios are fairly well understood with regards to % CaCO3 and breathability as well as tensile strength and their respective ratios. I believe that most good film developers will have a good feel for what they need to do with the process to accentuate certain film properties.”[93]
[92] Jezzi 1 [3.39].
[93] Jezzi 1 [3.41].
In the context of being asked about the values recited in claim 1 of the application, he stated:
“Generally, you would target a MD/CD ratio in the range of 3-7 depending on the particular application of your film, and about 3-5 for breathable films for use in sanitary products.”[94]
[94] Jezzi 1 [3.62.14].
Mr Richer comments as follows on this issue of film strength.
“There are different approaches available to the skilled addressee to address the issue of decreasing strength with lower basis weight. For example, the film composition may be varied to create a stronger film, the film may be subjected to different processing steps, and/or the film may be incorporated into a multi-layer film with other layers of the multi-layer film providing increased pin hole resistance and providing increased machine and cross directional strengths.”[95]
[95] Richer 1 [3.10].
When asked how he would adjust the process of manufacture of a film to improve its strength he stated:
“There are a number of options that I would consider, for example:
Strength can be controlled via selection of the appropriate resins…
Strength can be controlled through processing .. such as by stretching to align polymer chains, such as in the machine direction or the cross direction
Additional components could be addedStrength of the overall film may be enhanced by adding further layers…”[96][96] Richer 1 [3.39].
Dr Singh states that he agrees with the Mr Richer’s list of options for increasing strength. He states that he would add that he would have also considered stretching the film to align polymer chains (ie to provide “molecular orientation”) in both the machine direction and the cross direction.[97]
[97] Singh 1 [31].
Dr Singh provides several clarifications. He states that stretching does not necessarily correspond to imparting “molecular orientation”. For example, stretching a film in its melt state would not impart molecular orientation. Conventionally, to impart molecular orientation, films would be stretched “cold” – that is below the crystallisation temperature of the polymer.[98]
[98] Singh 1 [34]-[35].
Dr Singh also qualifies Mr Jezzi’s statement about the commercial drive toward lower basis weights, saying that at the priority date, there would have been reluctance to stretch a film to a basis weight of 15gsm or below due to the likely detriment to mechanical strength.[99]
[99] Singh 1 [29].
Dr Singh notes that "Cross Direction Orientation" (CDO) is also known as "Transverse Direction Orientation" (TDO).[100]
[100] Singh 1 [36].
In the context of replying to Mr Jezzi’s second declaration, Dr Singh refers to “Extrusion: The definitive Processing Guide and Handbook”,[101] a textbook dated 2005. Dr Singh states that this is a handbook “which is a compendium of information and notions which were common general knowledge at the earliest priority date.”[102] Dr Singh’s statement is consistent with the nature of the book, described as a “Guide and Handbook”, and its publication date more than 8 years before the earliest priority date, which is ample time for it to become widely known. I am satisfied that this reference can be considered material that the skilled person in the field knows exists and to which they would refer as a matter of course.
The problem
[101] Annexure NKS-6 to Singh 2.
[102] Singh 2 [46].
Regarding the formulation of the problem, the applicant referred to AstraZeneca as follows:
“If the problem addressed by a patent specification is itself common general knowledge, or if knowledge of the problem is s 7(3) information, then such knowledge or information will be attributed to the hypothetical person skilled in the art for the purpose of assessing obviousness. But if the problem cannot be attributed to the hypothetical person skilled in the art in either of these ways then it is not permissible to attribute a knowledge of the problem on the basis of the inventor’s “starting point” such as might be gleaned from a reading of the complete specification as a whole.” [103]
In other words, when formulating the problem, it is not permissible to incorporate information that is not available to the person skilled in the art as either common general knowledge or information available under section 7(3).
[103] [2014] FCAFC 99 at [202]-[203].
Dr Singh does not consider that there was market pressure to reduce film thickness below 15 gsm as this would make them too weak.[104] However, implicitly this suggests that there was a known problem in the art that lower basis weight films lacked mechanical strength. Mr Jezzi, who has considerable experience in the diaper industry, does consider that historically the industry was driving toward lower basis weight films as a cost reduction practice.[105] Mr Richer states that film strength is important from a production perspective.[106] Dr Singh considers that stretching in both the machine and cross direction (in other words, a balance of these orientations) would have been a known consideration when seeking to improve strength.[107]
[104] Singh 1 [29].
[105] Jezzi 1 [3.3].
[106] Richer 1 [3.55].
[107] Singh 1 [31].
The problem, as identified in the specification, is to provide breathable thermoplastic films having low basis weight, which have limited MDO and desirable properties including being substantially free of holes, good tensile strength and tear properties, which can be produced economically and efficiently on high speed production lines.[108]
[108] Description [0006].
Although this is the problem as identified in the applicant’s specification, I consider from the statements made by the experts above, all the aspects of this problem can be identified within the common general knowledge. I therefore consider that this articulation of the problem is within the boundaries set by the AstraZeneca decision.
Disclosure of US 4929303 (The 303 patent)
This document discloses a polyethylene film with good breathability and improved strength.[109] The film forming composition may be manufactured by a “blown bubble” process or by cast extrusion. The document states the following:
“Stretching or “Orientation” of the film may be carried out monoaxially in the machine direction (MD) or the transverse direction (TD) or in both directions (biaxially) either simultaneously or sequentially using conventional equipment and processes following cooling of the precursor film.
Blown films are preferably stretched in the machine direction or in both directions whereas cast films are preferably stretched in the transverse direction. For orientation in the MD, the precursor film is passed around two rollers driven at different surface speeds and finally to a take up roller. The second driven roller which is closest to the take up roll is driven faster than the first driven roller. As a consequence the film is stretched between the driven rollers.
Film orientation may also be carried out in a tentering device with or without MD orientation to impart TD orientation to the film…..”[110]
[109] Column 2 lines 40-55 of the 303 patent.
[110] Column 5 lines 34-50 of the 303 patent.
The examples, as pointed out by the applicant[111] are all directed to cast extruded films. Examples 6-19 state that all the films were produced “in the manner described above” indicating that they were cast extruded. I agree with the applicant that the teaching of this document is to preferably use transverse stretching for cast films. As noted above, transverse stretching is otherwise known as cross directional stretching.
[111] Applicant submissions [79].
The particular examples that are the focus of the inventive step consideration are examples 6, 9 and 12. Mr Jezzi has calculated the basis weight and the MD/CD load at break from Table II in the 303 patent. I provide below an excerpt of his table.[112]
[112] Jezz1 2 [20].
Example Basis weight MD/CD Load @ Break 6 13.6 0.4 9 17.0 0.4 12 17.0 9.2
I note the comments of Dr Singh in his declarations stating that he is unable to compare the film parameters described in the 303 patent with those claimed in the application due to the use of different or unstated methods to measure the various parameters.[113] However, putting aside this concern at this point I will firstly consider the issue of the MD/CD ratio as calculated by Mr Jezzi. Dr Singh considers the only example that has an MD/CD ratio of more than 1 as required by claim 1 of the application is example 12. However, that example has a basis weight of over 15 gsm. The only example with a basis weight below 15 is example 6, however that film has an MD/CD ratio well below 1. [114]
Consideration
[113] Singh 2 [17].
[114] Singh 2 [15]-[16].
Given these examples, I consider a fundamental question is whether the skilled person would have been motivated to alter these examples in any way. Using the words of the inventive step test in Wellcome, would the PSA, faced with the same problem, have taken as a matter of routine whatever steps might have led from this prior art to the invention, whether they be the steps of the inventor or not? I also note that the test requires that the PSA has a reasonable expectation of success. According to the Generic Health decision, it is “implicit in the characterisation of steps as routine” that there is “an expectation that an experiment might well succeed”. The expectation required is discussed in the decision in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2)[115](Bayer Pharma). In this decision (upheld on appeal) I note the comment of Jagot J that it is not enough to show that the skilled person would have an expectation of finding “some other useful result”; the expectation of the skilled person in the context of obviousness must be an expectation of producing the claimed invention.[116]
[115] [2013] FCA 279.
[116] Ibid at [68].
In key evidence for the opponent’s case, Mr Jezzi suggests that the skilled person, armed with the 303 patent would proceed in the following manner.
“Even though both the Sheth and Middlesworth film data has MD/CD ratios below 1.0 due
to their preference in choosing the TD for the predominant stretching, by simply adjusting
the draw differentials in both the MD and TD stretching devices, they could achieve breathable film properties with a ratio higher than 1.0 and obtain similar MVTR and tear
properties as those in Claim 1 of the Opposed Patent. It is clear when you consider the
examples of the Sheth patent that Sheth discloses a product where the ratio is greater than
1: See example. In my opinion, such adjustments would be routine to a person skilled in
the art using their common general knowledge. To achieve such adjustments would involve
no more than increasing the speeds of the MDO units stretching the film more in the MD
direction and reducing the stretch-width in the tenter frame to stretch the film less in the
CD.In my experience, a person skilled in the art would have reason to adjust the ratios
for the following reasons:
a. They were asked by the converter or product user to do so for competitive reasons;
b. Film elongation in the MD stretch of the film resulted in necking of the film;
c. To register the diaper. By ‘register’ I refer to the process in which registration
marks which are typically printed on the diaper backsheet and then laminated to a
non-woven fabric are used to ‘register’ the entire diaper by reference to these
registration marks such that the prints do not move. It is important for this process
that the appropriate MD/CD ratios are used, and these typically favour higher
MD/CD ratios along with the annealing and heat setting of the film in order to retainthese.”[117]
[117] Jezzi 2 [21].
Dr Singh replies that the films of the examples are cast films, and the 303 patent explicitly states that transverse stretching is preferred for cast films.[118] Mr Jezzi acknowledges this preference. The column 5 passage of the 303 patent quoted above does mention the use of stretching in the machine direction generally, but this is immediately followed by the paragraph that indicates that it is blown films that are preferably stretched in this way. This point was discussed at the hearing. I agree with the applicant that it is difficult to argue that the skilled person would be motivated to add MD stretching to examples that are made by the cast process. In my view, there would have to be strong motivation on the part of the PSA to do so.
[118] Singh 2 [12].
As indicated above, Mr Jezzi suggests three reasons that he considers are motivations for the skilled person to alter the disclosed process by “stretching the film more in the MD direction and reducing the stretch-width in the tenter frame to stretch the film less in the CD”. Dr Singh has commented on each of these points and provided references from the textbook “Extrusion: The definitive Processing Guide and Handbook” previously mentioned under the section on common general knowledge, to substantiate his claims.[119] I am inclined to give Dr Singh’s evidence on these points considerable weight given he has provided corroborating evidence for his views.
[119] Singh 2 [45]-[64], NKS-6.
Firstly, Dr Singh points to a known danger of increasing brittleness as a result of reducing the transverse directional strength when increasing the MDO, which may dissuade the skilled person from such a course.[120]
[120] Singh 2 [46].
Secondly, Dr Singh disagrees that the skilled person would add more stretch in the MD to address a necking problem, when this itself can be a cause of necking of the film.[121] Dr Singh suggests several other strategies to address the problem.[122]
[121] Singh 2 [48]-[50].
[122] Singh 2 [54]-[56].
Finally, Dr Singh explains that “registering” the diaper requires that the film retains its dimensions without undergoing excessive MD and/or CD shrinkage.[123] He considers that annealing alone is the common solution to the problem of film shrinkage and provides a reference in the textbook that suggests that annealing will reduce shrinkage.[124] There is no reference here to altering the MD/CD ratio.
[123] Singh 2 [59].
[124] Singh 2 [60].
I also note Mr Richer’s comments at this point. He notes, in the context of being questioned as to how the strength of a film could be increased, that several options that could be considered. As one option, he notes that strength can be controlled by stretching “in the machine direction or cross direction”.[125] He does not mention altering both the MD and CD stretch to achieve an appropriate balance. In my mind, this is a more complex adjustment than the options suggested by Mr Richer. Upon weighing up the evidence as to the options available to the skilled person, I am not persuaded on the balance of probabilities that increasing the stretch in the machine direction whilst reducing the stretch in the cross direction would be a routine option utilised by the skilled person to optimise the films of the 303 patent.
[125] Richer 1 [3.39].
Furthermore, in order to succeed on the ground of lack of inventive step, it must be established that the PSA, in taking routine steps leading from the prior art to the invention, has a reasonable expectation of success. In the words of the Generic Health decision, it is “implicit in the characterisation of steps as routine” that there is “an expectation that an experiment might well succeed.” In the facts of the current case, this translates to the PSA having a reasonable expectation of achieving a film having as basis weight of 15gsm or below which have limited MDO and desirable properties including being substantially free of holes, good tensile strength and tear properties, which can be produced economically and efficiently on high speed production lines
Mr Jezzi states that the skilled person could achieve film properties with a ratio higher than 1 by stretching the films in the MD direction,[126] despite the preference in the document for transverse stretching, but doesn’t provide evidence to substantiate his assertion that such a film would still retain all the desirable tensile and tear properties of the film, and the required breathability. Dr Singh states that “adjusting one parameter will have a significant effect on all the others.”[127] The onus lies with the opponent to make out the case. In my view, the opponent has not established on the evidence that the skilled person would have a reasonable expectation that, if the films of the 303 patent were subject to increased stretching in the machine direction, the other properties required would be maintained.
[126] Jezzi 2 [21].
[127] Singh 2 [14].
For these reasons I do not consider that the case for lack of inventive step has been made out.
Conclusion
The opposition is unsuccessful.
Costs
Costs normally follow the event. However, the opposition process has resulted in the applicant making amendments dated 11 June 2020, prior to the hearing, that narrowed claim 1 to films having and MD/CD ratio in the range of 1 to 10. The applicant comments that the changes were merely clarifying amendments, however I note that prior to this request to amend a significant number of documents were raised by the opponent in the evidence in support that were not pressed at the hearing. In this sense the opponent can be seen as being partially successful despite the opposition per se being unsuccessful.
As a consequence, I award costs against the applicant according to Schedule 8 of the Regulations up to the date the amendments dated 11 June 2020 were allowed, and from the date the amendments were allowed I award costs against the opponent according to Schedule 8 of the Regulations.
Cathy Douglas
Delegate of the Commissioner of Patents
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