Alistair Mann v Electronic Pain Assessment Technologies (epat) Pty Ltd

[2023] APO 1

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Alistair Mann v Electronic Pain Assessment Technologies (epat) Pty Ltd [2023] APO 1

Patent Application:     2015306075

Title:      A pain assessment method and system

Patent Applicant:       Electronic Pain Assessment Technologies (epat) Pty Ltd

Opponent:                 Alistair Mann

Delegate:                   Felix White

Decision Date:            12 January 2023

Hearing Date:            5 August 2022, by videoconference

Catchwords: PATENTS – automated pain assessment method and system by analysis of facial and other features – opposition to grant under s59 – novelty – all claims novel – inventive step – hindsight considered – all claims found obvious in view of common general knowledge – best method – inventor’s evidence demonstrated possession of prototype and additional information relating to performance of the invention – best method requirement not satisfied – support – technical contribution corresponds to the scope of the claims – all claims supported – manner of manufacture – substance of the invention determined to be automation of manual assessment methods – no patentable subject matter in application – application refused – costs awarded.

Representation:          Patent attorney for the applicant: Christian Schieber, Griffith Hack
  Counsel for the opponent: Clare Cunliffe
  Solicitors and Patent attorneys for the opponent: MinterEllison

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:     2015306075

Title:      A pain assessment method and system

Patent Applicant:       Electronic Pain Assessment Technologies (epat) Pty Ltd

Date of Decision:       12 January 2023

DECISION

The Opposition succeeds on the grounds of lack of best method, lack of inventive step and lack of manner of manufacture.   As there is no apparent prospect of overcoming all of these grounds by amendment, I refuse the application.  I award costs according to Schedule 8 against Electronic Pain Assessment Technologies (epat) Pty Ltd.

REASONS FOR DECISION

Background

1. Australian Patent Application 2015306075 (“The Application”) in the name of Electronic Pain Assessment Technologies (epat) Pty Ltd (“The Applicant”) is the Australian national phase application of PCT/AU2015/000501, filed on 18 August 2015 and claiming priority from Australian provisional application 2014903226.  Upon direction from the Commissioner, examination was requested on 22 February 2019.  The only objection raised during examination was under s40(3) of the Act[1] for lack of support, on the grounds that the claims as filed did not define essential computer implementation and encompassed mental acts: this was remedied by amendment on 23 April 2020 and acceptance of the application was duly published in the Official Journal on 14 May 2020. 

   [1] All legislative references are to the Patents Act 1990 (“The Act”) unless indicated otherwise.

2. A Notice of Opposition was filed under s59 on 14 August 2020 by Alistair Mann (“The Opponent”).  The Statement of Grounds and Particulars (“SG&P”), filed on 17 November 2020, listed grounds of

• Lack of manner of manufacture;

• Lack of novelty;

• Lack of inventive step;

• Lack of support, sufficiency and best method.

1. The Opponent later requested to amend the SG&P to include additional grounds of lack of clarity and utility, and to add additional prior art documents to the ground of lack of inventive step, as well as clarifying some of the particulars.  The request to add grounds and documents was refused by the Commissioner’s delegate on 9 April 2021: an amended SG&P with refinements to the particulars of sufficiency and support was allowed on 5 May 2021.  Although it is open to me under the provisions of s60(3) to take additional grounds into account when deciding this case, provided that the parties have been given an adequate opportunity to be heard, I do not see any need to investigate additional grounds in this case.

2. The Applicant filed a post-acceptance amendment to the claims and description under s104 on 11 May 2021, which was allowed on 13 August 2021.  All references to the description and claims in this decision refer to this amended specification.

3. The parties were heard on 5 August 2022 by videoconference.  The grounds pressed by the Opponent at the hearing were:

• Lack of manner of manufacture

• Lack of novelty in view of “Cerner” (US2013/0127620 A1: Exhibit KMP-27)

• Lack of inventive step in view of common general knowledge alone, or lack of inventive step in view of any of the following documents in combination with common general knowledge: Craig[2]; Guinsberg[3]; Mitsubishi[4]; Cerner; and Cohn[5]

• Lack of support

• Lack of best method

  [2] "Morphine pharmacokinetics and pain assessment in premature newborns", The Journal of Paediatrics, Vol. 135, No. 4: Exhibit KMP-23

  [3] "Physiological, hormonal, and behavioral responses to a single fentanyl dose in intubated and ventilated preterm neonates", The Journal of Paediatrics, Vol. 132, No. 6: Exhibit KMP-24

  [4] Japanese Patent Application No. 2001043345: Exhibits KMP-25 (original) and KMP-26 (machine translation)

  [5] "The Painful Face – Pain Expression Recognition Using Active Appearance Models", Proceedings of the 9th International Conference on Multimodal Interfaces, ICMI 2007, Nagoya, Aichi, Japan, November 12-15, 2007: Exhibit KMP-28

1. I will deal with the ground of manner of manufacture last, as it requires consideration of the substance of the invention which is illuminated by the consideration of the other grounds.

Applicable Law

1. The standard of proof that applies in the present case is the balance of probabilities. According to s60(3A) I can refuse the application if I am satisfied on the balance of probabilities that a ground of opposition has been named out.  However, s60(3B) requires that the Commissioner must not refuse an application where it is appropriate to give the Applicant a reasonable opportunity to remove a ground of opposition by amendment.

The person skilled in the art.

1. It is well established that the job of construing the specification is one for the Commissioner, but one which should be carried out from the perspective of the skilled addressee, and with a generous measure of common sense.  Therefore, before embarking on the task of addressing the specification, it is worthwhile to first establish who it is being addressed to.

2. The nominal skilled addressee or “person skilled in the art” is not a real person but is rather a hypothetical construct – a tool of analysis who has an interest in the field of the invention and has access to common general knowledge but no inventive ingenuity. 

3. The field of the invention relates to pain assessment systems and methods for determining an effect of a drug on pain of a patient.[6]

   [6] Description, p. 1 first paragraph (all page references are to the description unless indicated otherwise)

4. The Opponent submitted that the person skilled in the art is an expert in the field of pain assessment (who would need to work with a computer scientist) and argued that Prof Prkachin is such a person, and that Dr Hughes is not.[7]

   [7] Opponent’s written submissions (“OS”) at [6.1]

5. The Applicant countered that the evidence of Dr Hughes was more relevant (or at least that his evidence could provide assistance to the Commissioner) by drawing attention to the skilled person being one with an “ordinary but not exceptional knowledge” of the field[8] and that the skilled worker comprises a team.[9] 

   [8] Applicant’s written submissions (“AS”) at [48] and [50]

   [9] AS at [51], [63] and [73]

6. I am happy to apply the principles set down by Finklestein J in Root[10] that the skilled addressee is a team which includes not only those involved in making the invention but also those who will have a practical interest in using it.  Given that the field of the claimed invention is an automated method of determining the effect of a drug on a subject’s pain, which addresses a particular need in patients who cannot communicate their pain, I consider the skilled team to include clinicians (particularly in the neonatal and geriatric fields), pharmacists (particularly involved in pain management), pain psychologists and computer scientists.

   [10] Root Quality v Root Control Technologies Pty Ltd (2000) 49 IPR 225 at [70-71]

Common general knowledge

1. Common general knowledge is the background knowledge and experience available to all those working in the relevant art:

   "The notion of common general knowledge itself involves the use of that which is known or used by those in the relevant trade. It forms the background knowledge and experience which is available to all in the trade in considering the making of new products, or the making of improvements in old, and it must be treated as being used by an individual as a general body of knowledge.”[11]

   [11] Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9 at [292]

2. Guidance on this consideration was provided in British Acoustic Films Ld v Nettlefold Productions (1936) RPC 221 at 250:
   
   

   “In my judgement it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or a series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less merely because it is widely circulated. Such a piece of knowledge only becomes common general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.”

The expert evidence

1. The evidence filed within the regulated period consists of declarations from Professor K.M. Prkachin (for the Opponent) and Dr J.D. Hughes (one of the inventors of the opposed Application, for the Applicant). 

2. Prof Prkachin has been working in the field of pain measurement, and in particular the assessment of pain with facial expression, since the 1970s.[12]  During his career Prof Prkachin has authored a number of high impact papers in the field of pain psychology, including a 1992 paper[13] in the journal Pain “the Pain paper” with over 500 forward citations,[14] a 2009 publication[15] in the journal Image and Vision Computing “the Painful Face” which was also widely cited.[16]  He also authored a chapter[17] on “The Facial Expression of Pain” in the 2011 textbook Handbook of Pain Assessment.  It seems fair to say that Prof Prkachin is one of the leading experts in the field of pain psychology and pain assessment.

   [12] Prkachin #1 at [8-9]

   [13] Exhibit KMP-3

   [14] Exhibit KMP-4

   [15] Exhibit KMP-8

   [16] Exhibit KMP-9

   [17] Exhibit KMP-5

3. By virtue of his own research and also his role as a reviewer for numerous journals and grant applications[18] Prof Prkachin is clearly aware of much more than just what would be “generally known and accepted without question” by the hypothetical skilled worker in the field.  However, Prof Prkachin also has an extensive history of teaching undergraduate[19] and graduate[20] psychology students, so I am happy to accept that Prof Prkachin can provide evidence about what was generally known in the field of pain psychology.

   [18] Prkachin #1 at [41-44]

   [19] Prkachin #1 at [18(f)]

   [20] Exhibit KMP-2 p. 31-34

4. Dr Hughes is the Applicant’s Chief Scientific Officer and is one of the named inventors of the present application.  Dr Hughes has worked as a clinical pharmacist since 1978.  As a hospital pharmacist his duties included providing pain relief to geriatric patients and other patients with communication impairments.[21]  Dr Hughes also has approximately 20 years’ experience in academia where he taught clinical pharmacy and pharmacotherapy subjects including geriatric medicine, and since c. 1997 his clinical focus has been primarily on aged care.[22]

   [21] Hughes at [12-14]

   [22] Hughes at [15-18]

5. I am satisfied that Dr Hughes can provide evidence as to what a clinical pharmacist and/or an aged care health worker would have known and done as of the priority date, however I must bear in mind that as a named inventor he is neither an independent expert or devoid (as the hypothetical person skilled in the art would be) of inventive facility.

6. Given that I consider that the hypothetical skilled person in this field is a team, I find it helpful to have the perspectives of both a pain psychologist (Prof Prkachin) and a clinical pharmacist (Dr Hughes) to inform me.

7. I have summarised the declarants’ evidence, as well as the parties’ submissions thereto, in the following paragraphs.  I will refer to relevant portions of that evidence as required throughout this decision.

8. Prof Prkachin’s evidence in chief consists of his background and experience (paragraphs 1-50), a summary of pain and facial expressions as indicators of pain (54-72), manual (73-93) and automated (94-124) pain assessment systems; his approach to a hypothetical task of being asked to design a real-time pain assessment system as of the priority date (125-148); his comments on the prior art documents mentioned in the SG&P (149-202); his comments on the opposed application (202-260); and his comparison of the outcome of his hypothetical task (261-315) and the prior art documents (316-488) to the specification and allowed claims of the opposed application.  Prof Prkachin pointed out at several places[23] in his first declaration that he attempted to answer the questions posed by the Opponent’s solicitors from the standpoint of what was well-known and generally accepted in the field of pain as of the priority date.

   [23] Prkachin #1 at [50], [125], [150]

9. Dr Hughes’s evidence in answer consists of his background and the events leading up to the filing of the present application and the establishment of epat Pty Ltd[24] (paragraphs 1-33), and his responses to Prof Prkachin’s evidence on common general knowledge (34-98), the hypothetical task (99-127), the prior art documents (128-168), and the opposed application (169-214).  On the topic of common general knowledge, I would briefly note that Dr Hughes does not appear to explicitly direct his comments to what he considers was well-known and generally accepted in the field.  One asserted point of difference was that, in Dr Hughes’s opinion, the field of the invention was “developing methods and technology associated with the presence or absence of pain” and that specialists in that field would include pharmacists and clinicians rather than just pain psychologists.[25] As I mentioned earlier I concur with this assessment: the hypothetical skilled team represents all relevant specialists working together and sharing their common general knowledge.

   [24] Renamed in 2017 to PainChek

   [25] Hughes at [37-38]

10. Prof Prkachin’s evidence in reply consists of a further set of comments on the opposed application as amended (i.e. the claims at issue) (paragraphs 1-25) and comments regarding differences of opinion with Dr Hughes (paragraphs 26-116).

11. It is the job of the delegate to weigh evidence.  When there is any disagreement among (or controversy attendant to) the expert evidence on a point of fact material to this decision, I will weigh that as necessary.

12. The Applicant filed additional evidence for the Commissioner’s consideration under the provisions of reg 5.23.  This evidence consisted of an additional declaration by Dr Hughes, and a declaration by Dr J. Abbey, the developer of the Abbey Pain Scale.  Both these declarations contain evidence about existing pain assessment scales and tools.

13. At the oral hearing both parties referred to the reg 5.23 evidence.  I noted at the hearing that the Opponent had not had a formal opportunity to respond to this evidence (as required by reg 5.23(2)(c)), and thus in the event that I considered this evidence to be of importance for deciding this Opposition, I would give the Opponent a further opportunity to give evidence or make representations as per the regulations.  Since the evidence relating to existing pain assessment scales and tools would not have changed my findings on any of the grounds in this Opposition, I have not considered them under reg 5.23 and no further action is required.

Disclosure of the specification

1. The patent specification comprises 34 pages of description, three pages of drawings, followed by 21 claims.  The description sets out in the first paragraph that the field of the invention is a pain assessment system and a method for determining an effect of a drug on pain of a patient.  The description then sets out a brief “Background of the Invention” to the effect that pain assessment is a challenge in non-communicative patients such as dementia sufferers, and undiagnosed pain may cause other symptoms which can increase the cost of delivering care. 

2. The first page of the description then states that “[e]xisting tools that are based on American Geriatric Society’s (AGS) guidelines are not automated, highly subjective resulting in significant variability, and hence inconsistencies in pain management of patients.  There is need for improvement”.

3. Pages 2-12 of the description contain a “Summary of the Invention” which is a restatement of the claims.

4. The remainder of the description is devoted to a “Detailed Description of Specific Embodiments”.  The passage bridging pages 13-14 sets out that information indicative of pain, such as facial or vocal features, is captured and used to determine quantitative pain indicating information.  This can be performed after administration of a drug with reference to “reference information indicative of a reference level of pain”.  It describes that the level of pain (and responsiveness to drugs) can be objectively assessed which is advantageous in non-communicative patients such as dementia patients or infants, and that the invention has real time functionality which is advantageous for point-of-care use.

5. Page 14 then sets out applications of the invention including pain assessment in dementia, autism, paediatrics, or for research. 

6. Page 15 sets out that the reference information mentioned above can be derived from statistical information of a drug and can be in the form of an expected pain score between 0 (no pain) and 10 (maximum pain).

7. The description then discusses the embodiment of Figure 1, which is a fairly self-explanatory flow chart set out below:

1. The description clarifies that the first step of capturing information can be performed either before administering the drug, or after administering the drug but before the drug is expected to take effect.  The information is “indicative of features … capable of indicating pain”[26]  – examples of such features taken from the AGS’s “widely accepted pain indicators”.  Lists of facial, vocal, movement, behaviour, activity and physical indicators of pain are set out at p. 16-17 of the description.  There is no apparent doubt that these are all conventionally known pain indicators.   

   [26] p. 15 last paragraph

2. The description then indicates[27] that “in the specific example shown in Figure 1” (although Figure 1 is actually silent as to the following features) a plurality of facial features are captured by a device “such as a camera” in the form of a still or moving image.

   [27] p. 17 first full paragraph

3. The description then states[28] that the reference information on the reference level of pain is determined from the first information.  I understand this to be a different embodiment from the one discussed at p. 15 where the reference information was taken from statistical data only.

   [28] p. 17 second last paragraph

4. The description then states[29] that the determination of reference information can be carried out by an algorithm which identifies facial features from the image and compares them with predetermined data.

   [29] p. 17 last paragraph

1. The description describes at p. 18-19 that positional information of facial features (here, representing positions of the brow, the eyes and the lips) can be compared to predetermined data from e.g. the AGS’s pain indicators, and that a predetermined pain score can be allocated e.g. a binary pain score of 0 or 1 for each feature.

2. The description then describes that a software program may identify key face muscles, which would enable expressions to be analysed using the Facial Action Coding System (FACS) methodology, or the software program may learn from a database of images expressing the presence or absence of pain. 

3. The description then indicates than when assessing pain of an infant, a combination of physical, vocal and behavioural (such as consolability) features may be used.

4. At p. 20-21 the specification describes administration of the drug to the patient.  It states the drug is not necessarily an analgesic and the method could be used to monitor painful side effects of a drug.  The description discloses receiving and storing information about the drug and the patient (e.g. name, formulation, content or amount of the drug, and name, age, weight or historical data of the patient) and that the above information is used to estimate the time for the drug to have an effect on the patient.

5. The description then describes that after that estimated time has expired, a second step of receiving information about the patient e.g. a facial image taken by a camera, takes place, the level of pain after administration of the drug can be determined, and compared with the reference information on the reference level of pain to determine if the responsiveness of the patient to the drug is acceptable.

6. The description then indicates that “for example if it is determined that the effect of the drug of the pain experienced by the patient is below a predetermined threshold, a cause of the pain may be identified[30] and/or treatment of the patient may be determined.”

   [30] As an aside, I note that the Opponent criticised the application for not giving any detail on how the information on relative level of pain could be used to identify the cause of the pain.  However, I can think of at least one way this could be done: if the drug works through one analgesic pathway and the pain is not lessened, the cause of the pain must not be in the pathway that the drug acts on.

7. The description then describes an implementation of the system with reference to Figure 2.  This is a figure at a high level of generality setting out a server 200 with typical components of a server, a communications network 202 and user computing devices 204-208.  The description indicates that any suitable network and communications enabled computing device can be used.  A very generic description of the operation of the server is also provided.

8. The description then describes an “example implementation of the pain assessment system” as shown in Figure 3.  This figure (and accompanying description) is based on that of Figure 2 with the addition of features such as a control unit 302, databases containing drug information which are managed by a database management system, modules such as “information collector”, “pain level determiner”, “drug effect determiner” and “time period estimator”, and a connection to the “WHO pain ladder database” which is disclosed to provide information that could be used to determine treatment of the patient.[31]  These are essentially abstract representations of functional modules for performing the method steps previously described.  The passage of the specification discussing Figure 3[32] essentially repeats the previous description of the steps of the method.  One notable addition is an alarm signal that alerts the user when the drug is expected to have taken effect and a second reading should be taken.[33]

   [31] p. 31 first full paragraph

   [32] p. 25-31

   [33] p. 30-31 bridging paragraph.  During the oral hearing the Opponent took issue with the amount of enablement provided for the embodiment of “tactile feedback”; however I do not think it is in dispute that haptic wearable devices were available as of the priority date of August 2014.

9. The specification ends with 21 claims, of which claim 1 and 12 are independent.  Although rather lengthy, I will reproduce claim 1 in full here.  Claim 12 is a claim to a system substantially corresponding to the features found in claim 1. The full claim set is found as an annex to this decision. 

   1. A method for determining an effect of a drug on pain experienced by a patient, the method comprising:

providing reference information that is indicative of a level of pain experienced by the patient by:

- obtaining a camera-captured first image of facial features of a patient;

- determining first positional information for at least a subset of the facial features in the first image using a processor of a pain assessment system running an algorithm;

- comparing, by the processor running the algorithm, the determined first positional information with predetermined data that is indicative of accepted facial feature pain indicators;

- capturing one or more visually detectable non-facial features and/or at least one audible feature from the patient selected from a set of accepted visually and/or aurally identifiable indicators of pain; and

- determining the reference information using the results of the comparison step and the captured one or more visually detectable non-facial features and/or at least one audible feature of the patient, by the processor running the algorithm;

providing pain indicating information that is indicative of a level of pain experienced by the patient after administering the drug to the patient by:

- obtaining a second camera-captured image of the facial features of the patient, after administration of the drug;

- determining from the second image second positional information for the same facial features or subset of features as captured in the first image, using the processor running the algorithm;

- comparing, by the processor running the algorithm, the determined second positional information with the predetermined data;

-re-capturing the one or more visually detectable non-facial features and/or the at least one audible feature from the patient based on the set of accepted indicators of pain, after administration of the drug; and

- determining the pain indicating information using the results of the comparison step and the re-captured one or more visually detectable non-facial features and/or the at least one audible feature of the patient, by the processor running the algorithm;

and

using the processor running the algorithm in comparing the pain indicating information with the reference information and based on the comparison determine the effect of the drug on the pain experienced by the patient.

Claim Construction

1. I put it to the parties at the oral hearing that the method of claim 1 could be succinctly construed as:

   a.Calculating a first pain “score” based on

   i.Comparing face “positional information” from an image with reference “accepted indicators” of pain, and

   ii.Another, non-facial, piece of information, then

   b.Repeating this after administering a drug to the patient and comparing the scores.

2. The parties did not disagree with this construction.

3. The Applicant, during their oral submissions, summarised the invention even more succinctly as a multifactorial, two point in time, automated pain assessment.

4. The other independent claim, claim 12, can be summarised as a system comprising an “information collector”, a processor and a database configured to perform the method of claim 1.  Notably, this corresponds to the “system” mentioned in the first paragraph of the description and does not actually involve a feature of administration of a drug; nevertheless the system is “configured and arranged”, which I take to mean that the processor is programmed, to make pain assessments at two time points and compare the results.

5. The dependent claims mention various other aspects of the invention that I have touched on in my journey through the description, including use of the AGS criteria, timing for taking the two images before and after the drug has taken affect, storing information on the drug and/or the patient, and the nature of the non-facial information.  All of them are at a broad level of generality and as will become apparent it is not necessary to consider them in detail.

Novelty – Cerner

1. The only ground of novelty pressed by the opponent was in view of US2013/0127620 A1 (SIEBERS et al) in the name of Cerner Innovation, Inc. (“Cerner”).   In particular, the Opponent submits that claims 1 to 4, 7, 9, 12 to 15, 17 to 18 and 21 lack novelty.[34]  The Opponent referred to a claim table attached as Annex 1 of their submissions.  Their analysis of all of the elements of claim 1, vis-à-vis the evidence from the declarants as to what Cerner discloses, runs to some seven pages.

   [34] OS at 11.6

2. It is well established that the test for novelty is a reverse infringement[35] test: does the prior art information disclose something that would fall within the scope of the claim?  It is also well established that the prior art must provide a “clear and unmistakeable direction”[36] to do or make something falling within the scope of the claim.  If a direction could be carried out in multiple ways and not all of them would fall within the scope of the claim, it is not novelty destroying.

   [35] Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) CLR 228 at page 235; 13 ALR 605 at page 611

   [36] General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd (1972) RPC 457 at pages 485-486.

3. With this in mind, I will address whether Cerner provides a clear and unmistakeable direction of my succinct construction of the invention above:

   a.Calculating a first pain “score” based on

   i.Comparing face “positional information” from an image with reference “accepted indicators” of pain, and

   ii.Another, non-facial, piece of information, then

   b.Repeating this after administering a drug to the patient and comparing the scores

Evidence

1. Cerner is generally directed to systems and methods for managing patient fall risk.  It also discloses embodiments involving assisting a clinician during a medication administration process (Figures 12-15) and management of patient discomfort and pain management (Figures 16-20).

1. The embodiment of Figure 16 is the one that the Opponent draws attention to in their submissions, which references the section from paragraphs 163-192.

2. This section is entitled “Ambient sensing of patient discomfort”.  It discloses that Figure 16 depicts a pain management scene 1600 in which a number of ambient sensors are used to detect patient discomfort.  These involve cameras 1602 and audio sensors 1606 as well as vital sign, moisture and weight sensors.  The cameras are used to monitor the facial expressions of the patient to detect discomfort.[37]  The cameras may monitor the individual at regular intervals or may be activated in response to vital sign monitoring.[38]  This image is sent to a sensor interface with an algorithm for recognising discomfort.[39]  The system can also determine non-facial indicators of pain such as agitation[40] or audio indications such as coughing, groaning, crying and moaning.[41]

   [37] Cerner at [0166]

   [38] Cerner at [0167]

   [39] Cerner at [0168]

   [40] Cerner at [0171] and [0174]

   [41] Cerner at [0173]

3. I am satisfied that this provides a clear and unmistakeable direction, at least in a general sense, to calculate one “pain score” according to items a) i) and ii) of my construction.  This particular part of Cerner does not, however, provide any disclosure about repeating the process after administration of a drug (item b) of my construction).

4. The disclosure of Cerner does go on to indicate actions that can be triggered upon detection of pain.  These include alerting hospital staff, initiating aromatherapy or audiovisual therapy, or alerting a family member to commence a relaxation therapy.[42]

   [42] Cerner at [0181] – [0185]

5. Two passages of Cerner deal with administration of a drug:

6. Paragraph [0189] of Cerner discloses automatic administration of pain relief “after a determination is made that the patient is experiencing discomfort” … “Once the dosage of analgesic is administered, the patient is monitored as outlined above to ensure patient safety.”

7. Paragraph [0190] of Cerner discloses a situation for detecting whether a patient is receiving a negative reaction to an infusion. 

   “This may be manifested by alterations in the patient’s normal heart rate and respirations, seating, agitation, and facial expressions indicating discomfort or anxiety.  Using the ambient sensors discussed above, it is determined that the patient is experiencing a negative reaction to the infusion, and the system automatically terminates the infusion and notifies the caregiver.”

1. The question for determination of novelty is therefore whether or not [0189] and [0190] of Cerner provide a clear and unmistakeable direction to carry out all items a), i) ii) and b) of my construction, i.e. carrying out two facial + auditory pain assessments before and after administering a drug and comparing the results.  If this is not made out, then the claims are novel.

Submissions

1. The Opponent’s submissions as to novelty relied heavily on Prof Prkachin’s reading of Cerner.  Prof Prkachin discusses the relevant part of Cerner at 191 of his first declaration.  He understands the entire section of [0183-0199] to describe pain management applications where “facial expressions and audio recordings of a patient are analysed in order to determine whether the pain expressed by the patient exceeds a minimum pain threshold. … Based on the decisions, a further dosage of analgesic is automatically administered to the patient.  The system continues to monitor the patient in the same matter.  For example if the patient’s facial expressions after administration of the analgesic indicate continued discomfort, the system notifies a caregiver”.

2. I note that Prof Prkachin does not refer to which particular parts of Cerner are giving him these impressions.  Furthermore, Prof Prkachin was reviewing Cerner immediately after describing “My Design” of a hypothetical pain monitoring system.  I am therefore minded to reduce the weight of Prof Prkachin’s reading of Cerner given that it is likely tainted by the paradigm of his own “My Design”.

Consideration

1. It is the job of the delegate, albeit trying to stand in the shoes of the skilled person, to construe the specification and citations. 

2. Even assuming that the scenario of [0189] is triggered after discomfort has been detected by facial + auditory recognition, this paragraph only discloses monitoring “as outlined above” “to ensure patient safety”.  “As outlined above” could refer to any of the monitoring methods disclosed by Cerner.  “[T]o ensure patient safety” could be plausibly read to include monitoring vital signs rather than discomfort.  So even if paragraph [0189] could be read to include a second step of facial + auditory pain recognition, this is clearly not the only way it could be read.  There is also no mention of comparing the two scores.  This is therefore not a clear and unmistakeable direction in the sense of General Tire.

3. Paragraph [0190], on the other hand, clearly discloses that the sensors are determining discomfort (i.e. pain) using facial and non-facial data after the administration of an infusion (i.e. a drug).  However, I am not convinced that this paragraph can only be read in the context where a patient has been monitored prior to the infusion.  The paragraph starts with the relatively stand alone premise that “[s]ettings of other medical devices may also be adjusted to minimise patient discomfort”.  It also sits directly between the discussion of Figs 18 and 19 of Cerner but appears to relate to neither.

4. So even if [0190] could be read to include two pain assessments before and after drug infusion, this is clearly not the only way it could be read.  Likewise there is no mention of comparing the scores. This is therefore not a clear and unmistakeable direction either.

5. Claim 12 shares the essential features of claim 1, and all other claims depend directly or indirectly from these and share their features.  The ground of lack of novelty has therefore not been made out.

Inventive Step

1. The definition of inventive step is set out in subsections 7(2) and (3) of the Act:

   (2)  For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).

   (3)  The information for the purposes of subsection (2) is:

   (a)  any single piece of prior art information; or

   (b)  a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
   
   

2. The Opponent pressed the ground of lack of inventive step in light of common general knowledge alone, and also in light of common general knowledge considered with five different prior art documents.

Legal standards

1. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention.  In Wellcome Foundation Ltd v V. R. Laboratories (Aust.) Pty Ltd[43] 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 are the steps of the inventor or not.”
   
   

   [43] (1981) 148 CLR 262 at [286]

2. More recently, the High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd[44] referred to this approach with approval and further held:

   “That way of approaching the matter has an affinity with the reformulation of the ‘Cripps question’ by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157. This court had been referred to Olin in the argument in Wellcome Foundation. Graham J had posed the question:

   'Would the notional research group at the relevant date in all the circumstances directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce [the desired result]?'

   That approach should be accepted.”

   [44] (2002) 212 CLR 411 at [53]

1. The “starting point” for this analysis must come from the common general knowledge or prior art information.[45]  It is not permissible to merely use the inventors’ stated problem as the starting point for inventive step consideration unless that problem was already found in the prior art base.

   [45] AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 at [203]

2. This therefore creates an additional requirement to establish that the hypothetical addressee would in fact have been faced with the same problem as of the priority date.

The problem to be solved

1. Prof Prkachin was asked as to what, in his opinion, he would have proposed in response to the problem of assessing the effectiveness of an analgesic on a person in pain in real time.[46]  I am satisfied that this is a reasonable statement of the problem addressed by the present application, notwithstanding that the claims are in fact broader than this (they do not necessarily require the drug to be an analgesic).

   [46] Prkachin #1 at [125]

2. As I mentioned above, there is a threshold requirement to establish that the problem of assessing the effectiveness of an analgesic on a person in pain in real time would have been known to the hypothetical skilled addressee as of the priority date. 

1. Prof Prkachin had previously indicated that facial analysis using the facial action coding system (FACS) could be used to assess effectiveness of analgesics,[47] and that he discussed applications of the FACS such as this with, inter alia, clinicians, researchers, and psychology students.[48]  He also gave his opinion that it was clear to pain psychologists that this would be a suitable application for an automated system.[49]

   [47] Prkachin #1 at [17(a)(i)]

   [48] Prkachin #1 at [18]

   [49] Prkachin #1 at [94]

2. Dr Hughes’s evidence on this does not explicitly mention the problem of assessing the effectiveness of analgesics.  He states that computer vision systems were not considered to be well developed enough as of the priority date to be used in the clinical context, and although there was a belief that such systems might have future clinical applications, no such system had in fact been produced as of the priority date.[50]

   [50] Hughes at [77-81]

3. On balance I do not find this inconsistent with Prof Prkachin’s evidence.  The balance of the evidence suggests that the problem of assessing the effectiveness of an analgesic on a person in pain in real time was accepted as being a desirable goal in the field of pain and thus it is an appropriate starting point for analysis of inventive step.

Prof Prkachin’s solution

1. In response to the question of how to assess the effectiveness of an analgesic on a person in pain in real time, Prof Prkachin provided “My Design”. He stated that that this took into account only information that he regarded to be well known and generally accepted in the field of pain before the priority date,[51] and he provided this information before being shown the Opposed specification.

   [51] Prkachin #1 at [125]

2. The design used a computer vision system to capture footage of facial expressions,[52] a reference database[53] and a pain assessment model for quantifying level of pain[54] in which Prof Prkachin provides an example scoring system using facial (i)-(v) and non-facial (vi)[55] indicators of pain.

   [52] Prkachin #1 at [133 (a)] – the camera could be still or video

   [53] Prkachin #1 at [133 (b)]

   [54] Prkachin #1 at [133 (c)]

   [55] See also Prkachin #1 at [131]

3. At paragraph 140 of his evidence in support, Prof Prkachin then sets out an “Analgesic Assessment Algorithm” which includes receiving information on the patient and the analgesic (a), determining the level of pain in the patient using the Pain Assessment Model prior to administering the analgesic (b), estimating the time for the analgesic to take effect (c) and determining the level of pain again after the analgesic is administered (d).

4. This corresponds precisely to my construction set out above at paragraph 48, and indeed the Applicant’s own construction of “a multifactorial, two point in time, automated pain assessment”.  I am satisfied that “My design” takes all the features of claim 1.  The question, then, is whether it is reasonable to conclude that this design would have in fact been arrived at by the hypothetical skilled worker.

Criticisms of Prof Prkachin’s evidence

1. Given the precision with which Prof Prkachin arrived at the subject matter of the opposed claims, it is reasonable to put this evidence to some scrutiny.

2. The Applicant criticised the relevance of Prof Prkachin’s evidence from two angles:  on the one hand that he is at the forefront of computer vision research,[56] such that this expert knowledge provides a hindsight-like taint to his evidence.[57]  On the other hand the Applicant drew attention to Prof Prkachin’s specialisation in computer vision systems – at the oral hearing the Applicant found it surprising that someone with such a focus on pain recognition in the face would also contemplate including a non-facial component into the system.

   [56] AS at 67 and 174

   [57] AS at 170

3. The Opponent made a point during the oral hearing that Prof Prkachin’s extensive CV[58] does not include any patent applications, and submitted that on this basis Prof Prkachin could not be considered to be “inventive”.  I am not convinced that it follows that Prof Prkachin can himself inhabit the shoes of the hypothetical uninventive skilled worker, but he can certainly provide evidence as to on what he would have done based on what he understood to be generally known in the field of pain psychology.

   [58] Exhibit KMP-2

4. Dr Hughes considers that Prof Prkachin’s knowledge base far exceeds that of an “uninventive” person working in clinical pain assessment settings.[59]  Dr Hughes’s evidence is consistent with the Applicant’s contention[60] that Prof Prkachin’s opinions cannot be relied on to indicate what an uninventive skilled worker would know or do, because Prof Prkachin’s knowledge is greater than what such a worker would have had.

   [59] Hughes at [41], [99], and [120]

   [60] AS at [174]

5. Nevertheless the “uninventive person skilled in the art” is an avatar – a “pale shadow” of a real person.[61]  They cannot give evidence themselves.  It is a task for the delegate to evaluate what the avatar would have done bearing in mind the available evidence.

   [61] AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30 at [23]

6. For the purposes of the hypothetical task, Prof Prkachin states that he took into account only information that he regarded to be well-known and generally accepted in the field of pain prior to the priority date and did not use any knowledge or information from after that date.

7. Prof Prkachin was presented his hypothetical task after providing an overview of the use of facial expressions as an indicator of pain as at 18 August 2014.  In making this overview, Prof Prkachin noted that he was instructed to refer to only information that was generally accepted.  He understands that “well known and generally accepted” included articles that were “go-to” articles or references referred to regularly or known off by heart.   This is also consistent with the definition from British Acoustic Films. 

8. Although I cannot rule out the possibility that Prof Prkachin has been unintentionally infected with hindsight, he has clearly made an effort to give evidence that would be relevant to the British Acoustic Films test.  And even if it could be said that Prof Prkachin was “primed” by prior questions from the Opponent’s counsel, to consider recognition of facial expressions as a possible solution to the problem, I am satisfied that this starting point is consistent with the knowledge of a hypothetical skilled team that I have previously found to comprise clinicians, pharmacists, pain psychologists and computer scientists.

9. I am correspondingly minded to give appropriate weight to this evidence on the balance of probabilities.

Secondary considerations

1. Both Dr Hughes[62] and the Applicant’s submissions[63] point to the fact that no effective automated computer vision pain detection system had been implemented as of the priority date.  While the argument that “if something was so obvious, why had it not been done?” can sometimes be considered as a “secondary consideration” or a counterargument to hindsight-based assertion, to my mind it does not tip the balance against the weight of evidence that a person skilled in the art would have designed the claimed system based on generally accepted knowledge, in response to the problem of determining the effect of analgesics on a patient in pain.

   [62] Hughes at [11] and [116]

   [63] See e.g. AS at [180]

2. It is perhaps trite to point out that the specification itself only describes the invention at a high level of generality (at the design level, if you will) and the fact that no such system had been deployed clinically has very little weight against the obviousness of the design scheme.

The question of hindsight

1. The Applicant spent some time in their submissions[64] on the problem of hindsight and the various cautions against being infected by hindsight bias.  The Applicant quoted a 2007 article from Crennan J as saying, inter alia

   individuals routinely overestimate the ex ante predictability of events after they have occurred and, indeed, it has been asserted that individuals are not cognitively able to prevent knowledge through hindsight from impairing their analysis of events.[65]

   [64] AS at [163]-[172]

   [65] Crennan, S., “Obviousness: different paths through Scylla and Charybdis” IPSANZ conference 2007, passage bridging pp. 23-24

1. However, in this case there is no evidence that Prof Prkachin was at all aware of the Applicant’s invention when giving his evidence.  Indeed, he appeared to have been appropriately briefed: first summarising his own experience, then giving his understanding of common general knowledge in the field of pain, then being presented with the hypothetical task, and only after that being presented with prior art documents and thereafter being shown the opposed application.

2. At the oral hearing, the Applicant further developed the idea[66] that as an expert in his field, Prof Prkachin is somehow biased by his own expertise.  However, I am not aware of any precedent on this issue and it is difficult for me to see how mere expertise would bias Prof Prkachin to come up with the particular invention claimed, particularly since there is no evidence Prof Prkachin has been involved with developing any such system himself since the priority date.

   [66] Also raised in AS at [170]

3. To sum up my consideration of inventive step: it is difficult for me to conceive of any stronger evidence base for a finding of lack of inventive step in view of common general knowledge.  The case based on Prof Prkachin’s evidence is not outweighed by any evidence presented by the Applicant, and hindsight has been mitigated to, as far as I am aware, the maximum possible extent.  Although Prof Prkachin has indubitably more knowledge than the hypothetical skilled worker, he is aware of the standard of common knowledge and stated that he conducted his hypothetical task using only that subset. The Applicant has not presented any evidence that Prof Prkachin did other than utilise common general knowledge in undertaking his analysis.

Conclusion on inventive step

1. On the balance of probabilities in view of the available evidence, the method of claim 1 lacks inventive step in view of common general knowledge alone.  The system of claim 12 is analogous to claim 1, and likewise lacks inventive step.  All of the features in the dependent claims appear to me to be trivial or otherwise obvious specifications of how the uninventive skilled worker would put the invention into practice.  For example, using data on patient and/or drug characteristics to predict the time for taking the second measurement, as in claims 5-11, 16 and 20, is included as part of Prof Prkachin’s solution.[67]

   [67] Prkachin #1 at [136], [140](c) and (d).

2. Therefore, I find the ground of lack of inventive step based on common general knowledge alone is made out for all claims.  Although the Opponent additionally pressed lack of inventive step in view of a number of prior art documents in view of common general knowledge, it would be otiose to consider those particulars further.

Best Method

1. Section 40(2)(aa) of the Act provides that the complete specification must “disclose the best method known to the applicant of performing the invention”.

Applicable principles:

1. The Opponent pointed to cases dealing with Best Method including Firebelt[68]and Servier[69], and provided a summary of principles taken from paragraph 115 of Sandvik[70] as follows:

   [68] Firebelt Pty Ltd v Brambles Australia Ltd (2000) 51 IPR 531

   [69] Les Laboratoires Servier v Apotex Pty Ltd (2016) 247 FCR 61

   [70] Sandvik Intellectual Property AB v Quarry Mining & Construction Equipment Pty Ltd (2017)

   348 ALR 136

   (1) The purpose of the requirement in s 40(2)(a)[71] of the Patents Act to disclose the best method known to the applicant of performing the invention is to allow the public the full benefit of the invention when the monopoly expires: Servier at [108].
   
   
   (2) Although a patentee might not be explicitly required to act in good faith, principles of good faith underlie the best method requirement: Servier at [108].
   
   
   (3) The nature and extent of the disclosure required to satisfy the best method requirement will depend on the nature of the invention itself: Firebelt at [52]-[53], Servier at [108].
   
   
   (4) The key to understanding the obligation of the patentee is to understand that the section is directed to the method of performance of the invention. The monopoly is circumscribed by the claims, but the nature of the invention is as described in the whole of the specification: Servier at [124].
   
   
   (5) The requirement to describe the best method of performing the invention is ordinarily satisfied by including in the specification a detailed description of one or more preferred embodiments of the invention: Firebelt at [53]; Servier at [104]. See also Blanco White (5th ed) at [4-516]; Bodkin C, Patent Law in Australia (2nd ed, Thomson Reuters,
   2014) at [5280].

   [71] All of the cited decisions on best method refer to the pre-Raising the Bar section 40(2)(a).  However the provisions of that paragraph are identical to those of the applicable post-Raising the Bar section 40(2)(aa).

1. The Opponent’s written submissions highlighted the legal principle of a good faith disclosure of the best method of performance of the invention, so that an applicant is not placed in a significantly better position in terms of actually developing and producing the claimed invention compared to the skilled addressee.

2. The Applicant’s written submissions on precedent were to the effect that the best method requirement is assessed based on what the applicant knew at the time of filing and there is no requirement for the best method to be so identified in the specification.  The Applicant pointed to the guidance at 2.11.3.17 of the Patents Manual of Practice and Procedure that the question is one of fact and evidence.

3. In that vein, it is common for Patent Office decisions on best method to reference the analysis adopted by the Supreme Court of South Africa Transvaal Provincial Division in Enka BV v E I Dupont De Nemours & Co, cited with approval by Bennett J in Expo-Net Danmark A/S v Buono-Net Australia Pty Ltd (No 2)

(a) the method which the patentee failed to disclose is a method of performing the invention;

(b) the method is in fact a better method of performing the invention than the method disclosed in the specification;

(c) the method was known to the patentee at the time when the application for the patent was lodged at the Patent Office;

(d) the method is not disclosed in the specification; and

(e) the patentee knew that the method was better than the method(s) described in the specification.

1. Or, as summarised by the Deputy Commissioner of Patents in Kineta:[72]

   “1. what is the invention for which a best method must be provided;

   2. what method is described in the specification; and

   3. was the applicant aware of a better method?”

   [72] Kineta, Inc. [2017] APO 45 at [29]

Submissions:

1. The Opponent’s position, submitted at the oral hearing, is that Dr Hughes himself (one of the inventors) states in evidence that by November 2013 (before the priority date) a prototype App had been developed by a Swiss contractor (based on the inventors’ design) and delivered to the inventors.[73]  Additionally, the Opponent submits that Dr Hughes knew of specific ways to overcome systemic problems of computer vision systems.[74]  Relevantly, the Opponent submits that none of these were disclosed in the application.

   [73] Hughes at [29]

   [74] Hughes at [97] (a)-(d) and [118]

2. The Applicant’s written submissions were simply that the Opponent had not satisfied its onus of proof.  At the oral hearing the Applicant made further submissions to the effect that even if Dr Hughes had knowledge of technical or practical considerations for commercially implementing something within the scope of the claims, this is not relevant to disclosing the best method of performing the invention as claimed which the Applicant characterised as the simple principle of multifactorial, two point in time, automated pain assessment, which can be automated in any suitable way the addressee might choose.

Facts

1. The question of whether the Applicant knew a better method than that disclosed in the specification is necessarily a factual one.  The most relevant facts come from Dr Hughes’ own evidence.

2. At paragraphs 28-30 of his evidence in answer, Dr Hughes describes that he and his coinventors conceptualised and designed the invention described in this patent application, as a point-of-care pain assessment tool in the form of a mobile device incorporating artificial intelligence and smart automation.  This incorporated an automated facial recognition and analysis component and a component for non-facial pain indicators which could be done using checklists “or perhaps in the future automated”.  Dr Hughes describes that they engaged a company with expertise in facial analysis to build a prototype app based on this design and it was delivered in November 2013.  Dr Hughes then describes that he validated the automated facial recognition and analysis component against the Abbey Pain Scale.  Subsequent to this, the Applicant was established as a commercial entity (inherently before filing this patent application) and a further company was engaged to develop a commercial embodiment of the tool.

3. At paragraph 97(a)[75] of his evidence in answer, Dr Hughes states: “The issue of accommodating out of plane head movement as of August 2014 was addressable (and addressed by us) by the use of mobile or portable camera devices which, because of being mobile devices, can be temporarily placed in closer vicinity of a patient’s face and moved (i.e. adjusted) into the plane of the face during point-in-time assessment.”

   [75] I note that this was the only subparagraph at that part of Dr Hughes’s declaration that explicitly said what “us” (which I understand to be the inventors) had done.  Paragraphs b)-d) point to deficiencies that “could” or “can” be addressed but stop short of saying whether the inventors had done so.

4. What I can conclude from this is:

• The Applicant (and the inventors) had possession of a validated prototype facial recognition and analysis app before the priority date of this application.

• The app also contained checklists for inputting non-facial pain indicators

• The inventor also knew that mobile camera devices should be moved into the plane of the face.

Consideration

1. I have no evidence as to the nature of the validated facial recognition and analysis component of the prototype app. Dr Hughes did indeed confirm at paragraph 85 of his evidence in answer that, in developing their invention, he and his co-inventors employed algorithms and methodologies known in the field of facial recognition, but did not confirm exactly what they were.  It follows that that the prototype must have been configured to detect at least some specific facial features, to assign at least some specific scores or other analytical weightings to those specific features, and to give some kind of output that could be validated against the Abbey Pain Scale. 

2. The Opposed application does not provide any information on these.  Instead, it leaves it to the skilled addressee to fill in the specifics based on their common general knowledge. 

3. Given the lack of available evidence on the nature and configuration of the prototype, I am left with two possible scenarios.  One the one hand, the prototype was configured no better than the hypothetical person skilled in the art could have done based on the disclosure of the Opposed application and generally known algorithms in the art.  On the other hand, the inventors did carry out some research and validation before choosing optimal parameters.  Dr Hughes’ evidence at paragraph 30 is that a program of research and validation was carried out (again, before the founding of epat in 2014 and hence before the priority date).

1. The former case is consistent with the Applicant’s submissions on the issue, and I agree that if it were the case then the best method requirement would not be violated.  However, in my view the balance of probabilities supports the latter case.

2. It therefore appears to me that by not including the specifics of the prototype in the Opposed application, the Applicant has behaved in the way enjoined by Firebelt: “deliberately keep[ing] to himself something novel and not previously published which he knows of or has found out gives the best results, with a view to getting the benefit of the monopoly without giving to the public the corresponding consideration of knowledge of the best method of performing the invention.”   

3. A similar consideration applies to the need to place a mobile camera close to the face. The description indicates at a couple of locations[76] that the capturing element can be a “camera of a user computing device”, for example belonging to items 204, 206 or 208 of Figure 3 (a smartphone, a tablet or a desktop computer).  So the specification could be said to at least implicitly disclose the embodiment of mobile camera devices.  However, the specification does not mention the need to place the camera in close vicinity to the subject nor the need to align with the plane of the face.

   [76] p. 10 last full paragraph, and p. 25 second paragraph

4. The Applicant’s line of argument is that the invention is merely a simple principle.  But I do not find this consistent with the distinction drawn in Servier and Sandvik (item 4) between the claims that define the metes and bounds of the invention and the description which needs to describe the performance of the invention.

5. In this situation, given that a validated prototype existed, it seems to me that the specific facial features identified by the prototype should have been disclosed, as well as the weighting given to them and the comparison against the Abbey Pain Scale.  That seems to me to be an appropriate contribution of the best method requirement to the patent bargain that on the other hand a desultory description at a high level of generality cannot satisfy.

6. I therefore find on the balance of probabilities that the applicant was aware of a better method of performance than that disclosed in the application, and therefore the best method requirement is not satisfied.

Support

1. The Opponent set out the legal principles relating to support at 10.1 of their submissions, referring to Burley J’s decision in Merck[77] which in turn referred to the Deputy Commissioner’s decision in CSR.[78]  The principle expressed in these decisions is that the claimed invention must reflect the technical contribution of the application.

   [77] Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477

   [78] CSR Building Products Limited v United States Gypsum Company [2015] APO 72

2. The Opponent goes on to submit that the present claims are written as “claims by result” and the specification does not disclose the technical information required to actually analyse facial expressions and determine the effects of drugs on pain.[79]  The Opponent seems to then assert that the claims require solutions to problems that had not been solved at the priority date.[80]

   [79] OS at [10.11(a) and (b)]

   [80] OS at [10.11(c)]

3. I do not see how the Opponent’s assertions engage with the technical contribution test for s40(3).  These submissions might have been more apposite to the ground of clear and complete enough disclosure (s40(2)(a)) but even in that case, the claims do not require any particular degree of effectiveness of the method.  It seems to me that based on the admittedly general description of the specification and common general knowledge, the skilled address could analyse facial expressions and determine the effect of drugs on pain to some degree.

4. It also seems to me that the scope of the claims, as I have construed them, exactly corresponds to the technical contribution of the description as I understand it. 

5. This is consistent with my findings in terms of inventive step and manner of manufacture.  It is also consistent with the Applicant’s characterisation of the invention as the simple principle of multifactorial, two point in time, automated pain assessment.

6. The ground of lack of support therefore fails.

Manner of Manufacture

1. Paragraph 18(1)(a) of the Act sets out the basis for the manner of manufacture test:

   (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

Applicable principles:

1. The Opponent provided a summary of principles expressed in Australian Court decisions from NRDC[81] to Encompass[82] at 9.1-9.8 of their written submissions. The Applicant at 103-109 referred to Myriad[83] as well as criteria taken from the Patents Manual of Practice and Procedure.  One principle common to all these decisions that the test for patentable subject matter is one of substance rather than form and must be applied on a case by case basis.

   [81] National Research Development Corporation v Commissioner of Patents, [1959] HCA 67, (1959) 102 CLR 252

   [82] Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2019] FCAFC 161

   [83] D'Arcy v Myriad Genetics Inc [2015] HCA 35

2. After this Opposition was heard, the High Court in Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2022] HCA 29, while split 3:3 on the application of the Manner of Manufacture test to the cases at issue, appeared to agree on those same common general principles I identified above. Both pluralities also affirmed the correctness of previous Federal Court decisions (including those cited by the Opponent) while also appearing to confirm that an advance in computer technology is not a useful test for patentability.

3. The key question is therefore how to characterise the substance of the claimed invention and determine whether or not it is anything other than a mere scheme.

Submissions:

1. The Opponent’s submissions included that:

• The problem addressed in the Background of the Invention section is simply automation of a method, which is not technical in nature;

• The claims are written at a high level of generality, and all the components of the system were well known; and

• The methods merely require generic computer implementation, and that the present application is analogous to the situations in RPL, Research Affiliates, Encompass and Rokt,[84] in which generic computer implementation of a business method did not confer patentability.

• The Opponent also submitted during the oral hearing that the measured pain information is not an artificial state of affairs, and that the pain assessment method is not in substance a diagnostic method – rather it is a scheme for automating assessment of unspecified criteria.

  [84] Respectively: Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177; Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150; Encompass Corporation Pty Ltd v InfoTrack Pty Ltd [2019] FCAFC 161; and Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86

1. The Applicant’s submissions focused on:

• The application being a diagnostic method at its heart;

• The application is more analogous to Ariosa[85] in which a diagnostic method was found to be patentable subject matter;

• The images of a patient in pain are analogous to taking a physical sample: the pictures are “tangible” in the sense of NRDC;

• The application therefore falls within established principles of what is considered patentable subject matter, particularly since the administration of a drug is integral to the method, and treatment steps are found in some dependent claims.

  [85] Ariosa Diagnostics, Inc v Sequenom, Inc [2021] FCAFC 101

Consideration:

1. The key question comes down to determination of the substance of the invention.  This could be viewed in two ways:  on the one hand that the invention, as a multi-factorial automated assessment of pain, is in substance an improvement over, for example, single-factor automated pain assessments.  On the other hand, the invention is simply a mere scheme for automation of existing multi-factorial techniques, in particular the AGS factors, for assessing the effect of drugs (e.g. analgesia of uncommunicative patients). The former view would benefit the Applicant while the latter would benefit the Opponent.

2. On balance, I consider that the latter statement is a more accurate characterisation of the substance of the invention for the following reasons:

• The Applicant’s own characterisation of their invention in response to the Best Method requirement at the oral hearing being “automate according to your choice”;

• The fact that existing manual pain assessment tools (including the AGS factors) already included a mix of facial and non-facial considerations;

• The absence of any implementation examples means that no technical benefit was demonstrated in the application;

• The fact that the specification itself in the “background of the invention” describes automation of pain assessment as the only goal to be achieved, and yet the automation itself is only described in the most generic of terms; and

• The fact that, putting accusations of expertise bias aside, Prof Prkachin when faced with the hypothetical problem ended up describing the subject matter of the present specification more or less exactly (in fact arguably with more technical detail) indicates that the substance of the invention is more about the idea of automation than the implementation of the automation or any benefit other than the automation per se.

1. I am also not convinced that the Applicant’s reference to Ariosa is pertinent.  In Ariosa, the invention involved detecting a particular analyte (foetal cfDNA) in a particular sample (maternal serum or plasma) where it had not been previously known to be found.  The question at issue in Ariosa was whether the substance of the invention was a mere discovery or its practical application.  Both the primary judge and the full court found the latter.  However, in this case there is no suggestion that the inventors have discovered a new way of detecting pain – rather the invention involves the automation of existing tests using standard computing technology for its well-known and understood functionality.  I therefore agree with the Opponent that the analogy with RPL, Research Affiliates, Encompass and Rokt is more pertinent.

2. I therefore find that in substance, the present claims are nothing more than a scheme for automating conventional (manual) ways of assessing a patient’s response to a drug.  References in the dependent claims to additional factors such as providing information about the drug and/or the patient, or directions to give more drugs if appropriate, are merely conventional things that a clinician would have taken into account when carrying out the known manual methods.[86]  Seeking to dress a claim up in the form of a “diagnostic” or “treatment” when in substance it is nothing more than a business improvement cannot save it, in substance, from being unpatentable.

   [86] See e.g. Celgene Corporation [2012] APO 12 “Claims to a method including the step of administering thalidomide would not be a manner of manufacture as the essence of the invention does not lie in the useful arts”

3. Furthermore, I cannot find anything in the description that goes beyond either a restatement of conventional principles or generic statements as to how automation would be accomplished using generic detectors and processors in unspecified ways. It is uncomfortably apparent that beyond general references to using AGS criteria, the FACS, or machine learning, the description gives no indication of how the algorithm actually identifies facial features, or determines positional information, let alone carry out comparison steps, or how any of the predetermined data is predetermined.

4. Therefore, I cannot see any prospect that this ground of opposition could be overcome by an allowable amendment.

Conclusion

1. I have found that the grounds of lack of best method, lack of inventive step and lack of manner of manufacture have been made out.  At least some of these grounds have no apparent prospect of being overcome by amendment.  Consequently s60(3B) is not applicable and I refuse the application under s60(3A).

2. Costs typically follow the event and there is no reason to deviate in this case.  I therefore award costs according to Schedule 8 against the Applicant.

Felix White

Delegate of the Commissioner of Patents

ANNEX – Claims as amended

1. A method for determining an effect of a drug on pain experienced by a patient, the method comprising:
providing reference information that is indicative of a level of pain experienced by the patient by:
- obtaining a camera-captured first image of facial features of a patient;
- determining first positional information for at least a subset of the facial features in the first image using a processor of a pain assessment system running an algorithm;
- comparing, by the processor running the algorithm, the determined first positional information with predetermined data that is indicative of accepted facial feature pain indicators;
- capturing one or more visually detectable nonfacial features and/or at least one audible feature from the patient selected from a set of accepted visually and/or aurally identifiable indicators of pain; and
- determining the reference information using the results of the comparison step and the captured one or more visually detectable non-facial features and/or at least one audible feature of the patient, by the processor running the algorithm;
providing pain indicating information that is indicative of a level of pain experienced by the patient after administering the drug to the patient by:
- obtaining a second camera-captured image of the facial features of the patient, after administration of the drug;
- determining from the second image second positional information for the same facial features or subset of features as captured in the first image, using the processor running the algorithm;
- comparing, by the processor running the algorithm, the determined second positional information with the predetermined data;
-re-capturing the one or more visually detectable non-facial features and/or the at least one audible feature from the patient based on the set of accepted indicators of pain, after administration of the drug; and
- determining the pain indicating information using the results of the comparison step and the recaptured one or more visually detectable non-facial features and/or the at least one audible feature of the patient, by the processor running the algorithm;
and
using the processor running the algorithm in comparing the pain indicating information with the reference information and based on the comparison determine the effect of the drug on the pain experienced by the patient.

2. The method of claim 1, wherein the predetermined data is indicative of facial and non-facial pain indicators according to the American Geriatric Society’s accepted pain indicators.

3. The method of claim 1 or 2, wherein the step of providing the reference information comprises capturing the first image of the plurality of facial features of the patient after
administration of the drug but before the drug is expected to have an effect on the pain experienced by the patient.

4. The method of claim 1, 2 or 3, wherein the accepted set of visually detectable non-facial features includes one or more of the following: behavioural change features, psychological change features, physiological change features and physical change features.

5. The method of any one of the preceding claims, further comprising:

receiving and storing predetermined information in relation to one or both of the drug and the patient; and

using the predetermined information in relation to one or both of the drug and the patient to estimate a time period for the drug to have an expected effect on pain  experienced by the patient.

6. The method of claim 5, wherein the step of capturing the second image of the facial features of the patient and recapturing the one or more visually detectable non-facial
features and/or the at least one audible feature from the patient is conducted after the estimated time period has expired.

7. The method of any one of the preceding claims, further comprising, after the effect of the drug on the pain experienced by the patient is determined, identifying a cause and/or determining treatment of the pain experienced by the patient where it is determined that the effect of the drug on the pain experienced by the patient is below a predetermined
threshold.

8. The method of any one of claims 1 to 6, further comprising, after the effect of the drug on the pain experienced by the patient is determined, determining whether the level of pain experienced by the patient after administration of the drug is within a predetermined
acceptable level of pain.

9. The method of any one of the preceding claims, further comprising performing an additional administration of the drug to the patient or embarking in an alternative drug treatment for the patient where it is determined that the level of pain experienced by the patient after administration of the drug is above a predetermined acceptable level of pain.

10. The method of any one of claims 5 to 9, wherein the information in relation to the drug includes one or more of the following: name of the drug; manufacturer of the drug;
dose of the drug that is administered; content of the drug; pharmaceutical formulation; route of administration of the drug, such as oral, topical, transdermal or injectable; an
estimated time period for the drug to have an effect on a patient; and form of the drug, such as tablet, capsule, gel, patch or liquid.

11. The method of any one of claims 5 to 10, wherein the information in relation to the patient includes one or more of the following information: name of the patient; age of the
patient; weight of the patient; height of the patient; sex of the patient; data in relation to the effect of the or a further drug on the patient such as a time period for the drug
to effect a reduction of pain; allergies; side effects; and data in relation to previous drug administration.

12. A pain assessment system for determining an effect of a drug on pain experienced by a patient at a point-of-care location, comprising:
- an information collector operatively associated with an interface and configured for  receiving images of facial features of a patient and one or more visually detectable nonfacial features and/or at least one audible feature from the patient selected from a set of accepted visually / aurally identifiable indicators of pain;
- a processor; and
- a database accessible by the processor and containing an algorithm for determining information indicative of a level of pain experienced by a patient;
wherein the system is configured and arranged to perform the following functions:
a) determining first positional information for at least a subset of facial features in a first image of the face of the patient received at the information collector, using the processor running the algorithm;
b) comparing, by the processor running the algorithm, the determined first positional
information with predetermined data that is indicative of accepted facial feature pain
indicators;
c) determining reference information using the results of the comparison step b) and one or more visually detectable non-facial features and/or at least one audible feature of the patient as accepted as a pain indicator, captured and as received at the information collector, by the processor running the
algorithm;
d) determining from a second image of the face of the patient received at the information collector, after administration of the drug, second positional information for the same at least subset of features as captured in the first image, by the processor running the algorithm;

e) comparing, by the processor running the algorithm, the determined second positional
information with the predetermined data;
f) determining, by the processor running the algorithm, pain indicating information indicative of a level of pain experienced by the patient after administration of the drug using the results of the comparison step e) and the same one or more visually
detectable non-facial features and/or at least one audible feature of the patient received at the information collector after the administration of the drug;
g) comparing, by the processor running the algorithm, the pain indicating information with the reference information; and
h) based on the comparison step g), determining the effect of the drug on the pain experienced by the patient.

13. The system of claim 12, further comprising a capturing element arranged for capturing the first image and/or second image of the facial features of the patient and provide the
images via the interface to the information collector.

14. The system of claim 13, wherein the capturing element is a camera of a computing device, including one or more of a personal computer, a tablet computer, a laptop computer, a PDA and a smartphone.

15. The system of any one of claims 12 to 14, wherein the reference information is determined by the processor in that the second image is captured before the drug is expected to have an effect on the pain experienced by the patient.

16. The system of any one of claims 12 to 15, wherein the interface is arranged to receive  and provide to the information collector predetermined information in relation to one or both the drug and the patient, and wherein the processor is arranged to use the information in relation to the drug and/or the patient to estimate a time period for the drug to have an expected effect on pain experienced by the patient.

17. The system of any one of claims 12 to 16, wherein the predetermined data is indicative of facial and non-facial pain indicators according to the American Geriatric Society’s
accepted pain indicators.

18. The system of any one of claims 12 to 17, wherein the at least one non-facial visible feature of the patient relates to one or more of the following changes of the patient post
capturing the first image and after an expected time period for the drug to take effect after administration:

a behavioural change,

a psychological change,

a physiological change, and

a physical change.

19. The system of any one of claims 13 to 18, wherein the system is further arranged to make information indicative of the estimated time period accessible to the user computing device visually or aurally.

20. The system of any one of claims 14 to 19, wherein the system is further arranged to communicate to the computing device a time to take the second image based on a timing the drug is expected to have an effect on the pain experienced by the patient after its administration.

21. The system of any one of claims 12 to 20, wherein the pain assessment system is implemented in the form of a or the user computing device.