Mölnlycke Health Care AB

Case

[2023] APO 56

8 November 2023


IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Mölnlycke Health Care AB [2023] APO 56

Patent Application:              2017283178

Title:Procedure tray management

Patent Applicant:                 Mölnlycke Health Care AB

Delegate:Pradnya Satarkar

Decision Date:  8 November 2023

Hearing Date:  16 August 2023, via videoconference

Catchwords:  PATENTS – examiner’s objection– manner of manufacture– management of surgical procedure trays– user interface– in substance directed to a mere scheme– alleged invention not a manner of manufacture– application refused

Representation:  Patent attorney for the applicant: Ms Michelle Catto and Mr Charles Yip of FB Rice Pty Ltd

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:              2017283178

Title:Procedure tray management

Patent Applicant:                 Mölnlycke Health Care AB

Date of Decision:                8 November 2023

DECISION

The claims of the application, as proposed to be amended, do not define a manner of manufacture.

I do not see any subject matter in the body of the specification from which valid claims could be drafted to overcome this finding.

I refuse the application.

REASONS FOR DECISION

Background

  1. The Application (2017283178) was filed in the name of Mölnlycke Health Care AB (The Applicant) on 20 June 2017 as PCT application no. PCT/EP2017/065068 and entered the Australian National Phase on 08 January 2019. The Application claims priority from EP16175554.1 and has an earliest priority date of 21 June 2016.

  2. The Application had been the subject of four adverse reports. All four reports had included an objection to the claims as not defining a manner of manufacture. The first two reports also included an objection to the claims lacking inventive step.

  3. In response to the fourth adverse report issued on 18 January 2023, the Applicant requested to be heard on 10 February 2023.

  4. The Applicant filed their written submissions on 27 June 2023. The hearing was held on 16 August 2023 via videoconference.

  5. The examination of the present application is governed by the Patents Act 1990 (“the Act”) as amended by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (“the Raising the Bar Act”) as the application was filed after 15 April 2013.  Thus, the standard of proof that applies in the present case is the balance of probabilities (subsection 49(1)).  I must accept the application if satisfied on the balance of probabilities that the application complies with the Act.  If I am not so satisfied, then I can refuse the application.

  6. Pursuant to regulation 13.4(1)(g) when the Commissioner gives an applicant an opportunity to be heard in relation to an examiner’s objection and issues a written decision, the period for gaining acceptance of the application may be extended until three months from the date the decision is issued, or, pursuant to regulation 13.4(3), for a period of longer than three months if the Commissioner is satisfied that acceptance should be postponed.

    The Specification

  7. Along with their written submissions, the Applicant filed a fourth statement of proposed amendments on 27 June 2023. I do not see any issue around allowability of the proposed amendments. References to the specification in this decision relate to the specification as proposed to be amended in that statement.

  8. The field of the invention relates to management of surgical procedure trays.

  9. The background of the invention starts with the assertion that in order to use less package material, and hence reduce cost and environmental impact, and also save time during the surgical procedure, composite packages, referred to as “procedure trays” or “surgical trays”, including a plurality of different items have been introduced to the market. The specification then goes on to describe what appear to be well accepted features of the procedure tray such as- each procedure tray includes a large number of single use items ranging from protective gowns to laparoscopic and orthopaedic instruments, the procedure trays are packaged to arrange the items in the order they are expected to be used, and the packaging may provide efficient storage and balancing of trays.

  10. The background then discusses some of the known problems in the art as follows:

    “Despite the fact that the procedure tray is intended to include all single use items required for a procedure, additional items which are individually packaged, may still be used during the procedure. There may be various reasons for this, including different preferences of individual surgeons or nurses, minor deviations from the planned surgical procedure, etc. As each use of an individually packed item increases cost and amount of waste, there is a desire to minimize such use, and as far as possible optimize the procedure trays.

    However, the large number of different trays makes it extremely difficult to implement and oversee such optimization. Optimization is further complicated by the fact that actual users of the tray (surgeons and operating room nurses) typically do not have authority to directly order new trays, but this is typically handled by designated procurement officers, at the hospital or group of hospitals. The acts of identifying suitable modifications of various packs, verifying compatibility with existing procurement arrangements and eventually ordering and supplying a modified tray, therefore becomes a very complex largely manual process, involving several people at different organizational levels and physical locations. Also, hospital efficiency and especially efficiency in the operating theater is a driver for optimizing surgical tray offers and there is a need to provide a wide variety of components (sic) are ideally possible to add to the surgical tray.”

  11. The invention broadly relates to computer implemented process of optimising procedure trays, matching the needs of the surgical teams, thereby reducing the cost and environmental impact of excess packaging.

  12. A schematic block diagram of the present invention is represented in Fig 1 that I have reproduced below:

  13. The specification explains that a database server 2 is connected to a network such as internet and stores a database 3 including a plurality of procedure tray types 4. A plurality of workstations 5 are connected to the network (Wide area network) via a local area network 6 as is common within an organisation such as a hospital. The system also includes a server module 7 installed on the database server 2 and client modules 8, one installed on each workstation 5. The client module 8 has a user interface 10 which is used by a user to access the database 3.

  14. In broad terms, Fig 3 illustrates procedure tray management according to an embodiment of the invention. The steps in Fig 3 that I have reproduced below are assumed to succeed an initial log-on procedure, such that a current user 9 and procedure tray types associated with this current user are identified in the database 2:

  15. The specification provides a thorough explanation of Fig 3 as follows:

    “First, in step S1, a list of the identified procedure tray types 4 are presented to the user in an appropriate format. The specific details of such presentation may be different in different applications and may also be user dependent and possibly user controlled. The important point is that the current user is provided with an efficient overview of the procedure tray types that he or she is somehow associated with.

    Then, in step S2, user input is received by the interface 10, indicating a selected one of the procedure tray types in the list. As a result, in step S3, the list 41 of items of the selected procedure tray type is displayed on the interface. Again, the details of such presentation may vary, and may be adapted to or by the user. The list should provide the current user with basic information about the contents of the selected procedure tray type, and optionally relevant purchasing information such as prices and quantities, both of the complete tray and of individual items in the tray.

    Upon displaying the list of items, in step S4, the interface provides the current user with a possibility to modify the procedure tray type. Such modification may be related to adding a new sort of item, or to changing the number of items of a specific sort. Any information related to a specific item can be continuously updated to reflect the modification, and as an example, the total price of the selected procedure tray type may change as items are removed or added.

    After a modification is complete (e.g. after a user input indicating that no more modifications are desired), in step S5, a proposed modified procedure tray type is electronically communicated by the client module 8 to at least some, and potentially all, users in the list 44 of users associated with the selected procedure tray type. The communication is sent over the wide area network 1, and may be of various types. In some cases an automatically generated email is sufficient, while other situations may require specifically adapted communications between client modules 8 on different workstations 5 via the server module 7.

    From at least some users in the set, a confirmation is required, and such a confirmation process by another user is indicated in figure 3 by steps S6-S7. Step S6 is thus performed at another workstation 5' by another user 9' interacting with another client module 8'. The user interface 10' at this other workstation 5' is preferably configured to present to the user 9' any procedure tray type associated with the user for which a modification has been proposed. Such an indication may constitute the communication mentioned above, or may be in addition to a separate communication such as an email. The interface 10' may further allow the user to confirm the proposed modification e.g. by an appropriate user input (such as a mouse click or screen tap). In response to such input, the client module 8' in step S7 sends a confirmation to the server module 7.

    Returning to the process at the workstation 5 and the client module 8, in step S8 the confirmation is received from the server module 7. It is noted that the receipt of confirmation from at least one user may take place at later point in time, e.g. several days after a modification was proposed. In particular, the current user may have logged off and on several times during the intermediate time period. The interface 10 is preferably configured to keep a current user informed about the status of "pending" modification, i.e. to provide, each time a current user logs on, an overview of modifications which the user has proposed, and which other users have or have not confirmed the modification.

    When all required confirmations have been made, in step S9, the selected procedure tray type is updated in the database 3. Step S9 can be performed automatically by the server module 7 as soon as all required confirmations have been received. Alternatively, the server module 7 awaits a final go-ahead from the client module 8 in step S10. For example, the interface 10 may indicate to a current user when a proposed modification has been approved by all relevant user, and allow the current user to initiate a database update e.g. by an appropriate user input (such as a mouse click or screen tap).”

  16. The embodiment that best represents the features of the independent claims is illustrated in Fig 4 that I have reproduced below:

  17. The step of ‘determining recommended modification’ (S31) is explained in the specification as follows:

    “For example, as indicated by step S31a in figure 4, a particular procedure tray type may be compared with a reference tray type or template 50 stored in the database (see above). As a result of the comparison, items may be identified which are included in the reference tray type but not in the procedure tray type. Such items may be identified as recommended item additions, i.e., items that are recommended to be added to the particular procedure tray type, in order to make it comply with best practice as reflected by the reference tray type.

    The recommended additions may be listed in order of increased benefit, e.g. in terms of time saving, environmental impact or cost saving.

    In another example, as indicated by step S31b in figure 4, the database is queried to identify at least one available substitute item, i.e. an item which has equivalent technical properties as an item in the particular procedure tray type. Then, purchasing information stored in the database is used to assess the identified substitute items, in order to determine if a substitution would be beneficial to the purchasing entity. For example, it is important to ensure delivery reliability and maintained cost level. If such a beneficial substitution is found, a recommended item substitution is identified.

    It is noted that the determination in step S31 and the estimation of consequences in step S32 may be performed together, and indeed the estimation of consequences such as cost may be part of the determination in step S31.”

  18. The specification further explains that the users of the system may be categorised into different “roles”, for example: “purchaser”, “medical practitioner” or “administrator”. It goes on to state that different users may be assigned different rights (read/write) in the system based on their respective roles. The recommendations described above may only be communicated to users having specific roles. The presentation of consequences of recommended modification may be targeted to specific user roles as described:

    “For example, estimated set-up time savings may be presented only to users in the role of clinical practitioner, while estimated costs savings may be presented only to purchasers.”

  19. The specification then explains an implementation of an embodiment of the invention with reference to screen shots of the user interface. Fig 7 represents a dialogue box, provided by the interface when a modification has been proposed and is about to be communicated to other users. Fig 7 below is self-explanatory and shows the process flow such that a proposed modification is sent to “mandatory reviewers” with a provision of entering additional reviewers.

    The claims

  20. The amendments proposed on 27 June 2023 have 17 claims with 3 independent claims. Independent claims 1 and 13 are method claims while independent claim 10 is directed to computer readable instructions that when executed perform the steps of the method of claim 1. The entire claim set is reproduced at Annex A of this decision. Claims 1 and 13 are reproduced below:

    1.   1.   A method comprising:

    generating, based on procedure information and template information stored

    in a database, a user interface,

    wherein the procedure information indicates a plurality of procedure tray types, wherein each procedure tray type of the plurality of procedure tray types is associated with one or more users and a list of items to be included in a procedure tray of the procedure tray type for a type of surgical procedure of a plurality of types of surgical procedures,

    wherein the template information indicates, for each procedure tray type of the plurality of procedure tray types, a list of items required to perform the type of surgical procedure associated with the procedure tray type;

    causing, based on the procedure information and an interaction with the user interface by a current user of the user interface, one or more procedure tray types of the plurality of procedure tray types to be displayed;

    causing, based on a selection of a procedure tray type of the one or more procedure tray types by the current user, display of the list of items to be included in the selected procedure tray type;

    determining that the current user is associated with a first user role of a plurality of user roles, wherein each user role of the plurality of user roles is associated with one or more types of recommended modifications to be displayed at the user interface and one or more types of recommended modifications not be displayed at the user interface;

    determining, automatically, at least one recommended modification to the selected procedure tray type;

    causing, based on the at least one modification and the template information, and based on the current user being associated with the first user role, display via the user interface of the at least one recommended modification to the selected procedure tray type, wherein the at least one recommended modification is associated with the one or more types of recommended modifications that may be displayed at the user interface for

    the first user role;

    receiving a selection, by the current user, of the at least one recommended modification;

    sending, to at least one other user associated with the selected procedure tray type, at least one consequence associated with the selected at least one recommended modification;

    wherein the at least one consequence associated with the selected at least one recommended modification comprises an estimated waste reduction, the method further comprising causing display of the estimated waste reduction,

    wherein the method further comprises:

    determining at least two different user roles, wherein the at least two different user roles comprise at least one of a purchaser and a clinical practitioner;

    causing, based on the current user of the user interface being associated with the first user role of the at least two different user roles, display of an estimated time saving associated with the selected at least one recommended modification to the list of items to be included in the selected procedure tray type;

    receiving, based on sending the at least one consequence to the at least one other user, confirmation information associated with the selected at least one recommended modification;

    causing, based on the confirmation information, the user interface to indicate to the current user that the selected at least one recommended modification has been approved by the at least one other user;

    receiving, via the user interface, by input from the current user, wherein the input is configured to initiate a database update associated with the approved at least one recommended modification; and

    causing, based on the input from the current user, the database update to be initiated, wherein the procedure information stored in the database is updated to indicate the approved at least one recommended modification.

    13. A method comprising:

    generating, based on procedure information and template information stored in a database, a user interface,

    wherein the procedure information indicates a plurality of procedure tray types,

    wherein each procedure tray type of the plurality of procedure tray types is associated with one or more users and a list of items to be included in a procedure tray of the procedure tray type for a type of surgical procedure of a plurality of types of surgical procedures,

    wherein the template information indicates, for each procedure tray type of the plurality of procedure tray types, a list of items required to perform the type of surgical procedure associated with the procedure tray type;

    causing, based on the procedure information and an interaction with the user interface by a current user of the user interface, one or more procedure tray types of the plurality of procedure tray types to be displayed;

    causing, based on a selection of a procedure tray type of the one or more procedure tray types by the current user, display of the list of items to be included in the selected procedure tray type;

    determining that the current user is associated with a first user role of a plurality of user roles, wherein each user role of the plurality of user roles is associated with one or more types of recommended modifications to be displayed at the user interface and one or more types of recommended modifications not be displayed at the user interface;

    determining, automatically, at least one recommended modification to the selected procedure tray type;

    causing, based on the at least one modification and the template information, and

    based on the current user being associated with the first user role, display via the user interface of the at least one recommended modification to the selected procedure tray type, wherein the at least one recommended modification is associated with the one or more types of recommended modifications that may be displayed at the user interface for

    the first user role;

    receiving a selection, by the current user, of the at least one recommended modification;

    sending, to at least one other user associated with the selected procedure tray type, at least one consequence associated with the selected at least one recommended modification;

    wherein the at least one consequence associated with the selected at least one recommended modification comprises an estimated waste reduction, the method further comprising causing display of the estimated waste reduction,

    wherein the method further comprises:

    determining at least two different user roles, wherein the at least two different user roles comprise at least one of a purchaser and a clinical practitioner;

    causing, based on the current user of the user interface being associated with the first user role of the at least two different user roles, display of an estimated time saving associated with the selected at least one recommended modification to the list of items to be included in the selected procedure tray type;

    receiving, based on sending the at least one consequence to the at least one other user, confirmation information associated with the selected at least one recommended modification;

    causing, based on the confirmation information, the user interface to indicate to the current user that the selected at least one recommended modification has been approved by the at least one other user;

    receiving, via the user interface, by input from the current user, wherein the input is configured to initiate a database update associated with the approved at least one recommended modification; and

    causing, based on the input from the current user, the database update to be

    initiated, wherein the procedure information stored in the database is updated to indicate the approved at least one recommended modification;

    and

    causing manufacture of the selected procedure tray type based on the updated procedure information.

  1. Claims 1 and 13 are identical, apart from claim 13 having an additional feature of causing manufacture of the selected procedure tray. Although there is no disclosure of any manufacturing process in the specification, I understand the term ‘manufacturing’ here to mean packaging or assembling of the procedure tray with various selected items and as the Applicant submitted during the hearing, will be ultimately done after following the claimed process.

    The remaining objection

  2. The 4th adverse report contained only one objection relating to the claims as not defining a manner of manufacture as follows:

    “Claims 1-15 do not define a manner of manufacture within the meaning of Section 18(1)(a) of the Patents Act 1990. I have carefully considered the applicant’s amendments and submissions, but do not find them to be persuasive.

    The Applicant has amended independent claim 1 to include the features of:

    ••         wherein the at least one consequence associated with the at least one recommended modification comprises an estimated waste reduction, the method further comprising causing display of the estimated waste reduction,

    ••         wherein the method further comprises:

    •o    determining at least two different user roles, wherein the at least two different user roles comprise at least one of a purchaser and a clinical practitioner;

    •o    causing, based on the current user of the user interface being associated with a first user role of the at least two different user roles, display of an estimated time saving associated with the at least one recommended modification to the list of items to be included in the selected procedure tray type; and

    •o    causing manufacture of the selected procedure tray type.

    Similar amendments were made to the corresponding independent claim 12. The Applicant submits that: “According to the amended independent claims, the method includes, inter alia, automatic determination of a recommended modification to the procedure tray, display of an estimated waste reduction associated and an estimated time saving associated with the recommended modification……There is ingenuity displayed in recognising the shortcomings of existing surgical tray preparation methods, identifying a need to alter the manner in which surgical trays are prepared, and developing the improved method as defined in the amended claims.”

    The Applicant further submits that: “However, the working of the method produces a practical and useful result in the field of medical devices and surgical procedures, an area which is not inherently unpatentable.”

    While I agree that the claimed invention is related to medical devices and surgical procedures, the claimed invention does not solve a technical problem associated with medical devices and/or surgical procedures. Moreover, the claimed invention does not provide any technical improvement to existing procedure trays. The claimed invention is only directed to computerising or automation of existing manual process of procedure tray modification.

    Even though the claimed invention automatically determines a recommended modification to the procedure tray, I consider this as merely automating the procedure tray modification process without providing any technical improvement to the existing procedure trays.

    The Applicant further argues using Technological Resources Pty Limited v Tettman [2019] FCA 1889, Jagot J held (at [154]). This case law is related to a method of separating a mined material which is different to a method of recommending modifications to procedure trays.

    Even though the present invention involves the physical product of procedure trays, the invention is completely directed to automating the process of recommending modifications to the procedure trays, communicating the recommendations to different parties involved with the procedure, and cost and waste analysis of the recommended modification. The invention does not result in any improved product or manufacturing process.

    Therefore, I maintain that amended claims 1-15 do not define a manner of manufacture.”

    The law on Manner of manufacture

  3. Section 18 of the Patents Act 1990 sets out necessary conditions for a patentable invention. Among others, the invention must be ‘manner of manufacture within the meaning of section 6 of the Statute of Monopolies’.

  4. The High Court in the landmark case of National Research Development Corporation v Commissioner of Patents, set out a test clarifying the requirements for a patentable process as appropriate to the facts of the case:

    “The point is that a process, to fall within the limits of patentability which the context of the Statute of Monopolies has supplied, must be one that offers some advantage which is material, in the sense that the process belongs to a useful art as distinct from a fine art…that its value to the country is in the field of economic endeavour”.

  5. However, the High Court has not suggested any rigid formula to be applied unthinkingly. As is clarified in D’Arcy v Myriad Genetics Inc:

    “This Court in NRDC did not prescribe a well-defined pathway for the development of the concept of ‘manner of manufacture’ in its application to unimagined technologies with unimagined characteristics and implications.  Rather, it authorised a case-by-case methodology.”

  6. This case-by-case methodology requires consideration of the substance of the claimed invention, not simply the form of the claim. This point was made succinctly in Myriad by Gageler and Nettle JJ:

    “Whatever words have been used, the matter must be looked at as one of substance and effect must be given to the true nature of the claim.”

  7. Overtime, to assess patentable subject matter in the context of computer implemented inventions, a range of principles have been developed. These principles were usefully summarised by Robertson J in Rokt1 as follows:

    “The respondent submitted that the law as laid out in Research Affiliates and RPL Central held that:

    17.1 The Court must decide, as matter of substance not form, whether the claimed invention is the proper subject-matter for a patent: RPL Central at [99]; Research Affiliates at [106], [117].

    17.2 This requires consideration of both the claims of the Application and the invention described in the body of the specification: RPL Central at [114].

    17.3 The assessment is not done mechanically. There are no precise guidelines or mathematical formula. It is “a question of understanding what has been the work of, the output of, and the result of, human ingenuity” and then applying the developed principles: Research Affiliates at [116]. See further RPL Central at [112]:

    Recognising that the claims are to a method and system comprising a combination of integers, it is necessary to understand where the inventiveness or ingenuity is said to lie ...

    17.4 One well-settled principle is that a distinction exists between a technological innovation and a business innovation. A technological innovation is patentable. A business innovation is not: Research Affiliates at [94]; RPL Central at [100]. Consequently, a business method or scheme is not, per se, a proper subject for letters patent: RPL Central at [96]. Nor are abstract ideas, mere intellectual information or mere directions for use patentable: Research Affiliates at [101]; RPL Central at [100].

    17.5 A computerised business method or scheme can, in some cases, be patentable. However, “[w]here the claimed invention is to a computerised business method, the invention must lie in that computerisation”: RPL Central at [96] (emphasis added). This requires “some ingenuity in the way in which the computer is used”: RPL Central at [104]. It is not a patentable invention “to simply ‘put’ a business method ‘into’ a computer to implement the business method using the computer for its well-known and understood functions”: RPL Central at [96]. In other words, if the ingenuity lies in the business method or scheme alone, the invention will not be patentable despite the computer-implementation.

    17.6 Thus, a claimed invention must be examined to ascertain whether it is in substance a scheme or plan, or whether it can broadly be described as an improvement in computer technology: RPL Central at [96]. Contrary to [the applicant’s submissions at [49]], this is a binary distinction: the invention is either an unpatentable scheme or plan, or it is a patentable improvement in computer technology. In conducting the analysis, it is useful to:

    17.6.1 ascertain whether the contribution to the claimed invention is technical in nature: RPL Central at [99], Research Affiliates at [114];

    17.6.2 consider whether the invention solves a “technical” problem within the computer or outside the computer: RPL Central at [99]; Research Affiliates at [103];

    17.6.3 consider whether the invention results in an improvement in the functioning of the computer, irrespective of the data being processed: RPL Central at [99], Research Affiliates at [118];

    17.6.4 consider whether the invention requires merely “generic computer implementation”, as distinct from steps which are “foreign” to the normal use of computers: RPL Central at [99], [102]; Research Affiliates at [101]; and

    17.6.5 consider whether the computer is merely the intermediary, configured to carry out the method using program code for performing the method, but adding nothing to the substance of the idea: RPL Central at [99].”

  8. These principles are substantially uncontroversial and were accepted by Robertson J. Even though Rokt1 was later overturned by the Full bench of Federal Court in Rokt2, it was not due to any error in the principles themselves. These general principles remain consistent in view of subsequent decisions.

  9. The Full Court in Encompass Pty Ltd v InfoTrack Pty Ltd concurred with the principles of RPL Central and Research Affiliates set out in Rokt 1 above, explaining that:

    “In each case, the Full Court was seeking to describe the conceptual distinction between a manner of manufacture and an unpatentable abstraction.  In each case, the Full Court was explaining that a claimed method that is unpatentable does not change its legal character merely because the method is implemented by the instrumentality of a computer.”

  10. Recently, the Full Court in Commissioner of Patents v Aristocrat Technologies Pty Limited found that a game implemented on an electronic gaming machine was not patentable. On appeal to the High Court, the Court was evenly split, and pursuant to s 23(2)(b) of the Judiciary Act 1903, the appeal was dismissed, and the decision of the Full Court was affirmed. As such there is no binding precedent resulting from the High Court decision and the other Full Court decisions in this area (discussed above), including Research Affiliates, RPL Central, Encompass, Rokt2 remain undisturbed. All six members of the High Court treated those decisions as having been correctly decided. I note, however, that both sets of reasons from the High Court decision suggest a need for some caution in relation to the consideration of ‘advance in computer technology’ as part of the two-step analysis proposed by Middleton and Perram JJ in Aristocrat’21. In particular, the reasons of Kiefel CJ et al. point to the concept of an adaptation to computer technology as being a useful consideration. Nonetheless, the principles developed around the patentability of an invention in the earlier Full Court cases are preferred over the two-step analysis of Aristocrat’21.

  11. More recently, Moshinsky J in Ubipark reiterated the High Court’s finding in Aristocrat’21 and noted the correctness of the series of Full Court decisions dealing with computer implemented inventions, stating:

    “Both pluralities in Aristocrat expressed the following principles for assessing whether a claimed invention involves a manner of manufacture:

    (a) in considering whether there is patentable subject matter, the court should focus on the substance of what is claimed, and not the form, and accordingly there is a need to first characterise the invention (at [73], [101]-[103]);

    (b) schemes and plans that are not inherently patentable and which are merely implemented on a generic computer do not become patentable as a result (at [22], [24], [75]-[77], [121]-[122]); and

    (c) patentable subject matter may result where there is something more than mere implementation, which may include an improvement in the operation of the computer (at [25], [27], [77], [122]).”

    Consideration

  12. At the hearing, the Applicant explained that their submissions were mainly set out in two parts. Part A discusses that the invention provides an improved user interface and Part B discusses that the invention results in improved procedure trays. I have discussed these below:

    1. A.       The invention provides an improved user interface
  13. The Applicant refers to Aristocrat’16 while trying to draw analogy with the present application and states:

    “The Aristocrat decision concerned a gaming machine and presentation of game information in a way that allowed the game and bet to be selected in a single action. Here, the Delegate concluded that such presentation of information “would achieve a practical and useful result by simplifying the use of the gaming machine by the player” (emphasis added). We submit that the present invention is analogous, in that the claimed invention provides an improved user interface, as explained in more detail below.

    In Aristocrat, the Delegate provided that:

    “…the invention appears to require only generic computer implementation. However, it does not appear that it was normal (at the priority date) to configure a gaming machine interface in this particular way. Here information is located in a particular position and functionality is generated by the use of this positional location to improve the gaming machine. The contribution is technical in nature, and achieves a practical and useful result. On balance, I am satisfied that the claimed invention is a manner of manufacture”.

    Thus, it is clear that a novel user interface providing improved functionality may be considered a manner of manufacture, even where the claimed invention uses generic computing components. We submit that similar reasoning may be applied in respect of the user interface of the present application, as explained below.”

  14. It appears that the Applicant is conflating an improved user interface with a new user interface characterised only by the information presented. In Aristocrat’16, the delegate considered the invention to be patentable because the substance in that case was presenting the game information in a way that allowed the game and bet denomination to be selected in a single action. The prior art only mentioned selecting the game from a list of options, followed by selecting a bet denomination as two actions. Combining two actions in one was considered to form an improved user interface, hence an improved gaming machine, and the contribution was considered technical in nature. It could be clearly seen that in order to achieve the same outcome as that of the prior art, the invention in Aristocrat’16 used one click instead of two, hence providing an improved user interface in an objective or material sense.

  15. The presently claimed invention utilises a user interface for performing the steps of the claimed method. The claims do not appear to include any specific construction or material arrangement of the user interface resulting in an improvement in the interface unlike in Aristocrat’16. The present claims and the specification merely mention the user interface as a means for inputting and presenting data to process the steps of the claimed invention. Without any particular arrangement of the interface described, it is hard to identify any improvement in the interface.

  16. Leaving the fact that no specific arrangement for the interface is described in the present Application to one side, when asked at the hearing to explain the reference against which the Applicant alleges the present invention has an improved user interface, the Applicant pointed to D1-D3 cited by the examiner in Examination reports 1 and 2. Let me consider the disclosure of these citations in detail.

    D1: US 2014/0249515 A1 (William J. Martin) 04 September 2014

  17. D1 is directed to using a surgical template for arranging surgical instruments used for a particular surgical procedure in a preferred order. In some embodiments, the customizable surgical template is printed on a sterilizable sheet and provides graphical representations of surgical instruments laid out in order for a specific surgical procedure. The order may be different based on preferences of different surgeons.

    D1 is silent about a user interface where a list of items to be included in a selected procedure tray type are displayed, where user roles are associated with one or more types of recommended modifications to be displayed, a recommended modification is automatically determined, consequences based on the modification are displayed, receiving a selection of a procedure tray type by a  user and receiving an approval of the selected procedure tray type by at least one other user, and initiating an update to the database based on the selection.

    D2: US 2013/0110667 A1 (DEROYAL INDUSTRIES, INC.) 02 May 2013

  18. D2 is directed to management of custom medical procedural trays/kits where the application receives a customer request to change the configuration of one or more custom procedural kits associated with the customer account, the customer request is submitted from the customer computer via the communication network to the service provider computer. In some embodiments, the application then calculates a new price for the custom procedural kits based on the new component added/deleted.

    D2 is silent on the features of a modification being automatically determined, where user roles are associated with one or more types of recommended modifications to be displayed, consequences based on the modification are displayed, receiving a selection of a procedure tray type by a user and receiving an approval of the selected procedure tray type by at least one other user, and initiating an update to the database based on the selection.

    D3: WO 2013/036496 A1 (DEPUT SPINE, INC.) 14 March 2013

  19. D3 is directed to system and methods for performing various tasks associated with the surgical planning, inventory planning, intra-operative support, post-surgery logistics, and billing phases of surgical support and management. The system includes a scheduling module that maintains a first database for scheduled surgeries, and an inventory module that maintains a second database of an inventory of medical devices and determines based on the type of surgery whether a medical device required for the surgery is available in the inventory. In some embodiments, the inventory module maintains the second database in real-time and can display a list of items in the inventory. Other software modules such as ‘planning module’ used to communicate with the inventory module to reserve at least one inventory item, or a billing module that generates electronic billing information corresponding to medical devices used during the surgery may also be included.

    D3 is silent on the features of a modification being automatically determined, where user roles are associated with one or more types of recommended modifications to be displayed, consequences based on the modification are displayed, receiving a selection of a procedure tray type by a user and receiving an approval of the selected procedure tray type by at least one other user, and initiating an update to the database based on the selection.

  20. As is evidenced from the discussion of D1-D3 above, none of these citations carry out the exact method or achieve the same outcome as claimed in the present application. The ‘user interfaces’ in D1-D3 are different to that of the present application as they are used to perform different methods, each directed to a different outcome. Without a common reference point of achieving the same outcome, I do not consider it possible to assess any improvement in a ‘user interface’ in the manner of the delegate in Aristocrat’16. At the hearing, the Applicant asserted that should the system of D1 be used to perform the same method of the claimed invention, the user interface in D1 would use more clicks. I do not agree with this line of argument as it enters the realm of the hypothetical and leads to a similar situation as that in Carefusion where the delegate noted about the claimed user interface that “the benefits assigned to the applicant’s position are ones which arise over a hypothesised worse user interface, the existence of which is not supported by any statements in the specification or any evidence”. Hence, there is no basis to conclude that the alleged invention results in an improved user interface.

    1. B.       The invention culminates in improved procedure trays
  1. The Applicant submitted:

    “As one example, the recommended modification may minimise the number of items which are individually packaged, by including them in the tray. Individual packaging of items for use during a surgical procedure, results in increased time and waste associated with the procedure. As explained on page 12, lines 13-16 of the specification, when items are grouped in a modified procedure tray rather than provided as individually wrapped items, this has consequences in terms of time savings (as a result of fewer packages to open) and waste reduction (due to a reduction in packaging materials). As such, the recommended modifications to the surgical tray types may minimise individual component wrapping by identifying and implementing suitable modifications of the various tray types to reduce the environmental impact of excess packaging.

    Other considerations which may influence the recommended modifications may include the arrangement of items in layers of the selected procedure tray type, which may be associated with an expected order of use in the procedure, as defined in claim 16, and/or a space efficiency or stability of the complete tray, as defined in claim 17. These considerations may provide further technical efficiencies for the surgeon and/or theatre staff handling the trays and unpacking the items during the procedure.

    The overall process achieves a secondary practical and useful result in the production of a modified procedure tray with consequences for one or more of time, waste, or ease of handling, as explained above. These effects are clearly technical in nature and are not merely serendipitous, but are the intended outcomes of the execution of the method.

    We therefore disagree with the Examiner’s assertions that the method operates “without providing any technical improvement to the existing procedure trays” and that “the invention does not result in any improved product or manufacturing process” as noted in the fourth examination report.”

    On reading the specification, it is clear that recommended modifications to the existing ‘template’ trays are based on individual preferences or cost savings. Any waste reduction is a result of the modifications incorporated in the configuration of a surgical tray before all the items are packaged as a single sterile tray. Any efficiencies for a surgeon or theatre staff are due to their preferences adopted in forming a single surgical tray. To my mind, this is analogous to the administrative work carried out by hospital support staff sterilising all equipment/items and arranging them in the desired order for use by a particular surgeon in a specific surgery. That may make the surgeon’s job more convenient or efficient, however it cannot provide any technical efficiency or technical improvement in the sense required by the case law. As such, it appears that any improvement in the surgical tray is of subjective/logistical nature and cannot be considered technical. I can see great similarity between the present Application and CareFusion’9 in which the alleged invention related to aggregation of medication orders based on components of such orders while potentially reducing the chance of wastage of component medications and the delegate in CareFusion’9 concluded that the substance of the invention lay in the scheme. 

  2. For the sake of completeness, I will also assess the patentability of the alleged invention against some other considerations used in Rokt1, giving regard to the Applicant’s submissions related to those considerations.

    Does the invention result in improvement in the functioning of the computer, irrespective of the data being processed?

  3. I note that at the hearing, the Applicant mentioned that the appropriate starting point for assessing the contribution of the alleged invention should not be a manual process of procedure tray modification, but rather other computerised versions of the processes as disclosed in the prior art documents cited by the examiner. As an example, the Applicant discussed the process of D1 where the user can customise the tools or instruments present in a computer database and arrange on a graphical sheet (template) in a certain order depending on a user or surgeon preference. I have noted the difference between the process of D1 and that of the present application in the second part of paragraph 37 above. Consistent with that, the Applicant also pointed out that the process of the present Application has the additional features of automatically determining a recommended modification, associating user roles with different types of recommended modifications, displaying associated consequences of the modifications, and receiving approval from another user of the modification. The Applicant noted the advantages of the present method as reducing the risk of making a mistake by having an approval requirement built-in the process. I accept that at the priority date, computerised processes to modify procedure trays were well known.

  4. Having laid out D1 as a starting point, the Applicant stated that the contribution of the alleged invention is an improvement in the computerisation, that is improvement in the way that the method is implemented in the computer. I am unable to follow this leap in the reasoning. Against the backdrop of other computerised processes for customising procedure trays known at the priority date, I can readily accept that the contribution of the alleged invention is an improved method/scheme of customising procedure trays (taking into account user preferences, cost-savings etc.) which is implemented on a computer. However, this method/scheme remains administrative and logistical in nature. The specification or the submissions do not provide any suggestion of ingenuity in the computer implementation of the scheme or technical improvement outside of a computer. There is no mention of any technical difficulty overcome for computerisation of this scheme. At the level of abstraction of the alleged invention, it is clear to see that the ingenuity lies in the steps of the administrative scheme itself and not in the computer implementation of the scheme. Hence, I conclude that the invention does not result in any improvement in the functioning of the computer.

    Are there any steps foreign to the normal use of computer or does it require generic computer implementation?

  5. At the hearing, the Applicant submitted that using generic computing components doesn’t necessarily preclude the invention from comprising patentable subject matter. This may well be true in a general sense, however when the ingenuity lies in an administrative method or scheme, it is useful to consider whether the invention requires merely “generic computer implementation”, as distinct from steps which are foreign to the normal use of computers.

  6. The finding by the examiner of the claimed invention being novel and inventive, which is noted by the Applicant is a separate consideration. This was also noted by the Full Court in Rokt2- “Even if the scheme is new and ingenious, it is not made patentable merely because it can or must be implemented using computer technology”. The idea of identifying steps foreign to the normal use of computer was discussed in IBM where Burchett J found the production of the desired curve using fixed-point or integer arithmetic as opposed to floating-point arithmetic was foreign to the normal use of computers at the relevant priority date. There is no disclosure throughout the specification of utilising the computer to carry out the invention in the way a computer would not normally be used. The specification does not seem to provide any real detail of ways to implement the invention on the computer system. Hence, there is no reason to suppose that the invention requires any steps foreign to the normal use of computers. 

    Is there a practical and useful effect?

  7. The Applicant asserted that the alleged invention provided a practical and useful effect in the field of medical devices and surgical procedures. The Applicant submitted:

    “The claimed technology provides a technical solution to the technical problem of providing a user interface that allows for efficient management, modification, ordering, and manufacture of procedure tray types. The claimed user interface provides new functionality by adaptation to a specific user role, and by automatic determination and presentation of at least one recommended modification to the user. This has a practical and useful effect in not only promoting procedure tray modifications that lead to faster set-up and less waste, but also in enabling the user to interact with the interface in a new way, as explained further below.”

  8. I accept that the user interface and the method implemented thereon allows for efficient management and modification of procedure tray types which may colloquially be called a useful result, however as noted by the Deputy Commissioner in CareFusion’11: “Not every result which might colloquially be considered useful is relevant”. There needs to be a physical, tangible phenomenon coming into existence as mentioned at [114] of Research Affiliates for an invention to be considered relevantly useful.

  9. At the hearing, the Applicant in submitting that the alleged invention provides a physical and tangible effect, sought to draw parallels between the claimed invention in UbiPark and that in the present application. The Applicant submitted that in looking at the claimed invention as a matter of substance rather than form, Moshinsky J inferred that the opening of the gates and gaining access to the car park was indeed the result of the claimed method in UbiPark, even though not actually defined in the claim, which provided a concrete, tangible, physical and observable effect and produced an artificially created state of affairs. The Applicant further submitted that analogously, the method of modifying procedure trays in the present application ultimately results in manufacturing of those trays which can be called a physical and tangible effect.

  10. However, I do not consider that Moshinsky J develops narrower principles that only require “concrete, tangible, physical and observable effect” or “an artificially created state of affairs” to confer patentability. The Full Court in RPL Central while discussing patentability stated:

    “Is the mere implementation of an abstract idea in a well-known machine sufficient to render patentable subject matter? Is the artificial effect that arises, because information is stored in RAM and there is communication over the Internet or wifi, sufficient? Does any physical effect give rise to a manner of manufacture? Are the mere presence of an artificial effect and economic utility, without more, sufficient to determine manner of manufacture?

    It is not a question of stating precise guidelines but of deciding, in each case, whether the claimed invention, as a matter of substance not form, is properly the subject of a patent.”

  11. As is also clarified by the Full Court in Rokt2:

    “Even if a claim is to “an artificially created state of affairs of economic significance” it does not follow that the demonstration of a physical effect mandates patentability.”

  12. A similar observation was made by Nicholas J in F45 where he stated:

    “The authorities make clear that the demonstration of a “physical effect” does not necessarily mean that an invention satisfies the NRDC requirement that the invention result in an “artificially created state of affairs””.

  13. Clearly, having a ‘physical and tangible effect’ is not an ultimate test in assessing patentability. The case law seems to consider it not sufficient alone to confer patentability.

  14. I note that Moshinsky J when considering patentability of the claimed invention in UbiPark stated:

    “It is necessary to start by characterising the invention. In substance, the claims are directed to a communications system, computer program and smartphone configured to determine signal strengths of entry signals and exit signals to control a user’s entry into and exit from a restricted area, in conjunction with the use of authorisation data.”

  15. By characterising the invention this way, Moshinsky J appears to have emphasised the features of determining strengths of communication signals and using authorisation data to control a user’s entry and exit from a restricted area in forming a key aspect of the substance of the invention. His Honour appears to have found the substance of the claimed invention in UbiPark technical in nature and also to provide a physical and tangible effect.

  16. On the other hand, in substance the claims in the present application are directed to modification of procedure trays for a type of surgical procedure based on a variety of factors, automatically determining recommended modifications, displaying recommended modification and consequences associated with it, getting an approval for a selected recommended modification by another user. Clearly, the substance of the invention is an administrative method or scheme (although comprising reasonably complicated steps) implemented using well-known computer functions. I have already discussed above that there is no ingenuity in the computer implementation of the scheme. The feature of ‘manufacturing of the procedure tray’ does not alter the substance in any way.

    Balancing the considerations

  17. The invention can be characterised by the specific steps in the administrative scheme of modifying procedure trays. There is no ingenuity involved in the computerisation of this scheme. The user interface defined cannot be considered an improved user interface. The invention does not involve steps foreign to the normal use of computer or result in a practical or useful effect in the relevant sense. The computer is merely a tool to carry out the administrative scheme.

  18. Having regard to the complete specification, invention as claimed (in independent claims 1, 10 and 13, along with dependent claims 2 to 9, 11, 12, 14 to 17) and the above considerations, the substance or ingenuity of the invention lies in specific steps of the method for managing/customising procedure trays. This is merely an administrative scheme implemented on a computer system. The specification does not suggest any adaptation or alteration of the computer system in order to implement the scheme, indicating that the contribution to the claimed invention is not technical in nature. Hence, I find that independent claims 1, 10 and 13 are not for a manner of manufacture. The dependent claims add features like determining, at least one item that can be replaced with an available substitute, comparing prices of at least one item and available substitute item; information being displayed based on the determination of the user role; list of items comprising protective gowns, drapes and gloves etc. that are merely additional elements of the administrative scheme. Therefore, the dependent claims are also not for a manner of manufacture.

    Conclusion

  19. I conclude that the claimed invention is not for a manner of manufacture. I note the Applicant’s request at the hearing that I provide them an opportunity to amend if that would help them define patentable subject matter. Having reviewed the specification in detail, and in view of my considerations, I can see no subject matter that could be made the subject of a patentable claim. Hence, I consider no useful purpose would be served by an opportunity to amend. I therefore refuse the application.

    Pradnya Satarkar

    Delegate of the Commissioner of Patents

    Annex A

    1. A method comprising:
    generating, based on procedure information and template information stored in a database, a user interface,

    wherein the procedure information indicates a plurality of procedure tray types, wherein each procedure tray type of the plurality of procedure tray types is associated with one or more users and a list of items to be included in a procedure tray of the procedure tray type for a type of surgical procedure of a plurality of types of surgical procedures,

    wherein the template information indicates, for each procedure tray type of the plurality of procedure tray types, a list of items required to perform the type of surgical procedure associated with the procedure tray type;

    causing, based on the procedure information and an interaction with the user interface by a current user of the user interface, one or more procedure tray types of the plurality of procedure tray types to be displayed;

    causing, based on a selection of a procedure tray type of the one or more procedure tray types by the current user, display of the list of items to be included in the selected procedure tray type;

    determining that the current user is associated with a first user role of a plurality of user roles, wherein each user role of the plurality of user roles is associated with one or more types of recommended modifications to be displayed at the user interface and one or more types of recommended modifications not be displayed at the user interface;

    determining, automatically, at least one recommended modification to the selected procedure tray type;

    causing, based on the at least one modification and the template information, and based on the current user being associated with the first user role, display via the user interface of the at least one recommended modification to the selected procedure tray type, wherein the at least one recommended modification is associated with the one or more types of recommended modifications that may be displayed at the user interface for the first user role;

    receiving a selection, by the current user, of the at least one recommended modification;

    sending, to at least one other user associated with the selected procedure tray type, at least one consequence associated with the selected at least one recommended modification;

    wherein the at least one consequence associated with the selected at least one recommended modification comprises an estimated waste reduction, the method further comprising causing display of the estimated waste reduction,

    wherein the method further comprises:

    determining at least two different user roles, wherein the at least two different user roles comprise at least one of a purchaser and a clinical practitioner;

    causing, based on the current user of the user interface being associated with the first user role of the at least two different user roles,

    display of an estimated time saving associated with the selected at least one recommended modification to the list of items to be included in the selected procedure tray type;

    receiving, based on sending the at least one consequence to the at least one other user, confirmation information associated with the selected at least one recommended modification;

    causing, based on the confirmation information, the user interface to indicate to the current user that the selected at least one recommended modification has been approved by the at least one other user;

    receiving, via the user interface, by input from the current user, wherein

    the input is configured to initiate a database update associated with the approved at least one recommended modification; and

    causing, based on the input from the current user, the database update to be initiated, wherein the procedure information stored in the database is updated to indicate the approved at least one recommended modification.

    2. The method of claim 1, further comprising:
    storing, in the database, purchase volume information, wherein the purchase volume information comprises aggregated purchasing volumes of individual items for a purchasing entity;

    determining, based on the purchase volume information, at least one item from the list of items associated with the selected procedure tray type that may be replaced with an available substitute item based on a technical equivalency between the at least one item and the available substitute item;

    comparing prices and purchase volumes associated with the at least one item and the available substitute item; and

    determining, based on the comparison, the at least one recommended modification to the list of items to be included in the selected procedure tray type.

    3. The method of claim 1 or claim 2, further comprising:
    determining at least two different user roles, wherein the at least two different user roles comprise at least one of: a purchaser and a clinical practitioner; and

    adapting, based on an indication that a current user of the user interface is associated with a user role of the at least two different user roles, functionality of the user interface.

    4. The method of any one of the preceding claims, wherein
    causing display of the estimated time saving is based on determining that the first user role of the current user is a clinical practitioner.

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

    determining that the first user role of the current user is a purchaser;

    and

    causing, based on determining that the first user role of the current user is a purchaser, display of an estimated cost reduction associated with the at least one recommended modification to the list of items to be included in the selected procedure tray type.

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

    storing, in the database, purchase volume information, wherein the purchase volume information comprises aggregated purchasing volumes of individual items for a purchasing entity associated with the current user of the user interface; and

    determining, based on the purchase volume information and a request for aggregated purchasing volumes of one or more items, all items in the procedure tray types associated with the current user; and

    causing display of all the items in the procedure tray types associated with the current user.

    7. The method of any one of the preceding claims, wherein the list of items of each procedure tray type comprises at least one of: protective gowns, drapes, and gloves.

    8. The method of any one of the preceding claims, further comprising receiving, from a network server, the procedure information.

    9. The method of any one of the preceding claims, further comprising retrieving, from the database, the template information.

    10. One or more computer-readable media storing processor executable instructions that, when executed by at least one processor, cause the at least one processor to:

    generate, based on procedure information and template information stored in a database, a user interface, wherein the procedure information indicates a plurality of procedure tray types, wherein each procedure tray type of the plurality of procedure tray types is associated with one or more users and a list of items to be included in a procedure tray of the procedure tray type for a type of surgical procedure of a plurality of types of surgical procedures, wherein the template information indicates, for each procedure tray type of the plurality of procedure tray types, a list of items required to perform the type of surgical procedure associated with the procedure tray type;

    cause, based on the procedure information and an interaction with the user interface by a current user of the user interface, one or more procedure tray types of the plurality of procedure tray types to be displayed;

    cause, based on a selection of a procedure tray type of the one or more procedure tray types by the current user, display of the list of items to be included in the selected procedure tray type;

    determine, that the current user is associated with a first user role of a plurality of user roles, wherein each user role of the plurality of user roles is associated with one or more types of recommended modifications that may be displayed at the user interface and one or more types of recommended modifications that may not be displayed at the user interface;

    determine, automatically, at least one recommended modification to the selected procedure tray type;

    cause, based on the at least one modification and the template information, and based on the current user being associated with the first user role, display via the user interface of the at least one recommended modification to selected procedure tray type, wherein the at least one recommended modification is associated with the one or more types of recommended modifications that may be displayed at the user interface for the first user role;

    receive a selection, by the current user, of the at least one recommended modification;

    send, to at least one other user associated with the selected procedure tray type, at least one consequence associated with the selected at least one recommended modification;

    receive, based on sending the at least one consequence to the at least one other user, confirmation information associated with the selected at least one recommended modification;

    cause, based on the confirmation information, the user interface to indicate to the current user that the selected at least one recommended modification has been approved by the at least one other user;

    receive, via the user interface, input from the current user, wherein the input is configured to initiate a database update associated with the approved at least one recommended modification; and

    cause, based on the input from the current user, the database update to be initiated, wherein the procedure information stored in the database is updated to indicate the approved at least one recommended modification,

    wherein the at least one consequence associated with the selected at least one recommended modification comprises an estimated waste consequence, the processor-executable instructions further cause the at least one processor to cause display of the estimated waste consequence,

    wherein the at least one consequence associated with the selected at least one recommended modification comprises an estimated set-up time consequence, the processor-executable instructions further cause, based on the current user being associated with the first user role, the at least one processor to cause display of the estimated set-up time consequence.

    11. The one or more computer-readable media of claim 10, wherein the processor-executable instructions cause the at least one processor to cause manufacture of the selected procedure tray type based on the updated procedure information.

    12. The method of any one of claims 1 to 9, or the one or more computer-readable media of claim 10 or claim 11, wherein the input from the current user comprises at least one of: a mouse click or a screen tap.

    13. A method comprising:
    generating, based on procedure information and template information stored in a database, a user interface,

    wherein the procedure information indicates a plurality of procedure tray types,

    wherein each procedure tray type of the plurality of procedure tray types is associated with one or more users and a list of items to be included in a procedure tray of the procedure tray type for a type of surgical procedure of a plurality of types of surgical procedures,

    wherein the template information indicates, for each procedure tray type of the plurality of procedure tray types, a list of items required to perform the type of surgical procedure associated with the procedure tray type;

    causing, based on the procedure information and an interaction with the user interface by a current user of the user interface, one or more procedure tray types of the plurality of procedure tray types to be displayed;

    causing, based on a selection of a procedure tray type of the one or more procedure tray types by the current user, display of the list of items to be included in the selected procedure tray type;

    determining that the current user is associated with a first user role of a plurality of user roles, wherein each user role of the plurality of user roles is associated with one or more types of recommended modifications to be displayed at the user interface and one or more types of recommended modifications not be displayed at the user interface;

    determining, automatically, at least one recommended modification to the selected procedure tray type;

    causing, based on the at least one modification and the template information, and

    based on the current user being associated with the first user role, display via the user interface of the at least one recommended modification to the selected procedure tray type, wherein the at least one recommended modification is associated with the one or more types of recommended modifications that may be displayed at the user interface for
    the first user role;

    receiving a selection, by the current user, of the at least one recommended modification;

    sending, to at least one other user associated with the selected procedure tray type, at least one consequence associated with the selected at least one recommended modification;

    wherein the at least one consequence associated with the selected at least one recommended modification comprises an estimated waste reduction, the method further comprising causing display of the estimated waste reduction,

    wherein the method further comprises:

    determining at least two different user roles, wherein the at least two different user roles comprise at least one of a purchaser and a clinical practitioner;

    causing, based on the current user of the user interface being associated with the first user role of the at least two different user roles, display of an estimated time saving associated with the selected at least one recommended modification to the list of items to be included in the selected procedure tray type;

    receiving, based on sending the at least one consequence to the at least one other user, confirmation information associated with the selected at least one recommended modification;

    causing, based on the confirmation information, the user interface to indicate to the current user that the selected at least one recommended modification has been approved by the at least one other user;

    receiving, via the user interface, by input from the current user, wherein the input is configured to initiate a database update associated with the approved at least one recommended modification; and

    causing, based on the input from the current user, the database update to be initiated, wherein the procedure information stored in the database is updated to indicate the approved at least one recommended modification;

    and

    causing manufacture of the selected procedure tray type based on the updated procedure information.

    14. The method of claim 13 or the one or more computer-readable
    media of claim 11, wherein causing manufacture of the selected procedure tray type with the approved at least one recommended modification comprises:

    arranging the items to be included in the procedure tray in accordance with the selected procedure tray type and the approved at least one recommended modification; and

    packaging the arranged items.

    15. The method of any one of claims 1 to 9, or 12 to 14 wherein the at least one recommended modification comprises including a previously individually packaged item in the selected procedure tray type and wherein the at least one consequence associated with the selected at least one recommended modification comprises a reduction in time and/or waste
    associated with including the previously individually packaged item in the selected procedure tray type.

    16. The method of any one of claims 1 to 9, or 12 to 15 wherein the at least one consequence is associated with an arrangement of items in layers of the selected procedure tray type, and wherein the arrangement of items in layers is associated with an expected order of use in the procedure.

    17. The method of any one of claims 1 to 9, or 12 to 16 wherein the at least one consequence is associated with an arrangement of items in layers of the selected procedure tray type, and wherein the arrangement of items in layers is determined at least partly based on space-efficiency and/or stability of the selected procedure tray.

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