CareFusion 303, Inc - [2021] APO 10

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
CareFusion 303, Inc. [2021] APO 10

Patent Application: 2014268801
Title:Medication delivery management

Patent Applicant:                   CareFusion 303, Inc.
Delegate:  Dr N. R. Madsen
Decision Date:  26 February 2021
Hearing Date:  14 September 2020, via videoconference

Catchwords: PATENTS – section 45 – examiner’s objection – whether invention is a manner of manufacture – filling orders and delivering medications – alerting priority delivery of medications – allowability of amendments – invention in substance directed to a mere scheme – alleged invention not a manner of manufacture – opportunity to amend

Representation: Patent attorneys for the applicant: Michelle Catto, Manuel Schmidt and Rachel Hooke from FB Rice

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014268801
Title:Medication delivery management

Patent Applicant: CareFusion 303, Inc.
Date of Decision: 26 February 2021
DECISION
The claims of the application, as proposed to be amended, do not define a manner of manufacture. While I do not immediately see any subject matter of substance in the body of the specification from which valid claims could be drafted to overcome this finding, I will provide the applicant with an opportunity to amend the specification as the hearing and submissions did not address the specification in its entirety.
REASONS FOR DECISION
BACKGROUND

CareFusion 303, Inc. (“the applicant”) filed patent application 2014268801 on 19 May 2014. The application was filed as PCT application PCT/US2014/038657 based on US application 13/900482 having an earliest priority date of 22 May 2013. Examination was requested on 12 April 2018 and the application was subjected to four examination reports, the final of which issued on 6 July 2020. In those reports, the examiner has maintained an objection that the claims of the application, including the claims as proposed to be amended, do not define a manner of manufacture. The applicant subsequently requested to be heard on 20 July 2020 after filing a response with an amendment on 16 July 2020.
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.
The final date for acceptance of the application was 19 July 2020, however paragraph 13.4(1)(g) of the Patent Regulations is available to extend the time for gaining acceptance to 3 months (or longer if appropriate under sub-regulation 13.4(3)) from the date of the present decision.
SPECIFICATION
The alleged invention relates to the management of delivery of prepared medications in a healthcare facility. As a background, certain pharmaceutical drugs are compounded to fit patient needs such as solid pill or liquid form, avoidance of allergens, tailoring of dose, and addition of flavours. Compounding is particularly routine in the case of intravenous (IV) medication.
Where a patient is in a healthcare facility, a pharmacy within the healthcare facility may prepare medications such as IV infusions according to prescription. An appropriately trained pharmacist places an infusion solution in a bag, bottle, syringe, or other container with labels attached to the container. The infusion solution is held in a sorting area so that a sorting person can arrange for appropriate delivery to, for example, an intensive care unit. A delivery person retrieves the infusion solution and, naturally, ensures its delivery.
A delivery person may not have knowledge of the urgency of the medication to be delivered. Thus, even though the solution may be prepared and ready for delivery, the delivery person may leave without the urgently required solution. Therefore, another delivery person will need to be urgently dispatched to deliver the solution. Once delivered, the specification notes that, unsurprisingly, a clinician such as a nurse hangs the infusion solution from a rack, connects a tube between the infusion solution and an infusion pump and inserts a canula at the end of the tube for delivery of the infusion solution to the patient. It will become apparent that the problems that the specification seeks to solve relate to the effective notification of “urgent” medications that are required for delivery. Paragraphs [0007]-[0009] of the specification, as originally filed as follows, provide content to the Summary of the invention on page 3 of the specification, outlining what appears to be content closely related to the inventive concept:
According to certain embodiments of the present disclosure, a system for managing a delivery of prepared medications is provided. The system includes a memory that includes instructions, and one or more processors. The one or more processors are configured to execute the instructions to receive first information including a delivery deadline for a first medication, and receive second information including a preparation status of a second medication. The one or more processors are also configured to execute the instructions to compare the first information that includes the delivery deadline for the first medication with the second information that includes the preparation status of the second medication to determine whether the first medication should be indicated for delivery prior to completing preparation of the second medication, and provide a notification indicating when to deliver the first medication based on the determination.
According to certain embodiments of the present disclosure, a method for managing a delivery of prepared medications is provided. The method includes receiving first information including a delivery deadline for a first medication, and receiving second information including a preparation status of a second medication. The method also includes comparing the first information that includes the delivery deadline for the first medication with the second information that includes the preparation status of the second medication to determine whether the first medication should be indicated for delivery prior to completing preparation of the second medication, and providing a notification indicating when to deliver the first medication based on the determination.
According to certain embodiments of the present disclosure, a machine-readable storage medium that includes machine-readable instructions for causing a processor to execute a method for managing delivery of prepared medications is provided. The method includes receiving first information including a delivery deadline for a first medication, and receiving second information including preparation status of a second medication. The method also includes comparing the first information that includes the delivery deadline for the first medication with the second information that includes the preparation status of the second medication to determine whether the first medication should be indicated for delivery prior to completing preparation of the second medication, and providing a notification indicating when to deliver the first medication based on the determination.
The specification as originally filed then discusses the invention with respect to FIGs 1-5 essentially noting at [0010] and [0017] that one of ordinary skill in the art may practice the invention without specific details and that well-known structures have not been shown in detail so as to not obscure the disclosure. Consistent with the Summary, paragraphs [0018] and [0019] discuss the delivery management method with respect to the provision of a notification in the form of a message that may instruct a delivery person to wait for a medication to be complete or to proceed with a delivery.
The disclosed system determines, upon a delivery person identifying (e.g., by scanning) a medication, such as an infusion solution, to be delivered, whether there are any other prepared or almost prepared medications that need to be delivered to the area of the hospital to which the delivery person is delivering the identified medication. If another medication is available or almost prepared for delivery, and it would be preferable to deliver the other medication during the same delivery as the identified medication, such as based on an urgency of the other medication or an expiration or delivery time of either medication, then a notification is provided to the delivery person to wait for the other medication to arrive for the appropriate bin prior to leaving to deliver the identified medication. The notification can be provided as an alert on a display of a device at or near the bin-sorting area, and/or may be sent to a device of the delivery person, such as the delivery person's mobile device. If another medication is available or almost prepared for delivery, but it is not preferable to deliver the other medication during the same delivery as the identified medication, then either no notification is provided to the delivery person, or a notification is provided to the delivery person to proceed with delivering the identified medication.
In this manner, the disclosed system provides the delivery person with insight into the medication preparation process by determining whether the delivery person should request (for delivery to the appropriate bin) a prepared medication that is sitting in the bin-sorting area from a sorting person, or whether the delivery person should wait for an (sic) medication to finish being prepared. The disclosed system may determine how urgently the medications identified (e.g., scanned) for delivery need to be delivered by the delivery person, and how long the delivery person will need to wait to obtain any other medication for which the preparation is almost complete. The disclosed system may notify (e.g., by a visible or audible alert, such as a text message or notification window) the delivery person of an (sic) medication that is almost prepared if the system determines that the delivery person has sufficient time to wait for the preparation of the medication to complete, e.g., based on an estimated amount of time required to complete the preparation of the medication, the times that the identified medications need to be delivered by, and an estimated amount of time required to deliver the identified medications.
FIGs 1, 2 and 5 involve depictions of the technological architecture applied to implement the claimed invention. FIG 1 is discussed at paragraphs [0020]-[0030]. In summary, a pharmacy has a medication storage area 10, order preparation area 20 and delivery pickup area 30. A computer 40 is present at the pharmacy, and connected via a network to “other people” and their “associated devices” and these people may include a delivery person 2, a doctor 3, and a care provider 4. Involved in the order management process are “labels” 72 that can be scanned for example by scanning devices 24, 34 in the pharmacy. Of particular relevance to the claimed invention is the use of such “labels” which may be passive or active ID devices. Paragraph [0027] discusses these devices which may be provided on a package 70 for medications, as follows:
In the embodiments described above, the location ID devices 52, 62, 92 and/or the patient/medication ID device 72 are passive ID devices, meaning that certain action (e.g., scanning) has to be taken by the participant (e.g., a pharmacy technician or the delivery person 2) to retrieve information therefrom. In other embodiments, the ID devices can be active ID devices, meaning that the information retrieval from the ID devices occur automatically without an action taken by the participant. In some embodiments, the active ID devices can actively transmit signals containing the relevant information to the reader device 72 (sic) through a wireless link. The wireless link can use a variety of technologies including Bluetooth, ZigBee, wireless USB, and proprietary systems. In other embodiments, the active ID devices do not themselves transmit signals, but respond to query signals generated by a reader device (e.g., by altering impedance of an RF circuit therein) as the reader device passes by the ID devices in close proximity.
Each time a scanner scans an ID device, information read may be wirelessly transmitted to the computer 40 which manages the information associated with delivery.
FIGs 2 and 5 are block diagrams showing architecture of computer systems used in FIG. 1. It is abundantly clear that these FIGs depict generic computer architecture. FIG. 5 is discussed at paragraph [0050] of the specification, this being followed by paragraphs [0051]-[0059] which also discuss completely standard elements of computer systems in somewhat acute detail.
The invention is further described with reference to FIG. 3 which illustrates an example process for managing delivery of prepared medications where at [0038] it is noted that while FIG. 3 is described with reference to FIG. 2, its process may be performed by other systems.
The process 300 begins when information is received that includes a delivery deadline for a first medication that is at a pickup location. This information may be obtained for example, by scanning a barcode of/on a package for a first medication (in the claimed invention this takes the form of an active ID device and a reader device). Second information is then received which includes a preparation status of a second medication to be delivered to the pickup location which may include a current location of the second medication or an estimated amount of time remaining to finish preparing the second medication. Following this step, the delivery deadline for the first medication is compared to the preparation status of the second medication to determine whether the first medication should be indicated for delivery before the second. This determination may be based on a degree of urgency or time required to deliver items.
Importantly, following this comparison, if the result of the comparison suggests that one should not proceed with delivery of the first medication before the second, then a notification is provided to somebody to wait for preparation of the second medication before the first is delivered. If on the other hand the comparison does suggest to proceed with the delivery of the first medication, then a notification is provided to simply proceed with the delivery of the first medication.
Thus, in essence, the process described in FIG. 3 seeks to logistically prioritise delivery of certain medications based on their readiness and degree of completion of preparation. If a medication is urgent and it is nearly complete, then, provided the delivery of another (ready to be delivered) medication is not sufficiently urgent, a delivery person is informed to wait for the completion of the urgent medication before delivering the medications.
The description follows the discussion of FIG. 3 with discussion of specific embodiments that focus upon the filing of orders involving particular medicines (e.g. Vancomycin and Cefazolin) at [0042]-[0049].
On a plain reading of the specification, it is clear that there is focus on the invention relating to the management of medication delivery in the context of the analysis of information with respect to two separate medication orders such that information is provided to a delivery person to proceed with or wait before performing a delivery. This is the focus of the “Summary of the Invention” and also the specifically discussed embodiments relating to particular medicines. While technological architecture is discussed, it is done so at a high level where technical implementation parameters appears assumed knowledge of the person skilled in the art. In this regard, as an example the specification discusses the reading of labels on packages to gather information, and then briefly provides the option at paragraph [0027] of using active ID devices and an appropriate reader to perform this task automatically. I consider that the specification clearly assumes the person skilled in the art to be well equipped to implement such a technological arrangement. Moreover, it does not appear from the specification that the invention described seeks to solve any problems in computer technology.
The specification, as presently proposed to be amended, ends with 21 claims. Claims 1, 11 and 21 are independent. Claim 1 as proposed to be amended on 16 July 2020 reads as follows, and is representative of claims 11 and 21:
A system for managing a delivery of prepared medications, the system comprising:
an active identification (ID) device affixed to a first medication that is prepared for delivery, the active ID device configured to transmit signals containing identification information through a wireless link without a scanning action taken by a participant;
a reader device configured to receive medication identification information via a signal generated and transmitted wirelessly from the active ID device when the active ID device passes within a proximity of the reader device, without a scanning action performed by a participant;
a memory comprising instructions; and
one or more processors configured to execute the instructions to:
receive an indication that the active ID device affixed to the first medication passes within a proximity of the reader device, resulting in a wireless transmission between the reader device and the active ID device, the indication including an identification of the first medication, the wireless transmission and receipt of the identification occurring automatically without a scanning action taken by a participant;
in response to receiving the indication:
query for and receive, based on the received identification of the first medication, first information comprising a delivery deadline for the first medication;
query for and receive second information comprising a preparation status and an estimated amount of time to finish preparation of a second medication;
compare the received first information with the received second information; and
determine, based on a comparison of the first information with the second information, whether the first medication should be indicated for delivery prior to completing preparation of the second medication or whether to wait for the preparation of the second medication to be completed prior to delivering the first medication; and
when the first medication is indicated for delivery prior to completing the preparation, provide a notification to a mobile device remote from the system, the notification indicating the first medication should be indicated for delivery prior to completing preparation of the second medication; and
when the second medication is to be completed prior to delivering the first medication, provide a notification to the mobile device to wait for the preparation of the second medication to be completed prior to delivering the first medication, wherein instructions to provide a notification indicating when to deliver the first medication comprises instructions to provide an audible or a visible alert via an output device coupled with the processor.
The claim is introduced having an active ID device in association with a first medication that is prepared for delivery. A reader automatically reads this active ID device when the first medication is in proximity to the reader, such a concept being described as discussed above in paragraph [0027]. A computer then receives an indication of this reading, wherein the reading includes an identifier for the first medication. Responsive to the reading, information is queried for and received comprising a delivery deadline for the first medication. Second information comprising a preparation status of a second medication (including a time to completion) is also received. The information is compared and a determination is made as to whether the first medication should be indicated to be delivered before completion of the second medication or whether the delivery of the first medication should wait for completion of the second medication. Depending on this determination, relevant alerts are provided to a mobile device.

I note that the end of claim 1 refers to a feature wherein instructions to provide a notification indicating when to deliver the first medication comprises instructions to provide an audible alert or a visible alert via an output device coupled with the processor (my emphasis). At the hearing I noted to the applicant that while there was no specific antecedent in the claim to this particular processor, I construed the feature as referring to any one of the one or more processors defined earlier in the claim, hence I considered the claim clear.
More significantly however, I also noted that the claimed invention discusses the concept of affixing an active ID device to a first medication. This appears problematic from the point of view of sufficient description and support (s40) because it includes the idea of directly attaching an active ID device to a medicine, whether it be a solution in the form of an IV medicine, or a solid pill medication. The specification as filed appears to contemplate a more realistic concept of attaching such an ID device to packaging. Regardless, none of the issues before me turn on this point and the applicant’s representation suggested in the hearing that this would appear a reasonable and straight forward amendment that could be made to arrive at allowable amendments. We proceeded on this basis in the hearing.
MANNER OF MANUFACTURE
In National Research Development Corporation v Commissioner of Patents (“NRDC”), [1959] HCA 67, (1959) 102 CLR 252, the High Court provided a statement of the law regarding manner of manufacture. At page 275:-
“… 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”.
The High Court though was not laying down a precise formulation that can be applied unthinkingly. In D’Arcy v Myriad Genetics Inc (“Myriad”), [2015] HCA 35, at [23]:
“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.”
That case-by-case approach must have regard to the substance of the claimed invention, not simply the form of the claim. The point was made succinctly in the Myriad case by Gageler and Nettle JJ. At [144]:-
“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.”
Thus, it is clear that the assessment as to patentable subject matter in this context requires a consideration of the substance of the invention. To this point, in Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011, Beach J determined that non-invasive prenatal genetic testing based on maternal blood sampling was patent eligible subject matter, by first identifying what the substance of the invention was, in each relevant claim, noting that:
“Myriad confirms that the starting point for the resolution of the ‘manner of manufacture’ issue is the identification of what in substance each relevant claim is for. And relevant to this inquiry is the definition of the invention, which in turn depends upon the construction of the relevant claims read in light of the specification as a whole and the relevant prior art.”
To further guide the determination of patentable subject matter in the context of computer implemented inventions, a range of principles have been developed. The principles of law that apply to the present matter are substantially uncontroversial, being summarised in the decision of the delegate in Aristocrat Technologies Australia Pty Limited [2016] APO 49. There the delegate, at [35], sets out relevant considerations for patentability of inventions involving computer implementation arising from the Full Federal Court decisions of Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177; (2015) 328 ALR 458 (RPL Central) and Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150; (2014) 227 FCR 378 (Research Affiliates):
“I conclude that it is relevant to consider a range of matters. Without seeking to be exhaustive, these include:
·there must be more than an abstract idea, mere scheme or mere intellectual information;
·is the contribution of the claimed invention technical in nature;
·does the invention solve a technical problem within the computer or outside the computer;
·does the invention result in improvement in the functioning of the computer, irrespective of the data being processed;
·does the application of the method produce a practical and useful result;
·can it be broadly described as an improvement in computer technology;
·does the method merely require generic computer implementation;
·is the computer merely an intermediary or tool for performing the method while adding nothing of substance to the idea;
·is there ingenuity in the way in which the computer is utilised;
·does the invention involve steps that are foreign to the normal use of computers; and
·does the invention lie in the generation, presentation or arrangement of intellectual information.”
The recent Full Federal Court decision in Commissionerof Patents v RoktPte Ltd (Rokt) [2020] FCAFC 86 confirmed and applied these principles. While not explicitly identified by the Australian Courts, it appears a sensible approach consistent with the above principles for considering patentability, to consider whether the invention constitutes a technical solution and/or solves a technical problem. Such an approach was applied by the applicant in submissions for this matter.
Following the Rokt decision, the decision of Burley J in Aristocrat Technologies Australia Pty Limited v Commissioner of Patents (Aristocrat ‘20) [2020] FCA 778 at [91] formulated a two-step approach to considering patentability that can be viewed as follows:
1) Is the claimed invention for a mere scheme or a business method of the type that is not the proper subject of letters patents… if yes then,
2) Is the computer-implemented method one where invention lies in the computerisation of the method…
In addressing the first question, Burley J turned to the idea of a “machine of particular construction” at [98] in finding that an electronic gaming machine comprising a specific set of physical features was directed to a manner of manufacture (my emphasis added):
“…the invention may be characterised as a machine of particular construction which implements a gaming function… Simply put the machine that is the subject of the claims is built to allow people to play games on it. That is its only purpose… physical and virtual features of the display, reels, credit input mechanism, gameplay mechanism and game controller combine to produce the invention. It is a device of specific character.”
Examiner’s objection
The examiner maintains an objection under the ground of manner of manufacture in his fourth report. In the examiner’s report, reference is made to Aristocrat ’20 in addressing submissions of the applicant. In summary the examiner argues that the present application should answer the first stage of the two-step approach posed in Aristocrat ’20 in the affirmative noting that:
“…the physical system [involving an active ID device, reader device, and memory and processor that operates based on signals from the reader device to make determinations…] referred to by the applicant does not form part of the contribution of the invention, because elements i-iii stated above, are technical element that are ‘utilised for its basic, typical or well-known function’. I arrived at this conclusion after applying teaching from ROKT at [91].”
ROKT at [91] is a reference to the decision in Rokt where their honours noted that:
“The means of determining that this is so is primarily by a careful review of the specification in order to ascertain, by construing that document, whether the invention described and claimed is in substance any more than a scheme that utilises computers in such a way. This is a question of characterising the invention as set out in the specification.”
The examiner then referred to the specification at [0023]-[0037] and [0050]-[0059] where he identified as an example that:
“…paragraph [0027] speaks of an embodiment of the invention, where an active identification device is used rather than a passive identification (such as a barcode). Clearly, the applicant has not invented the active ID device, rather has applied a generally (sic) purpose transmitter device or RF device. Elements i-iii are integrated into a system; and a logistics scheme is plugged into the said integrated system. Therefore the substance of the invention does not lie in the physical system, rather in the logistics scheme.”
At this point, to supplement the identification of relevant law above, I emphasise the comments made by their Honours in Rokt and cited by the examiner in his fourth report that of great importance to a manner of manufacture consideration is careful construction of the specification and claim in question when performing the task of “characterising the invention”.
Consideration of specific submissions: Question 1 of Aristocrat ’20
The applicant’s submissions start by focussing upon the recent decision in Aristocrat ’20 where his Honour makes a point that simply isolating the inventive concept in determining whether or not the claimed invention is a mere scheme is an incorrect approach (at [99]). Such an observation by Burley J appears consistent with the ideas expressed in RPL Central and Research Affiliates which effectively point to a range of matters that one should seek to consider when determining patentability. In other words, one should not determine the substance and thus conclude as to patentability based on the “contribution to the art” alone. However, it must be borne in mind that an understanding of where the contribution lies in terms of ingenuity/inventiveness, is in fact a relevant factor in the overall consideration. This is made clear in Full Court decisions of RPL Central and Research Affiliates as follows
· “The specification makes it apparent that any inventive step arises in the creation of the index as information and as a scheme.” Research Affiliates at [118]
· “RPL Central does not claim any invention or ingenuity in any program or operation of a computer… Accordingly, the ingenuity must be in the steps of the method itself… [this being] a scheme or business method”. RPL Central at [110]
The applicant turns to the examination reports and suggests that the conclusion reached by the examiner has taken the approach of merely considering the substance on the basis of the elements “invented by the applicant”, not properly applying the principles. In looking at the four successive manner of manufacture objections it appears to me that other relevant factors have been addressed at least to a similar degree to their Honours in the Full Court decision in Rokt. These include:
·     In the first and second reports, the examiner identified that he considered that there was not improvement in the functioning of the computer technology.
·     In the third report the examiner suggested that the problem solved was not technical in nature but instead related to “management of logistics only”.
·     In the fourth report the examiner refers to the specification to identify that the technology/computer system is used for its basic, typical or well-known functions which appears akin to the idea that the technology used is merely an intermediary for performing the method in question.
That being said, in that the examiner appears to have applied collective principles, the applicant’s primary submission is that the claimed invention represents a system of particular construction that is clearly not a mere scheme or business method, and should not progress from the first question posed in Aristocrat ’20 to the second question. It is after passing to the second question of Aristocrat ’20 that Burley J seems to suggest the principles of RPL Central and Research Affiliates may be rigorously applied. In this regard the applicant submits:
“While the courts have made clear that patentability is not provided merely by implementation of a method or scheme in an electronic processing device which itself is not characterised, the present claims do not leave any apparatus uncharacterised. Rather, the claims require a specific combination of specific physical devices having a specific physical manner of interacting with each other. For example, the claims do not leave the reader or ID devices uncharacterised, but require that the active ID device and reader device having an automatic proximity-based communication with each other. Further, the physical elements of the system interact with the processor and processing steps in a particular manner.”
To determine whether what is before me is a device or system that might be characterised in accordance with paragraph [98] of Aristocrat ’20 I must turn to a careful construction of the specification in question. With an understanding of the specification in mind, it would appear that it is necessary to determine whether the device/machine/physical system of the claimed invention can be characterised as specific in the manner of Aristocrat ’20, or whether the device/machine/physical system is to be characterised as “generic”. It would appear from Aristocrat ’20 that there exists a distinction between the idea of a “specific-purpose device” and “general purpose computer systems” that arises in addressing the first question of the two-step test.
In accordance with the above construction of the claims and consistent with the features of the claimed invention identified by the applicant in their submissions, present in the claims as “technological architecture” implementing the invention are:
·     an active ID device affixed to a package
·     a reader device receiving information about the package/contents automatically when the active ID device is in proximity to the reader
·     a memory/processor (computer) that receives information from the active ID device via the reader
·     a remote mobile device which receives a message from the computer.
With reference to the specification, the use of an active ID tag is discussed at paragraph [0027] as an optional feature that provides advantages over passive ID devices, the advantage being information retrieval is automatic. The active and passive ID tags are presented as useful examples of “labels” that can be attached to a package containing medication and information thus read therefrom using some kind of reader. These ID devices may be read by a suitable reader device over a wireless link that may be a Bluetooth, ZigBee, wireless USB link or notably, undefined “proprietary systems” as also discussed in paragraph [0027]. There is no further detailed discussion of the physical arrangement of this active ID tag, nor of its technical operation. This knowledge appears assumed by the specification.
Information read by the reader device may be wirelessly transmitted to a processor (computer) over some type of data network, such as a personal area network (PAN), local area network (LAN), campus area network (CAN), metropolitan area network (MAN), wide area network (WAN), broadband network (BBN), the Internet, and the like (paragraph [0028]). In this regard, the connection between scanning/reader device and processor/computer is clearly conceptualised in the specification as a generic connection. Finally, the claimed processor/computer can send messages to a remote mobile device which may be a mobile device receiving a text message (paragraph [0037]). With reference to the figures that I have identified above, the architecture of the claimed invention is not defined or constructed to any further level of specificity. The active ID device can attach in any way to the package; any appropriate scanner can be used to read the active ID device; the scanner/reader can communicate in any appropriate way with a processor and the processor can communicate in any appropriate way with a mobile device.
Following the discussion above, it appears clear to me that none of the devices present which implement the claimed invention, have a specific construction. They each appear to me entirely generically constructed and are performing their usual task in the normal and generic manner. For example, my plain understanding of active ID tags is that they are simply attached to packages to allow automatic electronic tracking of information. These tags would inevitably be read by reader devices which communicate with processors/computers. Furthermore, computers are no doubt notoriously internet/network capable and thus inevitably arranged in potential communication with further mobile devices over such a generic connection. Thus, in short, I fail to see a device of particular construction in accordance with paragraph [98] of Aristocrat ’20, the claimed invention in Aristocrat ’20 including a well-defined and specifically constructed gaming machine that was subject to regulatory standards that imposed certain requirements on its construction.
While to some degree the electronic nature of the invention is “characterised” in that there is present in the claim an active ID device, this does not amount to the presence of a device of particular construction. Instead what is present in the claimed invention is a general-purpose package scanning system which includes a generic active ID device. Placing an active ID device on a package to electronically gather data about the package does not, on the face of the specification, appear substantially different in its generality to using, for example, a wireless mouse or a wireless keyboard to input data in a generic computer. In other words, the active ID device and the reader as described in the specification are no more specific than a wireless mouse or keyboard. While the use of a particular physical arrangement to input data could be said to be a “characterised” device, or a characterised method of inputting data, I do not see present a device or machine of particular construction comprising well-specified technological construction with a specific set of physical features that combine to produce a single purpose function, as was the case in Aristocrat ’20. While in Aristocrat ‘20, the physical gaming machine can only be used to play games, in the present case, the physical system as a whole can (e.g. through appropriate programming) be used for a variety of different functions where reading information from active ID devices is involved.
Following this logic, I fail to see a specific combination of physical devices having a specific manner of interacting with each other to produce a system or machine of particular construction. In the claimed invention, information is passed from one device to another in the plain and generic way of each of the devices operating as they would individually, to implement the relevant method. Each physical device forming part of the system is not altered in how it performs a particular step or the result that it produces through association with other steps of the method, the only thing linking them together being the method that is performed. The physical elements of the claim appear to work more as a concatenation of generic technological operations that serve to implement the claimed method.
A further useful analogy here might well be the claiming, for example, of the normal functions of data gathering, data modification and data delivery by way of the use of a computer scanner to gather data by scanning a document, a keyboard to modify said data, and a mobile device to receive an email containing said modified data. None of these well-known technological elements described in a generic manner would constitute a device of specific construction consistent with Aristocrat ’20. It is also not the case that the way these elements combine to produce a system generally interacting with a processor or processing steps could lie in a machine, device, or system of particular construction or character. Such an exemplary system, similarly to the arrangement of technical elements of the presently claimed invention, would constitute a general-purpose computer system.

The applicant expands on the submission I identify above by noting:
“…the examiner errs in considering the conventionality of each component of the system individually and in failing to consider the integration of the physical components with the software into a system having particular character… although the individual system components may be known, the working interrelationship of the claimed combination is not… the specific combination of software and hardware components, and their claimed interaction, forms the substance of the invention. The overall product is a system of particular construction with new functionality.”
The problem I see with this submission is that I cannot identify a particular working interrelationship between the components. Each of the components simply performs its usual task, the overall physical “system” not being anything more than the sum of its individual and generic parts. The role of the memory/processor (computer) in the claim and the use of newly functional software amounts to the analysis of data that has been gathered from the package and subsequent determination of a relevant alert that may be sent to a generic mobile device. As such, there is nothing I can identify that I could label as something specific about the combination of software and hardware, nor can I identify anything specific about the “integration” of components.
Relevantly to this point, the applicant suggests that the active ID device and the reader device function together with the processor to alert the delivery person as to when to commence delivery of a medication. The applicant further notes that the active ID and reader device are configured to communicate and trigger the processor only when in proximity of each other, therefore the delivery person is provided with data concerning delivery only when moving into proximity of that delivery. Consistent with my discussion above, the active ID device and reader are simply informing the processor that information has been detected, the processor then decides what to do with this information. The function of an active ID device to provide data when in proximity to a reader is, as far as I am aware and as I glean from the generic nature of the specification in particular paragraph [0027], precisely the generic function of such technology. When an active ID tag is brought close to a reader, then data may inevitably be automatically read. There is nothing further in the claim that provides for a device of particular construction in this regard.
The applicant also makes note that it is non-conventional for both an active ID device and a medication to be arranged in the claimed manner. Whether or not it is conventional to attach an active ID to a package wherein that package contains a medication (and not some other contents) appears to divert from the proper task of considering the specificity of construction of the device in question as per Aristocrat ’20. On the face of the specification, and applying a common sense understanding of technology, it does appear entirely generic to attach an active ID to a package (or for that matter any kind of object), in order to automatically track it and gather information about the package and/or its contents. What is inside the package cannot in and of itself, in my opinion, give rise to a device of particular construction.
In summary, the technological architecture as defined in the claimed invention as identified above is as follows:
·     an active ID device affixed to a package
·     a reader device receiving information about the package/contents automatically when the active ID device is in proximity to the reader
·     a memory/processor (computer) that receives information from the active ID device via the reader
·     a remote mobile device which receives a message from the computer.
I do not consider that this system comprises a device or system of particular construction or specific character within the meaning of Aristocrat ’20. Instead I consider the system is a straightforward arrangement of generically defined devices that normally are intended to be arranged in such way, each device performing its normal function, there being no well-specified machine similar to that in Aristocrat ’20. Instead, the claimed physical system can be considered akin to the claimed physical system in Rokt for example, where present in the claimed invention were a series of computers connected over a network incorporating a technical step of extracting data from a user interface interaction via the use of a “widget” delivered to a client device with web-based content, wherein data was transferred between those computers. Such an architecture failed to transform the advertising scheme of Rokt into a patentable invention.
It follows that I find with respect to the first question posed in Aristocrat ’20, that the claimed invention is for a scheme and thus must further thoroughly consider the claimed invention in light of the principles of RPL Central and Research Affiliates.

Broader considerations: Question 2 of Aristocrat ‘20
In accordance with my finding that the first question in Aristocrat ’20 is answered in the affirmative, I consider the claimed invention to be well represented in the specification by the scheme of FIG. 3 presented above. At the same time, I consider further features can be added to the visual depiction in FIG. 3 consistent with the scope of the claimed invention in more completely identifying the substance of the claimed invention. In this regard, before step 302, included within the substance of the claimed invention is the idea of providing information on a package containing medication and reading this information when the package is within the proximity of a certain reading location, this information is then received at step 302. With reference to my earlier discussion of the applicant’s submissions, these further features that can be added to FIG. 3 appear from my reading of the specification as implemented using a generic computerised tool of an active ID device and reader. This tool acts as an intermediary for the relevant method step. The tool provides the well-known and generic benefit of automation of such a step of location based information reading and transfer in the same manner that the memory and processor (computer) are used in the claimed invention for their well-known and generic benefit of fast data processing, and the remote mobile device is used for its well-known and generic benefit of efficiently and remotely receiving important information from computing devices.
Considering a number of other factors compiled from the RPL Central and Research Affiliates decisions identified above at paragraph 26, it appears clear to me from the specification and the discussion of the relevant technological components that there is no ingenuity in the manner in which the computers or technology is utilised, the elements themselves being generic and not combining as a system to produce any improvement in computer technology. Instead, the thrust of the specification appears to relate to the nature of data/information analysis to present alerts, this being exemplified in embodiments discussed with respect to the formulation and delivery of medications comprising for example, Vancomycin and Cefazolin. None of the steps are foreign to the normal use of computers, active ID devices and readers, each element of the system functioning in its normal way. In this regard, the invention appears to be in substance directed toward the data that is being processed and the decisions that are being made about that data such that certain alerts may be provided. On the face of the specification, the ingenuity of the invention appears to relate to the analysis, generation, and presentation of information.
I concede that such a concept described at a high level may not necessarily lack for a manner of manufacture, for example when further incorporating technical features which address a technical problem. Such a concept may also provide an effect that one might consider practical or useful in the broad sense (e.g. the effective scheduling of delivery of medicines). On this basis, further consideration is necessary to determine, for example, if the substance of the invention is technical in nature. In this regard I will now look to the problem that the claimed invention seeks to solve as a matter of substance, and the effect of this invention as a matter of substance.
The applicant submits that the claimed invention addresses a technical problem with the transmission of potentially large quantities of data to a mobile electronic device. They suggest that:
“In the absence of the claimed proximity detection between the reader and ID devices it would be extremely difficult to determine which alerts to provide to the delivery person and when to provide them. This is particularly true if the reader device is configured to receive information from multiple medication ID devices and/or multiple location ID devices.”
“The present invention provides a solution to this problem, by first determining that the reader device is within proximity of the medication to be delivered before providing the notification… the medication being within the proximity of the reader kicks off several automated queries to facilitate a determination of whether and when a notification should be delivered, all without user involvement. As such, only information required by the delivery person at that particular moment in time (i.e. when the delivery person is about to commence delivery of the first medication) is transmitted to the mobile device.”
The applicant argues that the effects of the claimed invention are:
·     Reduced burden on the user who might otherwise receive multiple arbitrary notifications related to every medication ready for delivery
·     This leads to a reduction in transmission of unwanted information
·     This reduction in transmission leads to reduction in overall bandwidth required for the relevant wireless interface
·     This further leads to the reduction in processing power required by the processing device
·     The processing steps add clear advantages in ensuring delivery of urgent medication orders in a timely and efficient manner
In summary, the applicant argues that the claimed invention produces a technical solution as it involves the use of proximity detection for the selective transmission of data over a wireless interface to an electronic device.
First of all, I am not satisfied that the claimed invention, as a matter of substance, addresses a technical problem with potentially large quantities of data being transmitted to a mobile electronic device. In this regard, there are no limitations to the technical capability of data transmission to a mobile device that are addressed or solved by the claim. The claimed invention seeks to send appropriate and timely pieces of information to a delivery person. The issue that there may be large quantities of data that may be sent to a delivery person is not a limitation in the technology, but simply a problem of management of information/logistics. That is, there might be too much information, so the skilled addressee needs to come up with a way of potentially producing less information.
The solution to this problem, as a matter of substance, includes the concept of providing a notification to a delivery person when a medication to be delivered is within proximity of a reading location. This solution, as discussed above, is implemented in the claimed invention using generic technology, being the active ID device and associated reader. While the generic technology provides the benefit of automation without user involvement, this amounts to the generic technology being merely used for its typical or well-known function. In other words, the substance of the invention involves identifying and reading information when a first medication is at a particular location and following this reading, subsequently implementing the steps of analysing information to arrive at an appropriate piece of advice for the delivery person to follow. So, while the delivery person is provided with improved information at the appropriate moment, I see this benefit as simply arising in the logistics or information analysis steps of the scheme. While the claimed invention as a matter of form makes it potentially easier and faster to generate alerts than those that may be generated manually, this is only by means of the automation of the steps of the scheme using computer technology for its basic function.
Such a conclusion is supported by reflection upon the specification which itself presents the issues solved by the invention to relate to the management of delivery actions discussed in the summary of the invention (paragraphs [0007]-[0009]). Here it appears that the specification addresses the issue that a delivery person may see a first medication is ready for delivery without being sufficiently informed that a potentially more urgent medication is almost ready for delivery. The solution to this problem, as a matter of substance, is the sequence of steps whereby when a first medication is read in a particular location, then a sequence of analysis steps is performed (FIG. 3) to determine if the delivery person should be told to wait, or not, before performing a delivery. I do not consider this to be technical subject matter.
Turning now to the effects of the invention identified by the applicant, I make the following observations:
·     The fact that there might be a reduced burden on a user (in the form of a delivery person) who might otherwise receive multiple arbitrary notifications related to every medication ready for delivery is merely a benefit arising in the optimum generation of information to a delivery person. This benefit is cognitive and administrative. It is not an effect commensurate with patentability.
·     There is no improved effect arising in the transmission of information as such. The substance of the invention may provide for optimisation of information with an effect of less information being sent but again this effect is insufficient to confer patentability.
·     The specification and the claimed invention do not appear to seek to address issues of bandwidth. The bandwidth of transmission is not improved in any way, it is only the information itself that may be improved. Similar can be said in relation to the processing power of the device. The substantive effect overall in the present invention is that relevant information is easier to obtain and can be provided more efficiently. This may lead to the more efficient delivery of medications. However as above, such an effect in not sufficient to confer patentability. The invention as a matter of substance, lies in a realm of merely organising human activity (Research Affiliates at [57]).
·     The processing steps add clear advantages in ensuring delivery of urgent medication orders in a timely and efficient manner, but these benefits lie in a mere scheme in the realm of administration and logistics of package/medication delivery and not in a realm of technical endeavour. While the mere scheme itself can be said to be “practical and useful”, this is insufficient for a positive finding of patentability (see Repipe Pty Ltd v Commissioner of Patents [2019] FCA 1956 at [39], Research Affiliates at [114] and RPL Central at [40]). This scheme is merely implemented using generic tools. There is no ingenuity as far as I can see in the use or function of technology.
Therefore, considering all the factors discussed above, I find that the claimed invention defined in the independent claims is directed towards a mere scheme. On a reading of the whole of the specification, the claimed invention does not seek to improve computer technology or overcome any particular technical problems. The claimed invention overcomes administrative/logistical problems associated with delivery persons not being appropriately informed of necessary deliveries by applying a scheme that gathers and analyses data and provides an instruction to a delivery person. While technical and scheme elements are present in the claimed invention, on balance, the substance of the invention lies in a scheme. This scheme is implemented in a general-purpose computer system and no inventive ingenuity in the implementation can be identified.
I have further considered each of the dependent claims. In summary, all of these claims further define the mere scheme by features relating to concepts such as: the definition of locations such as a pickup location; the definition of a preparation status as a location; information comprises delivery locations; comparison between information is based on a degree of urgency, delivery deadlines, time to prepare and time required to deliver a medication; notifications include a degree of urgency, time to prepare a medication; and, requesting that a second medication be delivered. None of the dependent claims seek to further characterise any technological components of the invention in the independent claims. Thus, my finding as to patentability is consistent with the nature of the claimed invention across all of the claims and is further supported by the specification which describes the use of computerised components only in generic terms.
My analysis of the specification early in this decision provides a clear picture of the nature of the subject matter described in the whole of the specification. I consider it clear that there is nothing further described in the body of the specification that could render the claims for a manner of manufacture if amended.
CONCLUSION
64. I conclude that the claimed invention, as a matter of substance, is not for a manner of manufacture. My analysis of the specification early in this decision provides a clear picture of the nature of the subject matter described in the whole of the specification. The claims as they currently stand are simply directed towards a scheme for managing medication delivery involving particular notifications. While it is not immediately apparent to me the particular manner in which the applicant may seek to amend, like the situation in Rokt Pte Ltd [2016] APO 66, the nature of such an amendment was not discussed at the hearing so I will provide a period in accordance with the Regulations for the applicant to consider amendments, this period being three (3) months from the date of this decision to gain acceptance.
Dr N. R. Madsen
Delegate of the Commissioner of Patents