CareFusion 303, Inc.
[2021] APO 12
•26 February 2021
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
CareFusion 303, Inc. [2021] APO 12
Patent Application: 2014268829
Title:Medication retrieval optimization
Patent Applicant: CareFusion 303, Inc.
Delegate: Dr S.D. Barker - Deputy Commissioner of Patents
Decision Date: 26 February 2021
Hearing Date: 29 September 2020 by videoconference. Further written comments were filed on 2 October 2020.
Catchwords: PATENTS – examiner objection – manner of manufacture – balance of considerations indicates the substance of the invention as claimed is a scheme – opportunity to amend
Representation: Patent attorneys for the applicant: Rachel Hooke, Manuel Schmidt, Michelle Cato of FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2014268829
Title:Medication retrieval optimization
Patent Applicant: CareFusion 303, Inc.
Date of Decision: 26 February 2021
DECISION
The invention as claimed is not a manner of manufacture. I allow the applicant the time remaining under regulation 13.4(1)(g) to propose amendments.
REASONS FOR DECISION
This matter arises under the Patents Act 1990 (the Act), and concerns patent application 2014268829 filed by CareFusion 303, Inc. on 16 May 2014. The application is presently undergoing examination. Four adverse reports have been issued, and the outstanding objections relates to the ground of manner of manufacture and allowability of amendments. The applicant asked to be heard in relation to the objections.
The specification
There are nine amendments proposed during the examination. Objection was raised to the allowability of amendment item 7. That amendment has been superceded by amendment item 9. In this decision I am considering the specification as proposed to be amended, and wherever I refer to the specification, it is a reference to the specification as proposed to be amended.
The invention as described
The field of the invention is the preparation of medications in a healthcare facility. In this environment it is often necessary for the facility to prepare medications for specific patient needs, as distinct from utilising medications in a form provided by a supplier. This is often required when the medication is in the form of an intravenous medication. The preparation of medications takes place in a pharmacy within the facility.
In general terms, the invention relates to a system for managing the retrieval of medication after it has been distributed but not used:
"The present disclosure generally relates to medication distribution, and, in particular, relates to systems and methods for managing retrieval of a prepared medication in a healthcare facility."[1]
[1] Specification at [0001].
The specification notes that a medication may be "discontinued" before use:
"In many instances, however, a medication for a patient may be designated as 'discontinued' after the medication has been prepared but prior to the infusion being administered to the patient. For example, a patient may be discharged while a medication is en route to the patient, and thus the medication will no longer be needed for the discharged patient. In such instances, an unused medication, which could have been reused to fill a new order for another patient, may remain at the discharged patient location or another location beyond an expiration date for the medication, thus causing the medication to go to waste."[2]
[2] Specification at [0005].
For the purposes of this decision I am treating this as a definition of discontinued in all instances as a medication that has not been used, even partially.
The retrieval that is envisaged involves the use of computers. The specification states that one aspect of the invention involves determining the location of unused medication and determining the order in which to retrieve unused medications.
"The method includes receiving an identification of a plurality of unused medications and a current location of each of the plurality of unused medications, and determining an order in which to retrieve at least two of the plurality of unused medications and return the at least two of the plurality of unused medications to a return location."[3]
[3] Specification at [0007].
The specification discusses using an ID device attached to the medication as part of this process:
"the system comprising: an active identification (ID) device affixed to respective packages of one or more medications prepared for delivery, the active ID device configured to transmit signals containing identification information through a wireless link; one or more reader devices configured to receive medication identification information via a signal generated and transmitted wirelessly from the active ID device when the active ID device is within a proximity of the one or more reader devices, without a scanning action performed by a participant"[4]
[4] Specification at [0011A].
The system provides a prioritisation of medications to be retrieved, and even suggest a route to locate the medications:
"The disclosed system provides a delivery person who is responsible for delivering and retrieving medications, such as infusion solutions, within a healthcare facility with a list of discontinued medications and their location in healthcare facility. The list of discontinued medications to be retrieved is ordered, for example, to identify an efficient route (e.g., based on distance, an urgency of retrieving a medication, etc.) for retrieving the discontinued medications. In certain aspects, if the delivery person is delivering medications to a particular area of the healthcare facility, then the list of discontinued medications can be ordered based on the areas to with the person is delivering. The delivery person may then retrieve the discontinued medications and return them to a workroom in the pharmacy."[5]
[5] Specification at [0020].
I infer that the purpose of retrieving unused medications is to enable reuse of the medication by a different patient:
"The determination can further be based on a likelihood of reuse of the unused package 70 or receipt of a new order for a medication that can be filled using the unused package 70."[6]
[6] Specification at [0037].
The process for managing the retrieval of medication is set out in Figure 3, reproduced here:
The nature of the system that carries out the process is very general, as shown in Figure 2:
The client 110 and the server 130 can be implemented on a computer, having the generic features shown in Figure 5:
The nature of this system is explained in general terms:
"FIG 5 is a block diagram illustrating an example computer system 500 with which the client 110 and server 130 of FIG 2 can be implemented. In certain aspects, the computer system 500 may be implemented using hardware or a combination of software and hardware, either in a dedicated server, or integrated into another entity, or distributed across multiple entities."[7]
[7] Specification at [0045].
The advantages of this system are twofold. First, the system provides a suggested route for a person to follow to retrieve medications (which would likely involve time savings). Second, the retrieval of discontinued medications can allow them to be reused rather than being wasted.
The specification provides an example of the operation of the system in Figure 1 by reference to how it could be used in the case of an anaesthetic IV solution. This example is essentially an explanation of what is in the Figures with reference to the name of specific medications. They assist understanding the concepts set out in the Figures. The example is not intended to provide precise instructions to create or use the system. The discussion relating to Figure 1 refers to using an ID device attached to the packaging of the medication, "such as a barcode label or a radio frequency identification (RFID) tag".[8] In the Figure, and all of the discussion, the ID device is exclusively a barcode label. The barcode label is manually scanned at different locations in the facility. Active ID devices are referred to as other embodiments.[9] Location information is storred in a database, along with information on patient name, medication name, scheduled delivery location, scheduled delivery time, expiration time for the medication, urgency of delivery, current location of medication, order status, return status.[10]
[8] Specification at [0022].
[9] Specification at [0029].
[10] Specification at [0031].
The program instructions encoded on the computer system may use
"any method well known to those skilled in the art, including, but not limited to, computer languages such as data-oriented languages (e.g. SQL, dBase), system languages (e.g. C, Objective-C, C++, Assembly), architectural languages (e.g. Java, NET), and application languages (e.g. PHP, Ruby, Perl, Python)"[11]
[11] Specification at [0048].
Other computer languages are also listed. The specification does not indicate a preference for any language.
The invention as explained
At the hearing the applicant provided further information about the way that the invention works. Most importantly, the applicant explained that a discontinued medication should be understood as a medication that has not been used to any extent.
The invention as claimed
The specification as proposed to be amended has 13 claims. The entire claim set is set out in the Annex to this decision. The claims are directed to a system, a method and a machine-readable storage medium. Claim 1 is reproduced here.[12]
[12] I have introduced some spacings and indentation between parts of the text to make the structure of the claim easier to understand.
A system for managing a retrieval of a prepared medication, the system comprising:
one or more active identification (ID) devices affixed to respective packages of one or more medications prepared for delivery, the active ID device configured to transmit signals containing identification information through a wireless link;
one or more reader devices configured to receive medication identification information via a signal generated and transmitted wirelessly from the active ID device when the active ID device is within a proximity of the one or more reader devices, without a scanning action performed by a participant;
a memory comprising instructions; and
one or more processors configured to execute the instructions to:
receive, via a network from a wireless bridge, identification information read from respective active identification devices affixed to respective packages of respective medications of a plurality of delivered medications as a result of the active identification devices passing within a proximity of the one or more reader devices, and the identification information being transmitted to the wireless bridge without a scanning action performed by a participant, the received identification information including a respective location within a healthcare facility of the respective medications;
determine, based on the received identification information, an identification of a plurality of unused medications that have been designated as discontinued before being administered to a patient, the plurality of unused medications including a first unused medication for a first patient that was delivered to the first patient’s location in the healthcare facility and is ready for retrieval from the first patient’s location, and a current location of each of the plurality of unused medications including an identification of each current location;
determine, based on receiving a new order for a medication that can be filled using the first unused medication, an order in which to retrieve the plurality of unused medications and return the plurality of unused medications to a return location based on an expiration date of at least one of the unused medications, an estimated amount of time to retrieve at least one of the unused medications, an estimated distance associated with retrieving at least one of the unused medications, a degree of urgency associated with at least one of the unused medications, and an estimated cost of at least one of the unused medications;
provide, to a mobile device remote from the system, for display by the mobile device, a listing of at least two of the plurality of unused medications based on the order for retrieving the at least two of the plurality of unused medications the listing including a graphical visualization of a route on a graphical map of the healthcare facility, the route indicating the order for retrieving the at least two of the plurality of unused medication from the respective current locations and returning the at least two of the plurality of unused medications to the return location, the visualization of the route being updated based on a current location of the mobile device.
The hardware elements of the system are simple to understand: readers for an ID device, a memory and a processor. The system also includes active ID devices attached to packages. The system receives information about orders for medication and unused medications. The system creates a list of medications to retrieve which is sent to a mobile device. A large amount of the claim relates to the criteria for determining the list.
Claim 7 is directed to a method for managing retrieval of a medication. The method has features that are also seen in claim 1. Claim 13 is directed to a machine-readable storage medium, which is characterised by the instructions it carries for a processor to carry out the steps of the method of claim 7.
The objection
The examiner formed the view that the substance of the claims is a scheme for retrieving medication, and consequently the invention defined by all claims is a scheme. The objection reads:
"The applicant submits that the claimed invention is 'not a mere scheme or business method'. Aristocrat Technologies Australia Pty Limited v Commissioner of Patents [2020] FCA 778 is cited in support of this argument, with further remarks that 'the invention may be characterised as a system of a particular construction which implements specific functions of medication tracking and routing. That is, the system is purpose-built to allow a user to track and route medications.'
However, I disagree that the invention may be characterised as a system of a particular construction, in that while the claimed system is certainly designed to allow a user to track and route medications, the underlying computer components are not specifically designed for that purpose.
In [0098] of Aristocrat, His Honour states (emphasis added):
'The result is that to the person skilled in the art, the invention may be characterized as a machine of a particular construction which implements a gaming function. It yields a practical and useful result. 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. In this regard, the 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 a specific character.'
As noted in [0069], claim 1 of the Aristocrat patent defines a 'gaming machine' that comprised a number of additional components. The gaming machine itself is the 'device of a specific character' that 'is built to allow people to play games on it' as 'its only purpose' (see also [0095]).
By contrast, the present invention only defines a set of integers that combine to implement a scheme. The complete specification makes no mention of any specific active identification device, reader device, memory or processor that has been designed for the sole purpose of performing the invention. As such, they do not define, either separately or in combination, a device of a specific character. They are merely well-known technologies linked together so as to implement the scheme of optimising the retrieval of unused medications, distributed across a healthcare environment, for use in the preparation of further medications.
Furthermore, the specification as a whole places no emphasis on the means of affixing the active ID devices to the packages. Paragraphs [0011A-C], [0022] and [0028] do not describe a specific method of attaching the ID devices to the packages, and as such, do not describe a specific device in the fashion of the specific gaming machine of Aristocrat. Instead, these paragraphs merely describe the generic attachment of one object to another. The claims of the present invention therefore have much more in common with those of the patent of Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86, which was found to be no more than a 'list of steps to be implemented using computer technology for its well-known and understood functions. Nothing in the specification suggests otherwise' [115].
The applicant further submits that the claimed invention provides 'a specific technical way to solve the problem of ensuring that urgent medications are timely delivered to patients under critical care' by allowing for 'optimized timing of delivery and/or retrieval of medications in combination with other medications.'
However, the optimisation is only achieved via the automation of communication between reader devices and active identifiers affixed to medication. This is not a problem of a technical nature or a technical way to implement the invention. It is merely the use of generic computer functionality to facilitate communication between two entities. As such, this is not an improvement in computer technology, and does not impart patentability onto the claimed invention.
The applicant suggests that 'the display of a graphical map is also a technical effect in itself, in that it changes the display of the computing device, which is then updated dynamically for the delivery person.'
However, this feature merely relates to the presentation of information, and as such is not technical. Nothing intrinsic about the graphical display itself is changed or updated; only the content of the information being displayed is changed.
The applicant argues 'it becomes readily apparent that the combination of technical features outlined above cannot be simply dismissed as forming part of the well-known and understood functions of a computer' and that 'the claims define a physical medication tracking system including a specific combination of technical elements which relate to each other in a specified way,' citing Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86 in support of this argument.
I confirm that the assessment this application has been made by a careful review of the specification as a whole. As part of the processing of assessing the substance, each and every feature must be considered independently to determine if there is any technical contribution in that feature. The assessment also involves consideration of the claims as a whole to determine any technical contribution in the combination, or arrangement of features. This approach was used in the examination of your application. That is, the features of the claimed invention have been considered independently and as a whole to determine the contribution to the art, hence the substance.
The combination of technical steps implementing the non-technical features does not result in any improvement to the computer or the functioning architecture of a computer. The specification does not provide specific technical details to indicate how the combination of the well-known functions of a computer result in the claimed invention contributing to a technical or material improvement in the computer or functioning of the computer. The combination of features is merely linked so as to implement the scheme, where the contribution to the art is considered to lie.
Therefore, in light of the above, I have concluded that the claimed invention, as a matter of substance, does not relate to patentable subject matter."
The examiner considered that the contribution of the invention is a scheme for providing information about medication to be retrieved.
The applicant's submissions
The applicant provided helpful written submissions. I will summarise some of those submissions.
·The system as a whole should be viewed as a device (or system) of particular construction. It is a new overall device.
·While the system contains generic components, the entire system cannot be characterised as generic.
At the hearing the applicant elaborated on these points. I will refer to these matters where relevant.
The law on manner of manufacture
Section 18(1) of the Act relevantly reads:
Subject to subsection (2), an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies;
The concept of manner of manufacture has developed over time, and is not readily reduced to a simple formula. The classic definition of manner of manufacture is set out in National Research Development Corporation v Commissioner of Patents:[13]
"The inquiry which the definition demands is an inquiry into the scope of the permissible subject matter of letters patent and grants of privilege protected by the section. It is an inquiry not into the meaning of a word so much as into the breadth of the concept which the law has developed by its consideration of the text and purpose of the Statute of Monopolies. ... The right question is: 'Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?' "[14]
[13] [1959] HCA 67, 102 CLR 252 (NRDC).
[14] NRDC at 269, [14].
The High Court then went on to set out a test in terms relevant to the facts of that case:
"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."[15]
and
"The effect produced by the appellant's method exhibits the two essential qualities upon which 'product' and 'vendible' seem designed to insist. It is a 'product' because it consists in an artificially created state of affairs, discernible by observing over a period the growth of weeds and crops respectively on sown land on which the method has been put into practice. And the significance of the product is economic; for it provides a remarkable advantage, indeed to the lay mind a sensational advantage, for one of the most elemental activities by which man has served his material needs, the cultivation of the soil for the production of its fruits."[16]
[15] NRDC at 275, [22].
[16] NRDC at 277, [25].
In Grant v Commissioner of Patents[17] the Full Court of the Federal Court considered whether a physical effect was required:
"A physical effect in the sense of a concrete effect or phenomenon or manifestation or transformation is required. In NRDC, an artificial effect was physically created on the land. In Catuity and CCOM as in State Street and AT&T, there was a component that was physically affected or a change in state or information in a part of a machine. These can all be regarded as physical effects. By contrast, the alleged invention is a mere scheme, an abstract idea, mere intellectual information, which has never been held to be patentable, despite the existence of such schemes over many years of the development of the principles that apply to manner of manufacture. There is no physical consequence at all."[18]
[17] [2006] FCAFC 120, 234 ALR 230 (Grant).
[18] Grant at [32].
The High Court has consistently made it plain that NRDC, and all other cases, were not laying down a precise formulation that can be applied unthinkingly:
"Nothing said in the Court's reasons for decision in that case can be taken as an exact verbal formula which alone captures the breadth of the ideas to which effect must be given."[19]
"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."[20]
[19] Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50, 253 CLR 284 (Apotex) at [83].
[20] D'Arcy v Myriad Genetics Inc [2015] HCA 35, 258 CLR 334 (Myriad) at [23].
That case-by-case approach must have regard to the substance of the claimed invention, not simply the form of the claim.[21] The point is made most succinctly by Gageler and Nettle JJ in the Myriad case:
"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."[22]
[21] Myriad at [6] and [88].
[22] Myriad at [144].
In Commissioner of Patents v RPL Central Pty Ltd[23] the Full Court of the Federal Court said the same thing in the context of a computer implemented invention:
"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. The basis for the analysis starts with the fact that a business method, or mere scheme, is not, per se, patentable. The fact that it is a scheme or business method does not exclude it from properly being the subject of letters patent, but it must be more than that. There must be more than an abstract idea; it must involve the creation of an artificial state of affairs where the computer is integral to the invention, rather than a mere tool in which the invention is performed. Where the claimed invention is to a computerised business method, the invention must lie in that computerisation. It is not a patentable invention simply to 'put' a business method 'into' a computer to implement the business method using the computer for its well- known and understood functions.
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."[24]
[23] [2015] FCAFC 177, 115 IPR 461 (RPL Central).
[24] RPL Central at [96] – [98].
The Full Court then went on to discuss a range of considerations that are helpful in the technology of the RPL Central case. The Full Court in Encompass Pty Ltd v InfoTrack Pty Ltd[25] did not find it necessary to revisit the correctness of RPL Central. These recent Full Court cases have focused upon the computer's role to ascertain whether the claimed invention involved "something more" than an abstract idea or scheme.[26]
[25] [2019] FCAFC 161, 372 ALR 646 (Encompass) at [7].
[26] Research Affiliates LLC v Commissioner of Patents [2014] FCAFC 150, 109 IPR 364 at [116], RPL Central at [96] and Encompass at [99]-[102].
In Aristocrat Technologies Australia Pty Limited[27] I summarised the considerations arising from RPL Central as:
[27] [2016] APO 49, 123 IPR 341.
"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."
Considering the context of the present invention, it is relevant to also note that methods of treatment of the human body are patentable:
"a method (or process) for medical treatment of the human body which is capable of satisfying the NRDC Case test, namely that it is a contribution to a useful art having economic utility, can be a manner of manufacture and hence a patentable invention within the meaning of s 18(1)(a) of the 1990 Act"[28]
[28] Apotex at [286].
What is the subject matter of the claims
The subject matter of the claims is straight forward. Claim 1 is directed to a system having several physical integers: active identification devices, reader devices, a memory, a processor and a mobile device. The system further has the means to receive input information about orders for medication. The system is programmed to create a list of medications to be retrieved. The list is sent to a mobile device along with a route for retrieving the medications. As already discussed, there are also claims directed to methods and machine-readable storage media. These different aspects are unified by the methodology of ordering the list.
Claim 7 is directed to a method for managing retrieval. It differs from the system claim in that it includes "returning the at least two of the plurality of unused medications to the return location". That is, this claim includes return of unused medication, but it does not go so far as to include use of the unused medication in the preparation of a new medication.
What is the contribution to the claimed invention
The specification provides little in the way of an explanation of the starting point for the development of the present invention. This is a pity. It appears that computer systems were used as a tool in the pharmacies of healthcare facilities. The nature of the computer systems is otherwise rather unclear, except that it seems they are unlike the system in the present application. At the hearing I suggested that principles of time management were well understood in the Australian community, and they would also have been part of the common general knowledge in all work places (including pharmacies and healthcare facilities).
In Aristocrat Technologies Australia Pty Limited v Commissioner of Patents[29] the Federal Court stated that a machine of particular construction which implemented a gaming function may be characterised as a machine and not a scheme:
"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. In this regard, the 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 a specific character."[30]
[29] [2020] FCA 778 (Aristocrat).
[30] At [98].
Consequently it was not necessary to consider the subsequent question of "whether the scheme has been 'put into a computer' ".[31]
[31] Aristocrat at [100].
In the present case, the system that implements the method is a network of servers and computing devices, along with readers and identification devices. The specification does not indicate whether or not the system, and its individual components, are able to carry out any other functions. If the system and its components were "locked down" so that the user could only carry out the single function of the method of the claims, I would expect to see something explicit in the specification. Unlike an electronic gaming machine, it seems more consistent with my experience of the world that the computing devices are able to perform additional functions, such as retrieving information from the internet, and routine office tasks such as receiving emails and reading documents. In the absence of clear language I am not prepared to infer that the system is a machine constructed to carry out a single purpose. It is not reasonable to view the system as a machine of particular construction.
The subject matter does not automatically dictate the substance of the invention, so it is necessary to consider the full range of considerations.
Does the invention as claimed solve a technical problem in the computer
The system is able to carry out the method. I do not consider that this represents the solution of a technical problem in the system. The specification does not otherwise suggest that the invention solves a technical problem in a computer or the system as a whole. I do not see any basis to consider that the invention solves a technical problem in a computer or the system.
Is there an improvement in the computer
The computers and the system as a whole are only improved to the extent that it can now carry out a function that it could not do previously. This in itself is not a relevant improvement when considering manner of manufacture.[32]
[32] Mere implementation on a computer is not sufficient: Repipe Pty Ltd v Commissioner of Patents [2019] FCA 1956 at [37], [44] – [47].
Does the invention use generic computer technology
Figures 2 and 5 indicate that the system is constructed of well known computing elements (each generic in itself). I cannot say whether the arrangement of the system as a whole (putting to one side the software elements) is normal.
Are there any steps foreign to the normal use of computers
The specification provides no details of how to implement the method on a computer system. This suggests that the applicant considers the method can be implemented using nothing more than the common general knowledge. Consequently I have no reason to believe that the system as claimed would utilise any steps foreign to the normal use of computers.
Is there a practical and useful result
The next question in this case is whether there is a practical and useful result. Not every result which might colloquially be considered useful is relevant. In Research Affiliates it was stated that it is not an artificial or patentable effect to merely implement a scheme:
"To take the words of NRDC at 268, the process does not produce 'either immediately or ultimately, a useful physical result in relation to a material or tangible entity.' The claimed method, the result of the ingenuity of the inventors, does not produce such a result; the ingenuity is in the scheme. Again, drawing from NRDC at 270, there is a useful result of the claimed process but there is no physical thing 'brought into existence or so affected as the better to serve man's purposes'. There is no 'physical phenomenon in which the effect, be it creation or merely alteration, may be observed' (NRDC at 276)."[33]
[33] At [114].
I note that the system displays an ordered list of medications. The mere presentation of information on a display is not sufficient, of itself, to provide a useful result.[34] However, the purpose of the system is to present improved information regarding retrieval of medicines in a pharmacy that will allow a reduction in the wastage of medicines.
[34] Consistent with the decision in Encompass.
It has been stated in a series of decisions involving applications by Bio-Rad Laboratories, Inc.[35] that an improved process that allowed a machine to be maintained operational had an artificial effect:
"the resulting reduction in the number of tests to be carried out and the reduction in the number of reference samples that are used are, in my view, 'artificial effects' "[36]
"I find the consequent reduced amount of current test sampling required to compute a variability estimate and establish a statistically valid assay range in this case is a physically observable effect within the meaning of that phrase as described in NRDC."[37]
[35] Bio-Rad Laboratories, Inc. [2017] APO 38 (Bio-Rad 2017), Bio-Rad Laboratories, Inc. [2018] APO 24 (Bio-Rad 2018), Bio-Rad Laboratories, Inc. [2019] APO 26 (Bio-Rad 2019).
[36] Bio-Rad 2018 at [57].
[37] Bio-Rad 2019 at [46].
The practical and useful result of reduced wastage is only achieved when the medications are retrieved and returned to the pharmacy in time to be reused. In the absence of timely retrieval and/or use by a pharmacist, there is no potential for such a result. I conclude that a practical and useful result can be achieved by the use of the system but is not assured.
Claim 7 is a method claim, that includes the additional feature of displaying a route for the retrieval of the unused medications. The presentation of this information could simplify the retrieval of unused medication, but there is no evidence to support this. In the absence of a demonstration that this is a helpful feature I am left with the feeling that it is just a bit of "bling" attached to the system.
Does the invention lie in the generation, presentation or arrangement of intellectual information
The invention involves the generation and presentation of information by ordering the list of medications for retrieval. However, the list is not simply intellectual information. The information is not presented so that the staff member can decide which medication to retrieve next. That decision has been made by the system, and the order has been optimised according to certain criteria. It is the order in which the medications will be retrieved in order to deliver the desired result. It is not fair to state that the invention lies merely in the generation and arrangement of intellectual information.
Balance of considerations
The invention uses generic computing technology to execute a scheme. The result lies in the field of pharmaceuticals, an area that is not inherently unpatentable.
The process has an element that is carried out by a system (the ordering of the list), and an element that is carried out by a person (retrieving the medications). Overall the process can achieve a practical and useful effect in reducing wastage of pharmaceutical material. This effect is more than a serendipity – it is the intended outcome of the logic in the ordering of the retrievals. However, claim 1 is not limited to situations in which this advantage is assured.
It is useful to consider where the ingenuity lies.[38] There is no evidence of ingenuity in implementing the process on a system, or in preparing the system. This normally indicates that the ingenuity lies in the way that the list is ordered rather than the implementation. In Myriad it was noted that there was ingenuity in the idea of looking for mutation in a person's BRCA1 gene. However, that was not sufficient to save the invention as it was further necessary to ask whether the claimed subject matter makes a contribution to that idea:
"Such ingenuity as that entails consists in the idea of examining an isolated fragment of a patient's naturally occurring DNA constituted of the BRCA1 gene for the presence or absence of the specified mutations and polymorphisms. The subject matter of the claim does not make any contribution to the inclusion of the specified mutations and polymorphisms in the mutated BRCA1 gene"[39]
[38] Ingenuity being that which adds to the sum of human knowledge: Myriad at [130].
[39] Myriad at [134].
In the present case it is hard to be sure whether there has been ingenuity in recognising a shortcoming in any existing system and identifying the need to either retrieve unused medications or alter the order in which the medicines are retrieved.
It is logical that the ordering of the list could be carried out manually, but as the invention is dealing with time critical steps (so as to avoid wastage of pharmaceuticals), the use of a computer to carry out its steps is an integral part of the way that the invention works and contributes to the invention.
There are thus some considerations suggesting that the contribution is a system, and others suggesting that it is a scheme that is implemented on a system. I note that it is the details of the scheme that are stressed in the description indicating that the locus of the ingenuity lies in the scheme for ordering the orders to be retrieved rather than in the system. However, there is the potential for a practical and useful result of the kind that is recognised by the patent system. The invention defined by claim 1 is potentially linked to this result, but the result is not guaranteed. Consequently the weight that I give to this consideration is minimal. I conclude that the contribution to the invention of claim 1 is a scheme. The same conclusion applies to the claims that are appended to claim 1: claims 2 – 6.
The invention defined by claim 7 is directed to a method which includes retrieving at least two unused medications. The method is particularly characterised by displaying a route to retrieve the medications. This feature could lead to improved retrieval of medications, or it could be just a bit of "bling". I am not satisfied that any particular weight should be given to this aspect of the invention. The contribution to the invention of claim 7 is a scheme. The same conclusion applies to claims 8 - 12.
The invention defined by claim 13 is a machine-readable storage medium. The balance of considerations for this claim follows from the consideration of claim 1.
Conclusion
In relation to the invention defined by all claims the contribution to the invention is a scheme, which is not a manner of manufacture.
This conclusion arises because the weight accorded to the practical and useful result is insufficient to disturb the balance of considerations. It might be possible to amend the claims to improve this balance. It is appropriate to allow the applicant the opportunity to try to amend the specification in line with this decision.
Dr S.D. Barker
Deputy Commissioner of PatentsANNEX: Claims as proposed to be amended
WHAT IS CLAIMED IS:
1. A system for managing a retrieval of a prepared medication, the system comprising:
one or more active identification (ID) devices affixed to respective packages of one or more medications prepared for delivery, the active ID device configured to transmit signals containing identification information through a wireless link;
one or more reader devices configured to receive medication identification information via a signal generated and transmitted wirelessly from the active ID device when the active ID device is within a proximity of the one or more reader devices, without a scanning action performed by a participant;
a memory comprising instructions; and
one or more processors configured to execute the instructions to:receive, via a network from a wireless bridge, identification information read from respective active identification devices affixed to respective packages of respective medications of a plurality of delivered medications as a result of the active identification devices passing within a proximity of the one or more reader devices, and the identification information being transmitted to the wireless bridge without a scanning action performed by a participant, the received identification information including a respective location within a healthcare facility of the respective medications;
determine, based on the received identification information, an identification of a plurality of unused medications that have been designated as discontinued before being administered to a patient, the plurality of unused medications including a first unused medication for a first patient that was delivered to the first patient’s location in the healthcare facility and is ready for retrieval from the first patient’s location, and a current location of each of the plurality of unused medications including an identification of each current location;
determine, based on receiving a new order for a medication that can be filled using the first unused medication, an order in which to retrieve the plurality of unused medications and return the plurality of unused medications to a return location based on an expiration date of at least one of the unused medications, an estimated amount of time to retrieve at least one of the unused medications, an estimated distance associated with retrieving at least one of the unused medications, a degree of urgency associated with at least one of the unused medications, and an estimated cost of at least one of the unused medications;
provide, to a mobile device remote from the system, for display by the mobile device, a listing of at least two of the plurality of unused medications based on the order for retrieving the at least two of the plurality of unused medications the listing including a graphical visualization of a route on a graphical map of the healthcare facility, the route indicating the order for retrieving the at least two of the plurality of unused medication from the respective current locations and returning the at least two of the plurality of unused medications to the return location, the visualization of the route being updated based on a current location of the mobile device.
2. The system of any claim 1, wherein the order is determined based on an estimated amount of time to retrieve each of the plurality of unused medications and a degree of urgency associated with at least one of the plurality of unused medications.
3. The system of claim 2, wherein the one or more processors is further configured to execute the instructions to associate a priority value to each of the plurality of unused medications, wherein the priority value is based on at least one of the expiration date of each of the plurality of unused medications, the estimated amount of time to retrieve each of the plurality of unused medications, the degree of urgency associated with each of the plurality of unused medications, the cost associated with each of the plurality of unused medications, and the estimated distance to retrieve each of the plurality of unused medications.
4. The system of claim 3, wherein the order in which to retrieve at least two of the plurality of unused medications is determined according to respective priority values of each of the at least two of the plurality of unused medications.
5. The system of claim 2 or claim 3, wherein the listing is provided for display on a mobile device, and wherein the estimated distance to retrieve each of the at least two of the plurality of unused medications is determined based on a current location of the mobile device.
6. The system of any one of the preceding claims, wherein the order is determined based on at least one of a likelihood of reuse of each of the plurality of unused medications, or receipt of a new order for a medication that can be filled using at least one of the plurality of unused medications.
7. A method for managing a retrieval of a prepared medication, the method comprising:
providing one or more active identification (ID) devices affixed to respective packages of one or more medications prepared for delivery, the active ID device configured to transmit signals containing identification information through a wireless link;
configuring one or more reader devices to receive medication identification information via a signal generated and transmitted wirelessly from the active ID device when the active ID device is within a proximity of the one or more reader devices, without a scanning action performed by a participant;
receiving, by one or more computing devices, via a network from a wireless bridge, received identification information read from respective active identification devices affixed to respective medication packages of a plurality of delivered medications as a result of the active identification devices passing within a proximity of the one or more reader devices, and the identification information being transmitted to the wireless bridge without a scanning action performed by a participant, the received identification information including a respective location within a healthcare facility of the respective medications;
determining, by the one or more computing devices, based on the received identification information, an identification of a plurality of unused medications that have been designated as discontinued before being administered to a patient, the plurality of unused medications including a first unused medication for a first patient that was delivered to the first patient’s location in the healthcare facility and is ready for retrieval from the first patient’s location, and a current location of each of the plurality of unused medications including an identification of each current location;
determining, by the one or more computing devices, based on receiving a new order for a medication that can be filled using the first unused medication, an order in which to retrieve the plurality of unused medications and return the plurality of unused medications to a return location based on an expiration date of at least one of the unused medications, an estimated amount of time to retrieve at least one of the unused medications, an estimated distance associated with retrieving at least one of the unused medications, a degree of urgency associated with at least one of the unused medications, and an estimated cost of at least one of the unused medications; and
providing, by the one or more computing devices, to a mobile device remote from the one or more computing devices, for display by the mobile device, a listing of at least two of the plurality of unused medications based on the order for retrieving the at least two of the plurality of unused medications the listing including a graphical visualization of a route on a graphical map of the healthcare facility, the route indicating the order for retrieving the at least two of the plurality of unused medication from the respective current locations and returning the at least two of the plurality of unused medications to the return location, the visualization of the route being updated based on a current location of the mobile device.
8. The method of claim 7, wherein the order is determined based on an estimated amount of time to retrieve each of the plurality of unused medications and a degree of urgency associated with at least one of the plurality of unused medications.
9. The method of claim 8, further comprising associating a priority value to each of the plurality of unused medications, wherein the priority value is based on at least one of the expiration date of each of the plurality of unused medications, the estimated amount of time to retrieve each of the plurality of unused medications, the degree of urgency associated with each of the plurality of unused medications, the cost associated with each of the plurality of unused medications, and the estimated distance to retrieve each of the plurality of unused medications.
10. The method of claim 9, wherein the order in which to retrieve the plurality of unused medications is determined according to respective priority values of each of the plurality of unused medications.
11. The method of any one of claims 7 to 10, wherein the listing is provided for display on a mobile device, and wherein the estimated distance to retrieve each of the plurality of unused medications is determined based on a current location of the mobile device.
12. The method of claim 7, wherein the order is determined based on at least one of a likelihood of reuse of each of the plurality of unused medications, or receipt of a new order for a medication that can be filled using at least one of the plurality of unused medications.
13. A machine-readable storage medium comprising machine-readable instructions for causing a processor to execute a method for managing a retrieval of a prepared medication, the method comprising:
configuring one or more reader devices to receive medication identification information via a signal generated and transmitted wirelessly from an active ID device affixed to a medication package when the medication package is within a proximity of the one or more reader devices, without a scanning action performed by a participant, wherein the active ID device is configured to transmit signals containing identification information through a wireless link;
receiving, via a network from a wireless bridge, received identification information read from respective active identification devices affixed to respective medication packages of a plurality of delivered medications as a result of the active identification devices passing within a proximity of the one or more reader devices, and the identification information being transmitted to the wireless bridge without a scanning action performed by a participant, the received identification information including a respective location within a healthcare facility of the respective medications;
determining, based on the received identification information, an identification of a plurality of unused medications that have been designated as discontinued before being administered to a patient, the plurality of unused medications including a first unused medication for a first patient that was delivered to the first patient’s location in the healthcare facility and is ready for retrieval from the first patient’s location, and a current location of each of the plurality of unused medications including an identification of each current location;
determining, based on receiving a new order for a medication that can be filled using the first unused medication, an order in which to retrieve the plurality of unused medications and return the plurality of unused medications to a return location based on an expiration date of at least one of the unused medications, an estimated amount of time to retrieve at least one of the unused medications, an estimated distance associated with retrieving at least one of the unused medications, a degree of urgency associated with at least one of the unused medications, and an estimated cost of at least one of the unused medications; and
providing, to a mobile device remote from the processor, for display by the mobile device, a listing of at least two of the plurality of unused medications based on the order for retrieving the at least two of the plurality of unused medications; the listing including a graphical visualization of a route on a graphical map of the healthcare facility, the route indicating the order for retrieving the at least two of the plurality of unused medication from the respective current locations and returning the at least two of the plurality of unused medications to the return location, the visualization of the route being updated based on a current location of the mobile device.
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