DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/13/2026 has been entered.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The priority of the instant application is:
Application #
Filed
Abandoned
Appeal
62/077,759
11/10/2014
11/10/2015
N
14/936,898
11/10/2015
2/12/2020
Y, Affirmed 101
16/780,307
2/3/2020
1/13/2023
N
The 14/936,898 Appeal Decision dated 12/4/2019 includes
From page 2:
THE INVENTION
Appellant's claimed invention is directed to a "pharmacy workflow management application" (Spec. 2: 12-13) used in "preparing a plurality of dose orders in a common batch according to a batch workflow" (Spec. 2: 13- 14 ).
From page 9:
Moreover, Appellant's purportedly improved abstract concept is still an abstract concept under the Guidance.
From page 10:
Accordingly, we determine the claim does not integrate the judicial exception into a practical application.
We agree with the Examiner that the claimed elements and combination of elements do not amount to significantly more than the judicial exception itself.
From page 11:
Accordingly, we affirm the Examiner's rejection of independent claim 1, and independent claims 129 and 143 and dependent claims 2, 3, 5, 7-13, 130, 131, 133, and 136-141 not separately argued with particularity. See Appeal Br. 31-38.
The Examiner notes the similarity between the instant claims and the claims from priority application 14/936,898. The substance of the instant invention has not changed since the Board’s decision.
Claim Objections
Claims 1 – 20 are objected to because of the following informalities: The Applicant does not mark the amended claim language. For example, “identifying an error state related to the dose order upon initiating a dose preparation protocol during a first processing;” was added with un-marked text. The Examiner is not aware of other amended text besides this limitation.
Appropriate correction is required.
Response to Amendment
In the amendment dated 3/13/2026, the following has occurred: Claims 1 and 11 have been amended.
Claims 1 – 20 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 – 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claim(s) recite(s) subject matter within a statutory category as a machine (claims 1 – 20) which recite the abstract idea steps of
a first database storing a plurality of different dose preparation protocols for associated compounded medication doses, each of the dose preparation protocols specifying
a name of the associated compounded medication dose,
at least one drug product,
at least one diluent product, and
operations for verifying the at least one drug product, the at least one diluent product, and the associated compounded medication dose;
a second database storing a plurality of dose order records, each dose order record specifying at least
the name of the compounded medication dose,
a volume of the at least one drug product,
a final volume of the compounded medication dose,
wherein the data from the respective databases is used to
determine which of the plurality of dose order records include the same at least one drug product and the same at least one diluent product,
aggregate dose order records of the plurality of dose order records as a batch order for the dose order records that include the same at least one drug product and the same at least one diluent product,
select the dose preparation protocol from the first database that is associated with the aggregated dose order records,
modify the dose preparation protocol based on an amount of the aggregated dose order records by
determining a total volume of the at least one drug product by summing the volume of the at least one drug product that is specified by each of the aggregated dose order records,
determining a total volume of the compounded medication doses by summing the volume of the compounded medication dose that is specified by each of the aggregated dose order records,
determining a total volume of the at least one diluent product by subtracting the total volume of the at least one drug product from the total volume of the compounded medication doses, and
applying the determined total volume of the at least one drug product to a first verification step of the operations for verifying the at least one drug product from the selected dose preparation protocol,
applying the determined total volume of the at least one diluent product to a second verification step of the operations for verifying the at least one diluent product from the selected dose preparation protocol,
applying the determined total volume of the compounded medication doses to a third verification step of the operations for verifying the total volume of the compounded medication from the selected dose preparation protocol,
creating a fourth verification step indicative that the compounded medication doses are provided in a separate container for each of the aggregated dose order records, and
updating at least some of the operations based on the total volume of the at least one drug product, the total volume of the compounded medication doses, and the total volume of the at least one diluent product, and
create a batch workflow using the modified dose preparation protocol;
a dose compounding station designed to
receive the batch workflow and the batch order,
list a first verification step for the total volume of the at least one drug product,
list a second verification step for the total volume of the at least one diluent product,
list a third verification step for the total volume of the compounded medication doses,
list a fourth verification step,
accessing a dose order record corresponding to a dose order;
identifying an error state related to the dose order;
receive an input indicative of a resolution of the error state;
verifying that the error state of the dose order record has been appropriately resolved; and
requeuing the dose order record upon verification of successful resolution of the error state of the dose order record.
The newly amended claims state that that that an alert is generated when there is an error state related to the dose order. However, how that error state is determined is not claimed. The specification also does not show how these error states are determined. It is understood that this error state determination is a manual operation performed by a user. The instant claims have this user “identifying an error state.”
These steps of claims 1 – 20, as drafted, understood as a whole and understood in the broadest reasonable interpretation in light of the specification, includes methods of organizing human activity. As stated within paragraph 3, “However, further developments would be beneficial to assist in improvements to the pharmacy workflow management application to promote efficiency, reliability, and accuracy related to the preparation and management of medication dose orders.” As stated within paragraph 70, “The present disclosure contemplates a pharmacy workflow management application that may facilitate pharmacy workflow management in relation to preparation of one or more doses at a pharmacy, hospital, or other facility at which doses are prepared for administration to a patient.”
As stated in MPEP §2106.04(a)(2)II. CERTAIN METHODS OF ORGANIZING HUMAN ACTIVITY
The phrase "methods of organizing human activity" is used to describe concepts relating to:
fundamental economic principles or practices (including hedging, insurance, mitigating risk);
commercial or legal interactions (including agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, and business relations); and
managing personal behavior or relationships or interactions between people, (including social activities, teaching, and following rules or instructions).
The invention is not directed toward a technological improvement or a technical improvement. The invention is directed at an improved “workflow management application” which is software used to overcome a workflow problem. In other words, it is the application of technology to the abstract idea.
Specification, paragraph 90
[0090] One embodiment of the present invention, involves presenting the dose preparation protocol to the operator in the form of a number of physical steps that must be performed in order to prepare the dose. As the operator performs each step or selected steps, verification that such step was performed must be entered by the operator or otherwise be confirmed by equipment that captures certain information presented by the operator. If during any step, a verification error arises and there is a question as to whether the step was properly performed, the dose order processing is prevented from continuing to the next step until the step is verified as being properly performed or until the dose order is flagged as being not completed due to an error. If this occurs, the operator can then receive the next dose order in the dose order queue for that particular workstation and start the dose preparation process for this new dose order. Thus, the operator may be presented with a recipe in which several, if not all, steps that are performed have the operator are interrogated to provide information that better ensures that each step was performed in accordance with the protocol. As discussed below, certain steps can be recorded by using one or more cameras or other equipment and thus, a record is compiled and saved for each dose order in case there is every any question as to the integrity of the dose order and whether an error was made in processing the dose order.
As discussed in the interview dated 1/11/2024, “applying” is a math operation performed after a user enters data into a computer. Also, the drug product and the diluent “is prepared” steps are potentially performed by the user.
The instant invention is applied to a technology. The inventive improvement is achieved only after the abstract idea is applied to technology in order to achieve the benefits of applying the abstract idea to technology. 2106.05(f) Mere Instructions To Apply An Exception (2) Whether the claim invokes computers or other machinery merely as a tool to perform an existing process.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 10 and 12 – 20, reciting particular aspects of how creating a label may be performed but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of a terminal or a server amounts to invoking computers as a tool to perform the abstract idea, see applicant’s specification paragraph 71), see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of access a plurality of dose order records amounts to mere data gathering, recitation of operative to print amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10 and 12 – 20, additional limitations which amount to invoking computers as a tool to perform the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The Examiner notes that the invention is directed toward providing better data. For example, the invention determines which constituents can fit into a container but the invention does not fill the container. For example, the invention determines the compounding order but does not actually compound the components. The end result is that the invention is directed to, as stated in paragraph 4, “In view of the foregoing, the present disclosure is generally related to various embodiments of pharmacy workflow applications.” Better data has a potential application and not a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 20; access a plurality …, receive, from a user by way of a user input ..., , e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); operable to receive … a product scan, e.g., electronic scanning or extracting data from a physical document, Content Extraction, MPEP 2106.05(d)(II)(v)
Additional Elements:
Computer system / workstation–
[0086] With returned reference to FIG. 1, local system 110 may also include a user interface 108
[0072] The local node may comprise one or more devices that may include hardware and/or software that may execute machine readable instructions stored as machine readable non-transitory data in a memory. The machine readable instructions, when executed by a processor may provide functionality related to the pharmacy workflow management application discussed herein. In this regard, the pharmacy workflow management application may include one or more processors operative to access machine-readable data stored in a storage medium (i.e., a memory) that provide instructions to the one or more processors for execution to provide the functionality described herein.
[0075] With initial reference to FIG. 1, a system 100 is depicted that includes a plurality of local systems 110. The local systems 110 may each comprise a local node in the system 100. The local systems 110 may each execute a pharmacy workflow management application 114. For instance, each local system 110 may include at least one local device executing a client application for providing functions related to the pharmacy workflow management application. As shown in FIG. 1, a plurality of local systems 110 may be provided that are each in operative communication with a central server 120. For example, the local systems 110 may be in operative communication the central server 120 by way of a wide area network 50 (e.g., the Internet).
[0078] A local system 110 may include a local database 112 for storage of information. As may be appreciated, the local database 112 may in fact include a collection of one or more databases collectively defining the local database 112. In an implementation of the present invention, the local system 110 may include a server that facilitates access to the database 112. The database may store data related to the current in process work and/or store archival data related to prior work completed at the pharmacy. The local database 112 may be a high-performance, highly scalable and SQL-compliant object database. In this regard, the database may scale easily to handle thousands of simultaneous users and potentially terabytes of data.
[0086] With returned reference to FIG. 1, local system 110 may also include a user interface 108. The user interface 108 may be generally operable to present and receive information associated with the batch workflow per the operation of the pharmacy workflow application 114.
Scanner –
From paragraph 92, “Conventionally scanning equipment can be used to scan ( e.g., a barcode) the product and then the user may be prompted to enter the Product Lot Number that is provided and the user may then enter the Product Expiration Date.
Weight Scale – It should be emphasized that the originally filed invention only includes “weight scale” within the original claims (1, 2, 8 – 12, and 18 – 20). More information about a pharmaceutical scale must come from outside the disclosed invention including the Royal Pharmaceutical Societies publication “Balances, Weights and Measures” taken from the “From S Maw, Son and Thompson’s 1882 wholesale catalogue.”
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 10 and 12 – 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
In sum, the specification is directed toward an improved workflow. The invention applies known technology to the abstract idea and achieves the benefits of applying that technology. There is no technological improvement and there is no technical improvement. The inventive concept between the parent application, 14/936,898 and the instant invention are the same. As stated in the parent application ‘898 12/4/2019 PTAB decision on page 11, “We agree with the Examiner that the claimed elements and combination of elements do not amount to significantly more than the judicial exception itself.”
Response to Arguments
Applicant’s arguments, see 35 U.S.C. § 112 Rejections, filed 3/13/2026, with respect to the rejection(s) of claim(s) 1 – 20 under 35 U.S.C. § 112 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. The Examiner notes again that the claim markings are not included.
Applicant's arguments filed 3/13/2026 have been fully considered but they are not persuasive
35 U.S.C. § 101 Rejections
The Applicant states, “The MPEP then goes on to recite non-limiting examples of claims which do not recite abstract ideas, including (emphasis added)
vi. a method of rearranging icons on a graphical user interface (GUI) comprising the steps of: receiving a user selection to organize each icon based on the amount of use of each icon, determining the amount of use of each icon by using a processor to track the amount of memory allocated to the application associated with the icon over a period of time, and automatically moving the most used icons to a position in the GUI closest to the start icon of the computer system based on the determined amount of use; and
The Examiner is aware of the full MPEP example. This includes the relationship between the icon and the memory. Features which are absent from the instant invention.
The Applicant states, “Even if, arguendo, the claim involves certain abstract ideas, the claim is not directed to the abstract idea. In the same way as the cited MPEP example, Claim 1 rearranges (requeues, in the instance of Claim 1), a location of a file based on received input, which is a non-abstract act having observable effect.” The Applicant is arguing three things. First, that the application of an abstract idea to technology makes the abstract idea less abstract. However, the courts have shown that this argument is not true. Second, that the movement of data is not a rearrangement. The data remains as data. Third, the comparison to the MPEP, in context, shows different fact patterns.
The Applicant states, “Here, the conclusory analysis provided in the Office Action does not establish the lack of a practical application or the integration of a judicial application into a practical application. Applicant respectfully submits that a preponderance of the evidence has not been provided in the Office Action to justify the rejection. For at least this reason, present Claim 1 is patentable.” The Examiner is certain of the claim. The result of the invention is data. That data has a potential application but not a practical application. The conclusion is based upon the claim itself.
The Applicant states, “Applicant has shown evidence that even the rearrangement of data has been found to involve eligible subject matter where that rearrangement is sufficient to show the claim does not recite the abstract idea when viewed as a whole, such as in the example of MPEP 2106.04(a)(l);” The Examiner stands by his understanding of the claimed invention in light of the specification.
The Applicant states, “For instance, at least the recitations discussed above, when viewed in the claim as a whole, involve the handling of error states by generating alerts, processing responses to the alerts, and requeueing dose orders according to the resolutions of alerts. None of these fit within the allegation that, "The result of the invention is data, " and such a conclusion squarely contradicts the noted findings under MPEP 2106.04(a)(1).” The Applicant’s opinion is noted. However, the instant invention does not rely upon memory usage when making decisions and therefore the fact patterns are different.
The Applicant states, “More recently, Director Squires co-authored an Appeals Review Panel (ARP) decision. Ex parte Desjardins.” The memo does not apply here for two very important reasons. First, the invention is not related to machine learning or artificial intelligence. Second, the instant invention is not a technological improvement. Further arguments directed towards Desjardins are moot.
The Applicant further states, “The ARP decision cited the Federal Circuit's 2016 Enfish, LLC v. Microsoft Corp. decision, which recognized that technical improvements can be found solely in software.” The comparison to Enfish is not correct because the Enfish specification describes the invention as a technological improvement to overcome a technical problem. The instant case shows the application of technology to the abstract idea. Further arguments directed towards Enfish are moot as the specification does not describe the invention as a technological improvement.
The Applicant states, “Applicant has previously noted that the claimed features, especially when viewed as a whole, and even if they could be said to relate to a software, recite a technical improvement over conventional pharmacy workflow application systems.” The Applicant’s opinion is noted. However, the Applicant’s opinion is not supported by facts.
The Applicant further states, “Applicant fails to see how a specification directed to data tables and software executing storage rules for that data table is any more of a technological improvement to overcome a technical problem than the claimed systems of the present application.” The Examiner believes, and the PTAB previously agreed, the instant invention applies technology to the abstract idea to obtain all the benefits of applying that technology to the abstract idea. The Examiner notes that the Applicant is describing a technological solution and not a technological problem.
The Applicant further states, “Applicant respectfully submits that no Office Action has properly addressed this argument in light of the above-noted ARP.” The ARP, as noted above, is not applicable to the instant invention.
The Applicant further states, “Rather, the Office Actions have only made conclusory remarks stating that the claims do not concern a technical problem.” From MPEP 2106.04(d)
The Supreme Court has long distinguished between principles themselves (which are not patent eligible) and the integration of those principles into practical applications (which are patent eligible). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’). Similarly, in a growing body of decisions, the Federal Circuit has distinguished between claims that are ‘‘directed to’’ a judicial exception (which require further analysis to determine their eligibility) and those that are not (which are therefore patent eligible), e.g., claims that improve the functioning of a computer or other technology or technological field. See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972). See, e.g., MPEP § 2106.06(b) (summarizing Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or computer functionality instead of being directed to abstract ideas).
The Applicant asserts that the invention is a technological improvement. However, the Specification describes the invention as a technological application. From MPEP 2106.05(a)
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., “thereby increasing the bandwidth of the channel”). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim “as a whole,” in other words, the claim should be evaluated “as an ordered combination, without ignoring the requirements of the individual steps.” When performing this evaluation, examiners should be “careful to avoid oversimplifying the claims” by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
The Specification does not show a technological improvement.
The Applicant states, “The present Specification at [0002] does not address "manual operation ", nor is this paragraph the only statement in the background section.” The paragraph 2 sentence includes “by the pharmacy”
In this regard, orders must be entered, received by the pharmacy, validated, and prepared according to manufacturer's specifications or established institutional guidelines.
The Applicant further states, “The background specifically contemplates that "at least partially automated pharmacy workflow management applications have been devised to assist in management of the receipt, processing, organization, preparation, verification, and tracking of medication dose orders in the pharmacy or the like. However, further developments would be beneficial to assist in improvements to the pharmacy workflow management application to promote efficiency, reliability, and accuracy related to the preparation and management of medication dose orders." (emphasis added). Sole focus on [0002] of the Specification in the face of [0003] is inconsistent with the principle that claims should be read in light of the Specification (and not in light of parts of the Specifiaction).” Examiner includes the full paragraph 3 here:
[0003] There are points in the foregoing process that may be susceptible to the loss or corruption of information due to miscommunication or other errors. This can be problematic in terms of logging and auditing of medication doses, which may be required by insurance and regulatory requirements. In tum, systems for management of pharmacy work flow have been proposed. For example, U.S. Provisional Patent Application No. 61/975,519 entitled "MANAGEMENT OF MEDICATION DOSE ORDERS" filed on Apr. 4, 2014, which is co-owned with the present application and incorporated by reference herein in its entirety, discloses certain embodiments of a pharmacy workflow management application. Accordingly, at least partially automated pharmacy workflow management applications have been devised to assist in management of the receipt, processing, organization, preparation, verification, and tracking of medication dose orders in the pharmacy or the like. However, further developments would be beneficial to assist in improvements to the pharmacy workflow management application to promote efficiency, reliability, and accuracy related to the preparation and management of medication dose orders.
From provisional application 61/975,519, the Applicant states on pages 3, 5/ 6, and 6/7
While many medications can be prepared by automated systems containing "built in" knowledge of correct preparation procedures, there are still large numbers of medication dose orders that require manual preparation, or institutions whose size precludes the incorporation of automation technology. The information and knowledge regarding how to prepare the medication is typically transferred verbally from one person to another. Thus, if a clinician receives an order for which he is unaware of the correct procedure for fulfillment, the clinician would have to request assistance, and thereby acknowledge a lack of training for that particular task. However, seeking training can be a source of embarrassment or be perceived as an undesired delay, either scenario providing a potential basis for the clinician to potentially use an improper procedure for the preparation of a particular medication, significantly increasing the possibility of a serious medication error due to flawed preparation procedures. Repeated conduct in this regard can result in "self trained" experience in a manner which is inconsistent with published procedures for handling that medication. Typically, the correct procedures are defined and written in a manual or other documentation. However, there is currently no efficient way to present the relevant excerpt of the manual to the clinician in relation to the particular medication order to be processed.
SUMMARY
The present disclosure generally relates to the management of medication dose orders. Specifically, the present disclosure may be utilized to manage dose order records maintained at a local server that are generated in response to receiving dose orders at a management system. The dose order records may be stored at the local server in corresponding relation to information regarding the received dose orders. The dose order records may include one or more dose order record data fields that may be populated with dose order metadata related to the dose order. The dose order metadata may be obtained from a received dose order (e.g., by way of a dose order entry system or the like) or may be associated with the dose order after receipt of the dose order (e.g., during the management, preparation, and/or distribution of the dose corresponding to the dose order).
Specifically, the management tool may provide a remote user the ability to access dose order records with respect to one or more stages of the pharmacy workflow. For instance, dose order records may include a status indicator (e.g., provided as dose order metadata for a corresponding given dose order record data field) that is indicative of the stage of the dose order record in a pharmacy workflow. Examples of statuses of dose orders include a status indicator for dose orders ready to be prepared at a workstation in the pharmacy (e.g., "at prep"), a status indicator for dose orders that have been prepared and are awaiting pharmacist review (e.g., "at checking"), a status indicator for dose orders that have been reviewed by a pharmacist and are ready for dispensation from the pharmacy ( e.g., "at sort"), or other appropriate status indicators corresponding to a state of a dose order relative to a pharmacy workflow. In tum, the management tool may provide a remote user the ability to view, modify, or otherwise manage dose order records at any one or more states of pharmacy workflow (e.g., including dose order records corresponding to dose orders that have not yet been prepared as well as dose orders corresponding to dose orders that have been prepared).
Returning to the bolded, “However, further developments would be beneficial to assist in improvements to the pharmacy workflow management application to promote efficiency, reliability, and accuracy related to the preparation and management of medication dose orders.” The Examiner understands this sentence in context of the provisional application. The provisional application partially automated the pharmacist activity. The instant invention would then further automate the pharmacist activity using the latest technology. The Examiner does not see an improvement of technology but rather the application of new technology.
The Applicant states, “Applicant respectfully disagrees. Claim 1 has been amended to recite, with direct support from at least [0151] of the Specification, that the error state is determined upon initiating a dose preparation protocol during a first processing. This clarifies and directly contradicts the conclusion of the Office Action that "this error state determination is a manual operation performed by a user." Paragraph 151 is included here:
[0151] The pharmacy workflow application 114 may execute a first processing 1008 sequence in order to generate an alert corresponding to an error state related to the dose order. The error state, as will be discussed in more detail below, may correspond to a plurality of potential errors of the dose order records. The potential errors may include, for example, parsing errors, unknown unit errors, unknown product errors, unknown route errors, and the like. The first processing 1008 may include attempting to initiate a dose preparation protocol such upon initial of the dose preparation protocol the pharmacy workflow application identifies the error state.
Paragraph 151 describes kinds of errors but it does not describe how “that the error state is determined upon initiating a dose preparation protocol during a first processing.” This determination still may be performed by a manual action.
A better idea of how the error state is obtain begins with paragraph 9, “this regard, the pharmacy workflow management application may identify critical issues, which may
include various errors such as an error regarding a dose order record, a password error, or other miscellaneous errors, and generate an alert corresponding to the identified error state.” However, what it measures is not stated. Paragraph 148, included here, also does not state how the issues are identified.
[0148] Turning next to FIG. 15, according to another embodiment, the pharmacy workflow application 114 may facilitate resolving critical issues associated with the pharmacy workflow management application 114 according generally to the method 1000. In this regard, the pharmacy workflow application 114 may be operable to identify various critical issues and display the identified critical issues in a common location to facilitate issue resolution. The identified critical issues may include various errors, such as an error regarding a dose order record, a password error, or other miscellaneous errors, as described in greater detail below. In this regard, according to one embodiment, errors associated with the dose order record may be identified and, in some instances, resolved within the pharmacy workflow queue. Accordingly, a dose order record with an error need not necessarily be prepared outside of the pharmacy workflow application.
Lastly, paragraph 164 describes rules used to determine duplicate dose orders, “For example, the rule may be written such that if selected ones of the metadata fields are identical between the first dose order record being reviewed and the other dose order records in the dose order queue, the dose order record being reviewed may be flagged is a potential duplicate order. Such a rule may be applied to the first dose order record when the record is initially populated the dose order queue.” Paragraph 121 further describes the rules.
In sum, the Examiner does not see how the error states are determined. Using the duplicate dose order as a guide, the error states are performed using some kind of logic rules. Those logic rules are either manually performed or automated by the system. As above, the invention applies technology to the abstract idea, manual logic rules, to obtain all the benefits of applying technology to the abstract idea.
The Examiner asserts that the invention is directed towards methods of organizing human behavior.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matsui et al Pub. No.: US 2014/0022569 A method of managing a mixed injection preparation process includes obtaining a mixed injection preparation instruction (e.g., a prescription) and obtaining information about a drug to be potentially included in the mixed injection according to the preparation instruction.
Buker et al Pub. No.: US 2003/0076736 Weighing and charging components of a product using a radio-frequency order picking and inventory control system (ROPICS) are disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached on M - T, M - F 8AM - 6PM.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
