DETAILED ACTION
Claims 1-20 are currently pending and have been examined.
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 .
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 an abstract idea without significantly more.
Subject Matter Eligibility Criteria - Step 1:
Claims 1-18 are directed to a method (i.e., a process); Claim 19 is directed to a system (i.e., a machine); and Claim 20 is directed to a CRM (i.e., a manufacture). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 19 includes limitations that recite at least one abstract idea. Specifically, independent claim 19 recites:
19. A computer system comprising:
one or more processors;
a display; and
memory;
wherein the memory stores one or more programs configured for execution by the one or more processors, and the one or more programs comprising instructions for:
obtaining a plurality of orders for compound prescriptions, via one or more web clients;
tracking information related to inventories including expiration dates for different lots of the inventories;
generating compounding tasks corresponding to the plurality of orders by analyzing ingredients necessary for fulfilling each order and assigning, for each order, a respective one or more lots for an inventory;
prioritizing and assigning the compounding tasks to a plurality of workstations, based on forecast demand, available supply, capacity, and the information related to the inventories;
providing one or more graphical user interfaces for a plurality of users, to process the plurality of orders at the plurality of workstations; and
in response to detecting a user of the plurality of users processing an order of the plurality of orders at a workstation of the plurality of workstations, updating the information related to the inventories, updating the compounding tasks, and/or providing an update on the one or more graphical user interfaces regarding a next compounding task performable at the workstation.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because obtaining order data for medication, tracking inventory data, generating compounding tasks, prioritizing and assigning tasks based on data, and updating information are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Accordingly, independent claim 19 and analogous independent claims 1 recite at least one abstract idea.
Furthermore, dependent claims 2-18 further narrow the abstract idea described in the independent claims. Claims 2 recites detecting a status of an order, Claims 3-5 recites retrieving and updating template data for medication preparation, Claims 6-9 recites tracking capacity, inventory, and forecast data; Claims 10 & 13-17 recites prioritizing and assigning medication tasks based on data; Claims 11-12 recites receiving medication compounding data and storing the data; Claim 18 recites compound data. These limitations only serve to further limit the abstract idea and hence, are directed towards fundamentally the same abstract idea as independent claim 19 and analogous independent claim 1, even when considered individually and as an ordered combination.
Independent claim 20 includes limitations that recite at least one abstract idea. Specifically, independent claim 20 recites:
20. A non-transitory computer readable storage medium storing one or more programs configured for execution by a computer system having a display, one or more processors, and memory, the one or more programs comprising instructions for:
rendering on a pharmacist user interface (UI), a plurality of fields configured to receive input from a user having a first level authority;
receiving ingredient data to create an active formulation via a plurality of fields corresponding to i) pharmaceutical ingredients in a formulary; ii) quantities of the pharmaceutical ingredients making up a compound pharmaceutical product; and/or iii) instructions for combining the pharmaceutical ingredients to produce the compound pharmaceutical product;
receiving a digital order for the compound pharmaceutical product;
in response to receiving the digital order, rendering on a workstation UI identified by a computer readable indicia, instructions for formulating the compound pharmaceutical product and compounding fields configured to receive input from a user having a second level of authority that is different from the first level of authority;
digitally recording, based on the computer readable indicia, receipt of pharmaceutical ingredients for formulating the compound pharmaceutical product;
receiving progressive inputs based on authorization from the user having a second level of authority into the compounding fields, the inputs being associated with quantities of pharmaceutical ingredients that are dispensed proximate the workstation UI;
receiving a digital completion entry from at the workstation UI indicating the digital order has been created; and
reconciling the quantities of pharmaceutical ingredients that have been dispensed in the creation of the compound pharmaceutical product with indicated quantities in the instructions for formulating the compound pharmaceutical product.
The Examiner submits that the foregoing underlined limitations constitute “methods of organizing human activity” because obtaining order data for medication, outputting instructions for formulating the medication, recording receipt of ingredients, receiving inputs regarding the preparation of the medication, and reconciling quantities of medication products are associated with managing personal behavior or relationships or interactions between people. For example, but for the system, this claim encompasses a person facilitating data access, receiving data, and outputting data in the manner described in the identified abstract idea. The Examiner notes that “method of organizing human activity” includes a person’s interaction with a computer – see MPEP 2106.04(a)(2)(II)(C). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Accordingly, independent claim 20 recite at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
19. A computer system comprising:
one or more processors;
a display; and
memory;
wherein the memory stores one or more programs configured for execution by the one or more processors, and the one or more programs comprising instructions for:
obtaining a plurality of orders for compound prescriptions, via one or more web clients;
tracking information related to inventories including expiration dates for different lots of the inventories;
generating compounding tasks corresponding to the plurality of orders by analyzing ingredients necessary for fulfilling each order and assigning, for each order, a respective one or more lots for an inventory;
prioritizing and assigning the compounding tasks to a plurality of workstations, based on forecast demand, available supply, capacity, and the information related to the inventories;
providing one or more graphical user interfaces for a plurality of users, to process the plurality of orders at the plurality of workstations; and
in response to detecting a user of the plurality of users processing an order of the plurality of orders at a workstation of the plurality of workstations, updating the information related to the inventories, updating the compounding tasks, and/or providing an update on the one or more graphical user interfaces regarding a next compounding task performable at the workstation.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computer system, processor, display, memory, web client, workstation, graphical user interface; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 19 and analogous independent claim 1 do not recite additional elements that integrate the judicial exception into a practical application.
Accordingly, the claims recites at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 2: This claim recites various types of devices and obtaining signal from the device and thus do no more than generally link use of the abstract idea to a particular technological environment or field of use without altering or affecting how the at least one abstract idea is performed (see MPEP § 2106.05(h)).
Claims 3-18: These claims recite to using a graphical user interface and amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Claim 8: These claim recites to using a trained model to forecast demand and amounts to an attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result and is equivalent to the words “apply it”. See MPEP 2106.05(f)(1).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
20. A non-transitory computer readable storage medium storing one or more programs configured for execution by a computer system having a display, one or more processors, and memory, the one or more programs comprising instructions for:
rendering on a pharmacist user interface (UI), a plurality of fields configured to receive input from a user having a first level authority;
receiving ingredient data to create an active formulation via a plurality of fields corresponding to i) pharmaceutical ingredients in a formulary; ii) quantities of the pharmaceutical ingredients making up a compound pharmaceutical product; and/or iii) instructions for combining the pharmaceutical ingredients to produce the compound pharmaceutical product;
receiving a digital order for the compound pharmaceutical product;
in response to receiving the digital order, rendering on a workstation UI identified by a computer readable indicia, instructions for formulating the compound pharmaceutical product and compounding fields configured to receive input from a user having a second level of authority that is different from the first level of authority;
digitally recording, based on the computer readable indicia, receipt of pharmaceutical ingredients for formulating the compound pharmaceutical product;
receiving progressive inputs based on authorization from the user having a second level of authority into the compounding fields, the inputs being associated with quantities of pharmaceutical ingredients that are dispensed proximate the workstation UI;
receiving a digital completion entry from at the workstation UI indicating the digital order has been created; and
reconciling the quantities of pharmaceutical ingredients that have been dispensed in the creation of the compound pharmaceutical product with indicated quantities in the instructions for formulating the compound pharmaceutical product.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the computer system, processor, display, memory, workstation graphical user interface; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, independent claim 20 does not recite additional elements that integrate the judicial exception into a practical application.
Thus, taken alone, any additional elements do not integrate the at least one abstract idea into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 1 & 19-20 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
As discussed above, regarding the additional limitations of the computer system, processor, display, memory, workstation graphical user interface; the Examiner submits that these limitations amount to merely using computers as tools to perform the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-9, 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tribble (US20190333618) in view of Osborne (US20240013150).
As per claim 1, Tribble teaches a method of automating preparation of compound prescription at a plurality of workstations having integrated therein a user interface and a registered quantity input hardware, based on forecasted quantities, ordered quantities and simultaneous usage data, the method comprising:
obtaining a plurality of orders for compound prescriptions, via one or more web clients (para. 16: dose orders received over network from external systems);
tracking information related to inventories including expiration dates for different lots of the inventories (para. 72: expiration date tracked regarding medication);
generating compounding tasks corresponding to the plurality of orders by analyzing ingredients necessary for fulfilling each order and assigning, for each order, a respective one or more lots for an inventory (para. 64-66: dose order analyzed and sent to workstation for fulfillment, supplies analyzed to determine sufficient supplies available to fulfill order);
prioritizing and assigning the compounding tasks to a plurality of workstations based on available supply, capacity, and the information related to the inventories (para. 62-66: dose orders assigned to various workstations based on various rules such as capacity of orders, availability of supplies, urgency, and other data);
providing one or more graphical user interfaces for a plurality of users, to process the plurality of orders at the plurality of workstations (para. 75: interface to prepare order); and
in response to detecting a user of the plurality of users processing an order of the plurality of orders at a workstation of the plurality of workstations, updating the information related to the inventories, updating the compounding tasks, and/or providing an update on the one or more graphical user interfaces regarding a next compounding task performable at the workstation (para. 74-75: number of steps displayed required to be performed to successfully prepare a medication product that is used to prepare a dose that is part of a dose order).
Tribble does not expressly teach prioritizing and assigning the compounding tasks to a plurality of workstations, based on forecast demand.
Osborne, however, teaches to where a system can analyze the database and/or log of prepared dose orders and generate dose orders in anticipation of use (para. 78). The system can analyze many variables to determine which medications should be prepared and stored in inventory such as determine which medications are most frequently ordered for patients, which medications are below a predetermined threshold in inventory, analyzing the frequency of which a particular medication is ordered and the expiration date and expected shelf-life of the particular medication (para. 78).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Osborne with Tribble based on the motivation of provide a centralized medication order management, fulfillment, and tracking system (Osborne – para. 14).
As per claim 2, Tribble & Osborne teach the method of claim 1. Tribble teaches further comprising:
interfacing with at least one device selected from the group consisting of: one or more scales, one or more scanners, and one or more mixers (para. 71: various devices connected to workstation); and
detecting a status of the order of the plurality of orders at the workstation, by obtaining one or more signals from the at least one device (para. 71: parameter received from device).
As per claim 3, Tribble & Osborne teach the method of claim 1. Tribble teaches further comprising:
retrieving one or more templates corresponding to the plurality of orders, wherein each template includes a set of instructions for a workflow and a formula (para. 17, 76, 94: protocol retrieved for drug order; protocol includes steps to make drug); and
providing, via the one or more graphical user interfaces, details to implement the formula using the workflow, at the plurality of workstations (para. 92: steps displayed).
As per claim 4, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein the one or more templates are customizable based upon one or more devices connected to each workstation (para. 71: protocol presented to the user is preferably coded to capture the progress made toward dose fulfillment. Thus, steps taken in completing the protocol or recipe are preferably coupled with specific operator input such as photographing a drug vial, weighing a syringe, and the like, with the inputs being captured and included in a data record that can be forwarded to the pharmacist for review and approval).
As per claim 6, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein the capacity corresponds to at least one of a number of workstations, and a number of users (para. 123: available workstations and the number of dose orders being handled by each workstation are identified by icons in the upper right corner of the screen.
As per claim 7, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein the available supply is tracked based on tracking information related to the inventories, at one or more warehouses, and/or at the plurality of workstations (para. 62-66: dose orders assigned to various workstations based on various rules such as capacity of orders, availability of supplies, urgency, and other data).
As per claim 8, Tribble & Osborne teach the method of claim 1. Tribble does not expressly teach wherein the forecast demand is obtained based on a forecasting model that is trained to predict demand based on historical data for compound prescription from the one or more web clients.
Osborne, however, teaches to where a system can analyze the database and/or log of prepared dose orders and generate dose orders in anticipation of use (para. 78). The system can analyze many variables to determine which medications should be prepared and stored in inventory such as determine which medications are most frequently ordered for patients, which medications are below a predetermined threshold in inventory, analyzing the frequency of which a particular medication is ordered and the expiration date and expected shelf-life of the particular medication (para. 78).
The motivations to combine the above mentioned references are discussed in the rejection of claim 1, and incorporated herein.
As per claim 9, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein prioritizing and assigning the compounding tasks to the plurality of workstations is based on planned shifts of the plurality of users, and/or operational efficiency of the plurality of workstations (para. 66: fulfillment system can determine the appropriate workstation among available resources to which the dose order can be assigned in view of the dosage order itself or priority requirement for completion).
As per claim 11, Tribble & Osborne teach the method of claim 1. Tribble teaches further comprising:
providing, via the one or more graphical user interfaces, for the user, while the user is processing the order, a real-time update regarding a weight of an ingredient and an expected range of weight for the ingredient according to a formula (para. 71-74: interface requires user to verify each step is complete including weighing preparation of drug; require user to enter measurement within an acceptable range and outputting and error); and
in response to detecting the weight of the ingredient is stabilized, displaying a final weight of the ingredient, allowing the user to record, and/or automatically recording the final weight of the ingredient for the order (para. 71: inputs being captured and included in a data record that can be forwarded to the pharmacist for review and approval).
As per claim 12, Tribble & Osborne teach the method of claim 1. Tribble teaches further comprising:
providing, via the one or more graphical user interfaces, for a super user different from the user processing the order, after the user processes the order, a summary of the processing of the order (para. 105: pharmacist can approve or reject dose order based on review of data record); and
in response to receiving a negative input from the super user regarding an incorrect compounding for the order, requeuing a task corresponding to the order to the plurality of workstations (para. 105-108: pharmacist can approve or reject dose order based on review of data record; rejected dose order sent back to order queue).
As per claim 13, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein prioritizing and assigning the compounding tasks to the plurality of workstations is based on batching one or more tasks that use an ingredient (claim 1; para. 46, 52: processing dose orders for batch processing; workstation assigned batch dose order and displays protocol for batch of orders).
As per claim 14, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein prioritizing and assigning the compounding tasks to the plurality of workstations is based on ordering tasks for one or more customers responsible for the plurality of orders received via the one or more web clients (para. 60: dose order assigned to workstation based on urgency assigned to order by user).
As per claim 15, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein prioritizing and assigning the compounding tasks to the plurality of workstations is based on a demand for one or more ingredients (para. 66: fulfillment system can determine the appropriate workstation among available resources to which the dose order; further consider the supplies required to fulfill the dose order and the supplies available at each workstation).
As per claim 16, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein prioritizing and assigning the compounding tasks to the plurality of workstations is based on task initiation prompted by a user request through the one or more graphical user interfaces thereby providing on-demand control (para. 54: operator can select dose order for processing and fulfillment).
As per claim 17, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein prioritizing and assigning the compounding tasks to the plurality of workstations is automatically triggered through a daemon to execute scheduled commands job (para. 61: server receives, stores, and parses the incoming dose orders (e.g., by using the label processing module and other software) and generates the work order queue that can then be posted at each workstation).
As per claim 18, Tribble & Osborne teach the method of claim 1. Tribble teaches wherein each compound includes a corresponding minimum inventory threshold to trigger a new order and/or a minimum batch size for a next order (para. 65: as dose orders are received and parsed, system can analyze the supplies necessary to fulfill the order. If insufficient supplies, additional supplies can be automatically ordered or the relocation of supplies from one workstation to another can be ordered such that at least one workstation will have the necessary supplies to fulfill the dose order).
Claim 19 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Tribble (US20190333618) in view of Osborne (US20240013150) as applied to claim 1 above, and in further view of Padmani (US20250006353).
As per claim 5, Tribble and Osborne teach the method of claim 1, but do not expressly teach further comprising:
providing to a first set of users of the plurality of users a dashboard to update the one or more templates; and
upon receiving an update the one or more templates, providing the updates, via the one or more graphical user interfaces.
Padmani, however, teaches to a user interface where a user can modify at least one of the characteristics of at least one of the plurality of formulary data records (para. 15-18). The updates are provided to the pharmacy workflow management application for use in the preparation or management of a dose order record (para. 87).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Padmani with Tribble and Osborne based on the motivation of promote efficiency, reliability, and accuracy related to the preparation and management of medication dose orders (Padmani – para. 3).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tribble (US20190333618) in view of Osborne (US20240013150) as applied to claim 1 above, and in further view of Utech (US20140350952).
As per claim 10, Tribble and Padmani teach the method of claim 1, wherein prioritizing and assigning the compounding tasks to the plurality of workstations is based on forecasting, inventory, outstanding orders, a time an order was approved, and (Tribble - para. 40, 66: fulfillment system can determine the appropriate workstation among available resources to which the dose order; further consider the supplies required to fulfill the dose order and the supplies available at each workstation; dose order includes time and date the prescription was entered, the reason for medication).
Tribble and Pamdni do not expressly teach to using target days of coverage for inventory management.
Utech, however, teaches to using parameters including days of supply for tracking inventory supply of medication products (para. 25).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Utech with Tribble and Padmani based on the motivation of effectively managing inventory to meet patient care needs and minimize waste through expiration and inventory that is not being utilized (Utech – para. 6).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tribble (US20190333618) in view of Padmani (US20250006353).
As per claim 20, Tribble teaches a non-transitory computer readable storage medium storing one or more programs configured for execution by a computer system having a display, one or more processors, and memory, the one or more programs comprising instructions for:
receiving a digital order for the compound pharmaceutical product (para. 16: dose orders received over network from external systems);
in response to receiving the digital order, rendering on a workstation UI identified by a computer readable indicia, instructions for formulating the compound pharmaceutical product and compounding fields configured to receive input from a user having a second level of authority that is different from the first level of authority (para. 74-75: number of steps displayed required to be performed to successfully prepare a medication product that is used to prepare a dose that is part of a dose order);
digitally recording, based on the computer readable indicia, receipt of pharmaceutical ingredients for formulating the compound pharmaceutical product (para. 71: each step is stored in data record regarding completion of step);
receiving progressive inputs based on authorization from the user having a second level of authority into the compounding fields, the inputs being associated with quantities of pharmaceutical ingredients that are dispensed proximate the workstation UI (para. 71-75: number of steps displayed required to be performed to successfully prepare a medication product that is used to prepare a dose that is part of a dose order; interface requires user to verify each step is complete including weighing preparation of drug; require user to enter measurement within an acceptable range and outputting and error);
receiving a digital completion entry from at the workstation UI indicating the digital order has been created (para. 71: each step is stored in data record regarding completion of step); and
reconciling the quantities of pharmaceutical ingredients that have been dispensed in the creation of the compound pharmaceutical product with indicated quantities in the instructions for formulating the compound pharmaceutical product (para. 65: as dose orders are received and parsed, system can analyze the supplies necessary to fulfill the order. If insufficient supplies, additional supplies can be automatically ordered or the relocation of supplies from one workstation to another can be ordered such that at least one workstation will have the necessary supplies to fulfill the dose order).
Tribble does not expressly teach rendering on a pharmacist user interface (UI), a plurality of fields configured to receive input from a user having a first level authority;
receiving ingredient data to create an active formulation via a plurality of fields corresponding to i) pharmaceutical ingredients in a formulary; ii) quantities of the pharmaceutical ingredients making up a compound pharmaceutical product; and/or iii) instructions for combining the pharmaceutical ingredients to produce the compound pharmaceutical product;
Padmani, however, teaches to a user interface where a user can modify at least one of the characteristics of at least one of the plurality of formulary data records (para. 15-18). The updates are provided to the pharmacy workflow management application for use in the preparation or management of a dose order record (para. 87).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Padmani with Tribble based on the motivation of promote efficiency, reliability, and accuracy related to the preparation and management of medication dose orders (Padmani – para. 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Klomp (US 20140350946 A1) teaches to a workflow method that may be utilized in pharmacies involving compounding operations. The method may classify prescriptions depending on the need to compound them, and may thereafter assign the location of the different pharmaceutical compositions for pharmacy personnel to retrieve them, or may locate the different chemicals needed to compound the required pharmaceutical compositions if the desired pharmaceutical compositions are not available in inventory.
DeCiccio (US 11664102) teaches to receiving a prescription for a non-sterile compound from a health care provider, identifying the non-sterile compound, batching the non-sterile compound for a compounding process, and formulating the identified non-sterile compound.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/Primary Examiner, Art Unit 3619
Prosecution Insights