DETAILED ACTION
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 .
Response to Amendment
Applicant’s “Amendment” filed on 03/11/2026 has been considered.
Claims 31-34, 38, 40, 42, 44, and 46-48 are amended. Claims 31-50 remain pending in this application and an action on the merits follow.
Applicant’s response by virtue of amendment to claims has not overcome the Examiner’s rejection under 35 USC § 101.
Double patenting rejection is withdrawn due to the amendment filed on 03/11/2026.
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 31-50 are rejected under 35 USC 101. The claimed invention is directed to non-statutory subject matter because claims 31-32 is directed to an abstract idea without significantly more. Claims 33-50 fail to remedy these deficiencies.
The claims 31-32 recite rendering inventory visibility, extracting inventory data, updating a first digital shelf, extracting current drug product pricing information, identifying a medication need, querying a drug product database to identify one or more drug products, selecting a recommended drug product, calculating a recommended quantity drug product, and dispensing at least a portion of the drug products.
The claims 31-32 recite identifying a medication need, querying a drug product database to identify one or more drug products, selecting a recommended drug product, and calculating a recommended quantity drug product steps as drafted, are processes that under broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a health system, a plurality of digital shelves, a cloud computing network, a robotic automated dispenser, and a drug product database”, nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the “the health system, the plurality of digital shelves, the cloud computing network, the robotic automated dispenser, and the drug product database” language, in the context of these claims encompasses a person manually identifies/observes a demand/need, identifies one or more products satisfied the demand/need, analyzes/selects one drug product that satisfies the demand/need, and calculates a recommended quantity. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The Claims 31-32 recite rendering, updating, and dispensing at least a portion of the drug products step as drafted, are processes that under broadest reasonable interpretation, cover performance of managing personal behavior, but for the recitation of generic computer components. That is, other than reciting “the health system, the plurality of digital shelves, the cloud computing network, the robotic automated dispenser, and the drug product database”, nothing in the claim element precludes the steps from practically being performed by organizing human activity. For example, but for the “the health system, the plurality of digital shelves, the cloud computing network, the robotic automated dispenser, and the drug product database” in the context of these claims encompasses a person manually maintains a plurality of digital shelves to render inventory visibility, updates inventory of the digital shelves, and dispenses/distributes/delivers drug products. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation by managing personal behavior but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application because extracting step is recited at a high level of generality (i.e., as a general means of extracting inventory data and current drug product information) and amounts to mere data gathering, which is a form of insignificant extra-solution activity. This judicial exception is not integrated into a practical application because the claims as a whole merely describe how to generally “apply” the concept of rendering, extracting, updating, identifying, querying, selecting, calculating, and dispensing in a computer environment. The claimed computer components such as the health system, the plurality of digital shelves, the cloud computing network, the robotic automated dispenser, and the drug product database are recited at a high level of generality and are merely invoked as tools to perform rendering, extracting, updating, identifying, querying, selecting, calculating, and dispensing steps. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims 31-32 are directed to an abstract idea.
The claims 31-32 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using the health system, the plurality of digital shelves, the cloud computing network, the robotic automated dispenser, and the drug product database to perform rendering, extracting, updating, identifying, querying, selecting, calculating, and dispensing steps amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore, the claims do not amount to significantly more than the recited abstract idea (Step 2B: NO). The claims 31-32 are not patent eligible.
The claims 33-39, 44-47, and 50 recite the steps of integrating with a third-party administrator, communicating to retrieve current accumulation data, selecting the recommended drug product, integrating with an enterprises resource planning software, extracting a general ledger, generating a purchase order, conveying the purchase order, ingesting a comprehensive drug product listing, parsing the comprehensive drug product listing into backend tables, articulating the backend tables, tracking price changes, predicting a future adjustment, calculating q weighted price, calculating a proportion of the identified drug product, determining whether the proportion exceeds a wholesaler threshold, generating a recommended pharmaceutical order, providing a drug product, receiving an output of the likelihood of the drug shortage, determining whether the likelihood of the drug product shortage meeting the threshold, generating a notification, sorting the plurality of drug products, identifying a top drug, ordering the top drug product in response to determining the top drug product has previously purchased, facilitating a transaction, generating a message indicating the top drug product is a new drug product, receiving an indication, communicating with pharmaceutical suppliers, determining a package size, and converting the indication to the package size available steps.
The limitation of steps listed above as drafted, are concepts that under broadest reasonable interpretation, cover performance of managing personal behavior and cover performance of the limitation in the mind but for the recitation of generic computer components. For example, steps listed above in the context of these claims encompasses a person/user manually performs all the steps. The ability of an application program interface, an enterprise resource planning software, and an algorithm trained to receiving, communicating, and outputting data is generic. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and the limitation by managing personal behavior but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping and “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
There are no additional claim element limitations recited in the claims 33-39, 44-47, and 50. Therefore, the claim does not amount to significantly more than the recited abstract idea. The claims 33-39, 44-47, and 50 are not patent eligible.
Claims 40-41, disclose insignificant helpful content to further describe content, such as extracting the inventory data and the current drug product process, which are merely descriptive content to further limit the abstract idea but not make it less abstract. Thus, the claims 40-41 are directed to an abstract idea.
This judicial exception is not integrated into a practical application because descriptive content in claims 40-41 further limit the abstract idea but not make it less abstract. Thus, the claims 40-41 are directed to an abstract idea.
There are no additional claim element limitations recited in the claims 40-41. Therefore, the claim does not amount to significantly more than the recited abstract idea (Step 2B: NO). The claims 40-41 are not patent eligible.
Claims 42-43 and 48-49, disclose insignificant helpful content to further describe content, such as identifying drug product preferences process, and selecting the recommended drug product, selecting a recommended supplier, which are merely descriptive content to further limit the abstract idea but not make it less abstract. Thus, the claims 42-43 and 48-49 are directed to an abstract idea.
This judicial exception is not integrated into a practical application because descriptive content in claims 42-43 and 48-49 further limit the abstract idea but not make it less abstract. Thus, the claims 42-43 and 48-49 are directed to an abstract idea.
There are no additional claim element limitations recited in the claims 42-43 and 48-49. Therefore, the claim does not amount to significantly more than the recited abstract idea (Step 2B: NO). The claims 42-43 and 48-49 are not patent eligible.
Claim Rejections - 35 USC § 103
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.
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.
Claims 31-33, 40, 44-46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0061375 to Laster et al., in view of U.S. Patent No. 10,685,308 to Avery, JR. et al., and further in view of Canadian Patent Application No. CA 2,693,893 to Bossi et al.
With regard to claim 31, Laster discloses a method comprising:
extracting inventory data for a first ordering location of the plurality of ordering locations from an inventory management solution located at the first ordering location (paragraphs 3, 8, and 64);
extracting current drug product pricing information from a plurality of pharmaceutical suppliers for a plurality of drug products (paragraph 100, the scheduler 110 performs price checking by accessing a table, spreadsheet, or other data that indicates prices corresponding to a stock keeping unit (SKU) or other product identifier.);
identifying a medication need for the first ordering location based on the inventory data, wherein the first ordering location comprises one or more of a hospital, a clinic, a surgical center, an urgent care facility, a pharmacy, or a consolidated service center (fig. 1, paragraph 98 and 106, For example, the scheduler 110 may generate an order to purchase items needed to bring the inventory up to the predicted level of need. These new probabilities are used to update the prediction of needed inventory at the medical facility, and the inventory is adjusted accordingly);
querying a drug product database to identify one or more drug products of the plurality of drug products satisfying the medication need (paragraphs 101-102 and 114, The scheduler 110 can take into account the date that each individual procedure is scheduled to occur, and cause supplies needed for various procedures to be stocked in advance of their respective scheduled dates); and
selecting a recommended drug product for the first ordering location, wherein the recommended drug product comprises: a release mechanism satisfying the medication need, wherein the release mechanism comprises immediate, delayed, sustained, or controlled (paragraphs 13, 81, 98, 108, 161, 177, and 277, the outputs of the predictive models 112 for each of multiple different scheduled procedures can be used to determine quantities of items that will permit a medical facility to meet the needs for each of the scheduled procedures. The scheduler 110 may communicate directly and automatically with suppliers to cause items to be ordered when the scheduler 110 detects use of the items or another decrease in inventory. The efficiency of the surgical management system may allow hospitals and other medical facilities to manage inventory of at least some items using a just-in-time delivery model. For example, a surgeon may indicate that a specific make, model, or type of implant is preferred. The scheduler 110 may adjust inventory automatically as the predicted needs change, or may indicate recommended adjustments for approval by employees of the medical facility. The various actions that the scheduler 110 may perform include ordering items, expediting delivery of previously ordered items, requesting items from another medical facility, and requesting that a manufacturer manufacture items. When inventory levels at the medical facility exceed predicted needs, the scheduler 110 may make adjustments that reduce inventory levels, for example, by delaying or cancelling orders or shipments. Examiner notes that the selected recommended product/medicine ordering comprising a just in time or expediting delivery, delayed to release order, and a preferred type is adjusted to meet the predicted needs, which is considered as “a release mechanism satisfying the medication need, wherein the release mechanism comprises immediate, delayed, sustained, or controlled”).
However, Laster does not disclose calculating a recommended quantity of the recommended drug product to procure for the first ordering location based on the inventory data and an expected unit-dose disbursement of the recommended drug product by the first ordering location; rendering inventory visibility for a health system by maintaining a plurality of digital shelves that are accessible via a cloud computing network, wherein each of the plurality of digital shelves represents an ordering location of a plurality of ordering locations within the health system; automatically updating a first digital shelf associated with the first ordering location based upon real-time updates ingested from the inventory management solution; wherein the recommended drug product comprises; a delivery form satisfying the medication need, wherein the delivery form comprises intravenous, oral suspension, oral solid, injectable, or topical, and a package satisfying the medication need.
However, Bossi teaches rendering inventory visibility for a health system by maintaining a plurality of digital shelves that are accessible via a cloud computing network, wherein each of the plurality of digital shelves represents an ordering location of a plurality of ordering locations within the health system (The system includes delivery apparatus remotely located from the care provider, wherein the apparatus stores a plurality of sealed unit dose packages that are delivered to a patient at a scheduled dosing time. The delivery apparatus is coupled to a control facility and to a computer terminal of the care provider by way of a secure communications network. In one example, the delivery apparatus features a controller for executing command
signals received from the control center and clinical software, as well as a storage area for storing unit dose packages. The apparatus delivers a sealed, unit dose package to the patient at a scheduled dosing time, in response to a command signal. In general, the control software 32 records and stores information related to the operation and contents of the delivery module 33, such as the types and locations of medication carriers 26 stored within the module 33, a complete inventory of the
unit dose packages 27 contained within each medication carrier 26, and a
history of all dose administration operations over a set time period. fig. 1, abstract, paragraphs 10 and 64); automatically updating a first digital shelf associated with the first ordering location based upon real-time updates ingested from the inventory management solution (The control software 35 protocols also enable the control center 101 to accurately monitor each unit dose package 27 contained within a particular delivery module 33 and update the database inventory records as each unit dose package 27 is delivered to a patient. paragraph 68); wherein the recommended drug product comprises; a delivery form satisfying the medication need, wherein the delivery form comprises intravenous, oral suspension, oral solid, injectable, or topical, and a package satisfying the medication need (A control center 101, such as a facility operated by INRange Systems, Inc., stocks custom packaged and prepackaged, unit dose prescription and non-prescription medical products, pharmaceuticals from various drug manufacturers and suppliers. Such therapeutic products include, but are not limited to, solid orally consumed doses, liquid orally consumed dosages, and injection devices that contain doses that are delivered or administered at the point of care. Each dosing regimen may include identifications of specific medications to be dispensed, data concerning such medications (i.e., dosage strengths, quantities, images of each medication, etc.), dosing schedules for each medication, etc., paragraphs 56 and 215).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Laster to include, rendering inventory visibility for a health system by maintaining a plurality of digital shelves that are accessible via a cloud computing network, wherein each of the plurality of digital shelves represents an ordering location of a plurality of ordering locations within the health system; automatically updating a first digital shelf associated with the first ordering location based upon real-time updates ingested from the inventory management solution; wherein the recommended drug product comprises; a delivery form satisfying the medication need, wherein the delivery form comprises intravenous, oral suspension, oral solid, injectable, or topical, and a package satisfying the medication need, as taught in Bossi, in order to quickly address a patient's non-compliance with a prescribed drug regimen in real time and minimizes disruptions to a patient's course of treatment while protecting patient information (Bossi, paragraph 9).
However, Avery teaches calculating a recommended quantity of the recommended drug product to procure for the first ordering location based on the inventory data and an expected unit-dose disbursement of the recommended drug product by the first ordering location (As another more particular example, if in the past a user (or users) have consistently expressed a brand preference when an item is not available for a particular facility, process 900 can determine that the user prefers a particular brand. In such an example, a particular item (e.g., a particular size of an item) is unavailable (e.g., when creating a facility order guide or at the time of ordering) or not available in a desired quantity, process 900 can suggest multiple items as alternatives such as an item from another supplier and an item from the same supplier in a different size, with the item from the other supplier being suggested first because it is less costly. If the user consistently chooses the item from the same supplier in spite of it appearing less desirable, process 900 can use this as a signal of brand preference for items from the first supplier. Examiner notes that a system to track inventory in the facility to generate an order guild, wherein the order guild includes suggesting an item from the same supplier in a different size to meet a desired quantity of ordering the item, for example, if the desirable quantity is 10 and the size offered is 5 per box, 2 boxes of the items from the sample supplier in a different size can be suggested, which can be considered as “calculating a recommended quantity of the recommended drug product to procure for the ordering location based on the inventory data and an expected unit-dose disbursement of the recommended drug product by the ordering location”. Examiner notes that the items can be any type of drug products, which can be packaged in different sizes with different measurement units, such as units/dose/dosage/pills/tablets, Fig. 1-2, abstract, col. 38, lines 1-15).
It would have been obvious to one of ordinary still in the art to include in the medicine items procurement based on the inventory management system of Laster the ability to calculating a recommended package quantity to be procured for the ordering location as taught by Avery since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
With regard to claim 32, the combination of references discloses the inventory management solution comprises a robotic automated dispenser that dispenses drug products located at the first ordering location (Bossi, fig. 1, abstract, The system includes delivery apparatus remotely located from the care provider).
With regard to claim 33, Laster discloses integrating with a third-party administrator by way of an application program interface (API) (paragraph 154, The scheduler 110 may communicate with the different parties in the supply chain using plug-in modules to access databases and records managed by different software platforms.); and communicating with the third-party administrator over the API to retrieve current accumulation data for the one or more drug products that satisfy the medication need, wherein the current accumulation data is applicable to a pharmaceutical regulation (paragraph 157, sufficient projected inventory (e.g., considering items in transit and currently available). Examiner notes that the projected inventory is accumulated by combining the current available and in transit, which is considered as “current accumulation data for the one or more drug products that satisfy the medication need”.); wherein selecting the recommended drug product for the first ordering location comprises selecting at least in part based on the accumulation data for the one or more drug products that satisfy the medication need (paragraph 158, Even if the warehouse inventory is not immediately shipped, the quantities can be updated to reflect the upcoming need. The case status that the scheduler 110 provides (for example, indicator 411 of FIG. 4) may be updated to show that timely delivery of the items has been secured.).
With regard to claim 40, Laster discloses extracting the inventory data from the inventory management solution comprises: integrating with the inventory management solution by way of a secure file transfer protocol (paragraph 286, It should be understood that the described program components and systems may generally be integrated together in a single software product or packaged into multiple software products.); receiving a file from the inventory management solution comprising the inventory data, wherein the inventory data comprises: current inventory quantities of the one or more current drug products; maximum inventory quantities for the one or more current drug products; minimum inventory quantities for the one or more current drug products; and expiration dates for the one or more current drug products that are currently located at the first ordering location (paragraphs 64, 114, 134, and 173, The scheduler 110 can also access inventory data 143 for medical facilities. To manage the inventory, the medical facility may have a database storing records of each physical item in inventory. FIG. 3D is a table 342 that shows a current inventory level 347. These quantities can be the smallest quantities that provide the minimum confidence level, or quantities that provide the minimum confidence level with no more than a maximum excess amount. scheduler 110 determines whether any of the scanned items have expired).
With regard to claim 44, Laster discloses generating a recommended pharmaceutical order for the first ordering location, wherein the recommended pharmaceutical order comprises an indication of the recommended drug product, the recommended quantity, the delivery form, the release mechanism, the package type, and the recommended pharmaceutical supplier (paragraphs 13, 81, 98, 108, 161, 177, and 277).
With regard to claim 45, Laster discloses providing a drug product associated with the medication need to an algorithm trained to calculate a drug shortage prediction for the drug product based on a plurality of factors; receiving an output from the algorithm indicating a likelihood of one or more of: a current shortage of the drug product associated with the medication need; or a future shortage of the drug product associated with the medication need; determining whether the likelihood of the drug shortage prediction meets a threshold; and in response to the likelihood of the drug shortage prediction meeting the threshold, generating a notification for a user comprising the drug shortage prediction for the drug product (paragraphs 136, 149, and 153, If components indicated as likely to be used are not available, the status indicator 411 can indicate a need for further action. For example, a green indicator may indicate that items have a high likelihood of being available when needed, for example, having a likelihood of at least a minimum threshold such as 90%. The case information 420 also includes status information 428, which can indicate which case(s) may be affected by a projected inventory shortage).
With regard to claim 46, Laster discloses selecting the recommended drug product comprises identifying two or more of the plurality of drug products that satisfy the medication need, and wherein the method further comprises sorting the two or more of the plurality of drug products to generate sorted drug products based on one or more of: unit price; supplier preference for the first ordering location; contract preference rating for the first ordering location; or package size and/or package configuration preferences for the first ordering location (paragraphs 152, different in prices).
With regard to claim 48, Laster discloses selecting the recommended drug product comprises selecting based on one or more of: supplier contract terms received from one or more of the plurality of pharmaceutical suppliers for the recommended drug product; supplier data received from the one or more of the plurality of pharmaceutical suppliers for the recommended drug product; current availability of the recommended drug product; pricing options for the recommended drug product comprising contractual pricing options, rebate pricing options, and/or government pricing program options; or packaging characteristics for the recommended drug product in light of packaging preferences for the first ordering location (paragraphs 152, 266 and 277).
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0061375 to Laster et al., Canadian Patent Application No. CA 2,693,893 to Bossi et al., U.S. Patent No. 10,685,308 to Avery, JR. et al., and further in view of U.S. Patent Application Publication No. 2018/0114169 to Wiig et al.
With regard to claim 34, the combination of references substantially discloses the claimed invention, however, the combination of references does not disclose integrating with an enterprise resource planning software by way of a secure file transfer protocol; and extracting a general ledger from the enterprise resource planning software, wherein the general ledger comprises an accounting record applicable to pharmaceuticals at the first ordering location.
However, Wiig teaches integrating with an enterprise resource planning software by way of a secure file transfer protocol; and extracting a general ledger from the enterprise resource planning software, wherein the general ledger comprises an accounting record applicable to pharmaceuticals at the first ordering location (the requirement, compliance and resource management methodology 100 or 120 or 140 can be configured with an application programming interface (API) to integrate (e.g., direct integration and/or database integration) with other software programs (e.g., MS Word, MS Excel, MS Project and Enterprise Resource Planning (ERP)). Enterprise Resource Planning (ERP) is an integrated software program/system that operates in near real time and/or real time, without relying on periodic updates with a common database, which supports (a) finance/accounting (general ledger, payables, cash management, fixed assets, receivables, budgeting and consolidation), paragraphs 97-98).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, integrating with an enterprise resource planning software by way of a secure file transfer protocol; and extracting a general ledger from the enterprise resource planning software, wherein the general ledger comprises an accounting record applicable to pharmaceuticals at the first ordering location, as taught in Wiig, in order to synthesize optimization of relevant process steps, requirements, resources and critical constraints for near real time and/or real time collaboration (Wiig, paragraph 14).
With regard to claim 35, the combination of references discloses generating a purchase order to procure the recommended quantity of the recommended drug product (paragraph 98, the scheduler 110 may generate an order to purchase items), wherein the purchase order complies with formatting requirements associated with an applicable pharmaceutical supplier (Avery, col. 24, lines 18-22, col. 25, lines 42-46, In some embodiments, the facility order guide can be formatted in any format that is suitable for presentation and/or submission to an application and/or service that can be used to place an order with one or more distributors based on the facility order guide), however, the combination of references does not disclose conveying the purchase order to the enterprise resource planning software.
However, Wiig teaches conveying the purchase order to the enterprise resource planning software (Enterprise Resource Planning (ERP) is an integrated software program/system that operates in near real time and/or real time, without relying on periodic updates with a common database, which supports supply chain management (order to cash, inventory, order entry, purchasing, product configurator, supply chain planning, supplier scheduling, inspection of goods, claim processing and commissions), paragraph 98).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, conveying the purchase order to the enterprise resource planning software, as taught in Wiig, in order to synthesize optimization of relevant process steps, requirements, resources and critical constraints for near real time and/or real time collaboration (Wiig, paragraph 14).
Claims 36, 41-42, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0061375 to Laster et al., U.S. Patent No. 10,685,308 to Avery, JR. et al., Canadian Patent Application No. CA 2,693,893 to Bossi et al., and further in view of U.S. Patent Application Publication No. 2010/0145506 to Waugh et al..
With regard to claim 36, the combination of references substantially disclose the claimed invention, however, the combination of references does not disclose ingesting a comprehensive drug product listing from a drug library.
However, Waugh teaches ingesting a comprehensive drug product listing from a drug library, wherein the drug library comprises a source listing of all drug products and associated unique drug product identifiers (the generic equivalent drug is selected in place of the brand-name drug); parsing the comprehensive drug product listing into backend tables of a database (paragraphs 44, 51, and 58, This list is typically drawn from a standard drug database commercially available within a given jurisdiction. An external database of standard SIG codes could be used as well (e.g., a list provided with the standard drug database mentioned above)); articulating the backend tables within a user interface (paragraphs 45-49, The drug list generally displays the following information: Drug Name, Available generic substitutions, and etc. Examiner notes that it’s a well-known technique to display/form a list of drugs in a specific way, such as a backend table, paragraphs 45, 47 and 50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Laster to include, ingesting a comprehensive drug product listing from a drug library, wherein the drug library comprises a source listing of all drug products and associated unique drug product identifiers; parsing the comprehensive drug product listing into backend tables of a database; and articulating the backend tables within a user interface, as taught in Waugh, in order to dispense drugs quickly, conveniently, securely, accurately and at less relative cost than traditional pharmacy-based dispensing systems (Waugh, paragraph 7).
With regard to claim 41, the combination of references discloses extracting the current drug product pricing information from the plurality of pharmaceutical suppliers comprises: integrating with each of the plurality of pharmaceutical suppliers by way of a secure file transfer protocol (Laster, paragraph 277, identifying, based on the contract data, multiple prices for the item indicated by different contracts with one or more suppliers offering the item for sale, and identifying, from among the multiple prices, the lowest price for the item and a particular supplier that has contractually agreed to sell the item at the lowest price); and one or more of receiving a file or communicating over an electronic data interchange with each of the plurality of pharmaceutical suppliers (Laster, paragraphs 279 and 286, A computer program may be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network). However, the combination of references does not disclose wherein the method further comprising parsing and articulating the current drug product pricing information into a database such that the current drug product pricing information is available to be rendered on a user interface.
However, Waugh teaches wherein the method further comprising parsing and articulating the current drug product pricing information into a database such that the current drug product pricing information is available to be rendered on a user interface (Waugh, paragraphs 44-49, 51, and 58).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, wherein the method further comprising parsing and articulating the current drug product pricing information into a database such that the current drug product pricing information is available to be rendered on a user interface, as taught in Waugh, in order to dispense drugs quickly, conveniently, securely, accurately and at less relative cost than traditional pharmacy-based dispensing systems (Waugh, paragraph 7).
With regard to claim 42, the combination of references discloses identifying drug product preferences for the ordering location, wherein identifying the drug product preferences comprises: determining a pricing preference for the first ordering location (Laster, paragraph 13, Examiner notes that the contracted price is considered as “a pricing preferences for the ordering location); and identifying medication ordering permissions for the first ordering location indicating which of the plurality of drug products the first ordering location has permission to purchase or obtain (Laster, Paragraph 277); wherein selecting the recommended drug product for the first ordering location comprises selecting further based on the drug product preferences (Laster, paragraph 152). However, the combination of references does not disclose identifying a formulary applicable to the ordering location…and determining whether a governmental pharmaceutical regulation applies to the first ordering location.
However, Waugh teaches identifying a formulary applicable to the first ordering location, wherein the formulary identifies two or more of the plurality of drug products that are interchangeable, and wherein the formulary further identifies whether the ordering location must comply with a restriction associated with any of the plurality of drug products (Waugh, paragraphs 41-42, 45-46, 50); determining whether a governmental pharmaceutical regulation applies to the first ordering location (Waugh, paragraph 44, Examiner notes that the dispensary located in the doctor's office or clinic applies regional drug regulation rules to sell a list of all drug approved for use by the regional authorities (e.g. for use in USA, Canada, etc.), which is considered as “determining whether a governmental pharmaceutical regulation applies to the ordering location”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, identifying a formulary applicable to the first ordering location, wherein the formulary identifies two or more of the plurality of drug products that are interchangeable, and wherein the formulary further identifies whether the ordering location must comply with a restriction associated with any of the plurality of drug products; determining whether a governmental pharmaceutical regulation applies to the first ordering location, as taught in Waugh, in order to dispense drugs quickly, conveniently, securely, accurately and at less relative cost than traditional pharmacy-based dispensing systems (Waugh, paragraph 7).
With regard to claim 49, the combination of references substantially disclose the claimed invention, however, the combination of references does not disclose selecting the recommended drug product comprises selecting based on data retrieved from a drug library comprising a listing of possible pharmaceutical equivalents and an indication of generic and brand-name versions of the plurality of drug products that satisfy the medication need.
However, Waugh teaches electing the recommended drug product comprises selecting based on data retrieved from a drug library comprising a listing of possible pharmaceutical equivalents and an indication of generic and brand-name versions of the plurality of drug products that satisfy the medication need (paragraphs 45 and 50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, selecting the recommended drug product comprises selecting based on data retrieved from a drug library comprising a listing of possible pharmaceutical equivalents and an indication of generic and brand-name versions of the plurality of drug products that satisfy the medication need, as taught in Waugh, in order to dispense drugs quickly, conveniently, securely, accurately and at less relative cost than traditional pharmacy-based dispensing systems (Waugh, paragraph 7).
Claims 37-39 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0061375 to Laster et al., Canadian Patent Application No. CA 2,693,893 to Bossi et al., U.S. Patent No. 10,685,308 to Avery, JR. et al., and further in view of U.S. Patent Application Publication No. 2010/0106653 to Sandholm et al.
With regard to claim 37, the combination of references substantially discloses the claimed invention, however, the combination of references does not disclose tracking price changes for an identified drug product over time, wherein the price changes are identified based on historical pricing data extracted from the plurality of pharmaceutical suppliers; and predicting a future adjustment to a unit-dose price of the identified drug product based on the tracked price changes.
However, Sandholm teaches tracking price changes for an identified drug product over time, wherein the price changes are identified based on historical pricing data extracted from the plurality of pharmaceutical suppliers (it may be that the buyer has one or more contracted suppliers for a given good or service. time-series for an item price and metrics such as minimum, maximum, median, average, and various percentile statistics. The CER system and method also collects additional relevant information, including for example current spot market or catalogue prices for items, paragraphs 9, 47, and 359); and predicting a future adjustment to a unit-dose price of the identified drug product based on the tracked price changes (a forecast of a future spot price on at least one good or service, paragraph 153).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, tracking price changes for an identified drug product over time, wherein the price changes are identified based on historical pricing data extracted from the plurality of pharmaceutical suppliers; and predicting a future adjustment to a unit-dose price of the identified drug product based on the tracked price changes, as taught in Sandholm, in order to source at the same time and with optimization used to determine the optimal outcome of a sourcing event (Sandholm, paragraph 15).
With regard to claim 38, the combination of references substantially discloses the claimed invention, however, the combination of references does not disclose calculating a weighted price for an identified drug product utilized by the first ordering location, wherein calculating the weighted price comprises calculated based on: a unit-dose quantity of the identified drug product purchased at a wholesaler acquisition cost; a unit-dose quantity of the identified drug product purchased at a government pricing program cost; and a unit-dose quantity of the identified drug product purchased at a group purchasing organization (GPO) cost.
However, Sandholm teaches calculating a weighted price for an identified drug product utilized by the first ordering location, wherein calculating the weighted price comprises calculated based on: a unit-dose quantity of the identified drug product purchased at a wholesaler acquisition cost; a unit-dose quantity of the identified drug product purchased at a government pricing program cost; and a unit-dose quantity of the identified drug product purchased at a group purchasing organization (GPO) cost (contracts may simply list unit prices for each of the contracted items. Sometimes, these prices may depend on external indices, such as commodity price indices. Businesses also make purchases to supplier with whom they do not have a procurement contract. The prices of these goods or services on the spot market are called the spot prices. A user may want to generate views of issues in regard to a particular item, including (a) summary information on the contracts for this item (total number, number expired, contract utilization), (b) summary information on the POs, invoice, and payments by status and amount that contain this item, (c) summary information on item pricing (minimum, maximum, average, median). Examiner notes that summary information on item pricing (minimum, maximum, average, median) is determined/calculated based on POs prices that is placed at different prices, such as sport price, contract price, commodity price indices, which is considered as “calculating a weighted price for an identified drug product …based on: …at a wholesaler acquisition cost …at a government pricing program cost, and …at a group purchasing organization (GPO) cost”, paragraphs 6-8 and 359).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, calculating a weighted price for an identified drug product utilized by the first ordering location, wherein calculating the weighted price comprises calculated based on: a unit-dose quantity of the identified drug product purchased at a wholesaler acquisition cost; a unit-dose quantity of the identified drug product purchased at a government pricing program cost; and a unit-dose quantity of the identified drug product purchased at a group purchasing organization (GPO) cost, as taught in Sandholm, in order to source at the same time and with optimization used to determine the optimal outcome of a sourcing event (Sandholm, paragraph 15).
With regard to claim 39, the combination of references substantially discloses the claimed invention, however, the combination of references does not disclose calculating a proportion of the identified drug product that is purchased at the wholesaler acquisition cost; and determining whether the proportion of the identified drug product purchased at the wholesaler acquisition cost exceeds a wholesaler threshold.
However, Sandholm teaches calculating a proportion of the identified drug product that is purchased at the wholesaler acquisition cost; and determining whether the proportion of the identified drug product purchased at the wholesaler acquisition cost exceeds a wholesaler threshold (Contracts may also include conditional offers, which are clauses that tie a trigger condition to an effect. For example, the ongoing prices may drop as a result of the cumulative past volume crossing a threshold. The trigger condition can include at least one of the following: the volume quantity of at least one good or service, summed over a plurality of purchase transactions associated with the first contract exceeds a quantity threshold, paragraphs 7 and 61).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, calculating a proportion of the identified drug product that is purchased at the wholesaler acquisition cost; and determining whether the proportion of the identified drug product purchased at the wholesaler acquisition cost exceeds a wholesaler threshold, as taught in Sandholm, in order to source at the same time and with optimization used to determine the optimal outcome of a sourcing event (Sandholm, paragraph 15).
With regard to claim 43, the combination of references substantially discloses the claimed invention, however, the combination of references does not disclose selecting a recommended pharmaceutical supplier for acquiring at least a portion of the recommended quantity of the recommended drug product, wherein the recommended pharmaceutical supplier is selected based at least in part on the current drug product pricing information extracted from the plurality of pharmaceutical suppliers.
However, Sandholm teaches selecting a recommended pharmaceutical supplier for acquiring at least a portion of the recommended quantity of the recommended drug product, wherein the recommended pharmaceutical supplier is selected based at least in part on the current drug product pricing information extracted from the plurality of pharmaceutical suppliers (Rather than pre-bundling goods and running one reverse auction for each bundle of goods (e.g., all surgical knees), the use of expressive sourcing allows for surgical devices, generic drugs, and other medical suppliers to be flexibly sourced. Through appropriately designed bidding languages each supplier can submit bids on the goods and services that it wants to supply, and these bids can then be combined at the end of the auction with optimization used to determine the set of winning suppliers and an allocation of goods to suppliers to maximize business value to the buyer. The outcome of a sourcing event specifies both an allocation of goods to each supplier (i.e., the quantity of each good or service to be purchased from each supplier during the course of a contract) the set of winning suppliers, and the bids provided by each winning supplier. This bid information includes for example all base prices along with any additional expressive bid information, paragraphs 15, 16, and 18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, selecting a recommended pharmaceutical supplier for acquiring at least a portion of the recommended quantity of the recommended drug product, wherein the recommended pharmaceutical supplier is selected based at least in part on the current drug product pricing information extracted from the plurality of pharmaceutical suppliers, as taught in Sandholm, in order to source at the same time and with optimization used to determine the optimal outcome of a sourcing event (Sandholm, paragraph 15).
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0061375 to Laster et al., Canadian Patent Application No. CA 2,693,893 to Bossi et al., and U.S. Patent No. 10,685,308 to Avery, JR. et al., and further in view of International Patent Publication No. WO 2009/045899 to O’Donoghue et al.
With regard to claim 47, the combination of references discloses identifying a top drug product based on the sorted drug products; determining whether the first ordering location has previously purchased the top drug product; in response to determining the first ordering location has previously purchased the top drug product, performing one or more of: automatically ordering the top drug product on behalf of the first ordering location by communicating with a supplier for the top drug product; or facilitating a user-initiated transaction for ordering the top drug product using one or more of secure file transfer protocol (SFTP), an application program interface (API), a fax message, or an email (Laster, paragraphs 266, 274, 277, these methods may further include the actions of identifying a price for the item indicated by a contract with a supplier, and transmitting, to the supplier, an order to purchase the item from the supplier at the price indicated by the contract with the supplier. identifying, from among the multiple prices, the lowest price for the item and a particular supplier that has contractually agreed to sell the item at the lowest price. Examiner notes that a lowest contract price item is considered as “the top drug product previously purchased”), however, the combination of references does not disclose in response to determining the first ordering location has not previously purchased the top drug product, generating a message indicating the top drug product is a new drug product for the first ordering location.
However, O’Donoghue teaches in response to determining the first ordering location has not previously purchased the top drug product, generating a message indicating the top drug product is a new drug product for the first ordering location (During the Phase III weighting methodology 706, the decision module 234 can provide the administrator 213, content provider, or mobile operator with the ability to specify the items that should be prioritized/de-prioritized in terms of the likelihood to be recommended to a user or subscriber. decision module 234 can utilize certain subscriber specific information, depicted as preference filters 760, to automatically filter the results. Blocking of previous purchases 764 - Decision module 234 operates to ensure that a subscriber will not be recommended an item the subscriber has already purchased; The Associate Recommender can then check that the items have not already been bought by the subscriber by using a filtering process 1311 that can also factor in device compatibility and metadata filtering, accessing device information 1313. Thereafter, Associate Recommender can add the items to the list and applies a confidence level using a weighting process 1307 in accordance with weighting rules 1309. Associate Recommender checks that the items are not already bought by the user or subscriber, adds the items to the list, applies weighting, verifies device compatibility, and then returns results to the decision recommender 234. In one example, the purpose of the compare recommender 1106 is to calculate the relationship between different items of content based on content metadata 1327 that receives inputs from a catalogue API 1329 that performs interface data ingestion. According to one example, the compare recommender 1106 can assist in solving the cold start problem for a new item (i.e., a new item added to the mobile operator or associated business system that has not been bought by anyone, yet). In one instance, the associate recommender 1104 may not be able to find any correlations for the new item, as no subscriber has bought this item and the item does not appear in any of the subscribers' histories, paragraphs 99-101, 133, and 135-146).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, in response to determining the first ordering location has not previously purchased the top drug product, generating a message indicating the top drug product is a new drug product for the first ordering location, as taught in O’Donoghue, in order to prioritize/de-prioritized items that can be suggested to a user (O’Donoghue, paragraph 99).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0061375 to Laster et al., Canadian Patent Application No. CA 2,693,893 to Bossi et al., and U.S. Patent No. 10,685,308 to Avery, JR. et al., and further in view of U.S. Patent Application Publication No. 2020/0299062 to Kazama et al.
With regard to claim 50, the combination of references substantially discloses the claimed invention, however, the combination of references does not disclose receiving an indication from a user to order a medication…and converting the indication from the user referring to the medication in the standard usable unit of measure to the package size available from the supplier.
However, Kazama teaches receiving an indication from a user to satisfy the medication need, wherein the medication need is indicated in a standard usable unit of measure; communicating with one or more of the plurality of pharmaceutical suppliers to identify at least one pharmaceutical supplier with available inventory of the recommended drug product that satisfies the medication need; determining a package size for the at least one pharmaceutical supplier with the available inventory of the recommended drug product; and converting the indication from the user referring to the medication need in the standard usable unit of measure to the package size available from the at least one pharmaceutical supplier (Even if the form of the order is “case”, there are instances in which the case article in the order is out of stock in the upper portion of the conveyance rack DS. In this case, the order determination unit 1700 executes a conversion process for the form 604 and the number 603. Specifically, the order determination unit 1700 converts the form of the order from “case” to “individual”, and converts the number of articles in the order from the number of cases to the number of individual articles, for example. The package unit field 705 is a storage region that stores the package unit of the article 702, as a value. If the form 604 of the article 702 (602) is “case”, then the package unit 705 is the number of individual articles for when the articles 702 are counted per case. That is, the form 604 defines the package unit 705 of the article 702. Also, if the form of the articles is not specified in the order, the order determination unit 1700 executes a form identification process. Specifically, for example, the order determination unit 1700 determines whether the form is “case” or “individual” on the basis of the number of ordered articles and the package unit 705 of the articles. The order determination unit 1700 compares the number 603 of ordered articles 602 and 702 with the package units 705 thereof. If the number 603 is a factor of the package unit 705, then the order determination unit 1700 determines that the form 604 of the article 602 is a case. In the case of the article B, the number 603 in the entry 153 is 100, and the package unit 705 in the entry 72 is “100”. Thus, the number 603 (100 items) is a factor of the package unit 705 (100) (the factor is 1, and therefore, the number is 100). Thus, the order determination unit 1700 sets the form 604 of the entry 153 to “case” and converts the number 603 from “100” to “1” (100 items÷package unit of 100). Even if the number 603 of articles B were “200”, the number is still a factor of the package unit 705. In this instance as well, the order determination unit 1700 sets the form 604 of the entry 63 to “case” and converts the number 603 from “200” to “2” (200 items÷package unit of 100). On the other hand, if the article is in inventory (step S1809: Yes), the management apparatus 302 generates picking operation instruction data for the selected article (case article) (step S1811), paragraphs 62, 125, 129-131, and 139).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the combination of references to include, receiving an indication from a user to order a medication… and converting the indication from the user referring to the medication in the standard usable unit of measure to the package size available from the supplier, as taught in Kazama, in order to provide a picking system to improve work efficiency (Kazama, paragraph 5).
Response to Arguments
Applicants' arguments filed on 03/11/2026 have been fully considered but they are not fully persuasive especially in light of the new art used in the rejections.
Applicants remark that “the combination of references does not disclose rendering inventory visibility for a health system by maintaining a plurality of digital shelves that are accessible via a cloud computing network, wherein each of the plurality of digital shelves represents an ordering location of a plurality of ordering locations within the health system; automatically updating a first digital shelf associated with the first ordering location based upon real-time updates ingested from the inventory management solution; wherein the recommended drug product comprises; a delivery form satisfying the medication need, wherein the delivery form comprises intravenous, oral suspension, oral solid, injectable, or topical, a release mechanism satisfying the medication need, wherein the release mechanism comprises immediate, delayed, sustained, or controlled, and a package satisfying the medication need”.
Examiner directs Applicants' attention to the office action above.
Applicants remark that “The above-noted claim elements improve the functioning of the computer system itself by enhancing data quality and improving user renderings accessible via a cloud computing network. Here, the combination of real-time data extraction and rendering of inventory visibility across a health system represent more than merely using computers as tools to perform abstract calculations. The above concepts instead transform how a health system manages, tracks, and visualization data across numerous geographic locations. These concepts integrate the alleged judicial exception of an "abstract idea" into the practical application of improving pharmaceutical supply chain reliability and patient access to medications, and this renders the claims patent- eligible under 35 U.S.C. § 101”.
Examiner does not agree. The claim limitation does not, for example, purport to improve the functioning of the computer itself. Nor does it effects an improvement in any other technology or technical field. The claimed computer components such as the health system, the plurality of digital shelves, the cloud computing network, the robotic automated dispenser, and the drug product database are recited at a high level of generality and are merely invoked as tools to perform rendering, extracting, updating, identifying, querying, selecting, calculating, and dispensing steps. There is no unconventional technology claimed, any technological improvements or new technology involved on Applicant’s invention. The digital shelves are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. They do not describe any particular improvement in the manner a computer functions. Instead, the claim amounts to nothing significantly more than using digital shelves via a health system and an internet to update inventories in various of locations and apply those determinations to efficiently recommend drug products. Under our precedents, that is not enough to transform an abstract idea into a patent-eligible invention.
Conclusion
Please refer to form 892 for cited references.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ARIEL J YU/Primary Examiner, Art Unit 3627
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