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 12/03/2025 has been considered.
Claims 1, 7, and 20 are amended. Claims 1, 3, 6, 7, 9, and 11-20 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. the specification does not support or describes “a product management repository comprising an onboarding interface communicably coupled to one or more input/output interfaces, a master catalog of inventory items, and a multichannel interface communicably coupled to the one or more input/output interfaces”.
Claims 1 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. the proposed limitation “the product information management repository automatically identifies any purchases ad inventory locations of a recalled products” is not supported in the specifications. In the specification, paragraph 43 describes Robotic Process Automation (RPA) 404 searches the May Product Information Management Repository (PIM) 406…to identify…”. Therefore, the product information management repository does not automatically identify the recalled products. Robotic Process Automation is performed to search the product information management repository to identify the recalled products.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification describes automatically creating an item add/change/delete request using a template (paragraph 12). However, the specification does not describe or support automatically creates a template for the add, change or delete request for the inventory item.
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, 3, 6, 7, 9, and 11-20 are rejected under 35 USC 101. The claimed invention is directed to non-statutory subject matter because claims 1 and 20 are directed to an abstract idea without significantly more. Claims 3, 6, 7, 9, and 11-19 fail to remedy these deficiencies.
The claims 1, 3, 6, 7, 9, 11-13, and 20 recite managing a supply chain, automating logistics and inventory management, identifying any purchases and inventory locations of a recalled product, generating instructions to remove/recall products, identifying any users or patients, creating/analyzing/managing data, creating/requesting to add/change/delete an item, processing/proving backordered items, accessing to data, optimizing preference card content and stocking levels using machine learning, maintaining data, and providing supply chain simulation, and providing pay, category management, operations, risk management, business management, and initiative management functions.
The Claims 1, 3, 6, 7, 9, 11-13, and 20 recite managing a supply chain which further comprising capturing data for logistics and inventory management, ingesting, enriching, and harmonizing information, receiving an add, change or delete request, searching information, creating and submitting a completed add, change or delete request, sending an auto-notification, identifying inventory locations of a recalled product, generating and sending an alert with instructions to remove/recall products, identifying any users or patients, sending notifications, creating/analyzing/managing data, creating a template for the add/change/delete request, processing/providing backordered items, accessing to data, maintaining data, and providing supply chain simulation, and providing/performing pay, category management, operations, risk management, business management, and initiative management steps as drafted, are processes that under broadest reasonable interpretation, cover performance of the limitation in the mind and/or managing personal behavior, but for the recitation of generic computer components. That is, other than reciting “one or more systems, modules, or data sources coupled to one or more input/output interfaces, one or more memories or databases, one or more processors communicably coupled to the one or more input/output interfaces and the one or more memories or databases, an information management platform communicably coupled to the one or more processors, wherein the information management platform comprises a process automation component, an application programming interface management component, a dynamic analytics component, and a data management component, and the data management component comprises a product management repository comprising an onboarding interface communicably coupled to one or more input/output interfaces, a master catalog of inventory items, and a multichannel interface communicably coupled to the one or more input/output interfaces”, nothing in the claim element precludes the steps from practically being performed in the mind and/or by organizing human activity. For example, but for “the systems, modules, or data sources, the input/output interfaces, the memories or databases, the processors communicably coupled to the input/output interfaces and the memories or databases, the information management platform communicably coupled to the processors, wherein the information management platform comprises the process automation component, the application programming interface management component, the dynamic analytics component, and the data management component which comprises the product information management repository, the onboarding interface, the input/output interfaces, and the multichannel interface” in the context of these claims encompasses a person manually manages a supply chain to enter/create/capture and to ingest, enrich, and harmonize data for logistics and inventory management, receives an add/change/delete request to search information, creates/forms a completed add/change/delete request for submission, sends a notification, identifying inventory locations of a recalled product, accesses data, maintains data, analyzes/manages data to identify inventory locations of a recalled product and any users or patients, instructs and alerts to remove/recall products, identifies any users or patients, sends notifications, creates a template for the add/change/delete request, processes/provides backordered items, optimize preference card content, provides supply chain simulation, and provides/performs pay, category management, operations, risk management, business management, and initiative management. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind and/or by managing personal behavior but for the recitation of generic computer components, then it falls within the “Mental Processes” and/or “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The Claims 1, 3, 6, 7, 9, 11-13, and 20 recite optimizing preference card content and stocking levels using machine learning is process that under broadest reasonable interpretation, cover performance of the limitation by utilizing mathematical algorithms/modeling but for the recitation of generic computer components. That is, other than reciting “machine learning”, nothing in the claim element precludes the steps from practically being performed by utilizing mathematical algorithms/modeling. In other words, the claimed method simply describes the concept of utilizing the machine learning algorithms/modeling to optimize preference card content and stocking levels. In particular, the courts have found mathematical algorithms to be abstract ideas (e.g., a mathematical procedure for converting one form of numerical representation to another in Benson. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation by utilizing mathematical algorithms/modeling but for the recitation of generic computer components, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application because automatically capture data for logistics and inventory management steps is recited at a high level of generality (i.e., as a general means of collecting data for analyzing/identifying step) 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 managing, capturing data, ingesting, enriching, harmonizing, receiving, searching, creating, submitting, sending, identifying, generating, creating/analyzing/managing, processing/providing, accessing, maintaining, optimizing, simulating, and performing steps in a computer environment. The claimed computer components such as the systems/modules/data sources, the input/output interfaces, the memories/databases, the processors, the information management platform, the process automation component, the application programming interface management component, the dynamic analytics component, the data management component, the product information management repository, the onboarding interface, the input/output interfaces, and the multichannel interface are recited at a high level of generality and are merely invoked as tools to perform managing, capturing data, ingesting, enriching, harmonizing, receiving, searching, creating, submitting, sending, identifying, generating, creating/analyzing/managing, processing/providing, accessing, maintaining, optimizing, simulating, and performing 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 1, 3, 6, 7, 9, 11-13, and 20 are directed to an abstract idea.
The claims 1, 3, 6, 7, 9, 11-13, and 20 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 systems/modules/data sources, the input/output interfaces, the memories/databases, the processors, the information management platform, the process automation component, the application programming interface management component, the dynamic analytics component, the data management component, the product information management repository, the onboarding interface, the input/output interfaces, and the multichannel interface to perform managing a supply chain, automating data capture, ingesting, enriching, and harmonizing, receiving, searching , creating and submitting, identifying, instructing, alerting, identifying, creating/analyzing/managing data, sending, creating/requesting, processing/proving backordered items, accessing, optimizing content, maintaining data, providing supply chain simulation, pay, category management, operations, risk management, business management, and initiative management 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 claim does not amount to significantly more than the recited abstract idea (Step 2B: NO). The claims 1, 3, 6, 7, 9, 11-13, and 20 are not patent eligible.
Claims 14-19, disclose insignificant helpful content to further describe content, such as procurement, payables, informatics and/or customer service, performance consulting, contracting, value analysis and/or formulary, inventory management, logistics, clinical support, operations support and/or CR, financial management, business continuity, and/or audit, business development and/or data integrity, portfolio management and/or project support, which are merely descriptive content to further limit the abstract idea but not make it less abstract. Thus, the claims 14-19 are directed to an abstract idea.
This judicial exception is not integrated into a practical application because descriptive content in claims 14-19 further limit the abstract idea but not make it less abstract. Thus, the claims 14-19 are directed to an abstract idea.
There are no additional claim element limitations recited in the claims 14-19. Therefore, the claim does not amount to significantly more than the recited abstract idea (Step 2B: NO). The claims 14-19 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 1, 3, 6, 7, 9, 11, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0288952 to Smith et al., in view of U.S. Patent Application Publication No. 2019/0087544 to Peterson., in view of International Patent Application Publication No. WO 2011/026146 to Cowand, and further in view of U.S. Patent No.10,762,511 to Pope et al.
With regard to claims 1 and 20, Smith discloses a computerized supply chain management system comprising:
one or more input/output interfaces communicably coupled to one or more systems, modules, data sources or devices (Fig. 3, paragraphs 18, 42, and 46, the computing device 9 is any device that generally comprises a user interface 3, an input device 4, and an output device 5. The memory device 8 is configured to store data, applications, modules, instructions or the like for enabling the system to execute the functionality described below in the various embodiments);
one or more memories or databases (Fig. 3, paragraphs 18 and 42, Referring to FIGS. 1-3, the most basic embodiment of the logistics management system generally comprises the following basic components: at least one processor 7 in communication with at least one memory device 8);
one or more processors communicably coupled to the one or more input/output interfaces and the one or more memories or databases (Fig. 3, paragraphs 18, 42, and 46, The processor 7 comprises one or more of a number of suitable computer processors capable of managing, processing, analyzing, storing, and retrieving the data within the system.);
an information management platform communicably coupled to the one or more processors, wherein the information management platform comprises a process automation component, an application programming interface management component, a dynamic analytics component, and a data management component, all of which work together to process data using the one or more processors in real-time (Fig. 3, Fig. 9, paragraphs 18, 39, 42, 46, 72, 89, and 130, The system is capable of providing real-time tracking and logistics management of inventory throughout the lifecycle of each tracked object. Referring to FIG. 9, the software application 16 comprises a platform 20 incorporating multiple functionality modules that are selected and arranged as appropriate for the particular purposes of the tracking system. In one embodiment of the method of logistics management, the method further comprises providing an RSS feed assembly and functionality);
the data management component comprises a product management repository comprising an onboarding interface communicably coupled to one or more input/output interfaces, a master catalog of inventory items, and a multichannel interface communicably coupled to the one or more input/output interfaces (Fig. 3, paragraphs 18, 39, 42, 43, 45-46, 60, 66, 89, and 130, the computing device 9 is any device that generally comprises a user interface 3, an input device 4, and an output device 5. The user interface 3 is operable to graphically illustrate output received from the system, and more specifically, from the processor 7. The dashboard 31 is the graphical interface between the user and the system. The database connection assembly 13 encapsulates all required logic to access the inventory of medical assets, account, and user database by providing a mechanism that enables the communication service 11, when invoked, to access the database connection assembly 13. The database 12 supports each user profile 1, which is a data profile containing data that relates to the user's representatives, existing inventory of medical asset, and other relevant information.), wherein the product management repository manages a supply chain using one or more automated processes executed by the one or more processors and the one or more systems, modules, data sources or devices (paragraphs 39, 89 and 130, the invention is a system for and method of providing integrated logistics management of inventory, wherein the system is operable from a single application on a mobile telecommunication device, such as a smart phone, tablet computer, or the like. The system is capable of providing real-time tracking and logistics management of inventory throughout the lifecycle of each tracked object. The RSS feed assembly is a live, real-time data and information feed reporting news and releases issued from the FDA or other sources, and the feed is accessible by the user application 16 on the mobile device 15.), and ingesting, enriching and harmonizing, by the one or more processors, information from the data sources, wherein one of the one or more automated processes receives, by the one or more processors, via the onboarding interface, an add, change or delete request for an inventory item, and automatically searches, by the one or more processors, the data sources or the master catalog for information relating to the inventory item in accordance with specified rules and analytics, creates and submits, by the one or more processors, via the multichannel interface completed data elements from the add, change or delete request that adds, changes or deletes the inventory item in the supply chain (paragraphs 66, 75-77, and 87-89, The dashboard 31 is the graphical interface between the user and the system, and the dashboard 31 displays visual indicators for access to the other features and processes. Case management data 60 comprises information pertaining to the user's inventory levels, the lots used during the case, the tray and lot numbers for the used medical assets, the purging of those used lots from the user's inventory list, requisition information for depleted medical assets, billing information, and other such information related to the medical assets used during the case. The requisition system captures all parts, lots, prices, descriptions, and other relevant case management data 60 onto a template or custom requisition form that is submitted to the manufacturer allowing for immediate replenishment of tray or device lots. In other words, the system automatically performs the step of automatically populating an electronic requisition form 63 with case management data captured in real-time during the surgical procedure. At that time, the representative uses the application 16 to access the case manager 25 to perform the step of calling up the specifically scheduled medical asset 61 from the user's medical asset inventory list, which is stored in the database, for management during the case. As the provider uses the lots during the procedure, the representative uses the case manager 25 for the step of designating used medical assets 62, such as used lots, accordingly. The representative repeats these steps for each tray and lot used by the provider during the case. At the end of the procedure, the representative has compiled an accurate set of case management data 60 listing of all medical assets used, both trays and lots. Examiner notes that performing the step of calling up the specifically scheduled medical asset 61 from the user's medical asset inventory list, captures all requisition information for depleted medical assets, billing information, and other such information related to the medical assets used during the case, and to create an accurate set of case management data 60 listing of all medical assets used, which is considered as “ingesting, enriching and harmonizing, by the one or more processors, information from the data sources and creates and submits, by the one or more processors, via the multichannel interface completed data elements from the add, change or delete request that adds, changes or deletes the inventory item in the supply chain”), and sends an auto-notification to a device of a requestor of the add, change or delete request (paragraphs 78 and 84, the inventory viewer 23 further comprises a reporting function that provides a web based view for users or representatives to access the tray, lot, surgery data, or other tracking parameters in real-time as soon as data has been entered. The processor 7 then automatically sends a notification to the representative that the required medical assets have been located and allocated.);
the product information management repository automatically identifies, by the one or more processors, any purchases and inventory locations of a recalled product, automatically generates and sends, by the one or more processors, an alert to inventory management dashboards with instructions to remove the recalled product, automatically generates, by the one or more processors, a product return for the recalled product, all in response a recall message for the recalled product (paragraphs 21, 66, 96, 120 and 130, The dashboard 31 is the graphical interface between the user and the system, and the dashboard 31 displays visual indicators for access to the other features and processes. By accessing the inventory assembly, the representative obtains data about all medical assets in the user's profile, the location of the medical assets, and data about the medical assets, such as dates, times, the name of medical facilities, mailing address of the location, and other customized data. The system is configured to issue this recall command in real-time, such as by push notifications to the software application 16 on the representatives mobile device 15. In this manner, a representative can remove a recalled tray from a medical procedure while the case is in progress, thereby enabling up-to-the-minute safety to the patient. For example, the FDA news feeds can be electronically gleaned for news relating to specific tray or lot numbers, and these numbers can be compared to and synched with the medical asset data in the user's profile 1. Upon locating a medical asset identification number in the database 12 for which an FDA release has been issued, the affected medical asset in the database 12 is flagged to obtain the representative's attention. Examiner notes that in response to the news feed regarding warnings, alerts, or recalls corresponding to certain medical assets, the system compares specific tray or lot numbers with the medical asset data in the user's profile 1, identifies/locates a medical asset identification number in the database 12 for which an FDA release has been issued, the affected medical asset in the database 12 via the dashboard is flagged to obtain the representative's attention, the flagged defective product will be removed from the inventory and is returned for refund, which is considered as “identifies, by the one or more processors, any purchases and inventory locations of a recalled product, automatically generates and sends, by the one or more processors, an alert to inventory management dashboards with instructions to remove the recalled product, automatically generates, by the one or more processors, a product return for the recalled product, all in response a recall message for the recalled product”.),
automatically identifies any users and patients impacted by the recalled product (paragraph 134, the representative can identify the patient in which each lot was installed), and automatically provides notifications to the one or more devices of the identified users and patients regarding the recalled product and the suitable substitutes (paragraph 134, Individual patients are notified that they have received a device that poses certain risks, according to the FDA notice); and
the application programming interface management component builds and provides, by the one or more processors, requisitions, and requests and processes, by the one or more processors, services (paragraphs 20 and 89-90, Upon discharge of a lot, the software uses the inventory assembly to automatically send a message to the manufacturer to order corresponding replacement medical assets. The case manager 25 also provides for an electronic requisition system for replenishing medical assets that were used or otherwise depleted from the profile 1 of medical asset inventory during the provider's performance of a case. The representative also uses the case manager 25 to create requisitions for billing purposes. This requisition form is a re-order form to replenish exhausted or depleted medical assets).
However, Smith does not disclose the dynamic analytics component automatically optimizes, by the one or more processors, procedure-based preference card content and associated stocking levels based on practice use patterns using machine learning; the application programming interface management component automatically processes and provides, by the one or more processors, alternatives for backordered items; and automatically determines, by the one or more processors, suitable substitutes for the recalled product, automatically identifies, by the one or more processors, any users and patients impacted by the recalled product, and automatically sends, by the one or more processors, notifications to the one or more devices of the identified users and patients regarding the recalled product and the suitable substitutes.
However, Peterson teaches the dynamic analytics component automatically optimizes, by the one or more processors, procedure-based preference card content and associated stocking levels based on practice use patterns using machine learning (The digital twin 130 continues to learn and improve as it receives and models feedback throughout the pre-procedure, during procedure, and post-procedure process including information regarding items used, items unused, items left, items missing, items broken, etc. the digital twin 130 and the monitor 700 can be used to dynamically model, monitor, train, and evolve to support surgery and/or other medical protocol, for example. If the item was not used in the procedure, then, at block 1322, the item is returned to the cart 400, tracked, and updated with respect to the central inventory to account for the item remaining after the procedure. Thus, if the item was used in the patient's surgery, the preference card and other record(s) can be updated to reflect that use. If the item was not used, then the patient does not need to be billed for the item and then item may not be listed on the preference card for that surgeon for the given procedure, for example. Examiner notes that the trained digital twin model/system dynamically update/optimizes the preference card and used/unused inventory level based on that use or not use, which is considered as “the dynamic analytics component automatically optimizes procedure-based preference card content and associated stocking levels based on practice use patterns using machine learning”, paragraphs 70-71, 76 and 89-91).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventory management system of Smith to include, the dynamic analytics component automatically optimizes, by the one or more processors, procedure-based preference card content and associated stocking levels based on practice use patterns using machine learning, as taught in Peterson, in order to improve patient and healthcare operation modeling and care (Peterson, paragraph 1).
However, Cowand teaches automatically identifies, by the one or more processors, any users and patients impacted by the recalled product, and automatically sends, by the one or more processors, notifications to the one or more devices of the identified users and patients regarding the recalled product and the suitable substitutes (By associating a patient record with each disbursement of a sample, MCK is able to maintain a database that can be used to identify each patient who has received a particular formulation. Because MCK has the capability of maintaining a complete EMR for each patient, in the event of a drug recall or alert, MCK can automatically generate relevant notices for delivery to affected patients, Paragraph 54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventory management system of Smith to include, automatically identifies, by the one or more processors, any users and patients impacted by the recalled product, and automatically sends, by the one or more processors, notifications to the one or more devices of the identified users and patients regarding the recalled product and the suitable substitutes, as taught in Cowand, in order to provide a streamlined procedure for tracking critical information and maintaining records (Cowand, paragraph 11).
However, Pope teaches the application programming interface management component automatically processes and provides, by the one or more processors, alternatives for backordered items (identifying, for a plurality of products, the availability status of the products as available or unavailable as one of at least backordered, replaced, and discontinued. using the data identifying respective substitute products, whether any substitute products have been identified for the requested product; and if one or more substitute products have been identified for the requested product, treating those as proposed substitute products. Examiner notes that both backordered and recalled products can be identified as unavailable, any substitute products have been identified by the unavailable status of products, which is considered as “automatically processes and provides, by the one or more processors, alternatives for backordered items”, claim 1 and col. 2, lines 1-54); and automatically determines, by the one or more processors, suitable substitutes for the recalled product (a computer implemented method for identifying to a user a substitute product corresponding to a recalled requested product is provided. claim 1 and col. 2, lines 1-54).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inventory management system of Smith to include, the application programming interface management component automatically processes and provides, by the one or more processors, alternatives for backordered items; and automatically determines, by the one or more processors, suitable substitutes for the recalled product, as taught in Pope, in order to inform the use that the desired product has been recalled and, optionally, identifying one or more substitute products to the user as alternative products (Pope, col. 1, lines 20-24).
With regard to claim 3, the combination of Smith and Peterson discloses the process automation component automates, by the one or more processors, logistics and inventory management processes using robotic process automation, intelligent data capture and cognitive automation (Smith, paragraphs 89, 108, and 130, In one embodiment, for example, the requisition system captures all parts, lots, prices, descriptions, and other relevant case management data 60 onto a template or custom requisition form that is submitted to the manufacturer allowing for immediate replenishment of tray or device lots. the system automatically performs the step of automatically populating an electronic requisition form 63 with case management data captured in real-time during the surgical procedure. The allocation process is automated by an intelligent suggestion module in which the system automatically retrieves a subset of tray serial numbers. Peterson, paragraphs 145 and 147, While progress with industrial equipment automation has been made over the last several decades, and assets have become ‘smarter,’ the intelligence of any individual asset pales in comparison to intelligence that can be gained when multiple smart devices are connected together. In definition, cognitive automation describes diverse ways of combining artificial intelligence (AI) and process automation capabilities to improve business outcomes. ).
With regard to claim 6, Smith discloses the application programming interface management component, by the one or more processors, creates, analyzes and manages one or more application programming interfaces (paragraphs 45 and 66, The communication service 11 is comprised of one or more application programming interfaces ("API"). Referring to FIG. 8, the system comprises a software suite 30 that forms the interface between the user and the system, enabling the user to manage the flow of process of the system and interact with data stores.).
With regard to claim 7, Smith discloses the application programming interface management component automatically, by the one or more processors, creates a template for the add, change or delete request for the inventory item (paragraphs 87 and 89, Thus, the case manager 25 gives the user immediate purge control over all medical assets used in the case, deleting any depleted stock out of the system in real-time. the requisition system captures all parts, lots, prices, descriptions, and other relevant case management data 60 onto a template or custom requisition form that is submitted to the manufacturer allowing for immediate replenishment of tray or device lots. In other words, the system automatically performs the step of automatically populating an electronic requisition form 63 with case management data captured in real-time during the surgical procedure. Examiner notes that Requisition forms are official documents for internal requests for goods, services, or resources. Therefore, a requisition form can be customized generated, which can be considered as “creates a template for the add, change or delete request for the inventory item”.).
With regard to claim 9, Smith discloses the dynamic analytics component provides, by the one or more processors, seamless access to data within the one or more memories or databases (paragraphs 21 and 43, the database 12 is accessible. By accessing the inventory assembly, the representative obtains data about all medical assets in the user's profile, the location of the medical assets, and data about the medical assets, such as dates, times, the name of medical facilities, mailing address of the location, and other customized data.).
With regard to claim 11, Smith discloses the data management component, by the one or more processors, integrates, cleans and maintains data within the one or more memories or databases (paragraph 77, For implant devices, the lifecycle begins at the time of the initial shipment by the manufacturer and continues until the time that the device expires, which may be several days, weeks, or years after the device is implanted into the patient. When a tray or lot is depleted from the medical asset inventory, such as by discarding the lot or implanting it into a patient, the representative updates the corresponding medical asset data, and the system will automatically notify the manufacturer that a replacement tray or lot is needed and the location of where such medical assets are needed. The tracking means includes the functions of identifying, logging, and recording a tray number or a lot number, and recording the time and location of the tray or lot during the entire lifecycle. In another embodiment, the tracking means comprises tracking parameters carrying additional information about the medical assets, such as the surgery location, physician name, tray identification, a picture of the facility, or other information as desired. The system enables the tracking function by connecting to the database 12, through the same communication service 11 that the mobile device 15 is remotely hydrating and utilizing.).
With regard to claim 13, Smith discloses the information management platform, by the one or more processors, provides one or more functions selected from procure to pay, category management, operations, risk management, business management, and initiative management (paragraphs 14, 18, 65, 67-69, 90, and 134).
With regard to claim 14, Smith discloses the procure to pay function comprises procurement, payables, informatics and/or customer service (paragraphs 68 and 90, The revenue tracker 34 enables the user to access, review, and store all electronic documentation and data relating to payments for and revenue from the medical assets used in the cases. the revenue tracker 34 is configured to interface with the user's accounting software so that the user's accounting books are automatically updated with revenue information. sent to the provider or health care facility to process billing, accounting, and payment procedures.).
With regard to claim 15, Smith discloses the category management function comprises performance consulting, contracting, value analysis and/or formulary (paragraphs 66-71, the software suite 30 comprises modules such as a dashboard 31, scheduler 32, case viewer 33, revenue tracker 34, inventory manager 35, and doctor preferences 36, to name a few. For example, the user could use the revenue tracker 34 to retrieve and view the revenue generated by representative X during month Y. Thus, the user is able to readily identify all medical assets within a certain medical facility, zip code, town, or other geographic area.).
With regard to claim 16, Smith discloses the operations function comprises inventory management, logistics, clinical support, operations support and/or CRM (abstract, paragraph 18).
With regard to claim 17, Smith discloses the risk management function comprises financial management, business continuity, and/or audit (paragraphs 14, 68, and 134, All of this data is documented on paper for corroboration in the event of an audit. For example, if the FDA issues a health warning or recall of a specific lot, the representative can immediately identify the location of each such lot currently in inventory, in addition to the tracking parameters of each such depleted lot. In embodiments where the representative receives FDA notice real-time, the representative has the ability to notify healthcare providers during a surgical procedure that the lot used in the procedure carries a newly discovered health risk or other defect.).
With regard to claim 18, Smith discloses the business management function comprises business development and/or data integrity (paragraph 65, The web application 19 includes features for managing sales teams and trays, such as by adding and managing representatives, adding and managing tray data, updating price lists. The web application 19 may also comprise fields for entering data, such as tray or lot information or other fields.).
With regard to claim 19, Smith discloses the initiative management function comprises portfolio management and/or project support (paragraphs 67 and 69, The case viewer 33 enables the user to access all information relating to a particular case, such information including data relating to the representative, facility, provider, patient, date of the case, the medical assets to be used, and other data relevant to the particular application of the tracking system. The case viewer 33 enables the user to have access to all cases within the user's profile 1, and to display certain data during a certain time period. The inventory manager 35 enables the user to manage all medical asset inventory included within the user's profile 1. For example, the user accesses, reviews, and edits data relating to one or more representatives, the medical assets currently at one facility, medical assets allocated to one or more cases, and all data about the medical assets).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0288952 to Smith et al., U.S. Patent Application Publication No. 2019/0087544 to Peterson, U.S. Patent No.10,762,511 to Pope et al, and International Patent Application Publication No. WO 2011/026146 to Cowand, and further in view of China Patent Application Publication No. CN 206557834 to Chen.
With regard to claim 12, the combination of references substantially disclose the claimed invention, however, the combination of references does not disclose an innovation sandbox component provides, by the one or more processors, supply chain simulation and application development.
However, Chen teaches an innovation sandbox component provides, by the one or more processors, supply chain simulation and application development (installing the analogue intelligent supply chain sandbox server system, and storing the collecting in the supply chain of the whole simulation information, Page 3, lines 36-38).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of references to include, an innovation sandbox component provides, by the one or more processors, supply chain simulation and application development, as taught in Chen, in order to collect supply chain simulation information by installing an intelligent supply chain sandbox server system (Page 3, lines 36-38).
Response to Arguments
Applicants' arguments filed on 12/03/2025 have been fully considered but they are not fully persuasive especially in light of the previously references used in the rejections.
Applicants remark that “the combination of references does not disclose the proposed amended limitations”.
Examiner directs Applicants' attention to the office action above.
Applicants remark that “Smith’s representative is a person, which is not a system that automatically performs the claimed functions in response to a recalled product. As a result, Smith does not disclose, teach or suggest “automatically identifies, by the one or more processors, any users and patients impacted by the recalled product, and automatically sends, by the one or more processors, notifications to the one or more devise of the identified users and patients regarding the recalled product”.
Examiner directs Applicants' attention to the office action above.
Applicants remark that “Peterson does not disclose, teach or suggest “the dynamic analytics component automatically optimizes, by the one or more processors, procedure-based preference card content and associated stocking levels based on practice use patterns using machine learning” as recited in claim 1".
Examiner does not agree. Peterson teaches practice use patterns (Thus, if the item was used in the patient's surgery, the preference card and other record(s) can be updated to reflect that use. If the item was not used, then the patient does not need to be billed for the item and then item may not be listed on the preference card for that surgeon for the given procedure, for example. paragraphs 70-71, 76 and 89-91).
Examiner notes that the item was used or not used, is considered as “practice use patterns” which can used to train a machine learning model.
Applicants remark that “applicant(s) respectfully submit(s) that Smith does not disclose, teach or suggest a process automation component having cognitive automation”.
Examiner directs Applicants' attention to the office action above.
Applicants remark that “the proposed amendment includes the data management component comprises a product information management repository comprising an onboarding interface communicably coupled to one or more input/output interfaces, a master catalog of inventory items,and a multichannel interface communicably coupled to the one or more input/output interfaces. Applicant(s) respectfully submit(s) that the hardware/software elements in combination “with the following steps recite additional elements that are sufficient to amount to significantly more that the judicial exception in claim 1”.
Examiner directs Applicants' attention to the office action above.
Applicant(s) respectfully submit(s) that claims 1 and 16 have similar characteristics to claim 1 of Example 42 – Method for Transmission of Notifications When Medical Records Are Updated, which was found to be patent eligible because the claim is integrated into a practical application”
Examiner does not agree. Example 42 discloses “converting…a non-standardized format to a standardized format…”. Claims 1 and 20 do not have similar characteristic to claim 1 of Example 42. Therefore, the claims are not patentable eligible.
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.
Any inquiry concerning this communication from the examiner should be directed to Ariel Yu whose telephone number is 571-270-3312. The examiner can normally be reached on Monday-Friday 9:00am-5:00pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Obeid Fahd A can be reached on 571-270-3324. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARIEL J YU/Primary Examiner, Art Unit 3627