DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed November 26, 2025.
Claims 1-17 are pending.
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 .
Information Disclosure Statement(s)
The information disclosure statement (IDS) submitted on 11/26/2025 was considered by the examiner.
Response to Amendment
Claims 1-17 remain pending in application.
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 1-17 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1, 9, and 17:
Eligibility Step 1 (does the subject matter fall within a statutory category?):Independent Claim 1 falls within the statutory category of machine. Independent Claim 9 falls within the statutory category of method. Independent Claim 17 falls within the statutory category of article of manufacture.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1, 9, and 17 (claim 1 being representative) claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea in the independent claims (claim 1 being representative) is:
receive inventory data characterizing inventory information wherein the inventory data comprises an indication of a location
and wherein the inventory data is in a format that is readable
update a master management list with the received inventory data
determine, based on the updated master management list, a procedure inventory list for a surgical procedure
the procedure inventory list including surgical equipment needed for the surgical procedure;
determine compatibility information
generate an indication in the procedure inventory list;
append the procedure inventory list;
the procedure inventory list, and the location
This abstract idea is “mental process” as it is merely making an evaluation, judgment, observation, or evaluation of inventory information to provide a procedure inventory list (see MPEP § 2106.04(a)(2), subsection III)
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1, 9, and 17 (claim 1 being representative) judicial exception is not integrated into a practical application.
Independent claim 1 recites the additional claim elements below:
an electronic management system
at least one manufacturer-sealed sterile surgical package containing a surgical instrument
an electronic records system of a healthcare facility
a virtual kit
one or more surgical systems
;transmit a signal with an encoded message using a first frequency bandwidth,
determine interference from another device using the first frequency bandwidth;
and retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth.
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional element, an electronic management system , is executing the abstract idea and recited as a general computer element or tool as “apply-it” to apply the abstract idea
The additional elements, (b), (c), and (e) are recited as generally linking the abstract idea to the healthcare environment
The additional elements, (d), is recited as generally linking the abstract idea to implementation by computer environment
The additional element, (f), (g), and (h) are recited as tools to apply the abstract idea as “apply-it” to gather and send data
Accordingly, independent claims 1, 9, and 17 as a whole does not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims do does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the computer element as analyzed above in step 2A prong 2, is merely applying and/or generally linking the abstract idea and therefore, does not amount to significantly more. The claim is patent ineligible.
Dependent Claims 2-8 and 10-16:
Eligibility Step 1 (does the subject matter fall within a statutory category?):The dependent claims 2-8 fall within the statutory category of machine. The dependent claims 10-16 fall within the statutory category of method.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-8 and 10-16 claimed invention is directed to an abstract idea without significantly more. The claims continue to limit the independent claim 1 and 7 abstract idea by (1) further limiting the types of data gathered for inventory information on the surgical equipment. Therefore, the dependent claims inherit the same abstract idea which is “mental process” as it is merely making an evaluation, judgment, observation, or evaluation of inventory information to provide a procedure inventory list (see MPEP § 2106.04(a)(2), subsection III)
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2-8 and 10-16 this judicial exception is not integrated into a practical application.
The dependent claims recite the below additional elements not already recited in the independent claims:
A first stockroom
An operating room
A second stockroom
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (1) a first stockroom, (2) an operating room, and (3) a second stockroom is recited in the manner of generally linking to the environment of a hospital
Accordingly, the dependent claims as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The dependent claims do not include additional elements that amount to significantly more for the same reasons given in Prong 2. The claims are patent ineligible.
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 (i.e., changing from AIA to pre-AIA ) 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, 2, 3, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, and 17 are rejected to under 35 U.S.C. 103 as being unpatentable over Dye et. al (hereinafter Dye) (US20110313894A1) in view of Smith et. al (hereinafter Smith) (US20140288952A1), in further view of Roh et. al (hereinafter Roh) (US20230104580A1), and in even further view of Richley et. al (hereinafter Richley) (US9571143B2),
As per claim 1, Dye teaches:
An electronic management system in electronic communication with a manufacturer-sealed sterile surgical package containing a surgical instrument, the electronic management system being configured to: receive inventory data characterizing inventory information of the manufacturer- sealed sterile surgical package, wherein the inventory data comprises an indication of a location of the manufacturer-sealed sterile surgical package, and wherein the inventory data is in a format that is readable by an electronic records system of a healthcare facility; (abstract discloses, “A system (800) using the identification device (305) can be used for order fulfillment, inventory management, location tracking, and other systems.” And see [0030] discloses, “Turning now to FIG. 1, illustrated therein is one exemplary surgical pack 100 suitable for use with embodiments of the invention. In one embodiment, the Surgical pack 100 is configured for disposable use, i.e., each item in the Surgical pack 100 is intended to be used once during a procedure, then discarded. Most surgical packs 100 include between twenty and thirty items. However, some can include as many as 200 items.” And see [0031] discloses, “In one embodiment, the surgical pack 100 is customized for both a particular procedure and a particular end user. As noted above, a Surgical pack for an appendectomy procedure in one Surgical center can include items that are different from a similar pack in another Surgical center due to the preferences of the medical staff.” And see [0032] discloses, “Examples of items that can be included in the surgical pack 100 include tubing, trays, bandaging materials, Scalpels, Syringes, needle and blade disposal devices, drapes, clamps, Suturing implements, disinfectants, antibiotic creams and lotions, masks, gloves, and so forth. As each Surgical pack is tied to a particular procedure, it will be clear to those of ordinary skill in the art having the benefit of this disclosure that other implements may be included with the Surgical pack as well.” And see [0033] discloses, “One or more of the components within the surgical pack 100 may be sterile. For example, in some embodiments Some of the implements will be sterile, having undergone a sterilization process in manufacture, while others are nonsterile. In other embodiments, all of the implements in the surgical pack 100 may be sterile.” And see [0029] discloses, “Surgical packs equipped with the identification devices can be monitored by one or more RFID interrogation devices that are disposed in various locations in the hospital or Surgical. Information relating to use of the surgical packs can be fed back through a network to a server that is accessible by the manufacturer, so that the proper orders Stemming from use can be created.” And see [0049] discloses, “Each of the control devices 506,606,706,666,776 is configured to be able to wirelessly identify its corresponding Surgical pack (100) to a remote reader. For example, in one embodiment, the control devices 506,606,706,666,776 can comprise a memory and processor. Identification information concerning the contents of the Surgical pack (100) can be stored in the memory. The memory can be read by the remote reader through the radiating elements 507,607,707,777. In addition to contents information, the memory can store other information as well. Such as manufacture date, shipment date, expiration dates, customer information, and so forth. Other information can further include the inventory history of the article to which the identification devices 505,605,705 are attached. Accordingly, the date that the surgical pack (100) entered inventory, the date that the surgical pack (100) left inventory, whether the surgical pack (100) has been opened, any movement within inventory, and similar information.” And see ([0074] discloses, “6. At the end user's location 802, other benefits of the system 800 become apparent. For example, once the boxes are received, they generally are transferred to a non sterile storage area 817 just inside the receiving dock door. A remote reader 818 in this storage location can help the end user identify what stock is located therein. The system 800 can further allow for the inventory to be visible on the terminal 811, as well as assist in locating inadvertently misplaced packs.” And see [0075] discloses, “7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819. A supply sufficient for between two and five days is generally stored in this sterile storage area 819. A remote reader 820 disposed in this location can do the following: First, it can ensure that the end user is properly rotating its stock. Sterile Surgical packs have expiration dates and need to be used on a FIFO basis. This system 800 helps ensure compliance with the FIFO usage. Second, the system 800 can help end users identify how long products are being Stored.” And see Fig. 8, e.g. 802 / examiner notes the control devices within figure 8 are interpreted as electronic management systems)
update a master management list with the received inventory data; ([0069] discloses, “1. To give the end user visibility at their terminal 811, based upon information delivered from the manufacturer system 810 across the network 809, to real-time data as to how many Surgical packs are in warehouses 814 disposed locally with their location 802, as well as the schedule for delivering those packs to the end user's location 802.” And see [0072] discloses, “4. As noted above, the manufacturer can provide real-time data for all Surgical packs to the end user at all stages of the process.” And see [0073] discloses, “5. If the end user has a remote reader 816 disposed at a receiving dock 815 at their location 802, either of the manufacturer or the end user can use the system 800 of FIG. 8 to check every single Surgical pack on every single pallet as it is received. In a typical delivery process, between two and ten pallets of Surgical packs are delivered at the receiving dock 815. With prior art systems, each box on each pallet had to be verified by either manually checking the item number printed on the box, or by manually scanning the barcode. Embodiments of the present invention dramatically reduce time spent receiving product at the receiving dock 815 by providing instant, cumulative scanning via the remote reader 816. The system 800 of FIG. 8 improves accuracy as well.” And see [0082]-[0089] discloses, beginning to end management of inventory from manufacture to hospital to end use / examiner interprets under BRI the scanning and inventory synonymous with a list of items received product at for example a terminal for the end user being scanned and input as updating a master management list with received inventory)
…[…]…,based on the updated master management list, ([0069] discloses, “1. To give the end user visibility at their terminal 811, based upon information delivered from the manufacturer system 810 across the network 809, to real-time data as to how many Surgical packs are in warehouses 814 disposed locally with their location 802, as well as the schedule for delivering those packs to the end user's location 802.” And see [0072] discloses, “4. As noted above, the manufacturer can provide real-time data for all Surgical packs to the end user at all stages of the process.” And see [0073] discloses, “5. If the end user has a remote reader 816 disposed at a receiving dock 815 at their location 802, either of the manufacturer or the end user can use the system 800 of FIG. 8 to check every single Surgical pack on every single pallet as it is received. In a typical delivery process, between two and ten pallets of Surgical packs are delivered at the receiving dock 815. With prior art systems, each box on each pallet had to be verified by either manually checking the item number printed on the box, or by manually scanning the barcode. Embodiments of the present invention dramatically reduce time spent receiving product at the receiving dock 815 by providing instant, cumulative scanning via the remote reader 816. The system 800 of FIG. 8 improves accuracy as well.” And see [0082]-[0089] discloses, beginning to end management of inventory from manufacture to hospital to end use / examiner interprets under BRI the scanning and inventory synonymous with a list of items as it necessarily receives products and logs it in the terminal for the end user facility at for example a terminal for the end user and being scanned and input therefore updating a master management list with received inventory)
transmit a signal using a first frequency bandwidth, wherein the signal comprises an encoded message that indicates ...[…]…and the location of the manufacturer-sealed sterile surgical package; [0086] discloses, “At decision 1102, remote readers can determine whether a pack has been opened. This is accomplished in one embodiment when the identification device is torn along its perforation, thereby changing the signals emitted by the identification pack that are readable by the remote readers. Other methods will be obvious to those of ordinary skill in the art having the benefit of this disclosure.” And see [0048] discloses, “Each identification device 505,605,705 can be con figured as an RFID tag in accordance with RFID standards known in the art. For example, control devices 506,606,706, 666,776 and corresponding radiating elements 507,607,707, 777 can be configured as conventional passive or active RFID tag, similar in function to those available from manufacturers.” And see [0059] discloses, “In one embodiment, a sufficient amount of remote readers 801,804.805 is placed in each location such that all areas in which Surgical packs may be are covered by the readers.” / examiner notes the art teaches RFID which at a frequency bandwidth transmits signals comprising encoded messages as one of ordinary skill would understand in the art)
However, Dye does not teach the underlined portion:
determine, based on the updated master management list, a procedure inventory list for a surgical procedure utilizing the surgical instrument, the procedure inventory list including surgical equipment needed for the surgical procedure;
determine compatibility information comprising a compatibility between the surgical instrument and a plurality of surgical systems; generate a virtual kit for the surgical procedure, wherein the virtual kit comprises an indication of the surgical instrument and an indication of one or more surgical systems, from the plurality of surgical systems, in the procedure inventory list; append the virtual kit to the procedure inventory list;
transmit a signal using a first frequency bandwidth, wherein the signal comprises an encoded message that indicates the procedure inventory list, the virtual kit, and the location of the manufacturer-sealed sterile surgical package;
determine interference from another device using the first frequency bandwidth; and retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth.
However, Smith does teach the underlined portion:
determine, based on the updated master management list, a procedure inventory list for a surgical procedure utilizing the surgical instrument, the procedure inventory list including surgical equipment needed for the surgical procedure; provide the procedure inventory list. ([0041] discloses, “The instruments are then “ pulled ” by the medical center material management department who provide the quantity , cost , and hospital number for each of the items pulled from the master inventory list to the pick sheet.” And see [0043] discloses, “The pick sheet ( further illustrated in FIG . 3 ) provides a list of instruments and materials that are required for Dr . Smith to perform his total hip replacement surgery.” )
transmit a signal using a first frequency bandwidth, wherein the signal comprises an encoded message that indicates the procedure inventory list, the virtual kit, and the location of the manufacturer-sealed sterile surgical package; ([0041] discloses, “The instruments are then “ pulled ” by the medical center material management department who provide the quantity , cost , and hospital number for each of the items pulled from the master inventory list to the pick sheet.” And see [0043] discloses, “The pick sheet ( further illustrated in FIG . 3 ) provides a list of instruments and materials that are required for Dr . Smith to perform his total hip replacement surgery.” )
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Dye’s teachings of automated tracking and inventory management updates at both hospital and manufacture site as previously cited with Smith’s explicit teachings of procedure inventory lists for a surgical procedure being determined, the motivation being Dye’s discloses the issues with manually counting and assessing inventory and discloses broadly the tying of inventory management to the surgical schedule of a provider (see [0024]-[0025] and see [0031] and see [0077]), therefore it would be obvious to someone of ordinary skill in the art to combine with Smith’s explicit teaching of published inventory procedure lists provided based on master management of inventory to explicitly provide increased transparency and tracking of automated determined procedure equipment tied to the surgical schedule as taught in Dye and give an increased efficient layer of review/oversight to the procedure equipment in real time as needed by providers.
However, Smith also doesn’t teach the underlined portion:
determine compatibility information comprising a compatibility between the surgical instrument and a plurality of surgical systems; generate a virtual kit for the surgical procedure, wherein the virtual kit comprises an indication of the surgical instrument and an indication of one or more surgical systems, from the plurality of surgical systems, in the procedure inventory list; append the virtual kit to the procedure inventory list;
transmit a signal using a first frequency bandwidth, wherein the signal comprises an encoded message that indicates the procedure inventory list, the virtual kit, and the location of the manufacturer-sealed sterile surgical package;
determine interference from another device using the first frequency bandwidth; and retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth.
However, Roh does teach the underlined portion:
determine compatibility information comprising a compatibility between the surgical instrument and a plurality of surgical systems; ([0021] discloses, “The advantages and benefits of the methods, systems, and apparatus disclosed herein include compatibility with best practice guidelines for performing surgery in an operating room, e.g., from regulatory bodies and professional standards organizations such as the Association for Surgical Technologists. The robotic surgical system disclosed provides a simplified means of assembling a kit of surgical implant components, such that a surgical implant is customized for a patient or an application while reducing cost. Using the embodiments disclosed, a kit of surgical implant components is provided to reduce cost while customizing a surgical implant for a patient or application.”) generate a virtual kit for the surgical procedure, wherein the virtual kit comprises an indication of the surgical instrument and an indication of one or more surgical systems, from the plurality of surgical systems, in the procedure inventory list; append the virtual kit to the procedure inventory list; (e.g. [0148] discloses, “In step 804, the assembly module 624 triggers the planning module 626 (see FIG. 6) to generate an implantation plan for the design, placement, and insertion of the implant 616. The insertion of the implant 616 can be performed manually by a surgeon, with the assistance of the surgical robot 602, or autonomously by one or more surgical robots. Alternatively, the implant 616 can be installed in part by a surgeon, and in part by the surgical robot 602 working autonomously. A surgeon and the surgical robot 602 can further perform actions in a synchronized manner. The planning module 626 generates a virtual model of a portion of the patient's anatomy or body, selects the implant components 618, places models of the implant components 618 in the virtual model, and selects tool paths and implantation parameters to facilitate insertion of the implant 616.” And see [0149] discloses, “In step 806, the assembly module 624 receives the implantation plan from the planning module 626. The implantation plan specifies at least one implant 616 that includes at least one implant component 618a, the placement of models of the implant components 618 in a virtual model of the patient, and the paths that surgical tools 154 (see FIG. 1) and the implant components 618 will take within the body of the patient during a surgical procedure to insert the implant 616. For example, the implant components 618 include 6 screws, each having a tulip head, two rods, and two plates, each made of titanium. The 6 screws are to be inserted 1 inch each into three vertebrae, one screw on either side of the spinous process on each vertebra.” And see [0162] discloses, “In step 830, the assembly module 624 determines whether the kit assembly is complete. The kit assembly is complete if there are no remaining implant components 618 or tools in the implantation plan that need to be selected and added to the kit. If more implant components 618 remain, the assembly module 624 returns to step 808 and selects another implant component from the implantation plan. For example, additional implant components 618 remain, therefore the kit assembly is not complete.” And see [0163] discloses, “In step 832, the assembly module 624 terminates the kit assembly when all implant components 618 and tools in the implantation plan have been selected, customized, and added to the kit.” And see [0164] discloses, “The method of FIG. 8 can be used to assemble implant kits, instrument kits, and other surgical kits. Example implant kits can include, without limitation, an instrument tray or case containing one or more assembled or unassembled implants. Example instrument kits can include, without limitation, an instrument tray or case containing one or more cannulas, obturators, hooks, scissors, clips, spreaders, scalpels, alignment guides (e.g., scope guides, endoscope guides, bronchoscope guides), drivers, irrigators, cautery hooks, dissectors, etc. Example surgical kits can contain, without limitation, one or more implants, instruments, and other items and components disclosed herein. Examples of surgical implants include, but are not limited to, screws (e.g., locking screws, spinal screws, pedicle screws, bone screws, facet screws), interbody implant devices (e.g., intervertebral implants, cages), fusion devices, plates, rods, disks (e.g., an artificial articulating disk), spacers (e.g., interspinous spacers, fixed body spacers), rods, expandable devices, stents, brackets, ties, scaffolds, fixation devices (e.g., plates/rod/screw assemblies, anchor plates, etc.), bolts, fasteners, joint replacements, knee joints, hip implants, or the like. Examples of instruments include, but are not limited to, cannulas, ports, imaging devices, screw guides, spreaders, insertion tools, or the like. Kits can be assembled locally (e.g., onsite at a healthcare facility, a surgical room, or another suitable location) using local inventory, locally manufactured items, off-site manufactured items, etc. The kits can be sterilized and then provided to the surgical team. FIG. 4A shows two surgical kits 453a, 453b in the surgical room for performing surgical procedures and can include components discussed herein.” And see [0166]-[0171])
transmit a signal using a first frequency bandwidth, wherein the signal comprises an encoded message that indicates the procedure inventory list, the virtual kit, and the location of the manufacturer-sealed sterile surgical package; (e.g. [0148] discloses, “In step 804, the assembly module 624 triggers the planning module 626 (see FIG. 6) to generate an implantation plan for the design, placement, and insertion of the implant 616. The insertion of the implant 616 can be performed manually by a surgeon, with the assistance of the surgical robot 602, or autonomously by one or more surgical robots. Alternatively, the implant 616 can be installed in part by a surgeon, and in part by the surgical robot 602 working autonomously. A surgeon and the surgical robot 602 can further perform actions in a synchronized manner. The planning module 626 generates a virtual model of a portion of the patient's anatomy or body, selects the implant components 618, places models of the implant components 618 in the virtual model, and selects tool paths and implantation parameters to facilitate insertion of the implant 616.” And see [0149] discloses, “In step 806, the assembly module 624 receives the implantation plan from the planning module 626. The implantation plan specifies at least one implant 616 that includes at least one implant component 618a, the placement of models of the implant components 618 in a virtual model of the patient, and the paths that surgical tools 154 (see FIG. 1) and the implant components 618 will take within the body of the patient during a surgical procedure to insert the implant 616. For example, the implant components 618 include 6 screws, each having a tulip head, two rods, and two plates, each made of titanium. The 6 screws are to be inserted 1 inch each into three vertebrae, one screw on either side of the spinous process on each vertebra.” And see [0162] discloses, “In step 830, the assembly module 624 determines whether the kit assembly is complete. The kit assembly is complete if there are no remaining implant components 618 or tools in the implantation plan that need to be selected and added to the kit. If more implant components 618 remain, the assembly module 624 returns to step 808 and selects another implant component from the implantation plan. For example, additional implant components 618 remain, therefore the kit assembly is not complete.” And see [0163] discloses, “In step 832, the assembly module 624 terminates the kit assembly when all implant components 618 and tools in the implantation plan have been selected, customized, and added to the kit.” And see [0164] discloses, “The method of FIG. 8 can be used to assemble implant kits, instrument kits, and other surgical kits. Example implant kits can include, without limitation, an instrument tray or case containing one or more assembled or unassembled implants. Example instrument kits can include, without limitation, an instrument tray or case containing one or more cannulas, obturators, hooks, scissors, clips, spreaders, scalpels, alignment guides (e.g., scope guides, endoscope guides, bronchoscope guides), drivers, irrigators, cautery hooks, dissectors, etc. Example surgical kits can contain, without limitation, one or more implants, instruments, and other items and components disclosed herein. Examples of surgical implants include, but are not limited to, screws (e.g., locking screws, spinal screws, pedicle screws, bone screws, facet screws), interbody implant devices (e.g., intervertebral implants, cages), fusion devices, plates, rods, disks (e.g., an artificial articulating disk), spacers (e.g., interspinous spacers, fixed body spacers), rods, expandable devices, stents, brackets, ties, scaffolds, fixation devices (e.g., plates/rod/screw assemblies, anchor plates, etc.), bolts, fasteners, joint replacements, knee joints, hip implants, or the like. Examples of instruments include, but are not limited to, cannulas, ports, imaging devices, screw guides, spreaders, insertion tools, or the like. Kits can be assembled locally (e.g., onsite at a healthcare facility, a surgical room, or another suitable location) using local inventory, locally manufactured items, off-site manufactured items, etc. The kits can be sterilized and then provided to the surgical team. FIG. 4A shows two surgical kits 453a, 453b in the surgical room for performing surgical procedures and can include components discussed herein.” And see [0166]-[0171])
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Dye’s teachings of automated tracking and inventory management updates at both hospital and manufacture site utilizing RFID as previously cited and Smith’s explicit teachings of procedure inventory lists for a surgical procedure being determined with Roh’s teachings of a virtual kit with compatibility information as previously cited, the motivation being Dye’s discloses the issues with manually counting and assessing inventory and discloses broadly the tying of inventory management to the surgical schedule of a provider (see [0024]-[0025] and see [0031] and see [0077]) and the use of RFID with antennas and typical bandwidths ([0060]) , therefore it would be obvious to someone of ordinary skill in the art to combine with Roh’s explicit teachings of compatibility and virtual kits to decrease the resources needed to manual count inventory and decrease human error while increasing the individualized compatibility the a surgeon, equipment, and procedure scheduling.
However, Roh does not explicitely teach the underlined portion:
determine interference from another device using the first frequency bandwidth; and retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth.
However, Richley does teach the underlined portion:
determine interference from another device using the first frequency bandwidth; and retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth. (Col. 10 lines 53-67 and Col. 11 lines 1-58 discloses determining an interference signal using normal first bandwidth then retransmitting signal at a second bandwidth that is different than the first)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Dye’s teachings of automated tracking and inventory management updates at both hospital and manufacture site utilizing RFID as previously cited and Smith’s explicit teachings of procedure inventory lists for a surgical procedure being determined and Roh’s virtual kit and compatibility information as previously cited with Richley’s teachings of determining interference and retransmitting signals as previously cited, the motivation being Dye’s discloses the issues with manually counting and assessing inventory and discloses broadly the tying of inventory management to the surgical schedule of a provider (see [0024]-[0025] and see [0031] and see [0077]) and the use of RFID with antennas and typical bandwidths ([0060]) , therefore it would be obvious to someone of ordinary skill in the art to combine with Richley’s explicit teaching to detect interference would keep the signal detected and focus signal transmission to ensure the surgical equipment is tracked appropriately while reducing resources needed to track surgical equipment.
As per claim 2, Dye does teach:
The electronic management system of claim 1, wherein the electronic management system is further configured to: receive, upon an initial detection of the at least one manufacturer-sealed sterile surgical package by the electronic management system, initial inventory data characterizing inventory information of the manufacturer-sealed sterile surgical package; and append the master management list with the initial inventory data. ([0074] discloses, “6. At the end user's location 802, other benefits of the system 800 become apparent. For example, once the boxes are received, they generally are transferred to a non sterile storage area 817 just inside the receiving dock door. A remote reader 818 in this storage location can help the end user identify what stock is located therein. The system 800 can further allow for the inventory to be visible on the terminal 811, as well as assist in locating inadvertently misplaced packs.” And see [0075] discloses, “7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819. A supply sufficient for between two and five days is generally stored in this sterile storage area 819. A remote reader 820 disposed in this location can do the following: First, it can ensure that the end user is properly rotating its stock. Sterile Surgical packs have expiration dates and need to be used on a FIFO basis. This system 800 helps ensure compliance with the FIFO usage. Second, the system 800 can help end users identify how long products are being Stored.” / examiner interprets under BRI the scanning and inventory synonymous with a list of items as it necessarily receives products and logs it in the terminal for the end user facility at for example a terminal for the end user and being scanned and input therefore updating a master management list with received inventory)
As per claim 3, Dye does teach:
The electronic management system of claim 1, wherein the inventory information includes a current location of the at least one manufacturer-sealed sterile surgical package. ([0074] discloses, “A remote reader 818 in this storage location can help the end user identify what stock is located therein. The system 800 can further allow for the inventory to be visible on the terminal 811, as well as assist in locating inadvertently misplaced packs. “ and see [0075] discloses, “7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819. A supply sufficient for between two and five days is generally stored in this sterile storage area 819.”)
As per claim 5, Dye does teach:
The electronic management system of claim 1, wherein the electronic management system is further configured to provide, upon detection that a first portion of the surgical equipment on the procedure inventory list is in a first location, instructions to transport the first portion to a second location. ([0075] discloses, “7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819. A supply sufficient for between two and five days is generally stored in this sterile storage area 819. A remote reader 820 disposed in this location can do the following: First, it can ensure that the end user is properly rotating its stock. Sterile Surgical packs have expiration dates and need to be used on a FIFO basis. This system 800 helps ensure compliance with the FIFO usage. Second, the system 800 can help end users identify how long products are being Stored.” And see [0077] discloses, “After storage in the sterile storage area 819, the Surgical packs are generally placed on a cart for delivery to their end usage point, which is generally an operating room. This cart can sit in a hallway or other temporary storage location for a brief time. The remote readers 801 disposed at the end user's location 802 can determine when a particular surgical pack is pulled from the shelf. Further, the system 800 can determine when the Surgical pack enters the operating room. Once the case cart is rolled into the Surgical Suite, the room is prepared for Surgery” / examiner notes that the movement of the surgical equipment from the first to a second location is necessarily instructions to transport)
As per claim 6, Dye does teach:
The electronic management system of claim 5, wherein the electronic management system is further configured to provide, upon detection that a second portion of the surgical equipment on the procedure inventory list is in a third location, instructions to transport the second portion to the second location. ([0075] discloses, “7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819. A supply sufficient for between two and five days is generally stored in this sterile storage area 819. A remote reader 820 disposed in this location can do the following: First, it can ensure that the end user is properly rotating its stock. Sterile Surgical packs have expiration dates and need to be used on a FIFO basis. This system 800 helps ensure compliance with the FIFO usage. Second, the system 800 can help end users identify how long products are being Stored.” And see [0077] discloses, “After storage in the sterile storage area 819, the Surgical packs are generally placed on a cart for delivery to their end usage point, which is generally an operating room. This cart can sit in a hallway or other temporary storage location for a brief time. The remote readers 801 disposed at the end user's location 802 can determine when a particular surgical pack is pulled from the shelf. Further, the system 800 can determine when the Surgical pack enters the operating room. Once the case cart is rolled into the Surgical Suite, the room is prepared for Surgery” / examiner notes that the movement of the surgical equipment from a third location to a second location is necessarily instructions to transport and that the operating room is disclosed as the end user location when transporting from any location)
As per claim 7, Dye does teach:
The electronic management system of claim 5, wherein the first location is a first stockroom within a hospital and the second location is an operating room within the hospital. ([0075] discloses, “ 7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819.” And see [0077] discloses, “After storage in the sterile storage area 819, the Surgical packs are generally placed on a cart for delivery to their end usage point, which is generally an operating room.”)
As per claim 8, Dye does teach:
The electronic management system of claim 6, wherein the first location is a first stockroom within a hospital, the second location is an operating room within the hospital, and the third location is a second stockroom within the hospital. ([0075] discloses, “7. After the initial storage in the non-sterile storage area 817, the packs are transferred to a sterile storage area 819. A supply sufficient for between two and five days is generally stored in this sterile storage area 819. A remote reader 820 disposed in this location can do the following: First, it can ensure that the end user is properly rotating its stock. Sterile Surgical packs have expiration dates and need to be used on a FIFO basis. This system 800 helps ensure compliance with the FIFO usage. Second, the system 800 can help end users identify how long products are being Stored.” And see [0077] discloses, “After storage in the sterile storage area 819, the Surgical packs are generally placed on a cart for delivery to their end usage point, which is generally an operating room. This cart can sit in a hallway or other temporary storage location for a brief time. The remote readers 801 disposed at the end user's location 802 can determine when a particular surgical pack is pulled from the shelf. Further, the system 800 can determine when the Surgical pack enters the operating room. Once the case cart is rolled into the Surgical Suite, the room is prepared for Surgery” / examiner notes the temporary storage location is an example of a third location for storage and the operating room is disclosed as the end users location.)
As per claims 9, 10, 11, 13, 14, 15, and 16 they are method claims which repeat the same limitations of claims 1, 2, 3, 5, 6, 7, and 8 the corresponding system claims, as a series of process steps as opposed to a collection of elements. Since the collective teachings and motivations to combine of Dye, Smith, Roh, and Richley disclose the structural elements that constitute the system of claims 1, 2, 3, 5, 6, 7, and 8 it is respectfully submitted that they perform the underlying process steps, as well. As such, the limitations of claims 9, 10, 11, 13, 14, 15, and 16 are rejected for the same reasons given above for claim 1, 2, 3, 5, 6, 7, and 8.
As per claim 17 it is an article of manufacture claim which repeats the same limitations of claim 9 the corresponding method claim, as a collection of executable instructions stored on machine readable media as opposed to a series of process steps. Since the teachings and motivation to combine of Dye, Smith, Roh, and Richley disclose the underlying process steps that constitute the method of claim 9 it is respectfully submitted that they likewise disclose the executable instructions that perform the steps as well. As such, the limitations of claim 17 are rejected for the same reasons given above for claim 9.
Claims 4 and 12 are rejected to under 35 U.S.C. 103 as being unpatentable over Dye et. al (hereinafter Dye) (US20110313894A1) in view of Smith et. al (hereinafter Smith) (US20140288952A1), in further view of Roh et. al (hereinafter Roh) (US20230104580A1), in even further view of Richley et. al (hereinafter Richley) (US9571143B2), and in even further view of Cain et. al (hereinafter Cain) (US20100161345A1)
As per claim 4, Dye, Smith, Roh, and Richley do not teach:
The electronic management system of claim 3, wherein the inventory information is received at periodic intervals.
However, Cain does teach:
The surgical system of claim 3, wherein the inventory information is received at periodic intervals. ([0091] discloses, “After the desired information about the item, including an item/product description, usage type, FIFO/LIFO flags, manner of tracking inventory, etc. are entered into the user's computer, the information relating to the received items is uploaded from the user's computer to the host computer by computer communications or the like. The received information is stored by the host computer for that particular user in one or more databases. The data may be uploaded to the host computer as soon as the data is received in the user's computer (i.e. if there is a connection between the user's computer and the host computer). Alternately, the data may be stored or cached in the user's computer until it is uploaded to the host computer (i.e., when an internet connection is established, or at periodic intervals, etc.), or simply stored and utilized on the user's computer without uploading.”)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Dye’s teachings of automated tracking and inventory management updates at both hospital and manufacture site as previously cited and Smith’s explicit teachings of procedure inventory lists for a surgical procedure being determined and Roh’s teachings as previously cited, and Richley’s teachings of interference signals as previously cited with Cains explicit teaching of taking inventory at periodic intervals, the motivation being Dye’s discloses the issues with manually counting and assessing inventory and the importance of end user visibility to inventory throughout the cycle of use (see [0024]-[0025] and see [0069] and see [0089]) and Smith discloses the issues with limited information throughout the inventory process ([0006]) and Richley discloses the isues with real time location tracking (see Col. 1 lines 20-30), therefore it would be obvious to someone of ordinary skill in the art to combine with Cains ’s explicit teaching of periodic intervals of information being provided for inventory to increase the transparency and real time tracking of inventory to decrease inefficient use of inventory and in some situations having lack of inventory due to insufficient demand forecasting or product tracking with too little information at too few intervals.
As per claim 12, it is a method claim which repeats the same limitations of claim 4, the corresponding system claim, as a series of process steps as opposed to a collection of elements. Since the collective teaching and motivations to combine of Dye, Smith, Roh, Richley, and Cain disclose the structural elements that constitute the system of claim 4, it is respectfully submitted that they perform the underlying process steps, as well. As such, the limitations of claim 12 are rejected for the same reasons given above for claim 4.
Response to Arguments Regarding 35 U.S.C § 101 Rejection
The applicant argues on page 1-3 of the submitted remarks that the rejection of pending claims 1-17 under 35 U.S.C § 101 should be withdrawn for the following reasons:
Under Step 2A Prong Two, a claim is not considered as being directed toward an abstract idea if the claim as a whole integrates the judicial exception into a practical application.2 Under the USPTO 2024 Guidelines, the evaluation involves (1) identifying any additional elements in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine if they integrate the exception into a practical application.3
In its Step 2A Prong Two analysis, the Office Action identified the additional elements "transmit a signal using a first frequency bandwidth, wherein the signal comprises an encoded message that indicates a location of the manufacturer-sealed sterile surgical package," "determine interference from another device using the first frequency bandwidth," and "retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth," but alleges that these elements merely recite "tools to apply the abstract idea as apply-it to gather and send data."4 However, the Applicant disagrees with this characterization. 1 Office Action dated 09/05/2025 at pages 2-7. 2MPEP 2106.04(d); See also USPTO 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence; See also USPTO July 2024 Subject Matter Eligibility Examples(https://www.uspto.gov/sites/default/files/documents/2024-AI-SMEUpdateExamples47-49.p 3 USPTO 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial lligence.4 Office Action dated 09/05/2025 at page 4-5.
The MPEP states that when determining whether a claim simply recites a judicial exception with the words "apply it," examiners should consider several factors.5 The first factor is whether the claim fails to recite details of how a solution to a problem is accomplished.6 In the present case, the claim clearly provides a mechanism for resolving signal interference. Rather than merely reciting the idea of a solution, the claim specifically recites that the interference can be overcome by switching to a second frequency bandwidth. Accordingly, the claim recites details of how the solution is accomplished.
The second factor mentioned in the MPEP is whether the claim invokes computers or other machinery merely as a tool to perform an existing process.7 Specifically, "'claiming the improved speed or efficiency inherent with applying the abstract idea on a computer' does not integrate a judicial exception into a practical application or provide an inventive concept."g However, "a claim that purports to improve computer capabilities or to improve an existing technology may integrate a judicial exception into a practical application or provide significantly more."9 In the present case, the claims are not merely relying on a generic computer for its speed or efficiency. Rather, the claims recite a technique for overcoming interference when transmitting signals.
Lastly, the MPEP states that examiners should consider the particularity or generality of the application of the judicial exception.10 Specifically, the MPEP states that "limitations that confine the judicial exception to a particular, practical application of the judicial exception may amount to significantly more or integrate the judicial exception into a practical application.""1 The present claims specifically apply to the tracking of a manufacturer-sealed surgical package and ensuring that the location of the package can be transmitted even when interference occurs. MPEP 2106.05(f). This is a very particular, practical application rather than elements that have broad applicability across many fields of endeavor. For at least these reasons, Applicant submits that the additional elements identified by the examiner do not amount to merely reciting "apply it." Consequently, claim 1 integrates the judicial exception into a practical application, such that
claim 1 is not directed to an abstract idea. Therefore, claim 1 and its dependent claims are patent-eligible under Step 2A Prong Two. For similar reasons, independent claims 9 and 17 and their dependent claims (if any) are also patent-eligible. Accordingly, the Applicant requests the withdrawal of the rejections under 35 U.S.C. §101.
Examiner appreciates applicant’s arguments but does not find them persuasive. The MPEP 2106.04(a)(2) states, “Examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above.
Examiner has identified that the amended claims are directed to “mental process” as it is merely making an evaluation, judgment, observation, or evaluation of inventory information to provide a procedure inventory list (see MPEP § 2106.04(a)(2), subsection III). Examiner determined this by identifying the specific limitations in the claims which recite an abstract idea.
Examiner notes that the abstract idea is not integrated into a practical application. The abstract idea cannot provide the improvement or practical application rather additional elements identified by the examiner are used to determine if a practical application or significantly more is present based on the recited claim language. The amended limitations while they may contain additional elements such as identified by applicant and examiner as transmit a signal with an encoded message using a first frequency bandwidth, determine interference from another device using the first frequency bandwidth; and retransmit the signal using a second frequency bandwidth that is different from the first frequency bandwidth these additional elements are claimed as “apply-it” and used as tools to gather data and output data for the determination of where inventory is that relates to surgical procedures therefore not enough to integrate into a practical application.
There is no technological improvement or unconventional recitation to the additional elements alone or combined with the abstract idea within the confines of the recited general purpose computer environment. The claim is not a very particular, practical application but rather elements that have broad applicability across many fields of endeavor as the limitations discussed by applicant in the aforementioned arguments are additional elements but are merely apply it and used as a tool implemented by computers to automate an otherwise mental human process of identifying inventory availability, compatibility of the inventory, and location of the inventory and could be done in any field, so although the claims recited a healthcare setting this technical environment is not technologically improved but rather generally linked to the claim as a wholes output of inventory management. Therefore, the claimed invention is using computers as a tool and generally linking to healthcare environment and any improvement present is an improvement to the abstract idea of the management of information associated with products flowing through that supply chain. Finally were applicants line of reasoning correct, the invention in Alice Corp. would have been subject matter eligible as it is an improvement to settlement risk mitigation.
Therefore, examiner maintains the rejection under 35 U.S.C 101.
Response to Arguments Regarding 35 U.S.C § 103 Rejections
Applicant argues on page 3-4 of the remarks the amended claims 1-17 in regards to 35 U.S.C § 103.
Applicant’s arguments with respect to claims 1, 9, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner maintains the § 103 rejection.
Prior Art Cited but Not Relied Upon
Austin et. al – US7518502B2
A system and method for identifying, locating, and managing inventory of sterilized medical devices located within a sealed sterilization case in preparation for a Surgical procedure. Communication tags, such as radio frequency identification (RFID) and/or Global Positioning System (GPS) tags, are connected to the medical device and communicate information wirelessly. Information is obtained from the communication tags and sent to the database where it is compared with the information in the database. The results may be displayed on the interface thereby providing the user with information about the medical instruments contained in the sealed sterilization case without breaking the seal of the sealed sterilization case.
Cannady et. al – US20170068788A1
A sterile processing information system receives data from a hospital clinical system representing scheduled Surgical procedures and identified hospital owned assets for the respective Surgical procedures, and also receives third party asset data electronically in a parsable data. vendor inventory management system representing scheduled Surgical procedures and the third party assets for the respective Surgical procedure. The system manages the sterile processing of both hospital and third party assets, and in particular creates a count sheet with a barcode for each of the third party assets.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687