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 .
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) filed 1/29/26. Claims 1, 9, 10, 16, 17, and 20 have been amended. Claims 21-23 are canceled. Claims 1-20, 24, and 25 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/29/26 has been entered.
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.
Claim(s) 1, 2, 5-8, 10, 13-15, 17-19, 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath et al. (US 2007/0027459 A1), in view of Swanson et al. (US 2017/0221112 A1), in view of Morris et al. (US 2010/0076453 A1), and further in view of Dantus (US 2014/0058367 A1). (A) Referring to claim 1, Horvath discloses a method comprising (abstract of Horvath):
obtaining, by the computing system, personnel identification information of a technician (para. 19, 41, and 49 of Horvath; The data that is received from the identifier (tag) is compared to the authorized data to determine whether, for example the patient is the correct patient, whether the surgeon and patient match up, whether the surgeon and treatment or patient and treatment match up, or whether a service technician is authorized to work on a particular machine, etc.);
obtaining, by the computing system, equipment identification information used in servicing medical equipment used for eye surgery, the medical equipment including at least the laser (para. 6, 15, 19-21, 49, 32, 34, and 54 of Horvath; note a system and method for configuring and data-populating a surgical system or device, such as a refractive laser eye surgery system, a vitro-retinal system, a cataract phacoemulsification system, or any other such surgical system. The controller 115 includes software and/or hardware 117 to implement the criteria 116 to determine whether data 104 sent by the RFID identifier 102 of the user tag 14 and received by the RFID reader 112 of the surgical device 16 indicates that the user of the tag 14 is authorized for that surgical device 16 and/or surgical procedure and/or service. Surgical devices require certain inputs before surgery can be performed. For example, patient data (e.g., name, age, sex, etc.), surgical data (e.g. type of surgery, body part, etc.), device settings (e.g., power, duration, etc.), confirmation of the surgeons preferred settings, service personnel inputs (e.g., calibration and maintenance records, software updates) and other such inputs have to be confirmed as up-to-date. The ophthalmic surgical device can be a laser or laser console, or a vitro-retinal surgical device.);
automatically and electronically authorizing, by the computing system, the technician to perform the servicing of the laser of the medical equipment based on both the personnel identification information of the technician and the equipment identification information of the service equipment (para. 19, 20, & 11 of Horvath; The data that is received from the identifier (tag) is compared to the authorized data to determine whether, for example the patient is the correct patient, whether the surgeon and patient match up, whether the surgeon and treatment or patient and treatment match up, or whether a service technician is authorized to work on a particular machine, etc. For example, the surgical device can be enabled if the received data matches authorized data criteria.);
permitting, by the computing system, the technician to download service instructions for performing the servicing of the laser of the medical equipment, the downloading permitted based on the authorization of the technician to perform the servicing of the laser of the medical equipment (para. 49-51, 11, 15, 20, 39, and 40 of Horvath; In a service technician embodiment of tag 14, the RFID identifier 102 can include identification data and security data, as discussed above, and, in addition, calibration data, necessary to calibrate the surgical device 16. For example, calibration data may comprise instructions or parameter settings including, for example, laser calibration settings for a particular probe or adaptation.);
providing, by the computing system, operating instructions to operate the laser during the eye surgery based on the servicing having been completed (para. 6, 21, 22, 32, 34, and 58 of Horvath; Surgical devices require certain inputs before surgery can be performed. For example, patient data (e.g., name, age, sex, etc.), surgical data (e.g. type of surgery, body part, etc.), device settings (e.g., power, duration, etc.), confirmation of the surgeons preferred settings, service personnel inputs (e.g., calibration and maintenance records, software updates) and other such inputs have to be confirmed as up-to-date. System embodiments can be implemented to configure a surgical device for surgery and/or data-populate various data fields within the surgical device. If the data received from the identifier tag satisfies the criteria, then the device can be enabled, configured and data-populated. Safety precautions can be implemented in the embodiments of the present invention, such as generating a message at the surgical device to a surgeon or service technician that, for example, this is not the correct patient, the patient and intended treatment do not match, or that a surgical device requires a certain upgrade or maintenance be performed. Identification, data, and/or calibration data can be used for various purposes. For example, a user interface that is presented on a display screen can be generated based on the particular surgical procedure that will be performed. Data can also be used to enable operating parameters that are compatible with the intended procedure and the intended patient and to disable operating parameters that are incompatible with the intended procedure or that the surgeon does not desire to use. Surgical device 318 is configured and data-populated based on the transferred data and can be made ready for surgery by a surgeon or other user by any other steps required for the procedure, including confirmation of the transferred data and surgical device 318 configuration.); and
performing, by the laser, a laser vision correction on an eye of a laser eye surgery patient (para. 58, 23, 20, and 32 of Horvath; provide a system and method for configuring and data-populating a surgical system or device, such as a refractive laser eye surgery system, a vitro-retinal system, a cataract phacoemulsification system, or any other such surgical system. The ophthalmic surgical device can be a laser or laser console, or a vitro-retinal surgical device).
Horvath does not expressly disclose obtaining, by the computing system, equipment identification information of service equipment used in servicing of medical equipment, the equipment identification information indicating whether the service equipment has been calibrated to perform the servicing of the medical equipment; storing, by a computing system associated with a medical system of a plurality of medical systems, first sensor data from a sensor configured to monitor an amount of energy consumed by a laser of the medical system; utilizing, by the computing system, the first sensor data of the amount of energy consumed by the laser to determine one or more issues associated with the medical system; and receiving, by the computing system, a log file from the medical equipment, the log file including second sensor data associated with a plurality of measurements of the laser after the technician has performed the servicing of the laser of the medical equipment.
Swanson discloses obtaining, by the computing system, equipment identification information of service equipment used in servicing of medical equipment, the equipment identification information indicating whether the service equipment has been calibrated to perform the servicing of the medical equipment (para. 13, 22, 23, 75, and 78 of Swanson; note the calibrating the equipment used to provide the testing service; the material cost data 116 may include an acquisition cost associated with each of the consumable materials used in part or in whole to complete the service, a cost associated with waste of one or more consumable materials (i.e. chemicals) used in control testing or calibration of testing instruments or equipment, among other costs. Where the service cost provider is configured for a testing business as described above, the service code details may include a department within the business tasked to perform the service (e.g., chemistry, immunology, hematology, cytogenetics, molecular, virology, coagulation, toxicology, etc), an instrument or instruments used to perform the service, a testing method to perform the service, a number of calibrations per timeframe (e.g., weekly, daily, etc), a number of repeat services per timeframe (e.g., weekly, daily, etc), a number of days per week the service is to be performed, a number of services bill per timeframe, a medical billing code associated with the service, a number of control test run per timeframe, a number of dilutions per timeframe, the cost variation limit, a cost review interval, an average number of minutes per service, a date of the most previous price update, a list of suppliers who supply the materials to perform the service, an average total material cost per service, and an average total labor cost per service.).
Morris discloses storing, by a computing system associated with a medical system of a plurality of medical systems, first sensor data from a sensor configured to monitor an amount of energy output by a laser of the medical system (para. 29 & 30 of Morris; a monitoring subsystem (not shown), residing in the surgical system 1300 and/or the central server system 1010, periodically measures and stores the total output of surgical laser energy over time for the various laser systems 1300 (e.g., in an energy history log, which can be stored in the corresponding surgical system profile database 1130). Preferably, the measurement is performed at system power-up and then periodically during operation (e.g., on an hourly basis throughout a day of operation, on a monthly basis, and the like). The monitoring subsystem 1350 collects these measurements as data points, and a predicted service period (e.g., based on a pre-determined algorithm) can be calculated by the diagnostics engine 1170 or the surgical system itself 1300.); utilizing, by the computing system, the first sensor data of the amount of energy output by the laser to determine one or more issues associated with the medical system (para. 29 & 30 of Morris; This predicted service period indicates, for example, a probable occurrence of a component failure, a standardized replacement life of the component, and the like. In one embodiment, a threshold (e.g., a minimum total energy output corresponding with a desired photoalteration effect or the like) is used to approximate the service period. This service period is then stored in the surgical system profile database 1130 and forwarded to one or more PDAs 1200, each associated with an available or appropriate technician. A service visit can then be scheduled in advance of the predicted service period, and the technician can verify the output energy levels and service the laser system 1300 (e.g., to prevent a predicted failure and any possible downtime associated therewith). For example, the service visit may include adjusting mirror positions, diode power, or other electrical settings to increase the output energy level from a predicted or detected decrease. In addition, the slope of the data points over time can be determined, either by the surgical system 1300 or the diagnostics engine 1170, to indicate a decline, change, or normal rate of the total energy output. For example, in the event the slope of the total energy output is steeper than a pre-determined threshold rate, the technician is notified of the operation fault of the surgical system 1300. Technician attention can thus be expedited to resolve an operation fault that may be indicative of a potential problem other than normal wear, for example, a failure of a component within the optical path of the laser.); and receiving, by the computing system, a log file from the medical equipment, the log file including second sensor data associated with a plurality of measurements of the laser after the technician has performed the servicing of the laser of the medical equipment (para. 23 & 29-31 of Morris; Technician attention can thus be expedited to resolve an operation fault that may be indicative of a potential problem other than normal wear, for example, a failure of a component within the optical path of the laser. Other aspects of the laser surgical system 1300 that can be monitored, verified, and/or calibrated utilizing the diagnostics system 1000 include, but are not necessarily limited to, beam steering error, coolant level error, shutter error, laser diode error, galvo positioning error, energy sensors, wavefront measurements, voltage measurements, and the like. History logs for each of these aspects of the laser surgical system 1300 can be stored in the surgical profile database 1130 and used to predict the operation or performance status of the system 1300 (e.g., predict when performance of one or more corresponding components of the system 1300 degrades beyond the pre-determined threshold level). The surgical system database 1130 stores information about each surgical system 1300, e.g., type of system 1300 (e.g., an excimer laser, a femtosecond laser, and/or an ultrasound system), model, account information, owner, schedule of surgeries, surgeons approved to use the system 1300, location, usage history, diagnostics information, such as error logs and service history, and the like.).
Dantus discloses amount of energy consumed by the laser (para. 62 of Dantus; The energy consumption of each laser is extremely low compared to traditional femtosecond sources used in ophthalmology so the present system can optionally, alternate lasers to make sure one or more are ready at all times. Each laser 53 advantageously costs approximately one third of traditional femtosecond laser systems which allow the present modular design to be cost effective. The reduced requirement for maintenance and the cost of immediate service warranty further helps the affordability of the proposed modular design. The design of a system with three such lasers is envisioned where if one laser fails, it can be removed in less than five minutes and sent for repairs, leaving the entire ophthalmic unit with one or more spare lasers while the failed module is being repaired or replaced.)
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Horvath’s method for configuring a surgical device to include the aforementioned features of Swanson, Morris, and Dantus. The motivation for doing so would have been to determine a real time cost of a service (para. 4 of Swanson), to prevent a predicted failure and any possible downtime (para. 29 of Morris), and to alternate lasers to make sure one or more are ready at all times (para. 62 of Dantus).
(B) Referring to claim 2, Horvath discloses wherein a first computing device is used to obtain the personnel identification information and a second computing device, different from the first computing device, is used to automatically and electronically authorize the technician to perform the servicing of the laser of the medical equipment (para. 19-21, 41, and 49 of Horvath).
(C) Referring to claims 5 and 13, Horvath discloses wherein the equipment identification information includes one or more qualifications or certifications of the equipment required for the equipment to be used in performing the servicing (para. 6, 11, 34, 42, and 58 of Horvath); and servicing of the laser of the medical equipment (para. 19-21 of Horvath).
Horvath does not expressly disclose information of the service equipment required for the service equipment to be used in performing the servicing of the medical equipment
Swanson discloses information of the service equipment required for the service equipment to be used in performing the servicing of the medical equipment (para. 22, 23, 75, and 78 of Swanson).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the information in Horvath to include the aforementioned feature of Swanson. The motivation for doing so would have been to determine a real time cost of a service (para. 4 of Swanson).
(D) Referring to claims 6 and 14, Horvath discloses wherein the equipment identification information includes an indication of if the service equipment has been calibrated within a threshold amount of time, or an indication of a date that the service equipment was last calibrated (para. 6, 11, 51, and 21 of Horvath).
(E) Referring to claim 7, Horvath discloses wherein obtaining the personnel identification information and obtaining the equipment identification information include at least one of the personnel identification information and the equipment identification information being electronically and wirelessly communicated to a computing device (para. 32-34, 40, and 56 of Horvath).
(F) Referring to claim 8, Horvath discloses wherein the electronic and wireless communication includes communicating via a radio frequency identification (RFID) device (abstract & para. 45, 20, 49, and 50 of Horvath).
(G) Referring to claim 15, Horvath discloses wherein obtaining the personnel identification information and obtaining the equipment identification information include receiving, by the computing system, at least one of the personnel identification information and the equipment identification information electronically and wirelessly (para. 32-34, 40, and 56 of Horvath).
(H) Referring to claim 18, Horvath discloses wherein obtaining the personnel identification information and obtaining the equipment identification information include at least one of the personnel identification information and the equipment identification information being electronically and wirelessly communicated to the system (para. 32-34, 40, and 56 of Horvath).
(I) Referring to claim 19, Horvath discloses further comprising a radio frequency identification (RFID) reader, and wherein the electronic and wireless communication is received via the RFID reader (abstract & para. 45, 20, 49, and 50 of Horvath).
(J) Referring to claim 10, Horvath discloses One or more non-transitory computer-readable media containing instructions which, when executed by one or more processors, causes a computing system to perform one or more operations, the computing system associated with a medical system of a plurality of medical systems, the operations comprising (see Figures 1-5 and para. 40-42 of Horvath):
obtaining, by the computing system, personnel identification information of a technician (para. 19, 41, and 49 of Horvath; The data that is received from the identifier (tag) is compared to the authorized data to determine whether, for example the patient is the correct patient, whether the surgeon and patient match up, whether the surgeon and treatment or patient and treatment match up, or whether a service technician is authorized to work on a particular machine, etc.);
obtaining, by the computing system, equipment identification information of equipment used in servicing medical equipment used for eye surgery, the medical equipment including at least the laser (para. 6, 15, 19-21, 49, 32, 34, and 54 of Horvath; note a system and method for configuring and data-populating a surgical system or device, such as a refractive laser eye surgery system, a vitro-retinal system, a cataract phacoemulsification system, or any other such surgical system. The controller 115 includes software and/or hardware 117 to implement the criteria 116 to determine whether data 104 sent by the RFID identifier 102 of the user tag 14 and received by the RFID reader 112 of the surgical device 16 indicates that the user of the tag 14 is authorized for that surgical device 16 and/or surgical procedure and/or service. Surgical devices require certain inputs before surgery can be performed. For example, patient data (e.g., name, age, sex, etc.), surgical data (e.g. type of surgery, body part, etc.), device settings (e.g., power, duration, etc.), confirmation of the surgeons preferred settings, service personnel inputs (e.g., calibration and maintenance records, software updates) and other such inputs have to be confirmed as up-to-date.);
automatically and electronically authorizing, by the computing system, the technician to perform the servicing of the laser of the medical equipment based on both the personnel identification information of the technician and the equipment identification information of the service equipment (para. 19, 20, & 11 of Horvath; The data that is received from the identifier (tag) is compared to the authorized data to determine whether, for example the patient is the correct patient, whether the surgeon and patient match up, whether the surgeon and treatment or patient and treatment match up, or whether a service technician is authorized to work on a particular machine, etc. For example, the surgical device can be enabled if the received data matches authorized data criteria.);
providing, by the computing system, access to the technician to download service instructions for performing the servicing of the laser of the medical equipment, the downloading permitted based on the authorization of the technician to perform the servicing of the laser of the medical equipment (para. 49-51, 11, 15, 20, and 39 of Horvath; In a service technician embodiment of tag 14, the RFID identifier 102 can include identification data and security data, as discussed above, and, in addition, calibration data, necessary to calibrate the surgical device 16. For example, calibration data may comprise instructions or parameter settings including, for example, laser calibration settings for a particular probe or adaptation.); and
providing, by the computing system, operating instructions to operate the laser during the eye surgery based on the servicing having been completed (para. 6, 21, 22, 32, 34, and 58 of Horvath; Surgical devices require certain inputs before surgery can be performed. For example, patient data (e.g., name, age, sex, etc.), surgical data (e.g. type of surgery, body part, etc.), device settings (e.g., power, duration, etc.), confirmation of the surgeons preferred settings, service personnel inputs (e.g., calibration and maintenance records, software updates) and other such inputs have to be confirmed as up-to-date. System embodiments can be implemented to configure a surgical device for surgery and/or data-populate various data fields within the surgical device. If the data received from the identifier tag satisfies the criteria, then the device can be enabled, configured and data-populated. Safety precautions can be implemented in the embodiments of the present invention, such as generating a message at the surgical device to a surgeon or service technician that, for example, this is not the correct patient, the patient and intended treatment do not match, or that a surgical device requires a certain upgrade or maintenance be performed. Identification, data, and/or calibration data can be used for various purposes. For example, a user interface that is presented on a display screen can be generated based on the particular surgical procedure that will be performed. Data can also be used to enable operating parameters that are compatible with the intended procedure and the intended patient and to disable operating parameters that are incompatible with the intended procedure or that the surgeon does not desire to use. Surgical device 318 is configured and data-populated based on the transferred data and can be made ready for surgery by a surgeon or other user by any other steps required for the procedure, including confirmation of the transferred data and surgical device 318 configuration.); and
conveying instructions, interpretable by the laser of the medical system, to cause the laser to perform a laser vision correction on an eye of a laser eye surgery patient (para. 58, 23, 20, and 32 of Horvath; provide a system and method for configuring and data-populating a surgical system or device, such as a refractive laser eye surgery system, a vitro-retinal system, a cataract phacoemulsification system, or any other such surgical system. The ophthalmic surgical device can be a laser or laser console, or a vitro-retinal surgical device).
Horvath does not expressly disclose obtaining, by the computing system, equipment identification information of service equipment used in servicing medical equipment, the equipment identification information indicating whether the service equipment has been calibrated to perform the servicing of the laser of the medical equipment, storing, by the computing system, first sensor data from a sensor configured to monitor an amount of energy consumed by a laser of the medical system; utilizing, by the computing system, the first sensor data of the amount of energy consumed by the laser to determine one or more issues associated with the medical system; receiving, by the computing system, a log file from the medical equipment, the log file including second sensor data associated with a plurality of measurements of the laser after the technician has performed the servicing of the laser of the medical equipment; recording, by the medical system, one or more tools utilized by the technician to perform the servicing of the laser of the medical equipment.
Swanson discloses obtaining, by the computing system, equipment identification information of service equipment used in servicing medical equipment, the equipment identification information indicating whether the service equipment has been calibrated to perform the servicing of the medical equipment (para. 13, 22, 23, 75, and 78 of Swanson; note the calibrating the equipment used to provide the testing service; the material cost data 116 may include an acquisition cost associated with each of the consumable materials used in part or in whole to complete the service, a cost associated with waste of one or more consumable materials (i.e. chemicals) used in control testing or calibration of testing instruments or equipment, among other costs. Where the service cost provider is configured for a testing business as described above, the service code details may include a department within the business tasked to perform the service (e.g., chemistry, immunology, hematology, cytogenetics, molecular, virology, coagulation, toxicology, etc), an instrument or instruments used to perform the service, a testing method to perform the service, a number of calibrations per timeframe (e.g., weekly, daily, etc), a number of repeat services per timeframe (e.g., weekly, daily, etc), a number of days per week the service is to be performed, a number of services bill per timeframe, a medical billing code associated with the service, a number of control test run per timeframe, a number of dilutions per timeframe, the cost variation limit, a cost review interval, an average number of minutes per service, a date of the most previous price update, a list of suppliers who supply the materials to perform the service, an average total material cost per service, and an average total labor cost per service.) and recording, by the medical system, one or more tools utilized by the technician to perform the servicing of the medical equipment (para. 22, 26, and 35 of Swanson; the labor cost data 114 may include a number of employees required to complete the service, a wage associated with each employee required to complete the service, a labor cost for the employee(s) performing instrument calibrations associated with the service, a labor cost of the employee(s) performing instrument controls, a labor cost of supervision of the employees performing the service, and/or a labor cost of verification of the service results, among others. The other data 124 may include information associated with an instrument or equipment cost used to provide each particular service (e.g., an overall or monthly purchase cost of the instrument(s), a lease or rental cost of the instrument(s)).).
Morris discloses storing, by the computing system, first sensor data from a sensor configured to monitor an amount of energy output by a laser of the medical system (para. 29 & 30 of Morris; a monitoring subsystem (not shown), residing in the surgical system 1300 and/or the central server system 1010, periodically measures and stores the total output of surgical laser energy over time for the various laser systems 1300 (e.g., in an energy history log, which can be stored in the corresponding surgical system profile database 1130). Preferably, the measurement is performed at system power-up and then periodically during operation (e.g., on an hourly basis throughout a day of operation, on a monthly basis, and the like). The monitoring subsystem 1350 collects these measurements as data points, and a predicted service period (e.g., based on a pre-determined algorithm) can be calculated by the diagnostics engine 1170 or the surgical system itself 1300.); utilizing, by the computing system, the first sensor data of the amount of energy output by the laser to determine one or more issues associated with the medical system (para. 29 & 30 of Morris; This predicted service period indicates, for example, a probable occurrence of a component failure, a standardized replacement life of the component, and the like. In one embodiment, a threshold (e.g., a minimum total energy output corresponding with a desired photoalteration effect or the like) is used to approximate the service period. This service period is then stored in the surgical system profile database 1130 and forwarded to one or more PDAs 1200, each associated with an available or appropriate technician. A service visit can then be scheduled in advance of the predicted service period, and the technician can verify the output energy levels and service the laser system 1300 (e.g., to prevent a predicted failure and any possible downtime associated therewith). For example, the service visit may include adjusting mirror positions, diode power, or other electrical settings to increase the output energy level from a predicted or detected decrease. In addition, the slope of the data points over time can be determined, either by the surgical system 1300 or the diagnostics engine 1170, to indicate a decline, change, or normal rate of the total energy output. For example, in the event the slope of the total energy output is steeper than a pre-determined threshold rate, the technician is notified of the operation fault of the surgical system 1300. Technician attention can thus be expedited to resolve an operation fault that may be indicative of a potential problem other than normal wear, for example, a failure of a component within the optical path of the laser.); receiving, by the computing system, a log file from the medical equipment, the log file including second sensor data associated with a plurality of measurements of the laser after the technician has performed the servicing of the laser of the medical equipment (para. 23 & 29-31 of Morris; Technician attention can thus be expedited to resolve an operation fault that may be indicative of a potential problem other than normal wear, for example, a failure of a component within the optical path of the laser. Other aspects of the laser surgical system 1300 that can be monitored, verified, and/or calibrated utilizing the diagnostics system 1000 include, but are not necessarily limited to, beam steering error, coolant level error, shutter error, laser diode error, galvo positioning error, energy sensors, wavefront measurements, voltage measurements, and the like. History logs for each of these aspects of the laser surgical system 1300 can be stored in the surgical profile database 1130 and used to predict the operation or performance status of the system 1300 (e.g., predict when performance of one or more corresponding components of the system 1300 degrades beyond the pre-determined threshold level). The surgical system database 1130 stores information about each surgical system 1300, e.g., type of system 1300 (e.g., an excimer laser, a femtosecond laser, and/or an ultrasound system), model, account information, owner, schedule of surgeries, surgeons approved to use the system 1300, location, usage history, diagnostics information, such as error logs and service history, and the like.).
Dantus discloses amount of energy consumed by the laser (para. 62 of Dantus; The energy consumption of each laser is extremely low compared to traditional femtosecond sources used in ophthalmology so the present system can optionally, alternate lasers to make sure one or more are ready at all times. Each laser 53 advantageously costs approximately one third of traditional femtosecond laser systems which allow the present modular design to be cost effective. The reduced requirement for maintenance and the cost of immediate service warranty further helps the affordability of the proposed modular design. The design of a system with three such lasers is envisioned where if one laser fails, it can be removed in less than five minutes and sent for repairs, leaving the entire ophthalmic unit with one or more spare lasers while the failed module is being repaired or replaced.)
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Horvath’s system for configuring a surgical device to include the aforementioned features of Swanson, Morris, and Dantus. The motivation for doing so would have been to determine a real time cost of a service (para. 4 of Swanson), to prevent a predicted failure and any possible downtime (para. 29 of Morris), and to alternate lasers to make sure one or more are ready at all times (para. 62 of Dantus).
(K) Referring to claim 17, Horvath discloses A system, comprising: one or more processors; and one or more non-transitory computer-readable media containing instructions which, when executed by the one or more processors, cause the system to perform one or more operations, the system associated with a medical system of a plurality of medical systems, the operations comprising (see Figures 1-5 and para. 40-42 of Horvath):
obtaining, by the system, personnel identification information of a technician (para. 19, 41, and 49 of Horvath; The data that is received from the identifier (tag) is compared to the authorized data to determine whether, for example the patient is the correct patient, whether the surgeon and patient match up, whether the surgeon and treatment or patient and treatment match up, or whether a service technician is authorized to work on a particular machine, etc.);
obtaining, by the system, equipment identification information of equipment used in servicing medical equipment used for eye surgery, the medical equipment including at least the laser (para. 6, 15, 19-21, 49, 32, 34, and 54 of Horvath; note a system and method for configuring and data-populating a surgical system or device, such as a refractive laser eye surgery system, a vitro-retinal system, a cataract phacoemulsification system, or any other such surgical system. The controller 115 includes software and/or hardware 117 to implement the criteria 116 to determine whether data 104 sent by the RFID identifier 102 of the user tag 14 and received by the RFID reader 112 of the surgical device 16 indicates that the user of the tag 14 is authorized for that surgical device 16 and/or surgical procedure and/or service. Surgical devices require certain inputs before surgery can be performed. For example, patient data (e.g., name, age, sex, etc.), surgical data (e.g. type of surgery, body part, etc.), device settings (e.g., power, duration, etc.), confirmation of the surgeons preferred settings, service personnel inputs (e.g., calibration and maintenance records, software updates) and other such inputs have to be confirmed as up-to-date.);
automatically and electronically authorizing, by the system, the technician to perform the servicing of the laser of medical equipment based on both the personnel identification information of the technician and the equipment identification information of the service equipment (para. 19, 20, & 11 of Horvath; The data that is received from the identifier (tag) is compared to the authorized data to determine whether, for example the patient is the correct patient, whether the surgeon and patient match up, whether the surgeon and treatment or patient and treatment match up, or whether a service technician is authorized to work on a particular machine, etc. For example, the surgical device can be enabled if the received data matches authorized data criteria.);
providing, by the system, access to the technician to download service instructions for performing the servicing of the laser of the medical equipment, the downloading permitted based on the authorization of the technician to perform the servicing of the laser of the medical equipment (para. 49-51, 11, 15, 20, and 39 of Horvath; In a service technician embodiment of tag 14, the RFID identifier 102 can include identification data and security data, as discussed above, and, in addition, calibration data, necessary to calibrate the surgical device 16. For example, calibration data may comprise instructions or parameter settings including, for example, laser calibration settings for a particular probe or adaptation.);
providing, by the system, operating instructions to operate the laser during the eye surgery based on the servicing having been completed (para. 6, 21, 22, 32, 34, and 58 of Horvath; Surgical devices require certain inputs before surgery can be performed. For example, patient data (e.g., name, age, sex, etc.), surgical data (e.g. type of surgery, body part, etc.), device settings (e.g., power, duration, etc.), confirmation of the surgeons preferred settings, service personnel inputs (e.g., calibration and maintenance records, software updates) and other such inputs have to be confirmed as up-to-date. System embodiments can be implemented to configure a surgical device for surgery and/or data-populate various data fields within the surgical device. If the data received from the identifier tag satisfies the criteria, then the device can be enabled, configured and data-populated. Safety precautions can be implemented in the embodiments of the present invention, such as generating a message at the surgical device to a surgeon or service technician that, for example, this is not the correct patient, the patient and intended treatment do not match, or that a surgical device requires a certain upgrade or maintenance be performed. Identification, data, and/or calibration data can be used for various purposes. For example, a user interface that is presented on a display screen can be generated based on the particular surgical procedure that will be performed. Data can also be used to enable operating parameters that are compatible with the intended procedure and the intended patient and to disable operating parameters that are incompatible with the intended procedure or that the surgeon does not desire to use. Surgical device 318 is configured and data-populated based on the transferred data and can be made ready for surgery by a surgeon or other user by any other steps required for the procedure, including confirmation of the transferred data and surgical device 318 configuration.); and
conveying instructions, interpretable by the laser of the medical system, to cause the laser to perform a laser vision correction on an eye of a laser eye surgery patient (para. 58, 23, 20, and 32 of Horvath; provide a system and method for configuring and data-populating a surgical system or device, such as a refractive laser eye surgery system, a vitro-retinal system, a cataract phacoemulsification system, or any other such surgical system. The ophthalmic surgical device can be a laser or laser console, or a vitro-retinal surgical device).
Horvath does not expressly disclose obtaining, by the system, equipment identification information of service equipment used in servicing medical equipment, the equipment identification information indicating whether the service equipment has been calibrated to perform the servicing of the laser of the medical equipment; storing, by the system, first sensor data from a sensor configured to monitor an amount of energy consumed by a laser of the medical system; utilizing, by the system, the first sensor data of the amount of energy consumed by the laser to determine one or more issues associated with the medical system; and receiving, by the system, a log file from the medical equipment, the log file including second sensor data associated with a plurality of measurements of the laser after the technician has performed the servicing of the laser of the medical equipment.
Swanson discloses obtaining, by the system, equipment identification information of service equipment used in servicing medical equipment, the equipment identification information indicating whether the service equipment has been calibrated to perform the servicing of the medical equipment (para. 13, 22, 23, 75, and 78 of Swanson; note the calibrating the equipment used to provide the testing service; the material cost data 116 may include an acquisition cost associated with each of the consumable materials used in part or in whole to complete the service, a cost associated with waste of one or more consumable materials (i.e. chemicals) used in control testing or calibration of testing instruments or equipment, among other costs. Where the service cost provider is configured for a testing business as described above, the service code details may include a department within the business tasked to perform the service (e.g., chemistry, immunology, hematology, cytogenetics, molecular, virology, coagulation, toxicology, etc), an instrument or instruments used to perform the service, a testing method to perform the service, a number of calibrations per timeframe (e.g., weekly, daily, etc), a number of repeat services per timeframe (e.g., weekly, daily, etc), a number of days per week the service is to be performed, a number of services bill per timeframe, a medical billing code associated with the service, a number of control test run per timeframe, a number of dilutions per timeframe, the cost variation limit, a cost review interval, an average number of minutes per service, a date of the most previous price update, a list of suppliers who supply the materials to perform the service, an average total material cost per service, and an average total labor cost per service.).
Morris discloses storing, by the system, first sensor data from a sensor configured to monitor an amount of energy output by a laser of the medical system (para. 29 & 30 of Morris; a monitoring subsystem (not shown), residing in the surgical system 1300 and/or the central server system 1010, periodically measures and stores the total output of surgical laser energy over time for the various laser systems 1300 (e.g., in an energy history log, which can be stored in the corresponding surgical system profile database 1130). Preferably, the measurement is performed at system power-up and then periodically during operation (e.g., on an hourly basis throughout a day of operation, on a monthly basis, and the like). The monitoring subsystem 1350 collects these measurements as data points, and a predicted service period (e.g., based on a pre-determined algorithm) can be calculated by the diagnostics engine 1170 or the surgical system itself 1300.); utilizing, by the system, the first sensor data of the amount of energy output by the laser to determine one or more issues associated with the medical system (para. 29 & 30 of Morris; This predicted service period indicates, for example, a probable occurrence of a component failure, a standardized replacement life of the component, and the like. In one embodiment, a threshold (e.g., a minimum total energy output corresponding with a desired photoalteration effect or the like) is used to approximate the service period. This service period is then stored in the surgical system profile database 1130 and forwarded to one or more PDAs 1200, each associated with an available or appropriate technician. A service visit can then be scheduled in advance of the predicted service period, and the technician can verify the output energy levels and service the laser system 1300 (e.g., to prevent a predicted failure and any possible downtime associated therewith). For example, the service visit may include adjusting mirror positions, diode power, or other electrical settings to increase the output energy level from a predicted or detected decrease. In addition, the slope of the data points over time can be determined, either by the surgical system 1300 or the diagnostics engine 1170, to indicate a decline, change, or normal rate of the total energy output. For example, in the event the slope of the total energy output is steeper than a pre-determined threshold rate, the technician is notified of the operation fault of the surgical system 1300. Technician attention can thus be expedited to resolve an operation fault that may be indicative of a potential problem other than normal wear, for example, a failure of a component within the optical path of the laser.); and receiving, by the system, a log file from the medical equipment, the log file including second sensor data associated with a plurality of measurements of the laser after the technician has performed the servicing of the laser of the medical equipment (para. 23 & 29-31 of Morris; Technician attention can thus be expedited to resolve an operation fault that may be indicative of a potential problem other than normal wear, for example, a failure of a component within the optical path of the laser. Other aspects of the laser surgical system 1300 that can be monitored, verified, and/or calibrated utilizing the diagnostics system 1000 include, but are not necessarily limited to, beam steering error, coolant level error, shutter error, laser diode error, galvo positioning error, energy sensors, wavefront measurements, voltage measurements, and the like. History logs for each of these aspects of the laser surgical system 1300 can be stored in the surgical profile database 1130 and used to predict the operation or performance status of the system 1300 (e.g., predict when performance of one or more corresponding components of the system 1300 degrades beyond the pre-determined threshold level). The surgical system database 1130 stores information about each surgical system 1300, e.g., type of system 1300 (e.g., an excimer laser, a femtosecond laser, and/or an ultrasound system), model, account information, owner, schedule of surgeries, surgeons approved to use the system 1300, location, usage history, diagnostics information, such as error logs and service history, and the like.).
Dantus discloses amount of energy consumed by the laser (para. 62 of Dantus; The energy consumption of each laser is extremely low compared to traditional femtosecond sources used in ophthalmology so the present system can optionally, alternate lasers to make sure one or more are ready at all times. Each laser 53 advantageously costs approximately one third of traditional femtosecond laser systems which allow the present modular design to be cost effective. The reduced requirement for maintenance and the cost of immediate service warranty further helps the affordability of the proposed modular design. The design of a system with three such lasers is envisioned where if one laser fails, it can be removed in less than five minutes and sent for repairs, leaving the entire ophthalmic unit with one or more spare lasers while the failed module is being repaired or replaced.)
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Horvath’s system for configuring a surgical device to include the aforementioned features of Swanson, Morris, and Dantus. The motivation for doing so would have been to determine a real time cost of a service (para. 4 of Swanson), to prevent a predicted failure and any possible downtime (para. 29 of Morris), and to alternate lasers to make sure one or more are ready at all times (para. 62 of Dantus).
(L) Referring to claims 24 and 25, Horvath does not expressly disclose discloses further comprising: recording, by the medical system, one or more tools utilized by the technician to perform the servicing of the laser of the medical equipment and wherein at least one of the one or more tools is an incorrect tool, an incorrectly utilized tool, a less efficient tool, an incorrectly calibrated tool, an unauthorized tool, or a correct tool.
Swanson discloses recording, by the medical system, one or more tools utilized by the technician to perform the servicing of the medical equipment and wherein at least one of the one or more tools is an incorrect tool, an incorrectly utilized tool, a less efficient tool, an incorrectly calibrated tool, an unauthorized tool, or a correct tool (para. 22, 26, and 35 of Swanson).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Horvath’s system for configuring a surgical device to include the aforementioned features of Swanson. The motivation for doing so would have been to determine a real time cost of a service (para. 4 of Swanson)
Claim(s) 3, 4, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath et al. (US 2007/0027459 A1) in view of Swanson et al. (US 2017/0221112 A1), in view of Morris et al. (US 2010/0076453 A1), in view of Dantus (US 2014/0058367 A1), and further in view of Schlabach et al. (US 2002/0026537 A1).
(A) Referring to claims 3 & 11 and 4 & 12, Horvath, Swanson, Morris, and Dantus do not expressly disclose wherein the personnel identification information includes one or more qualifications of the technician and wherein the personnel identification information includes an indication that the one or more qualifications of the technician are up to date.
Schlabach discloses wherein the personnel identification information includes one or more qualifications of the technician and wherein the personnel identification information includes an indication that the one or more qualifications of the technician are up to date (para. 12, 13, 89, and 90 of Schlabach).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Schlabach within Horvath, Swanson, Morris, and Dantus. The motivation for doing so would have been to determine whether or not the present qualifications of the service personnel meet the predetermined requirements and to provide training if the predefined qualifications for servicing the assembly are unmet (abstract of Schalbach).
Claim(s) 9, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horvath et al. (US 2007/0027459 A1) in view of Swanson et al. (US 2017/0221112 A1), in view of Morris et al. (US 2010/0076453 A1), in view of Dantus (US 2014/0058367 A1), and further in view of Mogatadakala (US 2019/0304600 A1).
(A) Referring to claims 9, 16, and 20, Horvath discloses generating the service instructions for the technician to perform the servicing of the laser of the medical equipment (para. 19-21, 49-51, 11, 15, and 39 of Horvath).
Horvath, Swanson, and Morris do not disclose further comprising determining the servicing of the medical equipment, comprising: receiving third sensor data of the amount of energy consumed by the laser; determining current classifiers based on the third sensor data; determining, without user input, at least two services to be provided to at least two of the plurality of medical systems as the medical equipment to be serviced; determining, based on prior classifiers and the at least two services to be provided, at least two additional services to be provided to the at least two of the plurality of medical systems.
Dantus discloses receiving third sensor data of the amount of energy consumed by the laser (para. 62 of Dantus).
Mogaradakala discloses further comprising determining the servicing of the medical equipment, comprising: receiving sensor data associated with a plurality of measurements of a plurality of medical systems (para. 97 of Mogatadakala); determining current classifiers based on the third sensor data (para. 97 of Mogatadakala); determining, without user input, at least two services to be provided to at least two of the plurality of medical systems as the medical equipment to be serviced (para. 97 of Mogatadakala); determining, based on prior classifiers and the at least two services to be provided, at least two additional services to be provided to the at least two of the plurality of medical systems (para. 84, 97-99, and 141-145 of Mogatadakala).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Dantus and Mogatadakala within Horvath, Swanson, and Morris. The motivation for doing so would have been to alternate lasers to make sure one or more are ready at all times (para. 62 of Dantus) and enable proactive service and maintenance of the medical diagnostic machine before the key components breakdown (para. 4 of Mogatadakala).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 10, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches low voltage communication between subsystems in a laser eye surgery system (US 2014/0128851 A1).
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687