DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments under 37 CFR 1.132 filed 08/07/2025 is sufficient to overcome the rejection of independent claim 1 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2019/0201082) in view of Falkenstein (US 20090248013 A1) as set forth in the last Office action because: Shelton in view of Falkenstein fail to fully teach all aspects of the amended claims.
Claims 1, 4, 5, 7-11, and 13-15 are currently pending.
Response to Arguments
Applicant's arguments filed 08/07/2025 regarding amendments to claim 1 under Shelton (US 2019/0201082) in view of Falkenstein (US 20090248013 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made further in view of Gregg (US 20110238063 A1).
Regarding applicants’ argument that that the modification of storing instructions for an evacuation device in an instrument memory instead of a generator memory would not have been obvious from the two publications (Shelton and Falkenstein). However, Examiner respectfully disagrees. Falkenstein teaches the electrosurgical instrument comprises a non-volatile instrument data memory that contains a data set with structured data (Fig 1A; [0163] the tool 40 can further comprise a memory 70. In some embodiments, the memory 70 comprises an encryption module 72 and a configuration device module 74. The encryption module 72 can be configured to facilitate an encrypted information exchange with the encryption module 26 on ESU 10. The configuration device module 74 can store operational parameter information about the tool 40. For example, in some embodiments, the configuration device module 74 can store information regarding the electrode assembly, the number of uses and total operational time of use of the tool, and other operational parameters). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Shelton to store the control instructions defining an on or off switching of the evacuation device or, for a switched-on state of the evacuation device, the respective power to be delivered by the evacuation device within the instruments non-volatile memory as taught by Falkenstein. Doing so allows for a separate memory to be associated with the device and is tailored to the specific needs of the instrument.
Furthermore, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to include the non-volatile memory in the instrument, since applicant has not disclosed that a non-volatile memory in an instrument solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the non-volatile memory stored in the generator.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4-5, 7-11, 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2019/0201082) in view of Falkenstein (US 20090248013 A1), further in view of Gregg (US 20110238063 A1).
Regarding claim 1, Shelton teaches an electrosurgical system (Shelton Fig 7, Electrosurgical system 50601) with an electrosurgical instrument (50630), an evacuation device (50600) and an electrosurgical generator (50640), to which the electrosurgical instrument and the evacuation device are connected ([0206] The utility conduit includes a cable that communicates electrical energy from the signal generator to the electrosurgical instrument), wherein the electrosurgical generator has a processor (Figs 5 & 7, Processor 50308 and 50408) and at least one generator data memory (Fig 6, Memory 50410) and is configured to convert entries in the generator data memory into control instructions for operating the evacuation device and ([0343] FIG. 34 shows a representation of instructions 53400 stored by a memory of a surgical system), during operation, to carry out control interventions corresponding to the control instructions for controlling the evacuation device ([0376] The instructions 53100 stored in the memory can be implemented by a processor configured to the evacuation device), wherein the entries in the memory defining the control instructions for operating the evacuation device are specific to a respective electrosurgical instrument and/or a respective operating mode ([0366] Such information can include, for example, a current operating mode of the surgical device and/or information regarding the intensity of a particular energy setting and/or delivery), the generator data memory contains an operating program, operating specifications, and a data structure, of which the operating program causes the processor to control the operation of the electrosurgical generator in conjunction with the electrosurgical instrument ([0188] The processor 50308 is coupled to a memory 50310 configured to store machine executable instructions to operate the electrosurgical system 50300 and/or subsystems thereof); the operating specifications can be called up by the processor, which is controlled by the operating program (Fig 51, memory circuit 504), when the electrosurgical generator is in operation, and they can influence the operation of the electrosurgical generator ([0194] The electrosurgical system 50300 (FIG. 5) and/or the surgical evacuation system 50400 (FIG. 6) can be programmed to monitor one or more parameters of a surgical system and can affect a surgical function based on one or more algorithms stored in a memory in signal communication with the processor 50308), but do not define any fixed operating sequences ([0202] The parameters can be operational or sensed); and data sets with structured data are stored in the data structure that contain references to operating specifications stored in the generator data memory ([0333] a processor within the surgical system can store information in a memory that is specific to the amount of smoke and/or contaminants produced when a clinician uses a particular surgical instrument for a specific duration. Such information can be stored directly in the memory of the processor)([0680] Instructions used to program logic to perform various disclosed aspects can be stored within a memory in the system), which allow for calling up individual references in a targeted manner by the operating program during operation, wherein the structured data contains entries that define control instructions for operating the evacuation device ([0551] The memory 624 may store various program instructions, which when executed may cause the processor 622 to perform a plurality of functions and/or calculations that influence the control of the evacuation device), and the electrosurgical instrument comprises a non-volatile instrument data memory that contains a data set with structured data ([0509] The system memory includes non-volatile memory) ([0401] the control circuit can access and/or reference expected pressures for the flow path based on historical data stored in a cloud), which data is compatible with the data structure of the electrosurgical generator and contains entries that define control instructions for controlling the evacuation device ([0539] The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 may comprise a microcontroller comprising one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement various processes described herein. The processor 502 may be any one of a number of single-core or multicore processors known in the art. The memory circuit 504 may comprise volatile and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of this disclosure) wherein the control instructions stored in the data memory ([0343] FIG. 34 shows a representation of instructions 53400 stored by a memory of a surgical system) and concerning the evacuation device define an on or off switching of the evacuation device ([0284] if the particle sensor 50848 downstream of the filter detects a particle count that is greater than the threshold amount Z at block 52318, the motor can be turned off at block 52322 to terminate the evacuation procedure and the surgical evacuation system can enter an override mode 52306), or, for a switched-on state of the evacuation device, the respective power to be delivered by the evacuation device ([0197] the smoke evacuator 50326 and/or the sensing and intelligent controls device 50324 therefor can be configured to adjust the evacuation flow rate and/or the pump's motor speed and, at a predefined particulate level, may operably affect the output power or waveform of the generator to lower the smoke generated by the end effector).
Shelton fails to fully disclose the electrosurgical instrument comprises a non-volatile instrument data memory that contains a data set with structured data, wherein the control instructions are stored in the non-volatile instrument data memory, wherein the electrosurgical system is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator.
However, Falkenstein teaches the electrosurgical instrument comprises a non-volatile instrument data memory that contains a data set with structured data (Fig 1A; [0163] the tool 40 can further comprise a memory 70. In some embodiments, the memory 70 comprises an encryption module 72 and a configuration device module 74. The encryption module 72 can be configured to facilitate an encrypted information exchange with the encryption module 26 on ESU 10. The configuration device module 74 can store operational parameter information about the tool 40. For example, in some embodiments, the configuration device module 74 can store information regarding the electrode assembly, the number of uses and total operational time of use of the tool, and other operational parameters), instructions are stored in the non-volatile instrument data memory (Fig 1A; [0163] the tool 40 can further comprise a memory 70. In some embodiments, the memory 70 comprises an encryption module 72 and a configuration device module 74. The encryption module 72 can be configured to facilitate an encrypted information exchange with the encryption module 26 on ESU 10. The configuration device module 74 can store operational parameter information about the tool 40. For example, in some embodiments, the configuration device module 74 can store information regarding the electrode assembly, the number of uses and total operational time of use of the tool, and other operational parameters); wherein the electrosurgical system is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator ([0156] The electrosurgical tool 40 can be electrically coupled to the electrosurgical unit 10. In some embodiments, an electronic coupler 30 such as an electrical wire, wire bundle, or cable can electrically couple the electrosurgical tool 40 to the ESU 10) ([0163] The encryption module 72 can be configured to facilitate an encrypted information exchange with the encryption module 26 on ESU 10). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Shelton to comprise a non-volatile memory in the electrosurgical instrument, to store the control instructions defining an on or off switching of the evacuation device or, for a switched-on state of the evacuation device, the respective power to be delivered by the evacuation device within the instruments non-volatile memory, wherein the electrosurgical system is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator. Doing so allows for a separate memory to be associated with the device and is tailored to the specific needs of the instrument as providing control instructions within a non-volatile memory is known in the art to yield the predictable result of enabling a device to be controlled via control instructions. Further, for a separate memory to be associated with the device and is tailored to the specific needs of the instrument and to transfer the data with the generator via exchange line.
Furthermore, it would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to include the non-volatile memory in the instrument, since applicant has not disclosed that a non-volatile memory in an instrument solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the non-volatile memory stored in the generator.
Further, Gregg teaches wherein the electrosurgical system is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator ([0026] A transmission line 36 may also be coupled between generator 12 and reposable instrument 20. Transmission line 36 may be a data line that transmits data between reposable instrument 20 and generator 12. Such data may include a device identifier for the generator 12, a device identifier for the reposable instrument 20, type of reposable instrument 20 being used, type of end effector 14 being used, type of electrosurgical generator 12 (e.g., ablation, electrosurgical, ultrasonic, etc.), number of times the reposable instrument 20 has been used, number of times the end effector 14 has been used, amount of energy delivered by the reposable instrument 20, amount of energy delivered by the end effector 14, amount of time the reposable instrument 20 has been coupled to the generator 12, whether the reposable instrument 20 has reached the end of the reposable instrument's 20 lifespan, whether the end effector 14 has reached the end of the end effector's 14 lifespan, readings from any sensors (not shown) disposed on the reposable instrument 20 or end effector 14, etc. Reposable instrument 20 may also transmit a signal to generator 12 to discontinue transmitting energy via transmission line 32). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Shelton in view of Falkenstein to include wherein the electrosurgical system is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator. Doing so allows for a separate memory to be associated with the device and is tailored to the specific needs of the instrument and to transfer the data with the generator via transmission line.
Regarding claim 4, Shelton discloses an electrosurgical system according to claim 1, wherein the processor is configured, by means of the operating program, to read specific control instructions for different electrosurgical instruments and/or different operating modes and to cause the specific control instructions to be converted into control interventions on the electrosurgical generator, the electrosurgical instrument, and/or the evacuation device (Fig 5 and 6; [0194] Systems can be programmed to monitor one or more parameters of a surgical system and can affect a surgical function based on one or more algorithms stored in a memory in signal communication with the processor 50308).
Regarding claim 5, Shelton discloses an electrosurgical system according to claim 1, wherein the control instructions defined by entries stored in a memory for control interventions on the evacuation device are conditional control instructions that define control interventions which are dynamically dependent on respective current operating states of the electrosurgical generator and/or on currently occurring operating parameter values (Fig 60 is a timeline depicting situational awareness of a surgical hub) ([0186] Situational awareness encompasses the ability of some aspects of a surgical system to determine or infer information related to a surgical procedure from data received from databases and/or instruments).
Regarding claim 7, Shelton discloses an electrosurgical system according to claim 6, wherein the electrosurgical generator is designed to convert such control instructions, which define the power to be delivered by the evacuation device ([0189] Connected between the processor 50308 and the power converter 50306 is a digital-to-analog converter (“DAC”) 50312. The DAC 50312 is adapted to convert a digital code created by the processor 50308 to an analog signal (current, voltage, or electric charge) which governs the voltage) (typical wave generators are adapted to maintain the selected settings throughout an electrosurgical procedure), into control interventions in the form of pulse sequences which, via pulse width modulation, cause the evacuation device to be switched on and off in rapid succession so that it is operated with a higher or lower capacity as a result ([0277] a pulse modulation circuit can employ pulse width modulation and/or pulse frequency modulation to adjust the length and/or frequency of the pulses).
Regarding claim 8, Shelton discloses an electrosurgical system according to claim 1, wherein the electrosurgical generator is designed to control the power delivered by the evacuation device during operation depending on a calculated parameter value or a parameter value detected by sensors (Figs 18 and 19, pressure sensor 50854) ([0285] the power level of the pump can be a function of a pressure differential across at least a portion of the surgical evacuation system) ([0330] the generator can automatically monitor tissue impedance and adjusts a power output to the energy device in order to reduce tissue damage, resulting in an efficient and accurate cutting effect at the lowest possible setting).
Regarding claim 9, Shelton discloses an electrosurgical system according to claim 1, wherein the electrosurgical generator features power measuring means for measuring the power output by an electrosurgical instrument (Fig 36, the externally-measured parameter is the power level of an electrosurgical signal supplied to an electrosurgical instrument by a generator (e.g. the electrosurgical instrument 50630 by the generator 50640 in FIG. 7) used in a surgical procedure) ([0188] the processor 50308 can determine the desired output power level at an electrode tip 50334).
Regarding claim 10, Shelton discloses an electrosurgical system according to claim 1, with one programming interface or several programming interfaces, by means of which the operating specifications and the data structure can be programmed ([0446] a user interface of the evacuation system can receive an input from a practitioner) ([0512] A user enters commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251).
Regarding claim 11, Shelton discloses a method of operating an electrosurgical system according to claim 1, wherein entries in the generator data memory are converted into control instructions for operating the evacuation device and ([0551] the memory 624 may store various program instructions, which when executed may cause the processor 622 to perform a plurality of functions and/or calculations described herein), during operation, control interventions corresponding to the control instructions for controlling the evacuation device are implemented ([0007] The computer readable instructions, when executed, further cause the machine to automatically transmit a drive signal to the motor to modify a speed of the motor based on the signal from the sensor), wherein entries defining the control instructions for operating the evacuation device in the generator data memory are specific to a respective electrosurgical instrument and/or a respective operating mode ([0555] Such program instructions may cause the processor 622 to control the firing, closure, and articulation functions in accordance with inputs from algorithms or control programs of the surgical instrument or tool) ([0556] one or more mechanisms and/or sensors such as, for example, sensors 630 can be employed to alert the processor 622 to the program instructions that should be used in a particular setting), and the entries defining the control instructions for operating the evacuation device are read from a data structure in an instrument data memory of an electrosurgical instrument ([0188] The processor 50308 is coupled to a memory 50310 configured to store machine executable instructions to operate the electrosurgical system 50300 and/or subsystems thereof).
Shelton fails to teach transferring data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator.
However, Gregg teaches transferring data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator ([0026] A transmission line 36 may also be coupled between generator 12 and reposable instrument 20. Transmission line 36 may be a data line that transmits data between reposable instrument 20 and generator 12. Such data may include a device identifier for the generator 12, a device identifier for the reposable instrument 20, type of reposable instrument 20 being used, type of end effector 14 being used, type of electrosurgical generator 12 (e.g., ablation, electrosurgical, ultrasonic, etc.), number of times the reposable instrument 20 has been used, number of times the end effector 14 has been used, amount of energy delivered by the reposable instrument 20, amount of energy delivered by the end effector 14, amount of time the reposable instrument 20 has been coupled to the generator 12, whether the reposable instrument 20 has reached the end of the reposable instrument's 20 lifespan, whether the end effector 14 has reached the end of the end effector's 14 lifespan, readings from any sensors (not shown) disposed on the reposable instrument 20 or end effector 14, etc. Reposable instrument 20 may also transmit a signal to generator 12 to discontinue transmitting energy via transmission line 32). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Shelton in view of Falkenstein to include transferring data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator. Doing so allows for a separate memory to be associated with the device and is tailored to the specific needs of the instrument and to transfer the data with the generator via transmission line.
Regarding claim 13, Shelton discloses an electrosurgical generator for an electrosurgical system according to claim 1, with a processor (Figs 5 & 7, Processor 50308 and 50408) and at least one generator data memory (Fig 6, Memory 50410), wherein the processor is configured to convert entries in the generator data memory into control instructions for operating the evacuation device and ([0551] the memory 624 may store various program instructions, which when executed may cause the processor 622 to perform a plurality of functions and/or calculations described herein), during operation, to carry out control interventions corresponding to the control instructions for controlling the evacuation device ([0007] The computer readable instructions, when executed, further cause the machine to automatically transmit a drive signal to the motor to modify a speed of the motor based on the signal from the sensor), wherein the entries in the memory defining the control instructions for operating the evacuation device are specific to a respective electrosurgical instrument and/or a respective operating mode ([0556] one or more mechanisms and/or sensors such as, for example, sensors 630 can be employed to alert the processor 622 to the program instructions that should be used in a particular setting).
Shelton fails to teach wherein the electrosurgical generator is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator.
However, Gregg teaches wherein the electrosurgical generator is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator ([0026] A transmission line 36 may also be coupled between generator 12 and reposable instrument 20. Transmission line 36 may be a data line that transmits data between reposable instrument 20 and generator 12. Such data may include a device identifier for the generator 12, a device identifier for the reposable instrument 20, type of reposable instrument 20 being used, type of end effector 14 being used, type of electrosurgical generator 12 (e.g., ablation, electrosurgical, ultrasonic, etc.), number of times the reposable instrument 20 has been used, number of times the end effector 14 has been used, amount of energy delivered by the reposable instrument 20, amount of energy delivered by the end effector 14, amount of time the reposable instrument 20 has been coupled to the generator 12, whether the reposable instrument 20 has reached the end of the reposable instrument's 20 lifespan, whether the end effector 14 has reached the end of the end effector's 14 lifespan, readings from any sensors (not shown) disposed on the reposable instrument 20 or end effector 14, etc. Reposable instrument 20 may also transmit a signal to generator 12 to discontinue transmitting energy via transmission line 32). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Shelton in view of Falkenstein to include wherein the electrosurgical generator is configured to transfer data sets with structured data contained in the data structure on the electrosurgical instrument into the data structure in the memory of the electrosurgical generator. Doing so allows for a separate memory to be associated with the device and is tailored to the specific needs of the instrument and to transfer the data with the generator via transmission line.
Regarding claim 14, Shelton discloses an electrosurgical generator according to claim 10, wherein the electrosurgical generator is designed to convert such control instructions (Processor 50408), which define the power to be delivered by the evacuation device ([0189] Connected between the processor 50308 and the power converter 50306 is a digital-to-analog converter (“DAC”) 50312. The DAC 50312 is adapted to convert a digital code created by the processor 50308 to an analog signal (current, voltage, or electric charge) which governs the voltage) (typical wave generators are adapted to maintain the selected settings throughout an electrosurgical procedure), into control interventions in the form of pulse sequences which, via pulse width modulation ([0277] a pulse modulation circuit can employ pulse width modulation and/or pulse frequency modulation to adjust the length and/or frequency of the pulses), cause the evacuation device to be switched on and off in rapid succession so that it is operated with a higher or lower capacity as a result ([0425] The varying supply of current can be accomplished by varying a pulse width modulation (PWM) duty cycle of an electrical input to the motor 50512) ([0426] a lower operating level of the motor 50512 can be more advantageous than turning the motor 50512 completely off when evacuation and/or suction is not needed).
Regarding claim 15, Shelton discloses an electrosurgical instrument for an electrosurgical system according to claim 1, with an instrument data memory containing data sets with structured data ([0511] program data stored either in the system memory or on the disk storage), which data contains entries defining the control instructions for operating an evacuation device ([0188] The processor 50308 is coupled to a memory 50310 configured to store machine executable instructions to operate the electrosurgical system 50300 and/or subsystems thereof).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached on (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794