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 . 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.
Claim Rejections - 35 USC § 103
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Odom (US 2008/0039831) in view of Truckai (US 2012/0101498) and Asher (US 2018/0333185).
Regarding claim 5, Odom discloses an electrosurgical forceps system/method that uses bipolar electrodes connected to a waveform generator to treat tissue where the energy is controlled by a controller (fig. 1). In particular the forceps includes a body (20), a shaft (12), two jaws (110, 120) each with electrodes (112, 122) which are connected to the waveform generator by a power cable (23). The waveform generator (20) includes the controller (fig. 3). One of the functions of the controller is the determination of initial impedance using a constant power before tissue is treated ([0031]) where that impedance is used to set various parameters ([0032]) not including a starting voltage. The various collected/calculated values are stored in memory ([0032]). Odom does not specifically disclose that the constant power is used to determine a voltage which is then used as the starting voltage for a treatment stage. Truckai discloses a tissue heating device that uses a constant power in an initiation stage not intended to substantially alter tissue to determine and record a voltage which is then used as the starting voltage for the treatment stage ([0064], fig. 11). Truckai teaches that the initiation stage is indicative of several parameters, at least some of which are relevant to forceps such as tissue impedance ([0065], compared to, for example, the abstract of Odom). Further, it is noted that Truckai explicitly states that the treatment voltage can be the same as the voltage determined during the initiation stage or the voltage can be higher or lower ([0064]), thus illustrating that choosing a starting voltage for a tissue heating procedure is well within the level of ordinary skill in the art. It has been held that the combination of know elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where in this case the "known elements" are the control steps by which energy parameters are determined for treating tissue. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system and method of Odom to include the hardware/software that would allow the controller to determine a starting voltage by applying a constant power and then using a measured and stored voltage determined during the application of constant power as the starting voltage for the subsequent treatment stage, as taught by Truckai, to produce the predictable result of treating tissue in a desired manner. Odom does not disclose that the sealing stage includes a hold time period at the end of which an impedance is measured to determine whether a vessel size is small or large. However, using impedance to determine vessel size is common in the art and vessel size is known to be directly relevant to the operation of a vessel sealing procedure. Asher, for example, discloses an electrosurgical sealing forceps system and includes the a sealing stage (fig. 8A) which includes measuring impedance (418) and comparing impedance to one or more thresholds (416) after a hold time (the time between 412 and 418) to determine if the vessel is small or large (420). It is noted that since the claim does not define “small” or “large,” “small” can be understood to be or include Asher’s “medium.” Asher further teaches that the size of the vessels dictates further generator operating parameters ([0063], see also discussion associated with fig. 11). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Odom to include the vessel size determination steps in the sealing stage to allow the controller to further control the energy delivery based on the size of the vessel being sealed.
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Odom and Truckai and Asher, further in view of Hareyama (US 2002/0032439).
Regarding claim 9 is, the system of Odom does not disclose the particular power and duration of the initiation stage. However, power and duration values are well within the level of ordinary skill in the art to determine and Applicant has not disclosed the values are critical or produce an unexpected result. Truckai discloses a range from ~0-15 seconds ([0064]) but, due to the type of ablation being performed, has a higher power range. But initiation stages at 10W are known in the art. Hareyama discloses a tissue heating system and teaches that 10W can be used during an initiation stage ([0131]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known power and duration for the initiation stage in the system/method of Odom, including any value between ~0-15 seconds as taught by Truckai, such as 100 ms, and 10W as taught by Hareyama, that would produce the predictable result of a functional electrosurgical system.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Odom and Truckai and Asher, further in view of Warren (US 2012/0067212).
Regarding claim 10, Odom does not disclose that the controller is configured to monitor for short circuits on the basis of “current flow” for a period of time. However, short circuits are commonly known to be directly relevant to the safe and effective electrosurgical procedures. Warren, for example, discloses an electrosurgical system and teaches that both time and current are used to determine if an electrical short has occurred so that a controller can stop the procedure before accidental shock occurs ([0059]), where it is noted that whatever actual values are employed by Warren are predetermined. Therefore, before the application was filed, it would have been obvious to further modify the system of Odom to include the use of current and time to determine if a short circuit condition exists, such as taught by Warren, to allow the system to control the electrosurgical procedure to prevent patient harm.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Odom in view of Truckai, Coulson (US 2015/0032100) and Yates (US 2015/0265347).
Regarding claim 11, Odom discloses an electrosurgical forceps system/method that uses bipolar electrodes connected to a waveform generator to treat tissue where the energy is controlled by a controller (fig. 1). In particular the forceps includes a body (20), a shaft (12), two jaws (110, 120) each with electrodes (112, 122) which are connected to the waveform generator by a power cable (23). The waveform generator (20) includes the controller (fig. 3). One of the functions of the controller is the determination of initial impedance using a constant power before tissue is treated ([0031]) where that impedance is used to set various parameters ([0032]) not including a starting voltage. The various collected/calculated values are stored in memory ([0032]). Odom does not specifically disclose that the constant power is used to determine a voltage which is then used as the starting voltage for a treatment stage. Truckai discloses a tissue heating device that uses a constant power in an initiation stage not intended to substantially alter tissue to determine and record a voltage which is then used as the starting voltage for the treatment stage ([0064], fig. 11). Truckai teaches that the initiation stage is indicative of several parameters, at least some of which are relevant to forceps such as tissue impedance ([0065], compared to, for example, the abstract of Odom). Further, it is noted that Truckai explicitly states that the treatment voltage can be the same as the voltage determined during the initiation stage or the voltage can be higher or lower ([0064]), thus illustrating that choosing a starting voltage for a tissue heating procedure is well within the level of ordinary skill in the art. It has been held that the combination of know elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where in this case the "known elements" are the control steps by which energy parameters are determined for treating tissue. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system and method of Odom to include the hardware/software that would allow the controller to determine a starting voltage by applying a constant power and then using a measured and stored voltage determined during the application of constant power as the starting voltage for the subsequent treatment stage, as taught by Truckai, to produce the predictable result of treating tissue in a desired manner. Odom does not disclose an open circuit condition is determined based on impedance being above a threshold for an amount of time. Open circuit conditions are known to be relevant to the operation of electrosurgical systems. Coulson discloses an electrosurgical system and teaches that an open state can be based on an impedance measurement relative to a threshold ([0060]) but does not discuss an amount of time. Yates discloses impedance is measured relative to a threshold for an amount of time to determine a circuit condition ([0069]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Odom to employ any commonly known features related to the safe and/or effective operation of the system, including determining an open condition based on an impedance threshold as taught by Coulson for an amount of time as taught by Yates that would produce the predictable result of allowing a system to operate in an appropriate manner under the operational conditions.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Odom and Truckai, Coulson and Yates, further in view of Hareyama.
Regarding claim 12 is, the system of Odom does not disclose the particular power and duration of the initiation stage. However, power and duration values are well within the level of ordinary skill in the art to determine and Applicant has not disclosed the values are critical or produce an unexpected result. Truckai discloses a range from ~0-15 seconds ([0064]) but, due to the type of ablation being performed, has a higher power range. But initiation stages at 10W are known in the art. Hareyama discloses a tissue heating system and teaches that 10W can be used during an initiation stage ([0131]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known power and duration for the initiation stage in the system/method of Odom, including any value between ~0-15 seconds as taught by Truckai, such as 100 ms, and 10W as taught by Hareyama, that would produce the predictable result of a functional electrosurgical system.
Allowable Subject Matter
Claims 1-4 are allowed.
Claims 6-8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 1-4, the prior art is well acquainted with various stages and discloses numerous control steps for various electrosurgical parameters including power, voltage, current and impedance, as shown by the prior art cited in the parent application (now U.S. 12,137,963) and various related applications (e.g. those that became U.S. 11,304,744, 11,786,293 and 12,262,934). However, the prior art does not disclose the claimed features (the number of stages, not substantially altering tissue, measuring voltage at an end time, having voltage ramp ups, etc.) together with the claimed relationships (the end voltage of one stage being the starting voltage of a subsequent stage, a ramp being slower than a subsequent ramp, etc.) as recited in claim 1. It is further noted the pending claims recite different details about the stages than the patented applications.
Regarding claims 6-8, controlling various energy parameters based on the size of the vessel being sealed is common in the art but the specific steps disclosed in these claims are not present in the prior art documents that provide details about the control mythology based on vessel size being small or large.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
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