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 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 39-47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 39 recites the limitation "the second energy signal generated by the first energy circuit" in lines 25-26. There is insufficient antecedent basis for this limitation in the claim.
Claims 40-47 are rejected by virtue of their dependency upon an indefinite base claim.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28, 32-37, 39 and 41-47 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton, IV et al. (US 2017/0202607) (“Shelton”) in view of Shimizu (US 2009/0131929).
Regarding claim 28, Shelton discloses a surgical generator (see 604, Fig. 32, see Figs. 30-31 for additional components as directed by [0234]), comprising: an ultrasonic energy circuit configured to generate an ultrasonic energy signal for activating an ultrasonic blade of a surgical instrument (see ultrasonic circuit 177 of Fig. 11 and ultrasonic transducer 530 of Fig. 31); a radiofrequency (RF) energy circuit configured to generate an RF energy signal for activating an electrode of the surgical instrument (see RF generator assembly 504 and electrode 515, Fig. 30); and a control circuit (see DDS circuit 1600 of the generator circuit and control circuit within the housing 548/648, [0237], [0337], and [0369]-[0372]) configured to: store a plurality of energy delivery algorithms (see DDS circuit 1600 coupled to a processor, controller, or a logic device of the generator circuit and to a memory circuit located in the generator circuit delivering different waveforms based on a stored lookup table on the generator circuit for each of the respective energy modes, [0369]-[0372]), each of the energy delivery algorithms comprising instructions executable to cause the ultrasonic energy circuit and the RF energy circuit to generate the ultrasonic energy signal and the RF energy signal according to defined waveform parameters (see non-volatile memory 1304 storing an energy modality program having corresponding instructions for delivering each respective energy according to the energy modality program/algorithm that was predefined when it was stored, [0337]-[0338], see also DDS circuit 1600 delivering different waveforms based on a stored lookup table on the generator circuit for each of the respective energy modes, [0371]-[0372]; see also [0338]); receive an algorithm selection signal from the surgical instrument, the algorithm selection signal designating a selected energy delivery algorithm from the plurality of energy delivery algorithms (see signal generated as a result of the energy modality actuator located on the handle of the surgical instrument such as a toggle switch or momentary contact switch that are being treated as buttons since they must be pressed, [0337]); receive an activation signal from the surgical instrument (see signal received as a result of switch 520a or 520b being activated for the ultrasonic or RF generator, [0230], [0234]-[0235]); and execute the selected energy delivery algorithm based on receiving the energy selection signal to automatically cause the ultrasonic energy circuit and the RF energy circuit to generate the ultrasonic energy signal and the RF energy signal according to the corresponding defined waveform parameters thereby activating the ultrasonic blade and the electrode (see [0230], and [0337]). However, Shelton fails to specifically disclose executing the selected energy delivery algorithm based on receiving the energy selection signal and the activation signal.
Shimizu teaches a surgical device with an end effector for treating tissue (see Fig. 1) and a mode selector switch (see parameter switch 51, Fig. 12) that is configured to modify the control modes that the handpiece operates in when it is activated including selection of the order of ultrasonic output and high-frequency output, output timings (see [0151] and [0156]-[0157]) as well as individual control and simultaneous control mode to change the behavior of the respective energy activation switches (see [0156] and [0162], see also corresponding [0099] and [0103]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mode selection switch as taught by Shelton to also cause the first activation switch to deliver the RF or ultrasonic energy modality according to the selected operating mode when actuated, thereby executing the selected energy delivery algorithm based on receiving the energy selection signal and the activation signal in light of Shimizu, the motivation being to provide the additional benefit of dynamically modifying the operation of the activation switches as needed for the particular energy demands of a specific procedure (see Shimizu [0156]-[0157] and [0162]).
Regarding claim 32, Shelton in view of Shimizu further teaches wherein the defined waveform parameters comprise a type of energy, a duty cycle, a voltage, a frequency, an impedance limit, a pulse width, or a current, or a combination thereof (see Shelton: ultrasonic, RF, or combination ultrasound/RF energy types, [0337] and control of output current, voltage, and frequency based on user input; [0366]-[0367] and [0371] in view of the additional modes provided by Lesko as detailed above as well as Shimizu [0151]).
Regarding claim 33, Shelton in view of Shimizu further teaches wherein the plurality of energy delivery algorithms comprises pre-defined algorithms and user-defined algorithms (see selection of pre-defined algorithms from the ultrasonic, RF, or combination ultrasonic/RF modes which constitutes a predefined list by a user since it had to be preprogrammed by a user to be available for selection which are defined by energy type, Shelton: [0337]; and the user-defined algorithms in light of the modifications to the pre-defined algorithms as a result of the combination made with Shimizu in the rejection of claim 28 above).
Regarding claim 34, Shelton in view of Shimizu further teaches wherein the selected energy delivery algorithm is a pre-defined algorithm, and wherein the control circuit configured to: receive a waveform parameter modification signal defining a modified waveform parameter for the selected energy delivery algorithm; generate a user-defined algorithm from the pre-defined algorithm incorporating the modified waveform parameter (see selection of pre-defined modes with the addition of user-defined changes to order and output timing to the pre-defined modes as provided by the combination of references).
Regarding claim 35, Shelton further discloses wherein the ultrasonic circuit comprises a first terminal removably couplable to the surgical instrument, and wherein the RF energy circuit comprises a second terminal removably couplable to the surgical instrument (see the ultrasonic and RF circuits having terminals that connect to the instrument when they are removably connected to the instrument, [0151]).
Regarding claim 36, Shelton further discloses a display, wherein the control circuit is configured to cause the display to indicate the selected energy delivery algorithm based on receiving the algorithm selection signal (see [0234]).
Regarding claim 37, Shelton further discloses wherein the control circuit is configured to receive the plurality of energy delivery algorithms from a memory of the surgical instrument (see custom wave shapes, their tissue effects, generator algorithms being fetched from memory of the surgical instruments, [0371] and [0376]).
Regarding claim 39, Shelton in view of Shimizu teaches a system comprising: a surgical generator as required by claim 38 (as detailed in the rejection of claim 28 above), and Shelton further discloses a surgical instrument couplable to the surgical generator (see 502 and 510, Fig. 30-31), the surgical instrument comprising: an end effector configured to: deliver first energy for treating tissue based on the first energy signal generated by the first energy circuit (see ultrasonic blade 516 configured to deliver ultrasonic energy generated by the ultrasonic circuit, [0230]); and deliver second energy for treating tissue based on the second energy signal generated by the second energy circuit (see electrode 515 configured to deliver RF energy from the RF circuit, [0230]); and a user interface configured to cause the surgical instrument to transmit the algorithm selection signal and the activation signal based on receiving a user input (see Shelton: switches 520a and 520b to activate the ultrasonic circuit and RF circuits, [0230], in light of the combination with the parameter switch of Shimizu in the rejection of claim 28 above).
Regarding claims 41-47, Shelton in view of Shimizu teaches the limitations of the claims under the same citations and rationale as relied upon in the rejection of claims 28, 32-37 and 39 above.
Claims 29-31 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Shimizu and in further view of Lesko et al. (US 2017/0164973).
Regarding claim 29-31, Shelton in view of Shimizu teaches the limitations of claim 28, however Shelton in view of Shimizu fails to specifically teach wherein the plurality of energy delivery algorithms comprises a sequential energy delivery algorithm comprising instructions executable to automatically cause the ultrasonic energy circuit and the RF energy circuit to sequentially generate the ultrasonic energy signal and the RF energy signal, a combined energy delivery algorithm comprising instructions executable to automatically cause the ultrasonic energy circuit and the RF energy circuit to concurrently generate the ultrasonic energy signal and the RF energy signal, or a duty cycle energy delivery algorithm comprising instructions executable to automatically cause the ultrasonic energy circuit and the RF energy circuit to cycle between generating the ultrasonic energy signal and the RF energy signal.
Lesko teaches a surgical instrument (see Fig. 1) configured for providing both RF and ultrasonic energy modes, the surgical instrument comprising a button (see button 126, Fig. 1) that may be may be activated to apply ultrasonic energy to tissue at a high power level (e.g., without also applying RF electrosurgical energy to tissue, applying RF electrosurgical energy to tissue simultaneously, or applying RF electrosurgical energy to tissue in a sequence with the ultrasonic energy) (see [0092]), wherein the mode comprising application of ultrasonic energy at a high power level and RF electrosurgical energy simultaneously which inherently requires a duty cycle for each of the energies to be set as a input parameter in [0092]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the plurality of energy modes for selection as taught by Shelton in view of Shimizu to include a sequential energy delivery algorithm comprising instructions executable to automatically cause the ultrasonic energy circuit and the RF energy circuit to sequentially generate the ultrasonic energy signal and the RF energy signal, a combined energy delivery algorithm comprising instructions executable to automatically cause the ultrasonic energy circuit and the RF energy circuit to concurrently generate the ultrasonic energy signal and the RF energy signal, and a duty cycle energy delivery algorithm comprising instructions executable to automatically cause the ultrasonic energy circuit and the RF energy circuit to cycle between generating the ultrasonic energy signal and the RF energy signal in light of Lesko, the motivation being to provide the advantage of providing the operator with varied control of the energy that is applied to the tissue through the end effector to accomplish the needed surgical functionality to effectively accomplish the desired treatment of tissue (see Lesko [0092]).
Regarding claim 40, Shelton in view of Shimizu and Lesko teaches the limitations of the claim under the same citations and rationale as that relied upon in the rejection of claims 29-31 above.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Shimizu and in further view of Wham et al. (US 2010/0191233).
Regarding claim 38, Shelton in view of Shimizu teaches the limitations of claim 28, however Shelton in view of Shimizu fails to teach wherein the control circuit is configured to download the plurality of energy delivery algorithms from a remote device.
Wham teaches an electrosurgical control system (see Fig. 3) wherein the control system that remotely configures the respective modules of the control system based on user input (see downloading/upgrading of the configuration files in [0120], [0143], [0145], [0156]-[0158]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surgical instrument as taught by Shelton in view of Shimizu such that the input parameter for each energy modes of the control circuit are remotely configured through a downloaded software update in light of Wham, the motivation being to provide the additional advantage of enabling the generator system to have a high degree of flexibility for performing a wide variety of different types of control for controlling the output of electrosurgical energy for use in a wide variety of types of procedures which may be performed under a wide variety of circumstances (see Wham [0158]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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