DETAILED ACTION
Applicant's amendments and remarks, filed 5/20/25, are fully acknowledged by the Examiner. Currently, claims 1-2, 5-9, 11-17, 20-25 are pending with claims 3-4, 10, and 18-19 canceled, claims 21-25 added, and claims 1-2, 5-6, 8-9, 11-13, 16-17, and 20 amended. The following is a complete response to the 5/20/25 communication.
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 Objections
Claims 10 and 18-19 are objected to because of the following informalities: A claim being canceled must be indicated as "canceled;" the text of the claim must not be presented. See MPEP 714.II(C). Appropriate correction is required.
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 8are 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 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: after “based on the cause of the error condition,
Claim 20 is dependent on canceled claim 19.
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(s) 1-2, 8, 13-14, 16-17, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak (US 2013/0197503) in view of Yates (US 5,810,811).
Regarding claim 1, Orszulak teaches a method of sealing tissue, comprising: performing an interrogation procedure by conducting a first energy between first and second jaw members of an electrosurgical instrument in an electrosurgical system, the first and second jaw member grasping tissue for treatment (jaws 110 and 120 of end effector 100 of electrosurgical forceps 12, with electrosurgical energy through first and second electrodes 112 and 122 of the first and second jaws, and detecting as in par. [0072]); sensing, during the interrogation procedure, at least one electrical parameter of the electrosurgical system (par. [0076] using impedance to determine error);
Detecting, based on the at least one electrical parameter, an error condition corresponding to a state of the electrosurgical system that prevent completion of a tissue treatment procedure comprising conducting electrosurgical energy between the first and second jaw members (detecting an error as in par. [0071]);
determining, based on one or more additional sensed parameters (par. [0076] and Fig. 10 RF voltage), a cause of the error condition (par. [0076] RF voltage calculated to determine difference in sourced energy and delivered energy). Orszulak is silent regarding outputting an alarm indicating the presence of the error condition and the cause of the error condition.
However, Yates teaches a forceps device with indicating an error condition and outputting an alarm indicating the error and the cause of the error (Fig. 10, col. 9 lines 31-50 audible sound with tone varying depending on impedance, and error indication when impedance is below or above a range).
It would have been obvious to one of ordinary skill in the art to modify Orszulak with the alarm indicating the error and cause of the error, as taught by Yates. This would allow for informing the user of treatment issues.
Regarding claim 2, Orszulak teaches wherein the additional sensed parameters comprises at least electrical feedback data from the electrosurgical energy (RF voltage as in par. [0076)).
Regarding claim 8, Orszulak teaches the method further comprising, based on the cause of the error, whether the error is recoverable (correct delivered RF energy as in par. [0076]).
Regarding claim 13, Orszulak teaches an electrosurgical system, comprising: an end effector assembly including first and second jaw members (110 and 120), at least one of the first or second jaw members movable relative to the other from a spaced-apart position to an approximated position for grasping tissue therebetween (110 and 120 to open and close to grasp tissue between); and an electrosurgical generator configured to supply electrosurgical energy to the first and second jaw members for conduction therebetween and through grasped tissue to treat the grasped tissue (generator 200 to supply energy to the forceps), the electrosurgical generator including a processor (controller 224) and memory (par. [0041]) storing instructions that, when executed by the processor, cause the processor to:perform an interrogation procedure by conducting a first energy between the first and second jaw members (par. [0062]);sense, during the interrogation procedure, at least one electrical parameter of the electrosurgical system (sensing impedance as in par. [0076]);detect, based on the at least one electrical parameter, and error condition corresponding to a state of the electrosurgical system that prevents completion of a tissue treatment procedure comprising conducting electrosurgical energy between the first and second jaw members (par. [0076]);
determine, based on one or more additional sensed parameters, a cause of the error condition (Fig. 10 and par. [0076] RF voltage calculated to determine difference in sourced energy and delivered energy).
Orszulak is silent regarding outputting an alarm indicating the presence of the error condition and the cause of the error condition.
However, Yates teaches a forceps device with indicating an error and outputting an alarm indicating the error and the cause of the error (Fig. 10, col. 9 lines 31-50 audible sound with tone varying depending on impedance, and error indication when impedance is below or above a range).
It would have been obvious to one of ordinary skill in the art to modify Orszulak with the alarm indicating the error condition and cause of the error condition, as taught by Yates. This would allow for informing the user of treatment issues.
Regarding claim 14, Orszulak teaches wherein the end effector assembly is disposed at a distal end of a handheld surgical instrument (end effector 100 at end of forceps as in par. [0034] and Fig. 3).
Regarding claim 16, Orszulak teaches wherein the one or more additional sensed parameters includes electrical feedback data from the electrosurgical energy (par. [0076] RF voltage).
Regarding claim 17, Orszulak teaches further comprising a sensor associated with the end effector assembly and outputting the one or more additional sensed parameters (par. [0076] sensor 229 sensing RF voltage).
Regarding claim 21, Orszulak teaches wherein the processor is further caused to:
determine, based on the cause of the error condition, that the error condition is recoverable (correct delivered RF energy as in par. [0076]); and
enable electrosurgical energy to be subsequently supplied from the electrosurgical generator to the end effector assembly (step 408).
Regarding claim 22, Orzulak teaches wherein the processor is further caused to:
output an indication that the error condition is recoverable (step 400 as in par. [0076]); and
output one or more instructions for recovering the electrosurgical system from the error condition (correct delivered RF energy as in par. [0076]).
Regarding claim 23, Orszulak is not explicit wherein the processor is further caused to:
determine, based on the cause of the error condition, that the error condition is not recoverable; and
inhibit the supply of the electrosurgical energy from the electrosurgical generator to the end effector assembly.However, Yates teaches controlling the generator to turn off the energy at a given impedance threshold (col. 9, lines 32-51).It would have been obvious to one of ordinary skill in the art to modify Orszulak with ending energy delivery as in Yates, to stop treatment in an unacceptable impedance range.
Regarding claim 24, Orszulak teaches wherein the error condition comprises at least one of: a short circuit, an open circuit, a sensed impedance outside of a specified range, a sensed voltage outside of a specified range, or a sensed power outside of a specified range (Fig. 10, par. [0077] differences in energy as power, voltage, impedance).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak in view of Yates, in further view of Behnke (US 9,192,424).
Regarding claim 5, Orszulak is not explicit wherein determining the cause of the error condition includes selecting the cause of the error condition from a debug list based upon the one or more additional sensed parameters.
However, Behnke teaches using a lookup table to generate an error signal based on an impedance (Fig. 5 and col. 9, line 50 to col. 10, line 7; lookup table for error signal corresponding to impedance).
It would have been obvious to one of ordinary skill in the art to modify Orszulak with the selecting the cause of the error from a debug list as in Behnke, allowing for determining the error that is affecting the treatment.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak in view of Yates, in further view of Behnke, in further view of Wolf (US 10,729,502).
Regarding claim 6, Orszulak is silent wherein selecting the cause of the error condition is performed by a machine learning program.
However, Wolf teaches machine learning to determine an error (col. 205, lines 20-37).
It would have been obvious to one of ordinary skill in the art to modify Orszulak with the machine learning of Wolf, allowing for the program to determine the correct error.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak in view of Yates, in further view of Krapohl (US 2013/0053840).
Regarding claim 7, Orszulak is not explicit wherein the debug list includes: a tissue grasping error, a field error, and an instrument error.
However, Krapohl teaches tissue grasping error (par. [0021] sufficient tissue contact), instrument and field errors (malfunctioning components as in par. [0036], and errors in sensors in the target area).
It would have been obvious to one of ordinary skill in the art to modify the combination such that the errors include the errors as in Krapohl, as known errors that affect treatment for a forceps device.
Regarding claim 9, Orszulak teaches the method further comprising: in a case where the error condition is determined to be recoverable, enabling electrosurgical energy to be subsequently conducted between the first and second jaw members (par. [0076] RF energy/tissue impedance corrected); but is not explicit in a case where the error condition is determined not to be recoverable, inhibiting the supply of electrosurgical energy to the first and second jaw members.
However, Krapohl teaches energy within a limit corrected, and energy outside a limit resulting in stopping supply of energy (Fig. 4 and par. [0037]).
It would have been obvious to one of ordinary skill in the art to modify Orszulak with the error resulting in either correction or energy termination as in Krapohl, to be able to either correct energy delivery, or ending treatment if an error cannot be corrected.
Claim(s) 11-12 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak in view of Yates, in further view of Yates II (US 2016/0058492).
Regarding claim 11, Orszulak is silent wherein the interrogation signal includes at least one pulse.
However, Yates II teaches interrogatory pulse to sense impedance of tissue between the jaws (par. [0144] sensing signal as a pulse).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Orszulak with measuring impedance with the interrogatory pulses of Yates II, as a method of detecting impedance in forceps devices.
Regarding claim 12, Orszulak is silent wherein the interrogation signal is a constant power signal. Yates Il teaches wherein the interrogation signal is a constant-power signal (par. [0144] voltage held constant).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Orszulak with measuring impedance with the interrogatory signals of Yates Il, as a method of detecting impedance in forceps devices.
Regarding claim 20, Orszulak is not explicit wherein the interrogation signal comprises at least one of a pulse signal or a constant-power signal.
However, Yates II teaches interrogatory pulse to sense impedance of tissue between the jaws (par. [0144] sensing signal as a pulse).
It would have been obvious to one of ordinary skill in the art at the time of invention to modify Orszulak with measuring impedance with the interrogatory pulses of Yates II, as a method of detecting impedance in forceps devices.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak in view of Yates, in further view of Tenney (US 2012/0158019).
Regarding claim 15, Orszulak is not explicit wherein the end effector assembly is coupled to a robotic surgical system.
However, Tenney teaches surgical forceps coupled to a robotic system (par. [0028] forceps and electrosurgical tools mounted to a robotic system).
It would have been obvious to one of ordinary skill in the art to modify Orszulak such that the forceps is coupled to a robotic structure as taught by Tenney, allowing for automated actuation of the device.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orszulak in view of Yates, in further view of Wham (US 2007/0173804).
Regarding claim 25, Orszulak is not explicit wherein the state of the electrosurgical system that prevents completion of the tissue treatment procedure comprises at least one of: excess moisture at the end effector assembly, material buildup on the end effector assembly, tissue insufficiently grasped by the end effector assembly, or foreign body interference.However, Wham teaches a similar device, with excessive fluid causing impedance changes as an error as in par. [0061].It would have been obvious to one of ordinary skill in the art that excess moisture at the end effector would be one of the causes of impedance changes resulting in an error.
Response to Arguments
Applicant's arguments filed 5/20/25 have been fully considered but they are not persuasive. Applicant argues that the prior art does not teach detecting an error condition that prevents completion of a tissue treatment procedure. However, Orszulak teaches performing an interrogation procedure (the measuring as in par. [0072]), detecting an error (par. [0076]), and determining a cause of the error (error due to differences in sourced and delivered energy).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794