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 amendment filed 10/10/2025 has been entered. Claims 1-2, 4-11, and 13-17 remain pending in the application, claims 3 and 12 are cancelled, and claim 18 is added. Applicant’s arguments to the claims have overcome the claim objections, the 112(b) rejections, and the interpretation of the rejection with respect to the trigger as claimed in claim 1 previously set forth in the Non-Final Office Action mailed 05/12/2025, however another rejection of Kapadia in view of Inoue is applied as outlined below.
Response to Arguments
Applicant’s arguments on pages 8-9 (Section A) and pages 10-11 (Section D) with respect to claims have been considered but are moot because the new ground of rejection does not rely on the previous interpretation of the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Arguments directed to the claims as amended are addressed in the body of the rejection below.
Applicant’s arguments on pages 9-10 with respect to sections B and C is not persuasive as Applicant argues the sensor of Kapadia is not arranged to transmit a signal that is representative for a force exerted on the at least one working element by tissue in contact with the at least one working element, and thus there is no force transfer from the working element to the sensor via the actuation rod. The Office respectfully disagrees. Paragraph 7 of Kapadia discloses “It would also be desirable to monitor these connector members for establishing force feedback from the end effector. In this regard, a clinician would be able to advantageously determine, for example, grasping forces of the end effector to improve precision and limit errors.” Paragraph 46 discloses “One or more connector members 26 are coupled to instrument tab 22 that extend along a shaft assembly 21 of surgical instrument 20 to end effector 100 thereof for effectuating movement of end effector 100 and/or portions thereof in response to movement of the one or more connector members 26… Additionally, and/or alternatively, connector members 26 can be moved for imparting forces to end effector 100, for example, to fire end effector (e.g., staples, clips, etc.).” Therefore, the rejection is maintained.
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 1, 5-11, 13-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kapadia et al. (US PGPub 2018/0064498) in view of Inoue et al. (US PGPub 2014/0228862), hereinafter known as “Kapadia” and “Inoue,” respectively.
With regards to claim 1, Kapadia discloses (Figures 1-3) a surgical instrument (figure 1B) comprising:
a distal part 20, wherein the distal part 20 comprises an elongated shaft 21, at least one working element 120 and an actuation rod 22 (paragraph 46), wherein the at least one working element 120 is movably mounted (paragraph 52 – movably mounted via the wrist assembly 110 that couples the jaw assembly 120 to the robot arm) on a distal end of the shaft 21 and wherein a first end of the actuation rod 22 is connected to the at least one working element 120 (via connector members 26), wherein the distal part 20 is free of electrical components (figure 1B – distal part 20 does not include the sensors or any electrical components),
a proximal part 5/9/14 (figures 1A-1B; paragraphs 38 and 56 - the operating console 5 is coupled with the controller 4, which is further coupled by electric drives to the robot arms 2, 3 which is coupled to the attachment device 9 and drive unit 14), wherein the proximal part 5/9/14 is connected to the distal part 20 (see coupling as disclosed paragraphs 44 and 46 – drive tab 18 is threadably coupled to drive member 17 which is part of the drive unit 14, drive tab 18 and instrument tab 22 is seen in figure 1B as the connection between the proximal part 9/14 and the distal part 20) and wherein the proximal part 9/14 comprises an actuator device 16 wherein the actuator device 16 comprises an actuation rod connector 17/18 directly connected to a second end of the actuation rod 22 (paragraphs 47 and 55 – drive tab 18 is directly connected to instrument tab 22 when it is powered by the motor 16 to push against and engage the instrument tab 22), wherein the actuator device 16 is configured to move the at least one working element 120 with respect to the shaft 21 by movement of the actuation rod 22 (paragraphs 47 and 54-55 - “motor 16 may be adjusted to move drive member 17 and drive tab 18 so that drive tab 18 pushes against and moves a corresponding instrument tab 22 of surgical instrument 20 in the same z-direction to move a component of surgical instrument 20 such as end effector 100 via connector member 26”), and
a sensor 19a arranged to transmit a signal that is representative for a force exerted on the at least one working element 120 by tissue in contact with the at least one working element 120 (paragraphs 7, 45 and 48-50),
wherein the sensor 19a is arranged on the actuation rod connector 18 to reduce friction in force transfer from the at least one working element 120 to the sensor 19a, which force transfer is via the actuation rod 22 (functional limitation – sensor 19a is arranged proximal to the at least one working element 120 and therefore does not directly interact with the at least one working element 120; paragraph 7 – “It would also be desirable to monitor these connector members for establishing force feedback from the end effector. In this regard, a clinician would be able to advantageously determine, for example, grasping forces of the end effector to improve precision and limit errors”; paragraph 46 – “One or more connector members 26 are coupled to instrument tab 22 that extend along a shaft assembly 21 of surgical instrument 20 to end effector 100 thereof for effectuating movement of end effector 100 and/or portions thereof in response to movement of the one or more connector members 26… Additionally, and/or alternatively, connector members 26 can be moved for imparting forces to end effector 100, for example, to fire end effector (e.g., staples, clips, etc.)”).
Kapadia is silent wherein the proximal part is releasably connected to the distal part, wherein the actuation rod connector is releasably connected to a second end of the actuation rod, and wherein the actuator device comprises a trigger mechanically connected to the actuation rod connector to mechanically transfer an actuation movement of a user to the actuation rod connector of the actuation device.
However, in a similar field of endeavor of surgical instruments, Inoue teaches (Figure 9) wherein the proximal part 9 is releasably connected to the distal part 2 (paragraph 54), wherein the actuation rod connector 11 is releasably connected to a second end 6a of the actuation rod 6 (paragraph 54), and wherein the actuator device comprises a trigger 32 mechanically connected to the actuation rod connector 11 to mechanically transfer an actuation movement of a user to the actuation rod connector 11 of the actuation device (paragraphs 54, 109 and 150).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal part of Kapadia to be releasably connected to the distal part as taught by Inoue for the purpose of cleansing and sterilizing the distal part while it is detached from the proximal part.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the instrument of Kapadia to include wherein the actuator device comprises a trigger mechanically connected to the actuation rod connector to mechanically transfer an actuation movement of a user to the actuation rod connector of the actuation device as taught by Inoue for the purpose of gaining more control of the device when handling it manually (Inoue teaches both the robotic control in figure 1 and the manual control in figure 9).
With regards to claim 5, Kapadia further discloses wherein the sensor 19a is configured to measure mechanical strain in the actuation rod connector 18 of the actuator device 16 (paragraph 61; functional limitation – force sensor 19a may include a strain gauge load cell, and since the force sensor is measuring the output loads on the connector members, it is capable of measuring the mechanical strain on the actuation rod connector 18 by way of measuring the mechanical strain on the connector members that are coupled with the actuation rod connector 18).
With regards to claim 6, Kapadia further discloses wherein the mechanical strain in the actuation rod connector 18 of the actuator device 16 is representative for the force exerted on the at least one working element 120 (paragraphs 7 and 61; functional limitation – sensors monitor the force feedback and grasping forces on the end effector, therefore the mechanical strain in the actuation rod connector is capable of being representative of the forces on the end effector 120).
With regards to claim 7, Kapadia further discloses wherein the distal part 20 is sensor-free (figure 1B- sensors 19a and 19b are located on the proximal part).
With regards to claim 8, Kapadia further discloses wherein the surgical instrument comprises a processor 4, and wherein the processor 4 is configured to determine the force exerted on a working element 120 on the basis of the signal of the sensor 19a (paragraphs 45 and 61-63).
With regards to claim 9, Kapadia further discloses wherein a further sensor 19b is arranged in the proximal part 14 (figure 1B), wherein the further sensor 19b is a position sensor 19b and wherein the further sensor 19b is configured to transmit a signal that is representative for a position of the at least one working element 120 with respect to the elongated shaft 21 of the distal part 20 (paragraphs 45 and 61-63 – measures the position of the at least one working element 120 by way of measuring the position of the drive tab 18 which engages with the instrument tabs 22 that move the connectors 26 to actuate the working element 120).
With regards to claim 10, Kapadia further discloses wherein the surgical instrument comprises a housing (figure 1B - outer casing of the proximal part 14) and wherein the further sensor 19b is configured to measure the position of the actuator device 16 with respect to the housing (paragraph 45 – “further sensor 19b is configured to measure a position and/or movement of output of motor 16”).
With regards to claim 11, Kapadia further discloses wherein the surgical instrument comprises a processor 4, and wherein the processor 4 is configured to relate a force exerted on a working element 120 (signal from sensor 19b) to the position of the at least one working element 120 with respect to the elongated shaft 21 of the distal part 20 (paragraph 61).
With regards to claim 13, Kapadia further discloses wherein the actuator device 16 comprises an actuator 16, and wherein the actuator 16 is configured to move the actuation rod connector 17/18 of the actuator device 16 (paragraphs 43-45).
With regards to claim 14, Kapadia further discloses wherein a processor 4 is configured to control the actuator 16, dependent on the value of the force exerted on the at least one working element 120 and a value from the position of the at least one working element 120 with respect to the elongated shaft 21 of the distal part 20 (paragraphs 61-62).
With regards to claim 15, Kapadia further discloses wherein the at least one working element 120 is a forceps (paragraphs 4 and 52).
With regards to claim 16, Kapadia further discloses a method to determine the force exerted on the at least one working element 120 of a surgical instrument of claim 8 (see claim 8 above) comprising the steps of:
receiving by the processor 4 of the signal that is representative for the force exerted on the at least one working element 120 (paragraphs 60-62), and
determining by the processor 4 the force that is exerted on the at least one working element 120 on the basis of the signal (paragraphs 57 and 60-64).
With regards to claim 18, Kapadia further discloses wherein the step of determining by the processor 4 the force that is exerted on the at least one working element 120 on the basis of the signal comprises calculating the force that is exerted on the at least one working element 120 on the basis of the signal (paragraphs 57 and 60-64).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kapadia in view of Inoue, and further in view of Lohmeier (US PGPub 2015/0173840), hereinafter known as “Lohmeier.”
With regards to claim 4, Kapadia/Inoue disclose the surgical instrument as claimed in claim 1. Kapadia/Inoue are silent wherein the actuation rod connector comprises a thinned section, having a substantially smaller cross sectional area than a cross sectional area in the remainder of the connection element and wherein the sensor is arranged at the thinned section.
However, in a similar field of endeavor of surgical instruments, Lohmeier teaches (Figures 34-36) wherein the actuation rod connector 11 comprises a thinned section (narrower center or 11; see figure 34), having a substantially smaller cross sectional area than a cross sectional area in the remainder of the connection element 11 (see figure 34) and wherein the sensor 31 is arranged at the thinned section (see figure 34 and paragraph 266).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surgical instrument of Kapadia/Inoue to have the actuation rod connector comprise a thinned section having a substantially smaller cross sectional area than a cross sectional area in the remainder of the actuation rod connector such that the sensor is arranged at the thinned section as taught by Lohmeier for the purpose of further protecting the sensor by having it in a recess to prevent unwanted damage or interference with the sensor.
Claims 2 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kapadia in view Inoue, and further in view of Davies et al. (US PGPub 20130345598), hereinafter known as “Davies.”
With regards to claims 2 and 17, Kapadia/Inoue disclose the surgical instrument as claimed in claim 1. Kapadia/Inoue are silent regarding the sensor as an optical sensor; and the sensor is a Fibre Bragg Grating sensor.
However, being reasonably pertinent to the particular problem with which Applicant is concerned with, namely to provide an optical Fibre Bragg Grating sensor, Davies teaches a sensor that is an optical Fibre Bragg Grating sensor (paragraph 21).
Therefore, the substitution of one known sensor (pressure sensing Fibre Bragg Grating sensor as taught in Davies) for another (force sensor 19a as taught in Kapadia) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since Davies teaches that a Fibre Bragg Grating sensor is suitable for sensing pressure and the substitution of the Fibre Bragg Grating sensor as taught in Davies would have yielded predictable results, namely, a sensor of Kapadia that would sensor the force applied to the trigger and the working element. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
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 MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 12/19/2025
/SARAH A LONG/Primary Examiner, Art Unit 3771
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