Patent Application 15776839 - SURGICAL INSTRUMENT

Title: SURGICAL INSTRUMENT
Application Information

Invention Title: SURGICAL INSTRUMENT
Application Number: 15776839
Submission Date: 2025-05-12T00:00:00.000Z
Effective Filing Date: 2018-05-17T00:00:00.000Z
Filing Date: 2018-05-17T00:00:00.000Z
National Class: 606
National Sub-Class: 205000
Examiner Employee Number: 94745
Art Unit: 3771
Tech Center: 3700
Rejection Summary

102 Rejections: 0
103 Rejections: 3
Cited Patents

The following patents were cited in the rejection:
Office Action Text



    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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.  Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on 04/07/2025 has been entered.
Response to Amendment
	The amendment filed 04/07/2025 has been entered. Claims 1-2, 4-11, and 13-17 remain pending in the application, and claims 3 and 12 are cancelled. Applicant’s arguments to the claims have overcome the interpretation of the rejection with respect to the trigger as claimed in claim 1 previously set forth in the Final Office Action mailed 11/07/2024, however an alternate interpretation of the proximal part is applied as outlined below.
Response to Arguments
Applicant's arguments filed 04/07/2025 have been fully considered and are persuasive with respect to claim 1, however a different interpretation of the proximal part is applied in view of Kapadia. Applicant argues on pages 8-9 in section A that the triggers 7, 8 of Kapadia are arranged at a distance from the attachment device 9 and drive unit 14, and therefore not part of the proximal part. The proximal part is now interpreted as the combination of 9/14 and the operating console 5. The operating console 5 is coupled with the controller 4, which is further coupled by electric drives to the robot arms 2, 3 (paragraphs 38 and 56). Therefore, the rejection is maintained.
Applicant’s arguments on page 9 with respect to section B is not persuasive as Applicant argues there is no direct mechanical connection between the trigger and the actuation rod connector as claimed in claim 1. The Office respectfully disagrees on the grounds that the claims do not require a direct mechanical transfer. The claims state “a trigger to mechanically transfer an actuation movement of a user to the actuation rod connector” in which paragraphs 38 and 56 disclose the trigger’s actuation to mechanically move the actuation rod connector 17/18 (paragraphs 47-48). Therefore, the rejection is maintained.
Applicant’s arguments on page 9 with respect to section C is not persuasive as Applicant argues the releasable connection between the distal part and the proximal part defined by the threadable connection between the drive member 17 and the drive tab 18 would result in the drive tab 18 being part of the distal part, and not the proximal part. Additionally, since the sensor 19a is mounted on the drive tab 18, the sensor would not be provided within the proximal part but instead the distal part, thereby making the distal part not free of electrical components. The Office respectfully disagrees. The drive tab 18 is part of the proximal part 14 as seen in figure 1B where the drive tab 18 is attached to the drive member 17. The drive tab 18 is not seen to be within the distal part which is identified as element 20, but instead the instrument tabs 22 are part of the distal part 20 which are connected to the drive tabs 18. Even if the releasable connection removes drive tab 18 from the proximal part, the drive tab 18 is not within the distal part 20. However, when coupled as seen in figure 1B, the actuation rod connector 18 is within the proximal part, and the sensor 19a is not within the distal part 20 as the sensor 19a and the drive tab 18 are not located within the distal part 20. Therefore, the rejection is maintained.
Applicant’s arguments on page 10 with respect to section D is not persuasive as Applicant argues that a cable as taught by Suzuki is not the same as an actuation rod as disclosed by Kapadia. The Office respectfully disagrees. It is unclear why the Applicant is referring to the cable to be similar to an actuation rod. The actuation rod 114 is disclosed to be part of the distal part, which functions as a transmission unit that transmits drive force generated by the drive mechanism 120 (paragraph 35 of Suzuki). This is similar to the function of the actuation rod 22 of Kapadia that functions to transmit drive force generated by the motor 16 (paragraphs 47-48 of Kapadia). Therefore, the rejection is maintained.
Claim Objections
Claim 4 is objected to because of the following informalities: 
Claim 4 line 3 “the cross sectional area” is suggested to read “a cross sectional area” for better antecedent basis.
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 9-11 and 16 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 9 recites in lines 1-2 “a position sensor is arranged in the proximal part” and is unclear if this is the same sensor as recited in claim 1, or if this is another sensor. For the purposes of examination, the Office will interpret the sensor in claim 1 to be “a first sensor” and the position sensor in claim 9 to be “a second position sensor.” Claims 10-11 are rejected due to their dependency on claim 9.
Claim 16 recites in line 5 “determining by the processor, optionally by calculating, the force that is exerted” and is unclear if the processor is needed or not, or if the processor is to use calculation or not. For the purposes of examination, the Office will interpret the claim to not require calculation.
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, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kapadia et al. (US PGPub 2018/0064498) in view of Suzuki et al. (US PGPub 2018/0206930), hereinafter known as “Kapadia” and “Suzuki,” 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 releasably 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 actuator device 16 comprises a trigger 7/8 to mechanically transfer an actuation movement of a user to the actuation rod connector 17/18 of the actuator device 16 (figure 1A; paragraphs 38 and 56), and
wherein the sensor 19a is arranged on the actuation rod connector 18 to reduce friction in force transfer between the at least one working element 120 and the sensor 19a (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).
Kapadia is silent wherein the actuation rod connector is releasably connected to a second end of the actuation rod.
However, in a similar field of endeavor of surgical instruments, Suzuki teaches (Figures 3-4) wherein the actuation rod connector 121 is releasably connected to a second end 114a of the actuation rod 114 (figure 4; paragraph 39).
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 actuation rod connector of Kapadia to also be releasably connected to the second end of the actuation rod as taught by Suzuki for the purpose of cleansing and sterilizing the distal part while it is detached from the proximal part (paragraph 37 of Suzuki).
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 position sensor 19b is arranged in the proximal part 14 (figure 1B) and wherein the position 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 position sensor 19b is configured to measure the position of the actuator device 16 with respect to the housing (paragraph 45 – “position 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, optionally by calculating (see 112(b) rejection above), the force that is exerted on the at least one working element 120 on the basis of the signal (paragraphs 60-62).
	Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kapadia in view of Suzuki, and further in view of Lohmeier (US PGPub 2015/0173840), hereinafter known as “Lohmeier.”
	With regards to claim 4, Kapadia/Suzuki disclose the surgical instrument as claimed in claim 1. Kapadia/Suzuki are silent wherein the actuation rod connector comprises a thinned section, having a substantially smaller cross sectional area than the 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 the 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/Suzuki to have the actuation rod connector comprise a thinned section having a substantially smaller cross sectional area than the 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 Suzuki, and further in view of Davies et al. (US PGPub 20130345598), hereinafter known as “Davies.”
	With regards to claims 2 and 17, Kapadia/Suzuki disclose the surgical instrument as claimed in claim 1. Kapadia/Suzuki 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
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                                                                                                                                                                                                        05/09/2025