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 .
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites “based” in line 6. This should be corrected to ---base---.
Claim 1 recites “the insertion force” and “the patient” in lines 8 and 12 respectively. These should be corrected to ---an insertion force--- and ---a patient---. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-9 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-19 of U.S. Patent No. US 11950865 B2. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant application 19/333501
US 11950865 B2
1. A surgical robot system for detecting the expected movement of a surgical instrument associated with the robot system, said robot system comprising:
a robot base; a robot arm connected to and in electronic communication with the robot base;
an end-effector connected to the robot arm and in electronic communication with the robot based, wherein the end-effector comprises a guide tube, and
wherein at least one strain gauge is positioned on a surgical instrument coupled to the end- effector, each strain gauge is configured to measure forces associated with the insertion force of the surgical instrument disposed in the guide tube, and
wherein the robot base is configured to receive the measured forces and indicate when the measured forces are outside of an expected range for the measured forces;
wherein the robot base is configured to monitor a bone movement of the patient caused by a force on the surgical instrument through a dynamic reference array attached to the patient; and
wherein the end effector is configured to automatically adjust the guide tube of the robot system to offset the bone movement based on the monitoring of the bone movement.
11. (Currently Amended) A surgical robot system for detecting the expected movement of a surgical instrument associated with the robot system, said robot system comprising:
a robot base; a robot arm connected to and in electronic communication with the robot base;
an end-effector connected to the robot arm and in electronic communication with the robot based, wherein the end-effector comprises a guide tube, and
wherein at least one strain gauge is positioned on a surgical instrument coupled to the end- effector, each strain gauge is configured to measure forces associated with the insertion force of the surgical instrument disposed in the guide tube, and
wherein the robot base is configured to receive the measured forces and indicate when the measured forces are outside of an expected range for the measured forces and moments;
wherein the robot base is configured to monitor a bone movement of the patient caused by a lateral force of the surgical instrument through a dynamic reference array attached to the patient; and
wherein the robot base is configured to automatically adjust the guide tube of the robot system to offset the bone movement based on the monitoring of the bone movement.
2.The system of claim 1, wherein the robot system is configured to provide a notification on a display associated with the robot system indicating skiving forces applied on the surgical instrument
12. The system of claim I 1, wherein the robot system is configured to provide a notification on a display associated with the robot system indicating skiving forces applied on the surgical instrument.
3. The system of claim 2, wherein the skiving force is a lateral force applied to the surgical instrument.
13. The system of claim 12, wherein the skiving force is a lateral force applied to the surgical instrument.
4. The system of claim 3, wherein the surgical instrument includes a tapered tip for cutting into bone.
14. The system of claim 13, wherein the surgical instrument includes a tapered tip for cutting into bone.
5. The system of claim 4, wherein each strain gauge is configured to monitor a deflection of the tip of the surgical instrument.
15. The system of claim 14, wherein each strain gauge is configured to monitor a deflection of the tip of the surgical instrument.
6. The system of claim 1, wherein the robot is configured to use a neural network for calculating the deflection of the surgical instrument.
16. The system of claim 11, wherein the robot is configured to use a neural network for calculating the deflection of the surgical instrument.
7. The system of claim 1, wherein the notification indicates that the surgical instrument has reached a maximum depth based on the position of the surgical instrument inside the patient.
17. The system of claim 11, wherein the notification indicates that the surgical instrument has reached a maximum depth based on the position of the surgical instrument inside the patient.
8. The system of claim 1, wherein the one or more forces are measured in at least one of an x, y, or z direction relative to the robot system.
18. The system of claim 11, wherein the one or more forces are measured in at least one of an x, y, or z direction relative to the robot system.
9. The system of claim 1, wherein the surgical instrument is one of a drill, an awl, a tap, and a screwdriver.
19. The system of claim 11, wherein the surgical instrument is one of a drill, an awl, a tap, and a screwdriver.
The difference is underlined in the table above. The instant claim recites end effector is adjusting guide tube. However, in claim 11 of US 11950865 B2, the robot base is connected to end effector and hence the movement of guide tube by the robot base will be via the end effector. i.e. the end effector is configured (by the robot base) to adjust the guide tube. (Note, this interpretation is also consistent with disclosure related to applicant Figs 6, 8, as to adjusting the guide tube by the robot base via the end effector). The instant claim is anticipated by the reference patent.
Claims 1-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-17 of U.S. Patent No. US 10874466 B2 in view of Haller [US 20100114288 A1]. The claims of the instant application and the claims of the reference patent are compared in the table below.
Instant application 19/333501
US 10874466 B2
1. A surgical robot system for detecting the expected movement of a surgical instrument associated with the robot system, said robot system comprising:
a robot base; a robot arm connected to and in electronic communication with the robot base;
an end-effector connected to the robot arm and in electronic communication with the robot based, wherein the end-effector comprises a guide tube, and
wherein at least one strain gauge is positioned on a surgical instrument coupled to the end- effector, each strain gauge is configured to measure forces associated with the insertion force of the surgical instrument disposed in the guide tube, and
wherein the robot base is configured to receive the measured forces and indicate when the measured forces are outside of an expected range for the measured forces;
wherein the robot base is configured to monitor a bone movement of the patient caused by a force on the surgical instrument through a dynamic reference array attached to the patient; and
wherein the end effector is configured to automatically adjust the guide tube of the robot system to offset the bone movement based on the monitoring of the bone movement.
11. (Currently Amended) A surgical robot system for detecting the expected movement of a surgical instrument associated with the robot system, said robot system comprising:
a robot base; a robot arm connected to and in electronic communication with the robot base;
an end-effector adapted to connect to the robot arm and be in electronic communication with the robot base, wherein the end-effector includes a guide tube, and
wherein one or more sensors are positioned on a surgical instrument coupled to the end- effector, the one or more sensors are configured to measure forces associated with the insertion force of the surgical instrument disposed in the guide tube relative to the robot arm, wherein the robot base is configured to receive the measured forces and indicate when the measured forces are outside of an expected range for the measured forces,
wherein the robot base is configured to monitor a bone movement of the patient caused by a lateral force of the surgical instrument through a dynamic reference array attached to the patient; and
wherein the robot base is configured to automatically adjust the guide tube by the arm to offset the bone movement based on the monitoring of the bone movement.
2.The system of claim 1, wherein the robot system is configured to provide a notification on a display associated with the robot system indicating skiving forces applied on the surgical instrument
12. The system of claim I 1, wherein the robot system is configured to provide a notification on a display associated with the robot system indicating skiving forces applied on the surgical instrument.
3. The system of claim 2, wherein the skiving force is a lateral force applied to the surgical instrument.
13. The system of claim 12, wherein the skiving force is a lateral force applied to the surgical instrument.
4. The system of claim 3, wherein the surgical instrument includes a tapered tip for cutting into bone.
14. The system of claim 13, wherein the surgical instrument includes a tapered tip for cutting into bone.
5. The system of claim 4, wherein each strain gauge is configured to monitor a deflection of the tip of the surgical instrument.
15. The system of claim 11, wherein the one or more sensors are positioned on the surgical instrument and the sensors monitor a deflection of the tip of the surgical instrument.
6. The system of claim 1, wherein the robot is configured to use a neural network for calculating the deflection of the surgical instrument.
16. The system of claim 11, wherein the robot is configured to use a neural network for calculating the deflection of the surgical instrument.
7. The system of claim 1, wherein the notification indicates that the surgical instrument has reached a maximum depth based on the position of the surgical instrument inside the patient.
17. (Original) The system of claim 11, wherein the notification indicates that the surgical instrument has reached a maximum depth based on the position of the surgical instrument inside the patient.
The differences are underlined in the table above.
The first difference is that instant claim recites end effector is adjusting guide tube. However, in claim 11 of US 10874466 B2, the robot base is connected to end effector and hence the movement of guide tube by the robot base will be via the end effector. i.e. the end effector is configured (by the robot base) to adjust the guide tube. (Note, this interpretation is also consistent with disclosure related to applicant Figs 6, 8, as to adjusting the guide tube by the robot base via the end effector). The instant claim is anticipated by the reference patent.
Secondly, in US 10874466 B2 the monitored forces are measured by a sensor instead of least one strain gauge. Haller in a related field of implants teaches a strain gauge (Haller ¶0052 "system may incorporate micro electromechanical systems (MEMS), nano-load cell bridges, strain gauges, or other technologies used to measure sub-micronewton forces"). Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to incorporate strain gauge for force measurement. This is only directed to combining prior art elements according to known methods to yield predictable results, as in MPEP 2143. I .A. The predictable result in this case is identifying insertion forces using known techniques so that force data is available for display or as inputs to the automated insertion algorithm.
Allowable subject matter
As per claim 1, Haller is considered closest to the claimed invention. Haller discloses a surgical robot system for detecting the expected movement of a surgical instrument associated with the robot system, said robot system comprising: a robot base; a robot arm connected to and in electronic communication with the robot base (Haller Fig 6); an end-effector connected to the robot arm and in electronic communication with the robot based (Haller Fig 6, ¶0047 item 660, “insertion head” corresponds to an end-effector), applying an insertion force to a surgical instrument to drive the instrument (Haller Fig 9 step 930 inherently requires force applied to surgical instrument) into a bone of a patient (Haller ¶0049 “drill directly from the skull surface to the cochleostomy”); monitoring one or more forces associated with the insertion force (Haller ¶0046 “”an insertion tool is used to insert the electrode while monitoring the applied forces.”), wherein the monitored forces are measured by at least one strain gauge positioned on the surgical instrument (Haller ¶0052 “The insertion tool (600) is equipped with force sensors that measure the insertion force…The sensors may be based … Further, the present system may incorporate micro electromechanical systems (MEMS), nano-load cell bridges, strain gauges, or other technologies used to measure sub-micronewton forces”); comparing the monitored forces to an expected range or (Haller Fig 9 step 940, here the operating parameters correspond to the claimed threshold values); providing a notification, via the robot system, upon detecting that the monitored forces fall outside of the expected range (Haller Fig 9 step 940, indication to take corrective action at step 960. If not surgeon is alerted. These are notifications). Shoham [US 20080221581 A1] further teaches Shoham teaches the surgical instrument is inserted through a guide tube (Shoham Fig 2, item 20, ¶0010 “a cylindrical guide tube having an inner bore down which a surgical tool may be inserted,”). Combination of Haller and Shoham does not expressly teach monitoring a bone movement of the patient caused by a force on the surgical instrument through a dynamic reference array attached to the patient; and automatically adjusting the guide tube of the robot system to offset the bone movement based on the monitoring of the bone movement as recited in the claim 1. Examiner does not find any references of record individually or in combination curing deficiencies as noted. The claims are not objected as allowable in view of pending double patenting rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797
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