DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-30 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/4/2026 has been entered.
Response to Arguments
Applicant argues that the invention taught by Morel et al. (US 20180028269 A1, 2018-02-01) (hereinafter “Morel”) can be distinguished from the instant invention because “Morel teaches switching from one control mode (where the system applies a first impedance) to another control mode (where the system applies another impedance) based on the state of the surgical instrument coupled to the robot arm.” See Remarks at 10 (emphasis in original). By contrast, according to Applicant, “[t]he claimed invention is directed to an operational mode where the system monitors the type of surgical instrument coupled to the robot arm and the current phase of the surgical procedure and automatically switches modes based on switching to a new surgical phase where a different impedance would be beneficial for the user.” Id. Applicant elaborates:
For example, if the system determines that the surgical instrument is a grasper, a first impedance is applied during grasping, but when the grasper is used for suturing in the suturing phase, the system applies a different impedance that is sufficient to provide more viscous control to the user during operation of the suture device, as described at para. [0279] of the instant application. Thus, upon receiving information that the system enters a second phase of the surgical procedure (e.g., the suturing phase) and knowing that the attached instrument is used in suturing, the system automatically applies a second impedance (different from the first impedance) to the robot arm to increase the level of viscosity felt by the user as the user moves the suturing device to thereby advantageously guide the user in performing a second surgical task ( e.g., suturing) during the suturing phase of the surgical
procedure. Thus, it was Applicant's insight that applying a different impedance to the robot arm and, accordingly, the surgical instrument coupled thereto automatically upon entering a different predetermined phase of the surgical procedure would provide significant benefits.
Id. at 10-11.
Applicant’s argument has been fully considered but it is not persuasive.
Implicit in Applicant’s argument are the following spurious distinctions: (1) the control modes of Morel vs. operational modes of the claimed invention; (2) the different applied impedances of Morel vs. the different phases of a surgical procedure of the claimed invention; and (3) the state of the surgical instrument of Morel vs. the type of surgical instrument of the claimed invention.
Concerning (1), nothing in Morel contravenes the notion that control modes can also be operational modes in the sense that different control regimes correspond to different operations (or usages). In fact, Morel expressly describes the different control modes as operational modes. See, e.g., [0030] (“Switching into a locked mode, or more generally switching from one mode of operation (with a given impedance) to another (with another impedance) . . .) (emphases added).
Concerning (2), nothing in Morel suggest that the different applied impedances are not used in different phases of a surgical procedure. In fact, Morel suggests that the controls modes correspond to different phases of a surgical procedure. See, e.g., [0217] (“According to one embodiment, the method consists of changing state between two control modes called the locked mode (designed to hold the instrument in position even if the operator lets it go) and the free mode (designed to leave the operator free to manipulate the instrument).”).
Concerning (3), as explained in the previous Final Rejection (and reproduced below), it would be obvious for the person of ordinary skill in the art at the time of the invention to use Morel’s teaching of measuring instrument impedance to provide fine-grained indications of different types of instruments.
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 1 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Morel et al. (US 20180028269 A1, 2018-02-01) (hereinafter “Morel”).
Regarding claims 1-6, 8-9, and 27-30, as discussed above (Response to Arguments incorporated by reference herein), Morel teaches a co-manipulation surgical system to assist with a surgical procedure performed using a surgical instrument having a handle (H), an operating end, and an elongated shaft therebetween, the co-manipulation surgical system comprising: a robot arm comprising a proximal end, a distal end configured to be removably coupled to the surgical instrument (20), a plurality of links, and a plurality of joints (e.g., Figs. 1, 2 and associated text); and a controller (U) operatively coupled to the robot arm and configured to permit the robot arm to be freely moveable responsive to movement at the handle of the surgical instrument for performing the surgical procedure using the surgical instrument, the controller programmed to: apply a first impedance to the robot arm to account for weight of the surgical instrument and the robot arm (e.g., [0076]); and apply a second impedance to the robot arm to adjust viscosity at the distal end of the robot arm to thereby guide a movement of the surgical instrument by the user during a predetermined phase of the surgical procedure (e.g., [0078]).
Concerning Morel’s teaching of identifying instrument type based on impedance properties: Morel teaches various control modes having predetermined impedances and predetermined switching criteria. According to Morel, the notion of impedance (of the robot or the instruments) can be generally understood as resistance to movement. See, e.g., [0221] (“One advantageous embodiment defines the free impedance as a low-value viscosity to allow its manipulation by the operator and/or the locking impedance comprises a sufficiently high stiffness to guarantee that the instrument will be held in position.”) (emphases added). Importantly, Morel teaches that switching criteria may be based on the measured impedance of instruments. See, e.g., [0079] (“. . . the locking criterion can be an immobility of the instrument for a predetermined period and the unlocking criterion can be a translation of the instrument along an instrument axis.”) (emphasis added). Note that immobility of the instrument corresponds to high impedance (i.e., with high resistance to movement) and translation of the instrument corresponds to a lower impedance (i.e., with lower resistance to translational movement). Such instrument impedances can be measurements supplied by the hinged arm. See, e.g., [0075] (“. . . criterion will use only measurements supplied by the hinged arm.”). Furthermore, critical for our purposes, such instrument impedances indicate surgical instrument type. So, even though Morel does not expressly disclose identifying surgical instrument type, Morel’s teaching of measuring instrument impedance would provide fine-grained indications of different types of instruments. Note that an instrument typology or classification may be carved along the different ranges of impedances or impedance properties (e.g., temporal properties such as “immobility of the instrument for a predetermined period”) along different axes, for instance.
Note that Morel also teaches compensating for the weight of the instrument, minimizing fatigue of user (e.g., [0026]) and various modes of operation for different instruments (e.g., [0030]). Note also that Morel also teaches various laparoscopic surgical instruments and procedures (e.g., [0095]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention taught by Morel such that the invention further comprises a controller programmed to: identify a type of the surgical instrument coupled to the distal end of the robot arm; receive information indicative of entering a first predetermined phase of the surgical procedure; apply a first impedance to the robot arm during the first predetermined phase to account for weight of the surgical instrument and the robot arm during performance of a first surgical task; receive information indicative of entering a second predetermined phase of the surgical procedure; and apply, upon entering the second predetermined phase of the surgical procedure, a second impedance to the robot arm based on the type of the surgical instrument to adjust viscosity at the distal end of the robot arm to thereby guide a movement of the surgical instrument by the user to perform a second surgical task during the second predetermined phase of the surgical procedure, the second impedance different from the first impedance (citations above incorporated by reference herein) (as recited in claim 1); a method for assisting with surgery, the method comprising: providing a robot arm comprising a proximal end, a distal end configured to be removably coupled to a surgical instrument, a plurality of links, and a plurality of joints, the robot arm configured to be freely moveable responsive to movement at the handle of the surgical instrument for performing a surgical procedure using the surgical instrument; identifying a type of the surgical instrument coupled to the distal end of the robot arm; receiving information indicative of entering a predetermined phase of the surgical procedure; applying a first impedance to the robot arm during the first predetermined phase to account for weight of the surgical instrument and the robot arm during performance of a first surgical task; receiving information indicative of entering a second predetermined phase of the surgical procedure; and applying, upon entering the second predetermined phase of the surgical procedure, a second impedance to the robot arm based on the type of the surgical instrument to adjust viscosity at the distal end of the robot arm to thereby guide a movement of the surgical instrument by the user to perform a second surgical task during the second predetermined phase of the surgical procedure, the second impedance different from the first impedance (citations above incorporated by reference herein) (as recited in claim 30) in order to improve the usability of the invention.
Claims 2-7, 8-20, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Morel in view of Zhen et al. (CN 113974837 A, 2022-01-28) (hereinafter “Zhen”).
Regarding claims 7, 10-20, and 26, as discussed above, Morel teaches a co-manipulation surgical system. Note that Morel also teaches compensating for the weight of the instrument, minimizing fatigue of user (e.g., [0026]) and various modes of operation for different instruments (e.g., [0030]). Note also that Morel also teaches various laparoscopic surgical instruments and procedures (e.g., [0095]).
Morel does not express teach using an optical sensor to identify types of surgical instruments. However, Morel teaches instrument calibration (e.g., [0175]).
Zhen teaches teach using an optical sensor to identify via machine learning or conventional computer vision (and calibrate) different types of surgical instruments (e.g., Fig. 1, claim 10, and “Background” section).
As explained above, Morel teaches identifying types of instruments based on their impedance properties. Admittedly, such identification (based on impedance properties) may not be sufficiently fine-grained. So, a person on ordinary skill in the art would be motivated to use the optical sensors taught by Zhen to identify different types of surgical instruments (and their various properties), such as suturing device, a stapling device, a retraction device, and other types of devices in order to enhance the usability of the invention for particular treatments.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Zhen with the invention taught by Morel such that the invention further comprises wherein the type of the surgical instrument comprises a suturing device, wherein the predetermined phase of the surgical procedure comprises a suturing phase, and wherein the second impedance is sufficient to provide more viscous control of the suturing device during the suturing phase of the surgical procedure (as recited in claim 2); wherein the type of the surgical instrument comprises a stapling device, wherein the second predetermined second phase of the surgical procedure comprises a stapling phase, and wherein the second impedance is sufficient to provide stiff grounding to facilitate force application of the stapling device during the stapling phase of the surgical procedure (as recited in claim 3); wherein the controller is configured to identify the predetermined phase of the surgical procedure based on the type of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 4); wherein the type of the surgical instrument is selected from a list comprising at least one of a wristed instrument, a stapling device, a dissection device, a suturing device, a retraction device, a tissue removal device, or a clip applier device (citations above incorporated by reference herein) (as recited in claim 5); wherein the controller is configured to apply the second impedance to the robot arm based on the type of the surgical instrument to adjust viscosity at the distal end of the robot arm to thereby guide the movement of the surgical instrument by the user during the second predetermined phase of the surgical procedure without actively causing movement of the robot arm (citations above incorporated by reference herein) (as recited in claim 6); wherein the one or more instrument parameters associated with the type of the surgical instrument comprise at least one of make, weight, center of mass, length, or shaft diameter of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 8); wherein the controller is configured to apply the first impedance to the robot arm to account for weight of the surgical instrument based on the one or more instrument parameters associated with the type of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 9); wherein the controller is configured to permit the robot arm to be freely moveable in a co-manipulation mode responsive to determining that force applied at the robot arm due to force applied at the handle of the surgical instrument exceeds a predetermined force threshold, while applying the first impedance to the robot arm to account for weight of the surgical instrument and the robot arm, and wherein the predetermined force threshold is selected based on the type of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 27); further comprising: a user interface operatively coupled to the controller, wherein the controller is configured to identify the type of the surgical instrument based on user input received by the user interface (citations above incorporated by reference herein) (as recited in claim 28); wherein the controller is configured to access a database comprising a plurality of types of surgical instruments, and wherein the user interface is configured to permit a selection of the type of the surgical instrument from the plurality of types of surgical instruments by the user (citations above incorporated by reference herein) (as recited in claim 29); wherein the controller is configured to automatically load a calibration file based on the type of the surgical instrument, the calibration file comprising one or more instrument parameters associated with the type of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 7); further comprising an optical sensor operatively coupled to the controller (citations above incorporated by reference herein) (as recited in claim 10); wherein the controller is configured to identify the type of the surgical instrument based on data collected by the optical sensor (citations above incorporated by reference herein) (as recited in claim 11); wherein the controller is configured to: identify one or more features of the surgical instrument based on data collected by the optical sensor; and identify the type of the surgical instrument based on the one or more features of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 12); wherein the one or more features of the surgical instrument comprise at least one of a manufacture logo, handle design, or instrument packaging (citations above incorporated by reference herein) (as recited in claim 13); wherein the one or more features of the surgical instrument comprise one or more instrument parameters of the surgical instrument, and wherein the controller is configured to compare the one or more instrument parameters with information stored in a database to identify the type of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 14); wherein the controller is configured to implement a neural network to identify the type of the surgical instrument based on data collected by the optical sensor, the neural network trained to generate class labels and identify surgical instruments within the data collected by the optical sensor (citations above incorporated by reference herein) (as recited in claim 15); wherein the controller is configured to identify the second predetermined phase of the surgical procedure based on data collected by the optical sensor (citations above incorporated by reference herein) (as recited in claim 16); wherein the controller is configured to: receive image data from a laparoscope operatively coupled to the controller; and identify the type of the surgical instrument based on the image data (citations above incorporated by reference herein) (as recited in claim 17); wherein the controller is configured to: receive image data from a laparoscope operatively coupled to the controller; and identify one or more anatomical structures based on the image data, and wherein the controller is configured to identify the second predetermined phase of the surgical procedure based on the one or more anatomical structures (citations above incorporated by reference herein) (as recited in claim 18); wherein the controller is configured to: determine a position and/or movement of the robot arm based on current kinematics of the robot arm; and identify the type of the surgical instrument based on the position and/or movement of the robot arm (citations above incorporated by reference herein) (as recited in claim 19); wherein the controller is configured to: determine if the type of the surgical instrument is a pre-approved surgical instrument; and impede or temporarily disable one or more functions of the co-manipulation surgical system if the type of the surgical instrument is not a pre-approved surgical instrument (citations above incorporated by reference herein) (as recited in claim 20); wherein the controller is configured to identify the type of the surgical instrument based on at least one of an RFID transmitter chip, a near field communication device, a barcode, a magnet based communication system, a reed switch, a Bluetooth transmitter, or an activation code associated with the surgical instrument (citations above incorporated by reference herein) (as recited in claim 26) in order to improve the usability of the invention.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Morel in view of Zhen, as applied to claim 20, and further in view of Roh et al. (US 11389248 B1, 2022-07-19) (hereinafter “Roh”).
Regarding claims 21-23, as discussed above, Morel (in view of Zhen) teaches a co-manipulation surgical system. Morel does not express teach haptic feedback. Roh teaches various sorts of user feedback, such as haptic and audible feedback. See, e.g., 29:29-62 (“A surgical program or plan (“surgical plan”) can include, without limitation, patient data (e.g., pre-operative images, medical history, physician notes, etc.), imaging programs, surgical steps, mode switching programs, criteria, goals, or the like. The imaging programs can include, without limitation, AR/VR programs, identification programs (e.g., fiducial identification programs, tissue identification programs, target tissue identification programs, etc.), image analysis programs, or the like. Surgical programs can define surgical procedures or a portion thereof. For example, surgical programs can include end effector information, positional information, surgical procedure protocols, safety settings, surgical robot information (e.g., specifications, usage history, maintenance records, performance ratings, etc.), order of surgical steps, acts for a surgical step, feedback (e.g., haptic feedback, audible feedback, etc.), or the like. The mode switching programs can be used to determine when to switch the mode of operation of the surgical robot 440. For example, mode switching programs can include threshold or configuration settings for determining when to switch the mode of operation of the surgical robot 440. Example criteria can include, without limitation, thresholds for identifying events, data for evaluating surgical steps, monitoring criteria, patient health criteria, physician preference, or the like. The goals can include intraoperative goals, post-operative goals (e.g., target outcomes, metrics, etc.), goal rankings, etc. Monitoring equipment or the surgical team can determine goal progress, whether a goal has been achieved, etc. If an intraoperative goal is not met, the surgical plan can be modified in real-time so that, for example, the post-operative goal is achieved. The post-operative goal can be redefined intraoperatively in response to events, such as surgical complications, unplanned changes to patient's vitals, etc.”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Roh with the invention taught by Morel (in view of Zhen) such that the invention further comprises wherein the controller is configured to generate an audible, visual, and/or haptic alert upon determination that the type of the surgical instrument is not a pre-approved surgical instrument (citations above incorporated by reference herein) (as recited in claim 21); wherein the haptic alert comprises application of an increased level of viscosity to the robot arm (citations above incorporated by reference herein) (as recited in claim 22); wherein the haptic alert comprises engagement of a braking mechanism of the co-manipulation surgical system to thereby prevent motion of the co-manipulation surgical system (citations above incorporated by reference herein) (as recited in claim 23);
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Morel, as applied to claim 1, and further in view of Frame et al. (US 20170238996 A1, 2017-08-24) (hereinafter “Frame”).
Regarding claim 25, as discussed above, Morel teaches a co-manipulation surgical system. Morel does not express teach detecting electromagnetic properties of an instrument to identify it. Frame teaches detecting electromagnetic properties of an instrument to identify it. See, e.g., [0092].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Frame with the invention taught by Morel such that the invention further comprises wherein the controller is configured to: measure an electrical resistance or magnetism of the surgical instrument coupled to the distal end of the robot arm; and identify the type of the surgical instrument based on the electrical resistance or magnetism of the surgical instrument (citations above incorporated by reference herein) (as recited in claim 25) in order to improve the usability of the invention.
Allowable Subject Matter
Claim 24 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not teach or suggest the claimed invention of the co-manipulation surgical system of claim 1, wherein the controller is configured to: send a vibration pulse to the surgical instrument coupled to the distal end of the robot arm; receive response data from the surgical instrument responsive to the vibration pulse, the response data indicative of impedance properties of the surgical instrument; and identify the type of the surgical instrument based on the impedance properties of the surgical instrument (as recited in claim 24).
For these reasons the claims are believed to be allowable over the art of record.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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 SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, William Thomson, can be reached on 571-272-3718. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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