DETAILED ACTION
The Examiner acknowledges the amendments received 14 April 2026. Claims 1-11 are withdrawn; claims 12-26 are pending.
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 Arguments
Applicant's arguments filed 14 April 2026 have been fully considered but they are not persuasive. The Applicant argues (page 8, “Remarks”)
These passages describe a tissue-sensing clamping control, namely, detecting how much tissue is grasped between the jaws and setting motor parameters in response to that tissue contact. This is not the same as the recitation of "determine an amount of orientation misalignment; and adjust the instrument based on the amount of orientation misalignment" of claims 12 and 20. The claims recite detecting a "an amount of orientation misalignment" and not a degree of tissue contact between the jaws and then adjusting "the instrument based on the amount of orientation misalignment." In contrast, Shelton's control circuit determines jaw position and tissue contact; it does not determine "an amount of orientation misalignment" as recited. Shelton's control circuit sets motor parameters based on tissue contact; it does not "adjust the instrument based on the amount of orientation misalignment" as recited.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Though the language of the claims differ, the Examiner explained how Shelton corresponds to the structures of the claim.
The Applicant further argues (page 9, “Remarks”):
Staples 150191 in Shelton are consumable tissue fasteners that are ejected from a cartridge during a single firing event. They are not "cables that are movable longitudinally" as recited in claims 12 and 20. A staple is not a cable, and being ejected once from a cartridge is not being "movable longitudinally" in the sense recited by the claims.
Additionally, the claims recite "an end effector movable by the cables." In Shelton, the end effector is not moved by the staples. Rather, Shelton discloses that the jaws are moved by a closure tube and the firing is driven by the I-beam 150178. (Shelton [ 0372], [0412].) The staples 150191 do not move the end effector as they are expelled from the end effector into tissue.
The Examiner respectfully disagrees with this assessment of Shelton. A prior art element can be shown as a functional equivalent to the claim limitation of “The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification” and/or “There are insubstantial differences between the prior art element and the corresponding element disclosed in the specification.” See MPEP 2183. The Applicant has not persuasively shown that the staples of Shelton differs in structure from the cables as claimed. Moreover, the staples of Shelton perform similar functions to the claimed cables, as shown in the Non-Final rejection, and reiterated below.
Claim Objections
In view of the amendments received 14 April 2026, the Examiner withdraws the objection to claims 14 and 16.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al (U.S. 2019/0201018). Shelton discloses (Figures 2-3, 25-27, 31 and 99) a surgical console (par. 0398) including a handle controller (par. 0400); a robotic arm (par. 0566-0567) including an instrument (“the surgical instrument can be a surgical tool mounted to a robotic arm of a robotic surgical system” in [0567]) having: a plurality of cables (staples 150191 in par. 0410-0411) that are movable longitudinally; and an end effector movable by the cables (par. 0410-0411; “the I-beam 150178 may, or fire, the surgical staple cartridge 150304. The surgical staple cartridge 150304 can include a molded cartridge body 150194 that holds a plurality of staples 150191 resting upon staple drivers 150192 within respective upwardly open staple cavities 150195. A wedge sled 150190 is driven distally by the I-beam 150178, sliding upon a cartridge tray 150196 of the surgical staple cartridge 150304. The wedge sled 150190 upwardly cams the staple drivers 150192 to force out the staples 150191 into deforming contact with the anvil 150306 while the cutting edge 150182 of the I-beam 150178 severs clamped tissue”), the end effector having a pair of opposing jaws (150300; par. 0424; Figures 25 and 28); and a processor (par. 0417) configured to: determine an amount of orientation misalignment; and adjust the instrument based on the amount of orientation misalignment (par. 0709-0711; “the control circuit 21002 can determine the degree of tissue contact according to the ratio of the sensor(s) 21004 that have detected the presence of tissue to the sensor(s) 21004 that have not detected the presence of tissue. Accordingly, the control circuit 21002 sets 21210 control parameters for the motor 21006 according to the determined 21206 position of the jaws and the determined 21208 degree of tissue contact”).
Regarding claim 13, Shelton discloses (par. 0372) the processor is further configured to calculate a motion axis based on a difference between a current instrument desired orientation and a previous instrument desired orientation, the current instrument desired orientation being based on an orientation of the handle controller (“a control system modifies a longitudinal position of a closure tube assembly based on the articulation angle θ. Such modifying of the longitudinal position of the closure tube assembly includes proximally retracting the closure tube assembly by a compensation distance (e.g., defined along the y-axis) as the end effector articulates and based on the articulation angle θ (e.g., defined along the x-axis).”).
Regarding claim 14, Shelton discloses (par. 0374) the processor is further configured to calculate a user delta orientation input (par. 0465-0469, particularly “The combination of one or more sensed parameters with derived parameters provides more reliable and accurate assessment of tissue types and tissue health, and allows for better device monitoring, control, and clinician feedback” in par. 0469) based on a second difference between a current orientation of the handle controller and a previous orientation of the handle controller (“a control system modifies a longitudinal position of a closure tube assembly based on the articulation angle θ. Such modifying of the longitudinal position of the closure tube assembly includes proximally retracting the closure tube assembly by a compensation distance (e.g., defined along the y-axis) as the end effector articulates and based on the articulation angle θ (e.g., defined along the x-axis).”).
Regarding claim 15, Shelton discloses (par. 0372) the processor is further configured to calculate an unadjusted instrument commanded orientation (par. 0465-0469, particularly “For example, during clamping, when tissue compression reaches a steady state—e.g., no significant rate of change occurs after a set period of time—the microcontroller can send a signal to the display alerting the clinician to start the next step in the operation, such as staple firing.” in par. 0467) by adding the user delta orientation input to a previous instrument commanded orientation (“a control system modifies a longitudinal position of a closure tube assembly based on the articulation angle θ. Such modifying of the longitudinal position of the closure tube assembly includes proximally retracting the closure tube assembly by a compensation distance (e.g., defined along the y-axis) as the end effector articulates and based on the articulation angle θ (e.g., defined along the x-axis).”).
Regarding claim 16, Shelton discloses (par. 0574) the processor is further configured to calculate a misalignment axis (par. 0465-0469, particularly “For example, in the case of jaw gap, knowing how much of the jaw is covered with tissue can make the gap measurement more useful and accurate. If a small portion of the jaw is covered in tissue, tissue compression may appear to be less than if the entire jaw is covered in tissue. Thus, the amount of jaw coverage can be taken into account by the microcontroller when analyzing tissue compression and other sensed parameters.” In par. 0465), which is a third difference between the current instrument desired orientation and the unadjusted instrument commanded orientation (“the surgical instrument 23102 and/or the surgical hub 23140 may be a situationally aware surgical instrument and/or a situationally aware surgical hub. Situational awareness refers to the ability of a surgical system, e.g., 23100, to determine or infer information related to a surgical procedure from data received from databases (e.g., historical data associated with a surgical procedure, e.g., 23149 and/or 23150) and/or surgical instruments (e.g., sensor data during a surgical procedure). For example, the determined or inferred information can include the type of procedure being undertaken, the type of tissue being operated on, the body cavity that is the subject of the procedure, etc. Based on such contextual information related to the surgical procedure, the surgical system can, for example, control a paired surgical instrument 23102 or a component thereof (e.g., 23110, 23120, and/or 23130) and/or provide contextualized information or suggestions to a surgeon throughout the course of the surgical procedure (e.g., via user interface 23118, 23128, 23138, 23148 and/or 23158).”).
Regarding claim 17, Shelton discloses (par. 0705) the processor is further configured to calculate an adjustment value based on an angle between the motion axis and the misalignment axis (“the surgical instrument can be configured to differentiate between parenchyma and vessels because parenchyma contacts a greater degree of the surfaces of the jaws and the jaws at a larger angle at the point of initial contact as compared to vessels. The surgical instrument can then control the motor to affect the jaw closure rate and adjustment threshold accordingly for the detected tissue type”).
Regarding claim 18, Shelton discloses (par. 0735) the processor is further configured to calculate the adjustment value using a first negative punishing factor in response to a cosine of the angle being positive (“the closure velocity drops 21434 until it reaches a negative closure velocity, indicating that the jaws 21013 are being opened in order to, for example, easily permit the tissue to be readjusted within the jaws 21013. The closure velocity then returns 21436 back to zero, the jaws 21013 stopped. Correspondingly, the FTC decreases 21430 to zero as the jaws 21013 are released from the tissue.”).
Regarding claim 19, Shelton discloses (par. 0735) the processor is further configured to calculate the adjustment value using a second negative punishing factor in response to a cosine of the angle being negative, the second negative punishing factor being larger than the first negative punishing factor (“the closure velocity drops 21434 until it reaches a negative closure velocity, indicating that the jaws 21013 are being opened in order to, for example, easily permit the tissue to be readjusted within the jaws 21013. The closure velocity then returns 21436 back to zero, the jaws 21013 stopped. Correspondingly, the FTC decreases 21430 to zero as the jaws 21013 are released from the tissue.”).
Regarding claim 20, Shelton discloses (Figures 2-3, 25, 31 and 99) a surgical console (par. 0398) including a handle controller (par. 0400); a robotic arm (par. 0566-0567) including an instrument (“the surgical instrument can be a surgical tool mounted to a robotic arm of a robotic surgical system” in [0567]) having: a plurality of cables (staples 150191 in par. 0410-0411) that are movable longitudinally; and an end effector movable by the cables (par. 0410-0411; “the I-beam 150178 may, or fire, the surgical staple cartridge 150304. The surgical staple cartridge 150304 can include a molded cartridge body 150194 that holds a plurality of staples 150191 resting upon staple drivers 150192 within respective upwardly open staple cavities 150195. A wedge sled 150190 is driven distally by the I-beam 150178, sliding upon a cartridge tray 150196 of the surgical staple cartridge 150304. The wedge sled 150190 upwardly cams the staple drivers 150192 to force out the staples 150191 into deforming contact with the anvil 150306 while the cutting edge 150182 of the I-beam 150178 severs clamped tissue”), the end effector having a pair of opposing jaws (150300; par. 0424; Figures 25 and 28); and a processor (par. 0417) configured to: determine an amount of orientation misalignment and an amount of jaw misalignment; adjust the instrument based on the amount of orientation misalignment (par. 0372 and claims 13 and 14 above); and adjust the pair of opposing jaws based on the amount of jaw misalignment (par. 0709-0711; “the control circuit 21002 can determine the degree of tissue contact according to the ratio of the sensor(s) 21004 that have detected the presence of tissue to the sensor(s) 21004 that have not detected the presence of tissue. Accordingly, the control circuit 21002 sets 21210 control parameters for the motor 21006 according to the determined 21206 position of the jaws and the determined 21208 degree of tissue contact”).
Regarding claim 21, Shelton discloses (par. 0502) the processor is further configured to determine a type of the instrument and to modify adjustment of the orientation misalignment based on the type of the instrument (“the signal generated by the electromagnetic source 152360 may be adjustable based on, for example, the type of staple cartridge 152356 installed in the second jaw member 152354, one or more additional sensor, an algorithm, and/or one or more parameters.”).
Regarding claim 22, Shelton discloses (par. 0503 and “For example, if jaw gap rate of change remains constant after a set period of time (e.g., 5 seconds), then the parameter may have reached its asymptotic value” in par. 0466) the processor is further configured to adjust a rate of convergence based on the type of the instrument (“The primary processor correlates the received signal to one or more parameters of the end effector 152350, such as, for example, the gap 152364 between the anvil 152352 and the staple cartridge 152356.” in par. 503).
Regarding claim 23, Shelton discloses (par. 0503) the processor is further configured to determine a type of the instrument and to modify adjustment of the jaw misalignment based on the type of the instrument (“The primary processor correlates the received signal to one or more parameters of the end effector 152350, such as, for example, the gap 152364 between the anvil 152352 and the staple cartridge 152356.”).
Regarding claim 24, Shelton discloses (par. 0230) a camera configured to capture an image of the end effector.
Regarding claim 25, Shelton discloses (par. 0230) the processor is further configured to determine the amount of orientation misalignment and the amount of jaw misalignment based on the image of the end effector.
Regarding claim 26, Shelton discloses (par. 0709-0711) the processor is further configured to modify adjustment of the orientation misalignment (“the amount of jaw coverage can be taken into account by the microcontroller when analyzing tissue compression and other sensed parameters” in par. 0465) based on a dimension of the pair of opposing jaws (“the control circuit 21002 can determine the degree of tissue contact according to the ratio of the sensor(s) 21004 that have detected the presence of tissue to the sensor(s) 21004 that have not detected the presence of tissue. Accordingly, the control circuit 21002 sets 21210 control parameters for the motor 21006 according to the determined 21206 position of the jaws and the determined 21208 degree of tissue contact.” in par. 0710).
Conclusion
THIS ACTION IS MADE FINAL. 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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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