DETAILED ACTION
This action is responsive to the application filed 7/21/26.
Claims 1-20 are finally rejected.
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.
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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 11, the claim recites “wherein the motor is positioned between the lever and the surgical tool grasper,” the examiner cannot find support for this limitation in the original disclosure, and therefore, considers it to be new matter. The examiner invites applicant to amend the claim to better conform with the written description requirement or to provide citations from the original disclosure demonstrating that applicant had possession of the limitation at the time of filing.
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.
Claim 11 is 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.
Regarding claim 11, the claim recites “wherein the motor is positioned between the lever and the surgical tool grasper.” The claim is indefinite since it is not clear how to construe the limitation ‘between’ in the context of the claim. For instance, it is not clear whether applicant intends to mean ‘between’ in a spatial sense, e.g. the motor is located spatially between the lever and the end effector, or if applicant means ‘between’ in a functional/operational sense, e.g. the motor is located along a drive train between the motor and the end effector. If the former, it is additionally unclear how to construe the metes bounds of ‘between’ considering that the claim does not specify the relative locations of either the ‘lever’ or the ‘surgical tool grasper’. Therefore, a POSITA would be unable to determine the metes and bounds of the limitation ‘between’ rendering the claim indefinite.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3-5 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trees et al. (US 20150209059, “Trees”).
Regarding claim 1 Trees teaches a surgical tool for a surgical robotic system (Abstract, “Methods and devices for controlling motorized surgical devices are provided.”), the surgical tool comprising: a surgical tool grasper (Abstract, “the methods and devices can allow a surgical device to grasp and cut tissue”) having a jaw operable to perform a surgical procedure (Fig. 4, jaws 208); a handle coupled to the surgical tool grasper (Fig. 1, stationary grip 22) and having a lever (Fig. 4, closure grip/closure trigger 204) operable to actuate the jaw (Par. 84, “When the closure trigger 204 is closed, the closure link 232 can push the spring cage 221 proximally, thereby compressing the first spring 222, which forces the yoke 220 proximally so as to close the jaws 208a, 208b via the jaw closure rod 218.”); an actuation combiner mechanism (Fig. 4, the actuation combiner mechanism can be considered the combination of closure link 232, spring cage 221, spring 222, yoke 220, ratchet 226, ramp 228, rack 216, and gear 214; pars. 84 and 93) coupled to the lever (Fig. 4, trigger 204 is coupled to closure link 232) and operable to rotate (Figs. 4-5, showing the rotation of closure link 232 and ratchet 226 which are aspects of the actuation combiner mechanism) to combine an actuation force output of the lever (Par. 84, “When the closure trigger 204 is closed, the closure link 232 can push the spring cage 221 proximally, thereby compressing the first spring 222, which forces the yoke 220 proximally so as to close the jaws 208a, 208b via the jaw closure rod 218.”) with an actuation force output of a motor (Fig. 4, yoke 220 can combine an actuated force applied by closure trigger 204 through spring 222 with an actuation force applied by motor 202 through ratchet 226; par. 93, “When the controller has confirmed the activation of the sensor 210, the controller can cause the motor 202 to turn on so as to begin moving the rack 216. In general, the motor 202 being turned on can allow further closure of the end effector 206, allow for the jaws 208a, 208b to move closer together so as to more securely grasp tissue held therebetween […] The rotation of the ratchet 226 can cause the ratchet 226 to engage the yoke 220, as shown in FIG. 6, and move the yoke 220 proximally.”) into an output link to control the jaw (Fig. 4, closure rod 218; par. 93, “The proximal movement of the yoke 220 can cause the jaw closure rod 218 to move proximally, thereby causing further closure of the jaws 208a, 208b.”); and one or more processors (Par. 80, “the controller 34 can include a variety of devices configured to process signals (e.g., a microprocessor, a central processing unit (CPU), a memory controller, etc.)”) configured to analyze a characteristic associated with the actuation force output of the motor to modify the actuation force output of the motor (Par. 94, “The motor 202 can be configured to power the gear 214 rotation until a predetermined threshold is reached as determined by the controller, such as passage of a predetermined amount of time, measurement of a predetermined amount of torque using a torque sensor (not shown) coupled to the gear 214, or measurement of a predetermined amount of movement. The controller can be configured to adjust an amount of the power provided to the gear 214 by the motor 202 so as to control a speed of the gear's rotation, and hence an amount of the jaw closure rod's proximal movement and accordant end effector closure, based on one or more factors such as the sensed tissue impedance and the sensed torque.”).
Regarding claim 3, Trees further teaches further comprising one or more sensors operable to measure the actuation force output by the motor, a size of a jaw gap or a position of the lever (Par. 80, ‘measurement of a predetermined amount of torque using a torque sensor coupled to the gear 214, or measurement of a predetermined amount of movement’).
Regarding claim 4, Trees further teaches wherein the processor is operable to determine, based on the actuation force output by the motor, a clamping force of the jaw on a tissue (Par. 70, “As discussed further below, one or more sensors can be positioned on the surgical device 100 and can be configured to sense data related to an applied force on tissue manipulated by the end effector 14.”).
Regarding claim 5, Trees further teaches wherein the surgical procedure is a sealing operation (Par. 72, “The axial length LA of the jaws 16a, 16b can also be selected based on the targeted anatomical structure for transection and/or sealing.”) and the processor is operable to dynamically modify the actuation force output of the motor to modify the clamping force of the jaw on the tissue or a size of the jaw gap to optimize the sealing operation (Par. 69, “the device can be configured to adjust an amount of power provided by a motor of the device based on an amount of input force that a user applies to an actuator of the device and/or can be configured to control drive direction of the motor based on the amount of input force. In some embodiments, the device can be configured to maintain a force applied to the device when the force reaches a predetermined force. […] In some embodiments, the device can be configured to adjust an amount of power provided to an end effector of the device based on a degree of the end effector's closure.”).
Regarding claim 8, Trees further teaches wherein the processor is operable to control a direction of the actuation force output of the motor based on a position of the lever (Par. 91, “The activation of the sensor 210 can cause the sensor 210 to transmit a signal to the controller that indicates activation of the sensor 210. The sensor 210 being activated can indicate to the controller that the motor 202 can be turned on since the end effector 206 has been closed by actuation of the closure trigger 204.”; par. 104, “When the closure trigger 404 is released from its fully actuated position, e.g., by the user letting go of the closure trigger, by manual release of the locking member, etc., the first sensor 410 can be deactivated. The deactivation of the first sensor 410 can cause the controller to cause the motor 402 to go in reverse until the sixth sensor 430 is actuated.”; par. 69, “the device […] can be configured to control drive direction of the motor based on the amount of input force”).
Claim(s) 1-2 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al. (US 20210290228, “Williams”).
Regarding claim 1, Williams teaches a surgical tool for a surgical robotic system (Par. 2, “The disclosure relates to a surgical instrument, and more particularly, to an endoscopic surgical stapling instrument having a power assisted handle assembly.”), the surgical tool comprising: a surgical tool grasper having a jaw (Fig. 1 and par. 54, “The loading unit 50 includes a proximal portion 52 and an end effector 54 including jaws having a cartridge assembly 56 and an anvil assembly 58, respectively, disposed adjacent the proximal portion 52.”) operable to perform a surgical procedure (Par. 69, “Tissue is placed between the jaws of the loading unit 50. Thereafter, the clinician actuates the trigger 112 to manually clamp tissue between the jaws.”); a handle coupled to the surgical tool grasper (Fig. 1, handles assembly 100) and having a lever (Fig. 1, trigger assembly 110 having a trigger 112) operable to actuate the jaw (Par. 69, “Thereafter, the clinician actuates the trigger 112 to manually clamp tissue between the jaws.”); an actuation combiner mechanism (Fig. 23, drive gear 370) coupled to the lever (Par. 66, “With reference now to FIG. 23, as the trigger 112 is squeezed in the direction of an arrow “P,” the tab 144 of the button 140 received in the distal button slot 358b rotates the alignment member 358, which, in turn, rotates the firing gear 356 in the direction of an arrow “A.” The teeth 352 of the firing gear 356 engage the inner teeth 336 of the connecting gear 330 and rotate the connecting gear 330 in the direction of an arrow “B.” The outer teeth 332 of the connecting gear 330 engage the inner teeth 378 of the drive gear 370 such that rotation of the connecting gear 330 causes rotation of the drive gear 370 in the direction of an arrow “C.””) and operable to rotate (Fig. 23, drive gear 370 rotates about a central pivot point) to combine an actuation force output of the lever (Par. 66 and fig. 23, trigger 112 rotates firing gear 356 which in turn rotates connecting gear 330 and drive gear 370) with an actuation force output of a motor (Par. 66, “In particular, when the motor 400 is activated, the motor 400 provides a rotational output commensurate with the size or increase in the size of the gap “G.” The pinion gear 410 is coupled to the motor 400 and has teeth 412 that engage the outer teeth 372 of the drive gear 370. In this manner, when the motor 400 is activated, the pinion gear 410 rotates in the direction of an arrow “F,” which, in turn, rotates the drive gear 370 in the direction of the arrow “C,” thereby assisting advancement of the rack 390. This reduces the amount of force required by a clinician to actuate the stapling instrument 10.”) into an output link to control the jaw (Fig. 23, rack 390; par. 62, “The clamping gear 310, the connecting gear 330, and the drive gear 370 are configured to cause predetermined amount of axial displacement of the rack 390 to enable clamping of the jaws with a single stroke of the trigger 112.”); and one or more processors configured to analyze a characteristic associated with the actuation force output of the motor to modify the actuation force output of the motor (Fig. 12 and par. 56, “The sensor 116 may be operatively coupled with, e.g., a printed circuit board 600 including a processor 610, to activate the motor 400. The size of gap “G” may be commensurate with the amount of power assist provided by the motor 400.”; in this case the measured ‘gap’ can be considered the ‘characteristic associated with the actuation force output of the motor’).
Regarding claim 2, Williams further teaches wherein the actuation combiner mechanism comprises a combiner wheel that rotates about a center pivot point (Fig. 23, drive gear 370 rotates about a central pivot point) and couples a lever input link from the lever and a motor input link from the motor to the output link (Fig. 23 and par. 66, drive gear 370 gets input from trigger 112 and motor 400 through gears 330/440 and transfers these input forces into rack 390).
Regarding claim 11, Williams further teaches wherein the motor is positioned between the lever and the surgical tool grasper (Fig. 1, showing motor 400 located between trigger assembly 110 and the end effector 54 as judged along proximal-to-distal axis of the device).
Regarding claim 12, Williams teaches a surgical tool for a surgical robotic system (Par. 2, “The disclosure relates to a surgical instrument, and more particularly, to an endoscopic surgical stapling instrument having a power assisted handle assembly.”), the surgical tool comprising: a surgical tool grasper having a jaw (Fig. 1 and par. 54, “The loading unit 50 includes a proximal portion 52 and an end effector 54 including jaws having a cartridge assembly 56 and an anvil assembly 58, respectively, disposed adjacent the proximal portion 52.”) operable to perform a surgical procedure (Par. 69, “Tissue is placed between the jaws of the loading unit 50. Thereafter, the clinician actuates the trigger 112 to manually clamp tissue between the jaws.”); a handle coupled to the surgical tool grasper (Fig. 1, handles assembly 100) and having a lever (Fig. 1, trigger assembly 110 having a trigger 112) operable to actuate the jaw (Par. 69, “Thereafter, the clinician actuates the trigger 112 to manually clamp tissue between the jaws.”); an actuation combiner mechanism (Fig. 23, drive gear 370) coupled to the lever (Par. 66, “With reference now to FIG. 23, as the trigger 112 is squeezed in the direction of an arrow “P,” the tab 144 of the button 140 received in the distal button slot 358b rotates the alignment member 358, which, in turn, rotates the firing gear 356 in the direction of an arrow “A.” The teeth 352 of the firing gear 356 engage the inner teeth 336 of the connecting gear 330 and rotate the connecting gear 330 in the direction of an arrow “B.” The outer teeth 332 of the connecting gear 330 engage the inner teeth 378 of the drive gear 370 such that rotation of the connecting gear 330 causes rotation of the drive gear 370 in the direction of an arrow “C.””) and operable to combine an actuation force output of the lever (Par. 66 and fig. 23, trigger 112 rotates firing gear 356 which in turn rotates connecting gear 330 and drive gear 370) with an actuation force output of a motor (Par. 66, “In particular, when the motor 400 is activated, the motor 400 provides a rotational output commensurate with the size or increase in the size of the gap “G.” The pinion gear 410 is coupled to the motor 400 and has teeth 412 that engage the outer teeth 372 of the drive gear 370. In this manner, when the motor 400 is activated, the pinion gear 410 rotates in the direction of an arrow “F,” which, in turn, rotates the drive gear 370 in the direction of the arrow “C,” thereby assisting advancement of the rack 390. This reduces the amount of force required by a clinician to actuate the stapling instrument 10.”) into an output link to control the jaw (Fig. 23, rack 390; par. 62, “The clamping gear 310, the connecting gear 330, and the drive gear 370 are configured to cause predetermined amount of axial displacement of the rack 390 to enable clamping of the jaws with a single stroke of the trigger 112.”), wherein the actuation combiner mechanism comprises a rotatable member that rotates about a center pivot point (Fig. 23, drive gear 370 rotates about a central pivot point) and couples a lever input link from the lever and a motor input link from the motor to the output link (Fig. 23 and par. 66, drive gear 370 gets input from trigger 112 and motor 400 through gears 330/440 and transfers these input forces into rack 390 ); and one or more processors configured to analyze a characteristic associated with the actuation force output of the motor to modify the actuation force output of the motor (Fig. 12 and par. 56, “The sensor 116 may be operatively coupled with, e.g., a printed circuit board 600 including a processor 610, to activate the motor 400. The size of gap “G” may be commensurate with the amount of power assist provided by the motor 400.”; in this case the measured ‘gap’ can be considered the ‘characteristic associated with the actuation force output of the motor’).
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(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trees in view of Weir et al. (US 20120209314, “Weir”).
Regarding claim 6, Trees fails to teach wherein based on the clamping force of the jaw or the jaw gap, the processor is operable to determine a characteristic of the surgical procedure comprising at least one of an overstuffed jaw condition, a sealing parameter, or an abnormal sealing sequence.
Weir teaches an analogous surgical tool for a surgical robotic system (Abstract, “End effectors with closing mechanisms, and related tools and methods are disclosed. The disclosed end effectors may be particularly beneficial when used for minimally invasive surgery.”), the surgical tool comprising: a surgical tool grasper having a jaw operable to perform a surgical procedure (Abstract, “An example surgical tool comprises a first and second jaw movable between a closed grasped or clamped configuration and an open configuration.”); and one or more processors (Par. 17, “an electronic data processor coupled to the drive system”) configured to analyze a characteristic associated with an actuation force output to optimize the surgical procedure (Par. 17, “In many embodiments, the drive system closes the jaws on tissue at a predetermined grasping force, the electronic data processor measures a distance between the jaws, and based on the measured distance between the jaws, the electronic data processor outputs to the user interface a prediction of success of clamping the tissue between the two jaws at a desired clamping force”); one or more sensors operable to measure the actuation force output by the motor, a size of a jaw gap or a position of the lever (Par. 51, “The separation may be measured directly by the processor from the actual jaw members or from images representing the positions of the jaw members, or from various sensors of the system. For example, a Hall-effect type sensor can be positioned near the anvil jaw pivot to measure the closure angle of the jaws.”); wherein the processor is operable to determine, based on the actuation force output by the motor, a clamping force of the jaw on a tissue (Par. 17, ‘the drive system closes the jaws on tissue at a predetermined grasping force’); wherein based on the clamping force of the jaw or the jaw gap, the processor is operable to determine the characteristic of the surgical procedure comprising at least one of an overstuffed jaw condition, a sealing parameter, or an abnormal sealing sequence (par. 10, “Many surgical applications involve clamping of a body tissue at a clamping force sufficient for cutting, sealing and/or stapling of the clamped tissue.”; par. 11, ‘In certain embodiments, the prediction may be based also on the stiffness of the tissue. The stiffness of the tissue may be input, if known, or may be estimated based on the grasping force and separation or on the rate of change of separation as the grasping force is applied. For example, the estimation of stiffness may be based on an empirically derived relationship between these factors and tissue stiffness.’).
Therefore, in view of Weir, it would have been obvious to POSITA at the time that the invention was filed to modify Trees by configuring the device to estimate the tissue stiffness based on a separation distance measured prior to the performance of a sealing operation, in order to predict the likelihood of success of the clamping during the sealing operation, as taught by Weir.
Regarding claim 7, Trees, as modified, further teaches wherein the sealing parameter comprises a stiffness of the tissue (Trees has previously been modified in view of Weir to utilize the device to estimate tissue stiffness prior to sealing; see Weir, par. 11, ‘In certain embodiments, the prediction may be based also on the stiffness of the tissue. The stiffness of the tissue may be input, if known, or may be estimated based on the grasping force and separation or on the rate of change of separation as the grasping force is applied. For example, the estimation of stiffness may be based on an empirically derived relationship between these factors and tissue stiffness.’).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trees in view of Lath et al. (US 20220313349, “Lath”).
Regarding claim 9, Trees fails to teach wherein the motor is further operable to output a micro-modulation frequency to the output link.
Lath teaches an analogous surgical robotic system (Par. 6, “As a medical example, when the computer-assisted device is being used to perform a minimally invasive surgical procedure […]”) which utilizes motor micro-modulation/dithering in order to obviate high frictional forces caused by static friction (Par. 42, “According to some embodiments, dithering (e.g., rapidly modulating) the amount of force and/or torque applied by the one or more actuators used to control the amount of grasp force between jaws 310 and/or the one or more electrodes 350 and the grasped material may address the friction issues without resulting in undesirable increases in the grasp force. In some examples, dithering helps convert the static friction in instrument 200 (e.g., in the one or more drive mechanisms) and/or between jaws 310 and/or the one or more electrodes 350 and grasped material to a dynamic friction that allows the application of suitable grasp forces on the grasped material while avoiding high spikes in force and/or torque applied by an actuator that may cause undesirable wear and tear to instrument 200.”).
Therefore, in view of Lath, it would have been obvious to POSITA at the time that the invention was filed to modify Trees by introducing a micro-modulation frequency to the output link, in order to obviate high frictional forces caused by static friction, as taught by Lath.
Regarding claim 10, Trees, as modified, further teaches wherein the micro-modulation frequency is operable to reduce an impact of frictional forces on an operation of the jaw or the lever (Trees has been modified by Lath to configure the motor to apply a micro-modulation frequency; see Lath, par. 42, “According to some embodiments, dithering (e.g., rapidly modulating) the amount of force and/or torque applied by the one or more actuators used to control the amount of grasp force between jaws 310 and/or the one or more electrodes 350 and the grasped material may address the friction issues without resulting in undesirable increases in the grasp force. In some examples, dithering helps convert the static friction in instrument 200 (e.g., in the one or more drive mechanisms) and/or between jaws 310 and/or the one or more electrodes 350 and grasped material to a dynamic friction that allows the application of suitable grasp forces on the grasped material while avoiding high spikes in force and/or torque applied by an actuator that may cause undesirable wear and tear to instrument 200.”).
Claim(s) 2, 11-12, 14-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trees in view of Williams.
Regarding claims 2 and 12, Trees teaches a surgical tool for a surgical robotic system (Abstract, “Methods and devices for controlling motorized surgical devices are provided.”), the surgical tool comprising: a surgical tool grasper (Abstract, “the methods and devices can allow a surgical device to grasp and cut tissue”) having a jaw operable to perform a surgical procedure (Fig. 4, jaws 208); a handle coupled to the surgical tool grasper (Fig. 1, stationary grip 22) and having a lever (Fig. 4, closure grip/closure trigger 204) operable to actuate the jaw (Par. 84, “When the closure trigger 204 is closed, the closure link 232 can push the spring cage 221 proximally, thereby compressing the first spring 222, which forces the yoke 220 proximally so as to close the jaws 208a, 208b via the jaw closure rod 218.”); an actuation combiner mechanism (Fig. 4, the actuation combiner mechanism can be considered the combination of closure link 232, spring cage 221, spring 222, yoke 220, ratchet 226, ramp 228, rack 216, and gear 214; pars. 84 and 93) coupled to the lever (Fig. 4, the ‘actuator combiner mechanism’ is coupled to trigger 204 through closure link 232) and operable to combine an actuation force output of the lever (Par. 84, “When the closure trigger 204 is closed, the closure link 232 can push the spring cage 221 proximally, thereby compressing the first spring 222, which forces the yoke 220 proximally so as to close the jaws 208a, 208b via the jaw closure rod 218.”) with an actuation force output of a motor (Par. 93 and fig. 4, yoke 220 can combine an actuated force applied by closure trigger 204 through spring 222 with an actuation force applied by motor 202 through ratchet 226; par. 93, “When the controller has confirmed the activation of the sensor 210, the controller can cause the motor 202 to turn on so as to begin moving the rack 216. In general, the motor 202 being turned on can allow further closure of the end effector 206, allow for the jaws 208a, 208b to move closer together so as to more securely grasp tissue held therebetween […] The rotation of the ratchet 226 can cause the ratchet 226 to engage the yoke 220, as shown in FIG. 6, and move the yoke 220 proximally.”) into an output link to control the jaw (Fig. 4, closure rod 218; par. 93, “The proximal movement of the yoke 220 can cause the jaw closure rod 218 to move proximally, thereby causing further closure of the jaws 208a, 208b.”), wherein the actuation combiner mechanism coupled to the lever (Fig. 4, trigger 204 is coupled to closure link 232) comprises a rotatable member (Figs. 4-6, closure link 232 and ratchet 226 are ‘rotatable members’); one or more processors (Par. 80, “the controller 34 can include a variety of devices configured to process signals (e.g., a microprocessor, a central processing unit (CPU), a memory controller, etc.)”) configured to analyze a characteristic associated with the actuation force output of the motor to modify the actuation force output of the motor (Par. 94, “The motor 202 can be configured to power the gear 214 rotation until a predetermined threshold is reached as determined by the controller, such as passage of a predetermined amount of time, measurement of a predetermined amount of torque using a torque sensor (not shown) coupled to the gear 214, or measurement of a predetermined amount of movement. The controller can be configured to adjust an amount of the power provided to the gear 214 by the motor 202 so as to control a speed of the gear's rotation, and hence an amount of the jaw closure rod's proximal movement and accordant end effector closure, based on one or more factors such as the sensed tissue impedance and the sensed torque.”).
Trees fails to teach wherein the rotatable member rotates about a center pivot point and couples a lever input link from the lever and a motor input link from the motor to the output link.
However, as discussed above with respect to the 102 rejection of claim 12 over Williams, Williams teaches an analogous device (See above), that comprises an actuation combiner mechanism (Fig. 23, drive gear 370) coupled to a lever (Fig. 23, trigger 112; par. 66, “With reference now to FIG. 23, as the trigger 112 is squeezed in the direction of an arrow “P,” the tab 144 of the button 140 received in the distal button slot 358b rotates the alignment member 358, which, in turn, rotates the firing gear 356 in the direction of an arrow “A.” The teeth 352 of the firing gear 356 engage the inner teeth 336 of the connecting gear 330 and rotate the connecting gear 330 in the direction of an arrow “B.” The outer teeth 332 of the connecting gear 330 engage the inner teeth 378 of the drive gear 370 such that rotation of the connecting gear 330 causes rotation of the drive gear 370 in the direction of an arrow “C.””) and operable to combine an actuation force output of the lever (Par. 66 and fig. 23, trigger 112 rotates firing gear 356 which in turn rotates connecting gear 330 and drive gear 370) with an actuation force output of a motor (Par. 66, “In particular, when the motor 400 is activated, the motor 400 provides a rotational output commensurate with the size or increase in the size of the gap “G.” The pinion gear 410 is coupled to the motor 400 and has teeth 412 that engage the outer teeth 372 of the drive gear 370. In this manner, when the motor 400 is activated, the pinion gear 410 rotates in the direction of an arrow “F,” which, in turn, rotates the drive gear 370 in the direction of the arrow “C,” thereby assisting advancement of the rack 390. This reduces the amount of force required by a clinician to actuate the stapling instrument 10.”) into an output link to control the jaw (Fig. 23, rack 390; par. 62, “The clamping gear 310, the connecting gear 330, and the drive gear 370 are configured to cause predetermined amount of axial displacement of the rack 390 to enable clamping of the jaws with a single stroke of the trigger 112.”), wherein the actuation combiner mechanism comprises a rotatable member that rotates about a center pivot point (Fig. 23, drive gear 370 rotates about a central pivot point) and couples a lever input link from the lever and a motor input link from the motor to the output link (Fig. 23 and par. 66, drive gear 370 gets input from trigger 112 and motor 400 through gears 330/440 and transfers these input forces into rack 390 ).
Therefore, in view of Williams, it would have been obvious to a POSTIA at the time that the invention was filed to modify the surgical instrument of Trees by replacing its mechanical drive linkage with the dual-input gear-and-rack for transmission assembly of Williams (Specifically, drive gear 370, connecting gear 330, pinion gear 440, rack 390 and motor 400).
A POSITA would have been motivated to combine these references for several reasons.
Firstly, a POSTIA would have regarded such a combination as simple substitution since both references teach different mechanisms for combining a manual introduced grasping force with a motor assisted grasping forces in the context of a surgical device for gasping tissue. Therefore, a POSITA would have found it obvious to substitute one motor assisted grasping mechanism for the other in order to arrive at the predictable result of a motor assisted grasping mechanism for grasping tissue in the context of a surgical device. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007).
Secondly, a POSITA would have further been motivated to combine the two references since POSTIA would have regarded the design of Williams to have certain advantages. For instance, a POSTIA would have been motivated to substitute the dual-input gear-and-rack for transmission assembly disclosed by Williams for the motor assisted closure mechanism natively disclosed by Trees in order to provide a mechanism that has capability to provide a high mechanical advantage in a spatially compact manner through the use of gear ratios, as disclose by Williams.
Furthermore, it would have been obvious to a POSITA to configure the controller of Trees to dynamically control the dual-input gear train transmission of Williams based on feedback from a continuous sensor input using conventional techniques known in the art (e.g., microprocessor programming, closed-loop feedback control, PWM etc.), in order to retain Trees’ ability to dynamically control the motor drive based on sensor information—for instance, to directly control the force output sensed at the jaw, as natively taught by Trees (Pars. 70, 80, 94).
Regarding claim 11, Trees, as modified, further teaches wherein the motor is positioned between the lever and the surgical tool grasper (Trees has previously been modified to comprises the dual-input gear-and-rack for transmission assembly of Williams; see Williams, fig. 1, showing motor 400 located between trigger assembly 110 and the end effector 54 as judged along proximal-to-distal axis of the device).
Regarding claim 14, Trees, as modified, further teaches one or more sensors operable to measure the actuation force output by the motor, a size of a jaw gap or a position of the lever (Par. 80, ‘measurement of a predetermined amount of torque using a torque sensor coupled to the gear 214, or measurement of a predetermined amount of movement’).
Regarding claim 15, Trees, as modified, further teaches wherein the processor is operable to determine, based on the actuation force output by the motor, a clamping force of the jaw on a tissue (Par. 70, “As discussed further below, one or more sensors can be positioned on the surgical device 100 and can be configured to sense data related to an applied force on tissue manipulated by the end effector 14.”).
Regarding claim 16, Trees, as modified, further teaches wherein the surgical procedure is a sealing operation (Par. 72, “The axial length LA of the jaws 16a, 16b can also be selected based on the targeted anatomical structure for transection and/or sealing.”) and the processor is further operable to modify the clamping force of the jaw on the tissue or a size of the jaw gap to optimize the sealing operation (Par. 69, “the device can be configured to adjust an amount of power provided by a motor of the device based on an amount of input force that a user applies to an actuator of the device and/or can be configured to control drive direction of the motor based on the amount of input force. In some embodiments, the device can be configured to maintain a force applied to the device when the force reaches a predetermined force. […] In some embodiments, the device can be configured to adjust an amount of power provided to an end effector of the device based on a degree of the end effector's closure.”).
Regarding claim 19, Trees, as modified, further teaches wherein the processor is operable to control a direction of the actuation force output of the motor based on a position of the lever (Par. 91, “The activation of the sensor 210 can cause the sensor 210 to transmit a signal to the controller that indicates activation of the sensor 210. The sensor 210 being activated can indicate to the controller that the motor 202 can be turned on since the end effector 206 has been closed by actuation of the closure trigger 204.”; par. 104, “When the closure trigger 404 is released from its fully actuated position, e.g., by the user letting go of the closure trigger, by manual release of the locking member, etc., the first sensor 410 can be deactivated. The deactivation of the first sensor 410 can cause the controller to cause the motor 402 to go in reverse until the sixth sensor 430 is actuated.”; par. 69, “the device […] can be configured to control drive direction of the motor based on the amount of input force”).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trees in view of Williams, as applied to claims 2, 11-12, 14-16 and 19, and further in view of Weir.
***Note that the combination of Trees in view of Weir, has previously been discussed with respect to claims 6-7, above and thus will not be reiterated.
Regarding claim 17, Trees, as modified, further teaches wherein based on the clamping force of the jaw or the jaw gap, the processor is operable to determine a characteristic of the surgical procedure comprising at least one of an overstuffed jaw condition, a sealing parameter, or an abnormal sealing sequence (Trees has previously been modified in view of Weir to utilize the device to estimate tissue stiffness prior to sealing; see Weir, par. 11, ‘In certain embodiments, the prediction may be based also on the stiffness of the tissue. The stiffness of the tissue may be input, if known, or may be estimated based on the grasping force and separation or on the rate of change of separation as the grasping force is applied. For example, the estimation of stiffness may be based on an empirically derived relationship between these factors and tissue stiffness.’).
Regarding claim 18, Trees, as modified, further teaches wherein the sealing parameter comprises a stiffness of the tissue (Trees has previously been modified in view of Weir to utilize the device to estimate tissue stiffness prior to sealing; see Weir, par. 11, ‘In certain embodiments, the prediction may be based also on the stiffness of the tissue. The stiffness of the tissue may be input, if known, or may be estimated based on the grasping force and separation or on the rate of change of separation as the grasping force is applied. For example, the estimation of stiffness may be based on an empirically derived relationship between these factors and tissue stiffness.’).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trees in view of Williams, as applied to claims 2, 11-12, 14-16 and 19, and further in view of Lath.
***Note that the combination of Trees in view of Lath, has previously been discussed with respect to claims 9-10, above and thus will not be reiterated.
Regarding claim 20, Trees, as modified, further teaches wherein the motor is further operable to output a micro modulation frequency to the output link (Trees has been modified by Lath to configure the motor to apply a micro-modulation frequency; see Lath, par. 42, “According to some embodiments, dithering (e.g., rapidly modulating) the amount of force and/or torque applied by the one or more actuators used to control the amount of grasp force between jaws 310 and/or the one or more electrodes 350 and the grasped material may address the friction issues without resulting in undesirable increases in the grasp force. In some examples, dithering helps convert the static friction in instrument 200 (e.g., in the one or more drive mechanisms) and/or between jaws 310 and/or the one or more electrodes 350 and grasped material to a dynamic friction that allows the application of suitable grasp forces on the grasped material while avoiding high spikes in force and/or torque applied by an actuator that may cause undesirable wear and tear to instrument 200.”).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8-9, 12-16, 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 8 of U.S. Patent No. 12,268,406 (‘406) in view of Trees.
Regarding application claims 1 and 12, claim 2 of ‘406 teaches a surgical tool grasper having a jaw operable to perform a surgical procedure; a handle coupled to the surgical tool grasper and having a lever operable to actuate the jaw; an actuation combiner mechanism coupled to the lever and operable to combine an actuation force output of the lever with an actuation force output of a motor into an output link to control the jaw, wherein the actuation combiner mechanism comprises a rotatable member that rotates about a center pivot point and couples a lever input link from the lever and a motor input link from the motor to the output link, but fails to teach one or more processors configured to analyze a characteristic associated with the actuation force output of the motor to modify the actuation force output of the motor.
Trees, however teaches an analogous device (see above), that comprises one or more processors (Par. 80) configured to analyze a characteristic associated with the actuation force output of the lever or the motor to optimize the surgical procedure (Par. 94).
Therefore, in view of Trees it would have been obvious to POSITA modify ‘406 by configuring the device with a controller configured to precisely control the output force of the jaw based on sensor feedback, in order to optimize the grasping force supplied to the tissue during sealing and cutting operations, as taught by Trees.
Regarding application claims 2, 13, 9 and 20, these claims are taught by claims 2 and 8 of ‘406 respectively.
Although, application claims 3-5, 8, 14-16 and 19 are not explicitly taught by the claims of ‘406 they are seen to be obvious over the disclosure of Trees, as discussed above.
Claims 6-7 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 and 8 of U.S. Patent No. 12,268,406 (‘406) in view of Trees and Weir.
Regarding application claims 6-7 and 17-18, although the claims of ‘406 fail to explicitly teach the limitations related to a processor configured to determine of a sealing parameter based on a clamping force of jaw, and that the sealing parameter is tissue stiffness, these limitations are seen to be obvious over the disclosure of Wier, as discussed above.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 and 8 of U.S. Patent No. 12,268,406 (‘406) in view of Trees and Lath.
Regarding application claim 10, although ‘406 fails to explicitly teach the limitations related to the use of a micro-modulation frequency to reduce frictional forces on the operation of the or lever, these limitations are seen to be obvious over the disclosure of Lath, as discussed above.
Claims 1-5 and 8, 12-16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of U.S. Patent No. 12,433,624 (‘624) in view of Trees.
Regarding application claims 1 and 12, claim 2 of ‘624 teaches a surgical tool grasper having a jaw operable to perform a surgical procedure; a handle coupled to the surgical tool grasper and having a lever operable to actuate the jaw; an actuation combiner mechanism coupled to the lever and operable to combine an actuation force output of the lever with an actuation force output of a motor into an output link to control the jaw, wherein the actuation combiner mechanism comprises a rotatable member that rotates about a center pivot point and couples a lever input link from the lever and a motor input link from the motor to the output link, but fails to teach one or more processors configured to analyze a characteristic associated with the actuation force output of the motor to modify the actuation force output of the motor.
Trees, however teaches an analogous device (see above), that comprises one or more processors (Par. 80) configured to analyze a characteristic associated with the actuation force output of the lever or the motor to optimize the surgical procedure (Par. 94).
Therefore, in view of Trees it would have been obvious to POSITA modify ‘624 by configuring the device with a controller configured to precisely control the output force of the jaw based on sensor feedback, in order to optimize the grasping force supplied during sealing and cutting operations, as taught by Trees.
Regarding application claims 2, this claim is further taught by claim 2 of ‘624.
Regarding application claim 13, this claim is further taught by claim 2 of ‘624
Regarding application claims 3-5, 8, 14-16 and 19 although these claims are not explicitly taught by the claims of ‘624, they are seen to be obvious over the disclosure of Trees, as discussed above.
Claims 6-7 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of U.S. Patent No. 12,433,624 (‘624) in view of Trees and Weir.
Regarding application claims 6-7 and 17-18, the claims of ‘624 fails to explicitly teach the limitations related to a processor configured to determine of a sealing parameter based on a clamping force of jaw, and that the sealing parameter is tissue stiffness, however these limitations are seen to be obvious over the disclosure of Wier, as discussed above.
Claims 9-10 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-2 of U.S. Patent No. 12,433,624 (‘624) in view of Trees and Lath.
Regarding application claims 9-10 and 20, ‘624 fails to teach the limitations related to the use of a micro-modulation frequency to reduce frictional forces on the operation of the or lever, however these limitations are seen to be obvious over the disclosure of Lath, as discussed above.
Response to Arguments
Applicant's arguments filed 7/21/26 with respect to the rejection of claim 1, as being anticipated by Trees, have been fully considered but they are not persuasive. The examiner disagrees that Trees cannot be construed to comprises an ‘actuation combiner mechanism […] operable to rotate.’ Trees for instance teaches a combiner mechanism that can comprises various rotating elements such as closure link 232 and ratchet 226, and therefore can be considered ‘operable to rotate’ according to the broadest reasonable interpretation of the claim language.
Further, with respect to claim 5, the examiner disagrees that Trees cannot be used to teach a processor configured to ‘dynamically modify the actuation force output of the motor’. Trees clearly discloses the use of feedback control to dynamically adjust the motor output in various ways. Therefore, the rejection is maintained.
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 ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights