DETAILED ACTION
This action is responsive to the application filed 5/11/22.
Claims 1-10 are 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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 6-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the claim recites that the ‘combiner wheel’ combines ‘an actuation force output of the lever with an actuation force output of a motor’. If the ‘combiner wheel’ takes as an input the output of the lever, it is unclear how it could in turn ‘control […] the lever’.
Claim 6 recites the limitation "the characteristic of surgical procedure". There is insufficient antecedent basis for this limitation in the claim.
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 coupled to the lever (Fig. 4, yoke 220 is coupled closure trigger 204 through spring 222 as disclosed in par. 84) and operable to combine; an actuation force output of the lever (Par. 84) with an actuation force output of a motor into an output link to control the jaw or the lever (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; “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. 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 lever or the motor to optimize the surgical procedure (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 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, “In some embodiments, the device can be configured to maintain a force applied to the device when the force reaches a predetermined force.”).
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 the lever position (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.”).
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 the 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 (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.”) parameter, or an abnormal sealing sequence (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 the operation of the jaw or the lever (Trees, as modified by Lath; 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 and 8-9 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 claim 1, claim 1 of ‘406 teaches a surgical tool for a surgical robotic system, the surgical tool comprising: 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 or the lever, but fails to teach one or more processors configured to analyze a characteristic associated with the actuation force output of the lever or the motor to optimize the surgical procedure.
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 and 9, these claims are taught by claims 2 and 8 of ‘406 respectively.
Although, application claims 3-5 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 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, 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 1-2 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 claim 1, claim 1 of 624 teaches a surgical tool for a surgical robotic system, the surgical tool comprising: 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 or the lever, but fails to teach one or more processors configured to analyze a characteristic associated with the actuation force output of the lever or the motor to optimize the surgical procedure.
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 claims 3-5 and 8, 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 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, 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.
Claim 9-10 is 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, ‘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.
Conclusion
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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