DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The claims filed on June 8th, 2026, have been entered. Claims 17-36 remain pending in the Application. The claim amendments overcome the previous claim objection.
Response to Arguments
The rejections of claims 17-21, 28-29, and 36 under 102(a)(1) and 103 over Houser et al. (Pub. No. 2012/0116391), claims 21-23 and 26-35 over Boudreaux et al. (Pub. No. 2013/0289591), and claims 24-25 under 103 over Boudreaux et al. over Parihar et al. (Pub. No. 2022/0061836) have been withdrawn in light of Applicant’s amendment made June 8th, 2026; specifically, Houser et al. does not disclose a preload mechanism and a toggle switch configured to adjust a preload of the preload mechanism, Boudreaux et al. does not disclose a pressure sensor not positioned on the end of the end effector and configured to sense a pressure related to a clamp force, and neither Houser et al. nor Boudreaux et al. disclose a preload mechanism configured to adjust a maximum clamping force of the clamp arm from a first maximum clamping force to a second different maximum clamping force.
Applicant’s arguments with respect to claim(s) 20-27 and 31-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Houser et al. (Pub. No. 2012/0116364).
Regarding claim 20, Houser et al. discloses an ultrasonic instrument (50D; FIGs. 5-7; [0045]) comprising:
a body (60D);
a shaft assembly (FIG. 5: unlabeled in this figure, labeled as 70A in FIG. 3) extending distally from the body (FIG. 5: the shaft extends distally from 60D), wherein the shaft assembly comprises an acoustic waveguide (210F; FIG. 11);
an end effector ([0045] 50D has a clamping end effector similar to end effector 140; FIG. 2), comprising:
an ultrasonic blade ([0044] the end effector has an ultrasonic blade), wherein the ultrasonic blade is in acoustic communication with the acoustic waveguide ([0025] the ultrasonic vibration of the ultrasonic blade is achieved through energy delivered by the acoustic waveguides), and
a clamp arm ([0048] the end effector has a clamp arm), wherein the clamp arm is pivotable toward and away from the ultrasonic blade in order to clamp tissue between the end effector and ultrasonic blade ([0048] the clamp arm can go between open and closed positions to clamp with the opposing blade); and
a pressure sensor (426), wherein the pressure sensor is not positioned on the end effector (FIG. 6: 426 is in 60D, and is not in the end effector), wherein the pressure sensor is configured to sense a pressure related to a clamp force associated with the clamp arm ([0045] 426 is used to determine the force applied to the end effector).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 21-23, 26-27, and 31-36 is/are rejected under 35 U.S.C. 103 as being obvious over Faller et al. (U.S. Patent No. 10,285,724) in view of Boudreaux et al. (Pub. No. 2013/0289591).
The applied reference Faller et al. has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 21, Faller et al. discloses an ultrasonic instrument (10; FIG. 1; C3:L22-24) comprising:
a body (12);
a shaft assembly (14) extending distally from the body (FIG. 1), wherein the shaft assembly comprises a clamp arm (64) and an acoustic waveguide (16);
an end effector (26; FIG. 2A) comprising an ultrasonic blade (66), wherein the ultrasonic blade is in acoustic communication with the acoustic waveguide (C9:L46-47: 66 is acoustically coupled to 16); and
a preload mechanism (714) configured to adjust a maximum clamping force of the clamp arm from a first maximum clamping force to a second maximum clamping force (C27:L29-49: 714 is used to adjust the pre-load value of 704, where if the force applied by the user to the trigger 32 is less than the pre-load value, then the clamping force is not limited; however, if the pre-load value is exceeded, 704 limits the clamping force to the pre-load value set by 714), wherein the first and second maximum clamping forces are different (C28:L20-28: the pre-load value is set by 714 between different values).
Faller et al. does not disclose a sensor configured to sense a clamping force of the clamp arm, wherein the end effector is configured to be activated at varying ultrasonic power levels based on the sensed clamping force.
Boudreaux et al. teaches in the same field of endeavor of ultrasonic blade instruments (Abstract), and discloses an ultrasonic instrument (100; FIGs. 1-3; [0163]) comprising an end effector (81) and a sensor configured to measure the clamping force of the clamp arm ([480] a sensor used to measure the clamping force of the blade 79 and clamp arm 56), wherein the end effector is configured to be activated at varying ultrasonic power levels based on the sensed clamping force ([0478] the clamping force measured by the sensor can act as an input that is used to trigger 56 to close against 79) for the purpose of monitoring the amount of clamping force being exerted by the instrument to ensure proper interaction between the instrument and the tissue ([0478]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Faller et al. to include a sensor, as taught by Boudreaux et al., for the purpose of monitoring the amount of clamping force being exerted by the instrument to ensure proper interaction between the instrument and the tissue.
Regarding claim 22, Faller et al. as modified further discloses a spring (C27:L20-22: 704 can be a tension coil spring), wherein the preload mechanism is operably coupled to the spring (C27:L22-24: the spring sets the pre-load by the connection to the biasing member of 704), wherein the preload mechanism is configured to vary a compression of the spring to thereby adjust the maximum clamp force (C27:L24-28: the pre-load is adjusted by stretching or compressing the spring).
Regarding claim 23, Faller et al. as modified by Boudreaux et al. further discloses the spring is operably coupled to the sensor (Faller et al. C27:L24-28: the spring compression is a proxy for the clamp force, and the modification by Boudreaux et al. in [0478] is to influence the amount of clamp force applied through the detection of the sensor, which necessitates the spring and sensor are operably coupled).
Regarding claims 26-27, Faller et al. as modified by Boudreaux et al. discloses the invention as claimed in claim 21, as discussed above. Faller et al. as presently modified does not disclose the preload mechanism comprises a torsional nut and a threaded rod, wherein the torsional nut is configured to advance along the threaded rod to thereby compress the spring to thereby adjust the maximum clamping force of the clamping arm.
Boudreaux et al. further discloses a preload mechanism (4120) comprising a torsional nut (4133; [0511]; FIG. 94), a threaded rod (4129; [0511]), and a spring ([5051; [0479]; FIG. 105), wherein the torsional nut is configured to advance along the threaded rod to thereby compress the spring to thereby adjust the maximum clamping force of the clamping arm ([0511] the degree to which 4133 is advanced along 4129 determines the acoustic connection between the waveguide and the end effector, which sets the maximum allowable clamping force) for the purpose of securing the spring in the preloaded position and ensuring the maximum clamping force will not vary during the operation ([0511]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Faller et al. to include a torsional nut and a threaded rod to adjust the spring compression and maximum clamping force, as taught by Boudreaux et al., for the purpose of securing the spring in the preloaded position and ensuring the maximum clamping force will not vary during the operation.
Regarding claim 31, Faller et al. as modified further discloses an amplitude switch (C6:L10: the triggering mechanism of generator 20) configured to adjust a power delivered to the ultrasonic blade (C6:L9-13: the triggering mechanism of generator 20 allows for control of the amplitude of electrical signal applied to 66).
Regarding claim 32, Faller et al. as modified further discloses the power is based on a position of the preload mechanism (C27:L29-49: the power of the ultrasonic blade is based on how much clamping force is being exerted by the end effector).
Regarding claim 33, Faller et al. as modified by Boudreaux et al. further discloses the power is based on the sensing of the sensor (Boudreaux et al. [0478] the clamping force measured by the sensor can act as an input that is used to trigger 56 to close against 79).
Regarding claim 34, Faller et al. as modified further discloses the power is selectable by a user (C27:L29-49: the power of the ultrasonic blade is based on how much clamping force is being exerted by the end effector, which is selected by the user when setting the pre-load position).
Regarding claim 35, Faller et al. as modified further discloses the shaft assembly is rotatable relative to the body (FIG. 2 and C8:L30-31: 14 can be rotated by distal rotation assembly 13), wherein the preload mechanism is configured to selectively engage and disengage from the shaft assembly in order to enable rotation of the shaft assembly (C13:L4-19: the rotation of the shaft assembly is linked to the use of the end effector, where alignment features ensure that the end effector is properly positioned after rotation before allowing transmission of ultrasonic energy or clamping force; therefore, the preload mechanism moves in and out of engagement with the shaft assembly by the interaction of the alignment features).
Regarding claim 36, Faller et al. as modified further discloses a trigger (32) mounted to the body and configured to selectively move the clamp arm (C9:L18-22: 32 is pivotably movable to create motion to actuate the jaws and clamping mechanism of the end effector), wherein the preload mechanism is operably coupled to the trigger (C26:L54-56: 710 is operably coupled to 32).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faller et al. in view of Boudreaux et al., and in further view of Parihar et al. (Pub. No. 2022/0061836).
Regarding claim 24, Faller et al. as modified by Boudreaux et al. discloses the invention as claimed in claim 21, as discussed above. Faller et al. does not disclose the preload mechanism comprises a solenoid.
Parihar et al. discloses a solenoid (71; FIGs. 2-5; [0184]) used to shift a transmission (62) between two different drive positions to determine the amount of force being output by the motor (80).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the preload mechanism of Faller et al. (compression spring) for the preload mechanism of Parihar et al. (solenoid) because both structures are functional equivalents at controlling the force output by a device, and the substitution of one for another would have the predictable result of allowing for control of the force of the device.
Regarding claim 25, Faller et al. as modified by Parihar et al. further discloses the solenoid is configured to adjust the maximum clamping force among discrete clamping force amounts (Faller et al. C27:L24-28: the spring compression is a proxy for the clamp force; and the modification by Parihar et al. means the solenoid takes the place of this control).
Allowable Subject Matter
Claims 17-19 are allowed.
Claims 28-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 17 and 28, the prior art does not suggest, in combination with the remaining claim limitations, that the ultrasonic instrument comprises a preload mechanism and a toggle switch configured to adjust the preload of the preload mechanism to adjust a level of clamp force associated with the clamp arm.
One prior art reference, Houser et al. (Pub. No. 2012/0116391), does not disclose, alone or in combination, both a preload mechanism and a toggle switch which adjusts the preload mechanism. Instead, Houser et al. discloses a preload mechanism 2100 and toggle switches associated with 2100 that do not change the preload or clamping force of 2100 ([0114]; FIG. 8).
Another prior art reference, Boudreaux et al. (Pub. No. 2013/0289591), does not disclose, alone or in combination, both a preload mechanism and a toggle switch which adjusts the preload mechanism. Instead, Boudreaux et al. only discloses a single mechanism 4120 for adjusting the total clamp force ([0479]; FIG. 93).
A third prior art reference, Faller et al. (U.S. Patent No. 10,285,724), does not disclose, alone or in combination, a toggle switch configured to adjust a preload of the preload mechanism. While Faller et al. teaches a toggle switch (30; FIG. 2), the toggle switch is used to adjust the power setting of the acoustic waveguide (16) rather than the preload mechanism (714), which is set during assembly of the instrument (C28:L20-28).
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 JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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