DETAILED ACTION
The following is a Final Office Action on the merits.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 4/23/2026.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Claim Objections
Claim 21 is objected to because of the following informalities: amend “the distal advancement” to -distal advancement- in ll. 13. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: amend “the distal advancement” to -distal advancement- in ll. 11. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: amend “the motor driving” to -the motor configured to drive- in ll. 15-16. Appropriate correction is required.
Claim 33 is objected to because of the following informalities: amend “the distal advancement” to -distal advancement- in ll. 14. Appropriate correction is required.
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.
Claims 21, 25-26, 33 & 37-38 is/are rejected under pre-AIA 35 U.S.C. 102(a) and 102(e) as being anticipated by Heard (2010/0274244).
Concerning claim 21, as illustrated in at least Fig. 2-5 & 12, Heard discloses a surgical instrument (electrosurgical instrument 120; [0058]), comprising:
an end effector (end effector 14; [0032]), comprising:
a first jaw comprising a first electrode; a second jaw comprising a second electrode, wherein the second jaw is rotatable relative to the first jaw about a pivot to grasp tissue between the first jaw and the second jaw, and wherein the first electrode and the second electrode are configured to deliver radiofrequency energy to the tissue grasped between the first jaw and the second jaw (jaw members 32, 34 comprising electrode segments 50 and are each pivotally coupled to the elongate shaft 16 by a respective pivot pin 36 and connect to an electrosurgical generator via connector 22; [0033], [0035-0036]); and
a sensor configured to measure an impedance associated with the tissue grasped between the first jaw and the second jaw (sensor(s) 70 may also include an impedance sensor to detect a characteristic of effectively sealed tissue; [0049]);
a drive beam (reciprocating member 54; [0037]) comprising:
a knife configured to cut the tissue grasped between the first jaw and the second jaw based on distal advancement of the drive beam (reciprocating member 54 includes a sharpened blade 56 at a forward edge that permits the reciprocating member 54 to transect tissue as the reciprocating member 54 is advanced through the knife channel 52; [0038]); and
a flange configured to cam against the second jaw to rotate the second jaw relative to the first jaw based on the distal advancement of the drive beam (flanges 62 each include a forward cam driver 66 at a distal end, and a cam engagement surface 68 extending laterally, permitting the reciprocating member 54 to engage the jaw members 32, 34 substantially over a length of the clamping surfaces 42, 44; [0040]);
a motor configured to drive the distal advancement of the drive beam (motor 130 may be activated to drive the reciprocating member 54; [0059);
a processor (controller 72; [0060]); and a memory coupled to the processor, (controller 72 may include an algorithm to receive information, thus an inherent memory; [0060]) the memory storing instructions (algorithm) that, when executed by the processor:
control a power of the radiofrequency energy delivered to the tissue grasped between the first jaw and the second jaw based on the impedance measured by the sensor (controller 70 interrupts application of energy once tissue sealing has been effected between sets of electrodes and may be configured to provide a signal to the electrosurgical generator to automatically discontinue the delivery of electrosurgical energy when sealing is complete; [0045], [0049]); and
control a power of the motor for driving the distal advancement of the drive beam based on the impedance measured by the sensor; and prevent the motor from driving the distal advancement of the drive beam until the tissue grasped between the first jaw and the second jaw is sealed based on the impedance measured by the sensor (controller 72 may include an algorithm to receive information from the electrodes 50 and sensors 70, 76 (FIGS. 9 and 10) to determine an appropriate time to advance and interrupt motion of the reciprocating member 54 when sealing is complete; [0049], [0058-0060]).
Concerning claim 25¸ Heard discloses the memory further stores instructions that, when executed by the processor, cause the motor (130) to: drive the drive beam (54) during a first time period; pause the drive beam (54) after the first time period; and drive the drive beam (54) during a second time period ([0045-0047]; Fig. 8A-C).
Concerning claim 26¸ Heard discloses the memory further stores instructions that, when executed by the processor (72), cause the motor (130) to change a direction in which the drive beam (54) is driven based on the measurement of the impedance ([0047], [0058], [0060]).
Concerning claim 33, as illustrated in at least Fig. 2-5 & 12, Heard discloses a surgical instrument (electrosurgical instrument 120; [0058]), comprising:
an end effector (end effector 14; [0032]), comprising:
a first jaw comprising a first electrode; a second jaw comprising a second electrode, wherein the second jaw is pivotable relative to the first jaw to transition the end effector from an open configuration to a closed configuration to grasp tissue between the first jaw and the second jaw, and wherein the first electrode and the second electrode are configured to deliver radiofrequency energy to the tissue grasped between the first jaw and the second jaw (jaw members 32, 34 comprising electrode segments 50 and are each pivotally coupled to the elongate shaft 16 by a respective pivot pin 36 and connect to an electrosurgical generator via connector 22; [0033], [0035-0036]); and
a sensor configured to measure an impedance parameter associated with the tissue grasped between the first jaw and the second jaw (sensor(s) 70 may also include an impedance sensor to detect a characteristic of effectively sealed tissue; [0049]);
a drive beam (reciprocating member 54; [0037]) comprising:
a knife configured to cut the tissue grasped between the first jaw and the second jaw based on distal advancement of the drive beam (reciprocating member 54 includes a sharpened blade 56 at a forward edge that permits the reciprocating member 54 to transect tissue as the reciprocating member 54 is advanced through the knife channel 52; [0038]); and
a flange configured to cam against the second jaw to rotate the second jaw relative to the first jaw based on the distal advancement of the drive beam (flanges 62 each include a forward cam driver 66 at a distal end, and a cam engagement surface 68 extending laterally, permitting the reciprocating member 54 to engage the jaw members 32, 34 substantially over a length of the clamping surfaces 42, 44; [0040]);
a motor configured to drive the distal advancement of the drive beam (motor 130 may be activated to drive the reciprocating member 54; [0059); and
a control system (controller 72; [0060]), configured to:
cause the motor to drive the distal advancement of the drive beam to clamp the tissue between the first jaw and the second jaw with the flange and to cut the tissue with the knife while the end effector is in the closed configuration (after the end effector 14 is moved from an open configuration to a closed configuration, motor 130 is activated to drive reciprocating member 54 such that cam engagement surfaces engage jaw members 32, 34 to define a gap distance “G” between electrodes 50 and cut tissue; [0041], [0058-0060]);
receive a measurement of the impedance parameter measured by the sensor during the time period (sensor(s) 70 may also include an impedance sensor to detect a characteristic of effectively sealed tissue; [0049]);
control a power of the radiofrequency energy delivered to the tissue grasped between the first jaw and the second jaw based on the impedance measured by the sensor (controller 70 interrupts application of energy once tissue sealing has been effected between sets of electrodes and may be configured to provide a signal to the electrosurgical generator to automatically discontinue the delivery of electrosurgical energy when sealing is complete; [0045], [0049]);
control a power of the motor for driving the distal advancement of the drive beam based on the impedance measured by the sensor; and prevent the motor from further driving the distal advancement of the drive beam until the tissue grasped between the first jaw and the second jaw is sealed based on the impedance measured by the sensor (controller 72 may include an algorithm to receive information from the electrodes 50 and sensors 70, 76 (FIGS. 9 and 10) to determine an appropriate time to advance and interrupt motion of the reciprocating member 54 when sealing is complete; [0049], [0058-0060]).
Claim 37 is rejected upon the same rationale as presented for claim 25.
Claim 38 is rejected upon the same rationale as presented for claim 26.
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 22-24, 27-32 & 34-36 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Heard (2010/0274244), as applied to claims 21 & 33, in further view of Zemlock et al. (2009/0090763, previously cited).
Concerning claim 22¸ Heard disclose the sensor (70) comprises a first sensor. Heard fails to disclose a second sensor configured to sense a speed of the drive beam. Zemlock et al. disclose a surgical instrument (10) comprising an end effector (160) having jaws (162, 164), a drive beam (220) configured to actuate a knife to sever tissue, a motor (200) configured to drive distal advancement of the drive beam (220), a processor (500/600) comprising a memory storing instructions to control a power of a motor (200) for driving the advancement of the of the drive beam (220) at a speed based on sensor measurements (as tissue thickness and/or speed of firing rod). Zemlock et al. further disclose a second sensor (418) configured to sense the speed of the elongate member (220) ([0111], [0150-0151]; Fig. 5). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Heard to further comprise a second sensor configured to sense a speed of the drive beam in order to provide the benefit of adjusting the motor speed, such as determining if the motor is malfunctioning, or the drive beam is at a mechanical stop as taught by Zemlock et al. ([0118-0125])
Concerning claim 23¸ Heard fails to disclose a visual feedback device in communication with the processor, wherein the visual feedback device is configured to display the speed of the drive beam sensed by the second sensor. However, Zemlock et al. further disclose a visual feedback device (120) in communication with the processor (500), wherein the visual feedback device (120) is configured to display the speed of the elongate member (220) sensed by the second sensor (418) ([0060], [0118-0121], [0148]; Fig. 3). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Heard to further comprise a visual feedback device in communication with the processor, wherein the visual feedback device is configured to display the speed of the drive beam sensed by the second sensor in order to provide the benefit of communicating information to the operator as taught by Zemlock et al. ([0060], [0065], [0172]).
Concerning claim 24¸ Heard fails to disclose a second sensor configured to sense a thickness of the tissue. However, Zemlock et al. disclose a second sensor configured to sense a thickness of the tissue ([0150]; Table 1). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Heard to further comprise a second sensor configured to sense a thickness of the tissue in order to provide the benefit of adjusting operation of the drive beam based on measured parameters as taught by Zemlock et al. ([0150])
Concerning claim 27, as illustrated in at least Fig. 2-5 & 12, Heard discloses a surgical instrument (electrosurgical instrument 120; [0058]), comprising:
an end effector (end effector 14; [0032]), comprising:
a first jaw comprising a first electrode; a second jaw comprising a second electrode, wherein the second jaw is rotatable relative to the first jaw to grasp tissue between the first jaw and the second jaw (jaw members 32, 34 comprising electrode segments 50 and are each pivotally coupled to the elongate shaft 16 by a respective pivot pin 36 and connect to an electrosurgical generator via connector 22; [0033], [0035-0036]); and
a sensor configured to measure an impedance associated with the tissue grasped between the first jaw and the second jaw (sensor(s) 70 may also include an impedance sensor to detect a characteristic of effectively sealed tissue; [0049]);
a drive beam comprising:
a knife configured to cut the tissue grasped between the first jaw and the second jaw based on distal advancement of the drive beam (reciprocating member 54 includes a sharpened blade 56 at a forward edge that permits the reciprocating member 54 to transect tissue as the reciprocating member 54 is advanced through the knife channel 52; [0038]); and
a flange configured to cam against the second jaw to rotate the second jaw relative to the first jaw based on the distal advancement of the drive beam (flanges 62 each include a forward cam driver 66 at a distal end, and a cam engagement surface 68 extending laterally, permitting the reciprocating member 54 to engage the jaw members 32, 34 substantially over a length of the clamping surfaces 42, 44; [0040]);
a motor configured to drive the distal advancement of the drive beam to clamp the tissue between the first jaw and the second jaw with the flange and to cut the tissue with the knife (motor 130 may be activated to drive the reciprocating member 54; [0059]; and
a control module (controller 72; [0060]) configured to:
control a power of radiofrequency energy delivered by the first and second electrode to the tissue grasped between the first jaw and the second jaw based on the impedance measured by the sensor (controller 70 interrupts application of energy once tissue sealing has been effected between sets of electrodes and may be configured to provide a signal to the electrosurgical generator to automatically discontinue the delivery of electrosurgical energy when sealing is complete; [0045], [0049]); and
control the motor power based on the impedance measured by the sensor (controller 72 may include an algorithm to receive information from the electrodes 50 and sensors 70, 76 (FIGS. 9 and 10) to determine an appropriate time to advance and interrupt motion of the reciprocating member 54 when sealing is complete; [0049], [0058-0060]).
Heard fails to disclose the motor driving the drive beam at a speed based on a motor power. However, Zemlock et al. disclose a surgical instrument (10) comprising an end effector (160) having jaws (162, 164), a drive beam (220) configured to actuate a knife to sever tissue, a motor (200) configured to drive distal advancement of the drive beam (220), a control module (500/600) configured to control the motor power and drive beam speed based on the measurement measured by the sensor measurements (such as tissue thickness and/or speed of firing rod). At the time of the invention, it would have been obvious to one of ordinary skill in the art to modify the invention of Heard to further comprise a motor configured to drive the drive beam at a speed based on a motor power; in order to provide the benefit of automatically adjusting operating parameters of the motor in response to sensed feedback signals as taught by Zemlock et al. ([0007], [0048], [0054], [0103], [0111], [0124-0125], [0147], [0150], [0153-0155], [0158], [0169], Table1)
Claim 28 is rejected upon the same rationale as presented for claim 22.
Claim 29 is rejected upon the same rationale as presented for claim 23.
Claim 30 is rejected upon the same rationale as presented for claim 24.
Claim 31 is rejected upon the same rationale as presented for claim 25.
Claim 32 is rejected upon the same rationale as presented for claim 26.
Claim 34 is rejected upon the same rationale as presented for claim 22.
Claim 35 is rejected upon the same rationale as presented for claim 23.
Claim 36 is rejected upon the same rationale as presented for claim 24.
Response to Arguments
Applicant’s arguments with respect to the claims 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Bales et al. (2009/0138006) discloses a motor activated cutting blade.
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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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