DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant’s amendment filed 8/11/2026 has been entered.
Claims 1-20 are cancelled.
Claims 21-40 are new and now pending.
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 21-23, 30-34, and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 9-11 of US Patent 9,408,606 (cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other as outlined below:
Note although the language outlined below is different between the two claims the claims are not patentably distinct. The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by 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, 1052, 29 USPQ2d 2010, 2015-16 (Fed. Cir. 1993).
Regarding Claim 21 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct. As outlined below, Claims 9-11 of US Patent 9,408,606 (recitations thereof in BOLD) discloses each feature of Claim 21 of the instant Application.
21. A surgical device for use with a robot (“A surgical instrument for use with a robotic system”), the surgical device comprising:
an end effector (“an end effector”) comprising a firing beam (“a firing sled”);
a drive shaft (“a rotary drive shaft”) actuatable to drive the firing beam (“to apply said rotary control motions to said firing sled”);
a firing driver (“a second rotary driven gear”) transitionable between a first configuration and a second configuration (“for movement into and out of meshing engagement with said first rotary driven gear”), wherein the drive shaft (“a rotary drive shaft”) is drivable by a rotary input from the robot in the first configuration to drive the firing beam through at least a portion of the end effector (“a firing sled movable relative to said staple cartridge between a first position and a second position in response to rotary control motions applied to said firing sled” and “said rotary drive shaft to apply at least one said rotary control motion to said firing sled”), and wherein the drive shaft (“rotary drive shaft”) is not drivable by the rotary input in the second configuration (as outlined, the drive shaft comprises the second gear mounted thereon and the claim recites “to selectively move said second rotary driven gear out of meshing engagement with said first rotary driven gear” and therefore not drivable by rotary input from the “driven element”); and
a manual actuator (“a manually-actuated reversing system” must have some form of actuator) rotatable (note Claims 10-11 recite the system comprising rotatable gears (i.e. “ratchet gear”) to switch configurations) to:
transition the firing driver (“a second rotary driven gear”) into the second configuration (“out of meshing engagement with the first rotary driven gear”); and
drive the drive shaft (“rotary drive shaft”) to retract the firing beam proximally (“rotary control motions to said second rotary driven gear to cause said rotary drive shaft to apply at least one said rotary control motion to said firing sled to move said firing sled in a reversing direction”).
Regarding Claim 22 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
22. The surgical device of Claim 21, further comprising a drive interface gear (“a first rotary driven gear”) rotatable by the rotary input from the robot (via “driven element” and “rotary drive gear”), wherein the firing driver (“a second rotary driven gear”) comprises a drive shaft gear (“a second rotary driven gear”) shifted into meshing engagement with the drive interface gear (“a first rotary driven gear”) based on transitioning the firing driver into the first configuration (“movement into and out of meshing engagement with said first rotary driven gear”).
Regarding Claim 23 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
23. The surgical device of Claim 22, further comprising a reversing gear (a reversing gear”-Claim 10) movable based on rotation of the manual actuator (claim 11 outlines pivotal movement of the rachet gear to move the reversing gear”), wherein the reversing gear is meshingly engaged with the drive shaft gear (“meshing engagement with said second rotary driven gear”), and wherein movement of the reversing gear by the manual actuator is configured to cause the drive shaft gear (“second rotary driven gear”) to disengage from the drive interface gear (“first rotary driven gear”), thereby transitioning the firing driver from the first configuration into the second configuration (“as said reversing gear is pivoted from the unactuated position to the actuated position, said reversing gear axially biases said second rotary driven gear out of meshing engagement with said first rotary driven gear”-Claim 11).
Regarding Claim 30 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
30. The surgical device of Claim 21, wherein the end effector is configured to receive a stapling cartridge (“an end effector, comprising: a staple cartridge”), and wherein driving the firing beam distally through at least a portion of the end effector causes ejection of staples from the staple cartridge received by the end effector (“a firing sled movable relative to said staple cartridge between a first position and a second position in response to rotary control motions … configured to eject said staples from said staple cartridge”).
Regarding Claim 31 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
31. A surgical device for use with a robot (“a surgical instrument for use with a robotic system”), the surgical device comprising:
an end effector (“a end effector”) comprising a firing beam (“a firing sled”);
a drive shaft (“a rotary drive shaft”) actuatable to drive the firing beam through at least a portion of the end effector (“to apply said rotary control motions to said firing sled”);
a firing drive assembly (“a second rotary driven gear”) transitionable between a first configuration and a second configuration (“for movement into and out of meshing engagement with said first rotary driven gear”), wherein the firing drive assembly in the first configuration actuates drive shaft to drive the firing beam through at least a portion of the end effector based on receiving a rotary drive motion from a drive interface of the robot (“a firing sled movable … a first position and a second position in response to rotary control motions applied to said firing sled” and “said rotary drive shaft to apply at least one said rotary control motion to said firing sled”), and wherein the firing drive assembly (“a second rotary driven gear”) in the second configuration prevents the rotary drive motion from actuating the drive shaft (as outlined the drive shaft comprises the second gear mounted thereon and the claim recites “to selectively move said second rotary driven gear out of meshing engagement with said first rotary driven gear” and therefore not drivable by rotary input from the “driven element”); and
a manually actuatable reversing assembly (“a manually-actuated reversing system”) configured to transition the firing drive assembly (“a second rotary driven gear”) to the second configuration and cause the drive shaft to proximally drive the firing beam through at least a portion of the end effector based on receiving a manual actuation input (“a manually-actuated reversing system …to selectively move said second rotary driven gear out of meshing engagement with said first rotary driven gear and apply manually-generated, rotary control motions to said second rotary driven gear to cause said rotary drive shaft to apply at least one said rotary control motion to said firing sled to move said firing sled in a reversing direction”).
Regarding Claim 32 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
32. The surgical device of Claim 31, wherein the firing drive assembly (“a second rotary driven gear”) comprises
a drive interface gear (“a first rotary driven gear”) rotatable by the drive interface of the robot (via “driven element” and “rotary drive gear”); and
a shaft gear (“a second rotary driven gear”) rotatable to actuate the drive shaft (“rotary control motions to said second rotary driven gear to cause said rotary drive shaft to apply at least one said rotary control motion”), wherein the drive interface gear (“a first rotary driven gear”) and the shaft gear (“a second rotary driven gear”) are meshingly engaged in the first configuration of the firing drive assembly (“a second rotary driven gear movably mounted… into and out of meshing engagement with said first rotary driven gear”).
Regarding Claim 33 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
33. The surgical device of Claim 32, wherein the manually actuatable reversing assembly comprises:
an actuator (associated with “ratchet gear”-Claim 10) configured to receive the manual actuation input (“the manually-generated, rotary control motions to said reversing gear”); and
a reversing gear meshingly engaged with the shaft gear (“a reversing gear in meshing engagement with said second rotary driven gear”), wherein the reversing gear is configured to shift the shaft gear out of engagement with the drive interface gear (“said reversing gear axially biases said second rotary driven gear out of meshing engagement with said first rotary driven gear”), thereby transitioning the firing drive assembly to the second configuration, based on the actuator receiving the manual actuation input (“a ratchet gear supported for selective meshing engagement with said reversing gear such that manual actuation of said ratchet gear applies the manually-generated, rotary control motions to said reversing gear”).
Regarding Claim 34 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
34. (New) The surgical device of Claim 33, wherein the manually actuatable reversing assembly further comprises an arcuate gear (“ratchet gear”-Claim 10; note although not claimed as “arcuate”, such a shape is common in gearing configurations as any rounded gear is “arcuate”) movable from an unactuated position to an actuated position based on the actuator receiving the manual actuation input, wherein the arcuate gear meshingly engages the reversing gear based on moving from the unactuated position to the actuated position (as outlined in Claims 10-11).
Regarding Claim 40 of the instant Application, Claims 9-11 of US Patent 9,408,606 renders the Claim patentably indistinct.
40. A surgical device for use with a robot (“A surgical instrument for use with a robotic system”), the surgical device comprising:
an end effector (“an end effector”) comprising a firing beam (“a firing sled”);
a drive shaft (“a rotary drive shaft”) configured to drive the firing beam (“to apply said rotary control motions to said firing sled”);
a firing drive assembly (“a second rotary driven gear”) configured to operatively couple the drive shaft (“a rotary drive shaft”) to a drive interface (via “driven element”, “a first rotary driven gear”, and “rotary drive gear”) of the robot and cause the drive shaft (“a rotary drive shaft”) to drive the firing beam (“a firing sled”) based on receiving a rotary drive motion from the drive interface (“a second rotary driven gear movably mounted to said rotary drive shaft of said shaft assembly for movement into and out of meshing engagement with said first rotary driven gear wherein the drive system is in operable engagement with said driven element to apply robotically-generated actuation motions to said driven element to cause said rotary drive shaft to apply at least one said rotary control motion to said firing sled”); and
a bailout actuator (“a manually-actuated reversing system”) configured to cause the firing drive assembly (including “a second rotary driven gear”) to decouple the drive shaft (“a rotary drive shaft”) from the drive interface and cause the drive shaft to retract the firing beam within the end effector based on receiving a manual bailout input (“apply manually-generated, rotary control motions”; “a manually-actuated reversing system … to selectively move said second rotary driven gear out of meshing engagement with said first rotary driven gear and apply manually-generated, rotary control motions … to cause said rotary drive shaft to apply at least one said rotary control motion to said firing sled to move said firing sled in a reversing direction”).
Claims 28-29 and 38-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 9-11 of US Patent 9,408,606 in view of Zemlock (US PGPUB 2009/0090763).
Regarding Claims 28-29 and 38-39 of the instant Application, Claims 9-11 of US Patent 9,408,606 disclose several features of the claimed invention including a shaft assembly intermediate the end effector and the firing driver (“a shaft assembly operably coupled to said end effector”-Claim 9 and since the “firing driver” is “a second rotary driven gear” which is mounted to the “rotary drive shaft”, the shaft assembly is positioned as claimed), however, Claims 9-11 of US Patent 9,408,606 are silent on wherein the end effector is rotatable relative to the shaft assembly about an articulation joint and wherein the end effector comprises a first jaw and a second jaw pivotable relative to the first jaw, and wherein the firing beam is drivable along one of the first jaw or the second jaw.
Attention is brought to Zemlock which outlines an end effector (160; Figure 1) rotatable relative to the shaft assembly (140 and body portion 168) about an articulation joint (mounting portion 166; Para. 0050) and wherein the end effector (160) comprises a first jaw (164) and a second jaw (162) pivotable relative to the first jaw (164; Para. 0049), and wherein a firing beam (213; Figure 8) is drivable along one of the first jaw or the second jaw (162, 164; Para 0082).
The use of an articulating end effector comprising jaws and a firing member is common structure of a surgical stapling instrument. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Claims 9-11 of US Patent 9,408,606 to comprise such and end effector and firing beam as taught by Zemlock in order to readily grasp, manipulate and fasten the tissue being operated on.
Claims 21, 29-31, 39 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4, 7, 8 of US Patent 10,485,541 (cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other as outlined below:
Regarding Claim 21 of the instant Application, Claims 1-4 of US Patent 10,485,541 render the Claim patentably indistinct. As outlined below, Claims 1-4 of US Patent 10,485,541 (recitations thereof in BOLD) discloses/render obvious each feature of Claim 21 of the instant Application.
21. A surgical device for use with a robot (“a surgical tool for use with a robotic system”), the surgical device comprising:
an end effector (“a surgical end effector”) comprising a firing beam (“a firing member”);
a drive shaft (“a firing shaft”) actuatable to drive the firing beam (“a firing shaft operably interfacing with said firing member to apply firing motions thereto”);
a firing driver (“a second rotary drive assembly”) transitionable between a first configuration and a second configuration (“movable between a first engaged position, … a disengaged position”), wherein the drive shaft (“a firing shaft”) is drivable by a rotary input from the robot (via “the rotary output members”) in the first configuration (“a first engaged position”) to drive the firing beam through at least a portion of the end effector (“said second rotary drive assembly to apply rotary firing motions to said firing shaft in a first rotary direction” and “firing shaft operably interfacing with said firing member to apply firing motions thereto”), and wherein the drive shaft (“firing shaft”) is not drivable by the rotary input in the second configuration (“a disengaged position, wherein said second rotary drive assembly is disengaged from said first rotary drive assembly” and therefore the shaft is not drivable by the rotary/robot input); and
a manual actuator (“a manually-actuatable control system”) configured to:
transition the firing driver into the second configuration (“move said second rotary drive assembly out of operable engagement with said first rotary drive assembly”); and
drive the drive shaft to retract the firing beam proximally (“apply additional rotary firing motions to said firing shaft” per Claim 1 and “said additional rotary firing motions to said firing shaft in said second direction, said firing shaft causes said firing member to move in a proximal direction towards said starting position” per Claim 4).
Note that although Claims 1-4 of US Patent 10,485,541 do not explicitly disclose the manual actuator/“a manually-actuatable control system” being rotatable, this is not viewed as a patentably distinguishable feature as in order to apply rotary firing motions some form of rotational actuation must occur.
Regarding Claim 29 of the instant Application, Claims 1-4 of US Patent 10,485,541 renders the Claim patentably indistinct.
29. The surgical device of Claim 21, wherein the end effector comprises a first jaw and a second jaw pivotable relative to the first jaw, and wherein the firing beam is drivable along one of the first jaw or the second jaw (“a first jaw and a second jaw; and a firing member axially movable between a starting position and an ending position within said first and second jaws”; note it can be reasonably implied that the jaws are pivotable relative to one another).
Regarding Claim 30 of the instant Application, Claims 1-4, 7 and 8 of US Patent 10,485,541 renders the Claim patentably indistinct. Although Claims 1-4 of US Patent 10,485,541 do not readily disclose the end effector is configured to receive a stapling cartridge, and wherein driving the firing beam distally through at least a portion of the end effector causes ejection of staples from the staple cartridge received by the end effector such features are clearly outlined in Claim 8 of US Patent 10,485,541 and would be obvious to one of ordinary skill in the art to incorporate into the tool of Claims 1-4 of US Patent 10,485,541 as such structure is common in surgical staplers and would allow the tool to readily fasten tissue clamped.
Regarding Claim 31 of the instant Application, Claims 1-4 of US Patent 10,485,541 render the Claim patentably indistinct. As outlined below, Claims 1-4 of US Patent 10,485,541 (recitations thereof in BOLD) discloses/render obvious each feature of Claim 21 of the instant Application.
31. A surgical device for use with a robot (“a surgical tool for use with a robotic system”), the surgical device comprising:
an end effector (“a surgical end effector”) comprising a firing beam (“a firing member”);
a drive shaft (“a firing shaft”) actuatable to drive the firing beam through at least a portion of the end effector (“a firing shaft operably interfacing with said firing member to apply firing motions thereto”);
a firing drive assembly (“a second rotary drive assembly”) transitionable between a first configuration and a second configuration (“movable between a first engaged position, … a disengaged position”), wherein the firing drive assembly in the first configuration (“a first engaged position”) actuates drive shaft (“a firing shaft”) to drive the firing beam through at least a portion of the end effector based on receiving a rotary drive motion from a drive interface of the robot (“said second rotary drive assembly to apply rotary firing motions to said firing shaft in a first rotary direction” and “firing shaft operably interfacing with said firing member to apply firing motions thereto”), and wherein the firing drive assembly in the second configuration (“a disengaged position”) prevents the rotary drive motion from actuating the drive shaft (“a disengaged position, wherein said second rotary drive assembly is disengaged from said first rotary drive assembly” and therefore the shaft is not drivable by the rotary/robot input); and
a manually actuatable reversing assembly (“a manually-actuatable control system”) configured to transition the firing drive assembly to the second configuration (“move said second rotary drive assembly out of operable engagement with said first rotary drive assembly”) and cause the drive shaft to proximally drive the firing beam through at least a portion of the end effector based on receiving a manual actuation input (“apply additional rotary firing motions to said firing shaft” per Claim 1 and “said additional rotary firing motions to said firing shaft in said second direction, said firing shaft causes said firing member to move in a proximal direction towards said starting position” per Claim 4).
Regarding Claim 39 of the instant Application, Claims 1-4 of US Patent 10,485,541 renders the Claim patentably indistinct.
39. The surgical device of Claim 31, wherein the end effector comprises a first jaw and a second jaw pivotable relative to the first jaw, and wherein the firing beam is drivable along one of the first jaw or the second jaw (“a first jaw and a second jaw; and a firing member axially movable between a starting position and an ending position within said first and second jaws”; note it can be reasonably implied that the jaws are pivotable relative to one another).
Regarding Claim 40 of the instant Application, Claims 1-4 of US Patent 10,485,541 render the Claim patentably indistinct. As outlined below, Claims 1-4 of US Patent 10,485,541 (recitations thereof in BOLD) discloses/render obvious each feature of Claim 21 of the instant Application.
40. A surgical device for use with a robot (“a surgical tool for use with a robotic system”), the surgical device comprising:
an end effector (“a surgical end effector”) comprising a firing beam (“a firing member”);
a drive shaft (“a firing shaft”) configured to drive the firing beam (“a firing shaft operably interfacing with said firing member to apply firing motions thereto”);
a firing drive assembly (“a second rotary drive assembly”) configured to operatively couple the drive shaft (“a firing shaft”) to a drive interface of the robot (via “a first engaged position” with “a first rotary drive assembly”) and cause the drive shaft to drive the firing beam based on receiving a rotary drive motion from the drive interface (“said second rotary drive assembly to apply rotary firing motions to said firing shaft in a first rotary direction” and “firing shaft operably interfacing with said firing member to apply firing motions thereto”); and
a bailout actuator (“a manually-actuatable control system”) configured to cause the firing drive assembly to decouple the drive shaft from the drive interface (“a disengaged position, wherein said second rotary drive assembly is disengaged from said first rotary drive assembly”) and cause the drive shaft to retract the firing beam within the end effector based on receiving a manual bailout input (“apply additional rotary firing motions to said firing shaft” per Claim 1 and “said additional rotary firing motions to said firing shaft in said second direction, said firing shaft causes said firing member to move in a proximal direction towards said starting position” per Claim 4). .
Claims 28 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-4 of US Patent 10,485,541, in view of Zemlock (US PGPUB 2009/0090763).
Regarding Claims 28 and 38 of the instant Application, Claims 1-4 of US Patent 10,485,541 disclose several features of the claimed invention including a shaft assembly intermediate the end effector and the firing driver/drive assembly (“an elongate shaft assembly operably coupled to said surgical end effector”-Claim 1 and since the “firing driver” is “a second rotary drive assembly” which is comprised by the “tool mounting portion”, the shaft assembly is positioned as claimed), however, Claims 1-4 of US Patent 10,485,541 are silent on wherein the end effector is rotatable relative to the shaft assembly about an articulation joint.
Attention is brought to Zemlock which outlines an end effector (160; Figure 1) rotatable relative to the shaft assembly (140 and body portion 168) about an articulation joint (mounting portion 166; Para. 0050) and wherein the end effector (160) comprises a first jaw (164) and a second jaw (162) pivotable relative to the first jaw (164; Para. 0049), and wherein a firing beam (213; Figure 8) is drivable along one of the first jaw or the second jaw (162, 164; Para 0082).
The use of an articulating end effector comprising jaws and a firing member is common structure of a surgical stapling instrument. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Claims 1-4 of US Patent 10,485,541 to comprise such an articulatable end effector as taught by Zemlock in order to readily grasp, manipulate and fasten the tissue being operated on.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-22, 26, 28-32, 36, and 38-40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith (US PGPUB 2010/0089970), in view of Dachs II (US PGPUB 2012/0150192).
Regarding Claim 21, Smith discloses a surgical device (10; Figure 1), the surgical device (10) comprising:
an end effector (12; Figure 1) comprising a firing beam (knife bar assembly 750; Figure 56);
a drive shaft (700; Figure 57) actuatable to drive the firing beam (knife bar assembly 750; Para. 0134);
a firing driver (710) transitionable between a first configuration (Figure 56) and a second configuration (Figure 57), wherein the drive shaft (700) is drivable by a rotary input from a motor (702) in the first configuration to drive the firing beam (750) through at least a portion of the end effector (12; Para. 0134), and wherein the drive shaft (700) is not drivable by the rotary input (of 702) in the second configuration (Figure 57;Para. 0135); and
a manual actuation system (800, 715) configured to:
transition the firing driver (710) into the second configuration (Figure 57; Para. 0135-0136); and
drive the drive shaft (700) to retract the firing beam (750) proximally (Para. 0135-0136).
However, Smith fails to explicitly disclose the device (10) for use with a robot such that the rotary input is from a robot and further, Smith fails to disclose the manual actuation system including a singular actuator being rotatable to do both transition the firing driver into the second configuration and drive the drive shaft to retract the firing beam proximally.
First, attention can be brought to the teachings of Dachs II which includes a surgical device (tool 62; Figure 5B or 70; Figure 6A; see "stapler" mentioned in Paras. 0004, 0007-0008, 0091, 0125, 0133, etc.) wherein the device (62, 70) is for use with a robotic system (370; Figure 22) comprising a plurality of rotary drivers (390, 396, 408, 402; Figure 22), an enclosure (72-note the enclosure shown in Figure 5B) removably coupleable to the robotic system (via frame 82), a first rotary actuator (interface 400) configured to be driven by a first rotary driver (390) of the plurality of rotary drivers (390, 396, 408, 402; Para. 0140) to perform a firing function (via actuator 378; Para. 0136 describes a cutting/stapling function), a second rotary actuator (interface 394) is configured to be driven by a second rotary driver (main shaft motor 390) of the plurality of rotary drivers (390, 396, 408, 402; Para. 0140), and further rotary actuators (406, 412) configured to be driven by other rotary drivers (402, 408) for carrying out other control functions (Para. 0140).
Use of robotic systems have been continually incorporated with surgical tools/devices. It would have been obvious to one of ordinary skill in the art at the time of the invention to have incorporated the device of Smith to be useable with a robotic system as taught by Dachs II. By incorporating the device of Smith into a robotic system, the device can be used in a manner that increases a surgeon's dexterity when working on an internal surgical site as well as to allow a surgeon to operate on a patient from a remote location (outside the sterile field) as outlined by Dachs II (Para. 0006).
Secondly, attention can be brought to another embodiment of Figures 54-55 of Smith which includes a manual actuator (lever including a crown gear 624 incorporated therewith; Paras. 0128-0129) wherein the manual actuator (lever, 624) is rotatable to transition the firing driver (621-623) into the second configuration (Figure 55; engaged with crown gear 624; Para. 0128 outlines ”lever crown gear 624 can include a cam surface, such as cam surface 640, for example, which can be engaged by a cam extending from the manual retraction lever” and therefore it can be reasonably implied that rotation of the lever engages the cam 640 to engage the crown gear 624 with central gear 622) and drive the drive shaft (600) to retract a firing beam (via 600) proximally (Para. 0128-0129).
As outlined by the embodiment of Figures 54-55 of Smith, a singular manual actuator (i.e. a lever) can be readily rotated to shift a firing driver/drive system between configurations as well as drive the drive shaft to retract a firing beam. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have integrated the yoke (715) with the manual retraction mechanism (800) of the embodiment of Figures 55-56 of Smith to be one mechanism as taught by the embodiment of Figures 54-55 of Smith. By modifying the embodiment of Figures 55-56 of Smith in this manner, the shifting of configurations and the manual retraction can be carried out with the same mechanism/actuator.
Further note it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1993). Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations. See MPEP 2144.04 (V)(B).
Regarding Claim 22, Smith, as modified, discloses a drive interface gear (708) rotatable by the rotary input from the robot (note modification above), wherein the firing driver (710) comprises a drive shaft gear (710) shifted into meshing engagement with the drive interface gear (708) based on transitioning the firing driver (710) into the first configuration (Figure 56; Para. 0134).
Regarding Claim 26, Smith, as modified, discloses several features of the claimed invention including a shaft spring (720) configured to bias the firing driver (710) toward the second configuration (Figure 57), however, the spring (720) does not bias the driver (710) to the first configuration (Figure 56). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have rearranged the spring to bias the driver towards the first configuration (Figure 56), since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations. See MPEP 2144.04 (VI)(A).
Regarding Claim 28, Smith, as modified, discloses a shaft assembly (8; Figure 1 including 750 extending therethrough) intermediate the end effector (12) and the firing driver (710), wherein the end effector (12) is rotatable relative to the shaft assembly about an articulation joint (at 14; Figure 1; Para. 0056).
Regarding Claim 29, Smith, as modified, discloses the end effector (12) comprises a first jaw (24) and a second jaw pivotable relative to the first jaw (22), and wherein the firing beam (750) is drivable along one of the first jaw (22) or the second jaw (24; Para. 0134).
Regarding Claim 30, Smith, as modified, discloses the end effector (12) is configured to receive a stapling cartridge (34; Figure 3), and wherein driving the firing beam (750) distally through at least a portion of the end effector (12) causes ejection of staples from the staple cartridge (34) received by the end effector (see Para. 0134 which outlines a staple sled).
Regarding Claim 31, Smith discloses a surgical device (10; Figure 1), the surgical device (10) comprising:
an end effector (12; Figure 1) comprising a firing beam (knife bar assembly 750; Figure 3);
a drive shaft (700; Figure 57) actuatable to drive the firing beam (knife bar assembly 750) through at least a portion of the end effector (Para. 0134);
a firing drive assembly (708, 710, 713, 720) transitionable between a first configuration (Figure 56) and a second configuration (Figure 57), wherein the firing drive assembly (708, 710, 713, 720) in the first configuration (Figure 56) actuates drive shaft (700) to drive the firing beam (750) through at least a portion of the end effector (12) based on receiving a rotary drive motion from a drive interface (motor shaft, gear box 701) of a motor (702; Para. 0134), and wherein the firing drive assembly (708, 710, 713, 720) in the second configuration prevents the rotary drive motion from actuating the drive shaft (700; Paras. 0135-0136); and
a manually actuatable reversing assembly (800, 717) configured to transition the firing drive assembly (708, 710, 713, 720) to the second configuration (Figure 57; Para. 0135-0136) and cause the drive shaft (700) to proximally drive the firing beam (750) through at least a portion of the end effector (12) based on receiving a manual actuation input (from 810; Para. 0135-0136).
However, Smith fails to explicitly disclose the device (10) is capable of use with a robot such that the rotary drive motion is from a robot.
Attention can be brought to the teachings of Dachs II (see rejection of Claim 21 above).
Use of robotic systems have been continually incorporated with surgical tools/devices. It would have been obvious to one of ordinary skill in the art at the time of the invention to have incorporated the device of Smith to be useable with a robotic system as taught by Dachs II. By incorporating the device of Smith into a robotic system, the device can be used in a manner that increases a surgeon's dexterity when working on an internal surgical site as well as to allow a surgeon to operate on a patient from a remote location (outside the sterile field) as outlined by Dachs II (Para. 0006).
Regarding Claim 32, Smith, as modified, discloses the firing drive assembly comprises:
a drive interface gear (708) rotatable by the drive interface (of motor/gear box 701) of the robot (as modified); and a shaft gear (710) rotatable to actuate the drive shaft (700), wherein the drive interface gear (708) and the shaft gear (710) are meshingly engaged in the first configuration (Figure 56) of the firing drive assembly (see Para. 0134).
Regarding Claim 36, Smith, as modified, discloses several features of the claimed invention including a shaft spring (720) configured to bias the shaft gear (710) towards meshing with a reverse gear (832) but does not disclose the spring (720) is configured to bias the shaft gear towards the drive interface gear (708)
It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have rearranged the spring to bias the driver towards the drive interface gear, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations. See MPEP 2144.04 (VI)(A).
Regarding Claim 38, Smith, as modified, discloses a shaft assembly (8; Figure 1 including 750 extending therethrough) intermediate the end effector (12) and the firing driver (710), wherein the end effector (12) is rotatable relative to the shaft assembly about an articulation joint (at 14; Figure 1; Para. 0056).
Regarding Claim 39, Smith, as modified, discloses the end effector (12) comprises a first jaw (24) and a second jaw pivotable relative to the first jaw (22), and wherein the firing beam (750) is drivable along one of the first jaw (22) or the second jaw (24; Para. 0134).
Regarding Claim 40, Smith discloses a surgical device (10; Figure 1), the surgical device (10) comprising:
an end effector (12; Figure 1) comprising a firing beam (knife bar assembly 750; Figure 3);
a drive shaft (700; Figure 57) configured to drive the firing beam (knife bar assembly 750) through at least a portion of the end effector (Para. 0134);
a firing drive assembly (710, 713, 720) configured to operatively couple the drive shaft (700) to a drive interface (708) of a motor (702) and cause the drive shaft (700) to drive the firing beam (750; Para 0134) based on receiving a rotary drive motion from the drive interface (708; Para. 0134); and
a bailout actuation system (800, 717) configured to cause the firing drive assembly (710, 713, 720) to decouple the drive shaft (700) from the drive interface (708) and cause the drive shaft (700) to retract the firing beam (750) within the end effector (12) based on receiving a manual bailout input (from 810; Para. 0135-0136). .
However, Smith fails to explicitly disclose the device (10) is capable of use with a robot such that the rotary drive motion is from a robot. Further, Smith does not explicitly disclose the bailout actuation system is a singular bailout actuator to both decouple the drive shaft from the drive interface and cause the drive shaft to retract as claimed.
First, attention can be brought to the teachings of Dachs II (see rejection of Claim 21 above).
Use of robotic systems have been continually incorporated with surgical tools/devices. It would have been obvious to one of ordinary skill in the art at the time of the invention to have incorporated the device of Smith to be useable with a robotic system as taught by Dachs II. By incorporating the device of Smith into a robotic system, the device can be used in a manner that increases a surgeon's dexterity when working on an internal surgical site as well as to allow a surgeon to operate on a patient from a remote location (outside the sterile field) as outlined by Dachs II (Para. 0006).
Secondly, attention can be brought to another embodiment of Figures 54-55 of Smith which includes a bailout/manual actuator (lever including a crown gear 624 incorporated therewith; Paras. 0128-0129) wherein the manual actuator (lever, 624) is rotatable to transition the firing driver (621-623) into the second configuration (Figure 55; engaged with crown gear 624; Para. 0128 outlines ”lever crown gear 624 can include a cam surface, such as cam surface 640, for example, which can be engaged by a cam extending from the manual retraction lever” and therefore it can be reasonably implied that rotation of the lever engages the cam 640 to engage the crown gear 624 with central gear 622) and drive the drive shaft (600) to retract a firing beam (750) proximally (Para. 0128-0129).
As outlined by the embodiment of Figures 54-55 of Smith, a singular manual actuator (i.e. a lever) can be readily rotated to shift a firing driver/drive system between configurations as well as drive the drive shaft to retract a firing beam. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have integrated the yoke (715) with the manual retraction mechanism (800) of the embodiment of Figures 55-56 of Smith to be integrated into one bailout actuator/mechanism as taught by the embodiment of Figures 54-55 of Smith. By modifying the embodiment of Figures 55-56 of Smith in this manner, the shifting of configurations and the manual retraction can be carried out with the same mechanism/actuator.
Further note it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1993). Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations. See MPEP 2144.04 (V)(B).
Claims 27 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Smith (US PGPUB 2010/0089970), in view of Dachs (US PGPUB 2012/0150192), as applied to Claims 22 and 32, and in further view of Zemlock (US PGPUB 2009/0108048).
Regarding Claims 27 and 37, Smith, as modified, discloses several features of the claimed invention and further teaches a solenoid for decoupling/locking a drive shaft (Para. 0138) but does not readily disclose a solenoid configured to move/shift the firing driver/shaft gear (710) toward the first configuration/into meshing engagement with the drive interface gear (708).
Attention can be brought to the teachings of Zemlock which includes a surgical device (100; Figure 1) which includes a solenoid (220; Figure 4) for shifting a drive gear (200) to place the device into different driving modes/configurations (see Para. 0032).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized a solenoid as taught by Zemlock to shift the firing driver/shaft gear of Smith to the first configuration/into meshing engagement with the drive interface gear. By utilizing such a solenoid as taught by Zemlock, the firing driver/shaft gear can be returned to its first configuration selectively.
Allowable Subject Matter
Claims 23, 33 and 34 would be allowable if the Double Patenting rejection outlined above is overcome.
Claims 24-25 and 35 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 Claim 23, Smith, as modified, discloses several features of the claimed invention including a reversing gear (ratchet face 832) movable based on rotation of the manual actuator (717, 800 as modified), wherein the reversing gear is meshingly engaged with the drive shaft gear (710; Para. 0135-0136), however, Smith, as modified, does not disclose wherein movement of the reversing gear (832) by the manual actuator is configured to cause the drive shaft (710) gear to disengage from the drive interface gear (708), thereby transitioning the firing driver (710) from the first configuration (Figure 56) into the second configuration (Figure 57).
Similarly regarding Claim 33, Smith, as modified, discloses the manually actuatable reversing assembly (800, 717) comprises an actuator (810) configured to receive the manual actuation input (Para. 0135-0136); and a reversing gear (832) meshingly engaged with the shaft gear (710), but does not disclose wherein the reversing gear (832) is configured to shift the shaft gear out of engagement with the drive interface gear, thereby transitioning the firing drive assembly to the second configuration, based on the actuator receiving the manual actuation input.
Response to Arguments
Applicant's arguments filed 8/11/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on Pages 9-11 that:
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In response to Applicant's argument that there is no suggestion to combine the references, the Examiner recognizes that references cannot be arbitrarily combined and that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references. In re Nomiya, 184 USPQ 601 (CCPA 1915). However, there is no requirement that a motivation to make the modification be expressly articulated. The test for combining references is what the combination of disclosures take as a whole would suggest to one of ordinary skill in the art. In re McLaughlin, 110 USPQ 209 (CCVA 1971). References are evaluated by what they suggest to one versed in the art, rather than by their specific disclosures. In re Bozek, 163 USPQ 545 (CCPA. 1969).
In this instance, Smith teaches a motorized surgical instrument with a manual or bailout actuator/reversing assembly. As outlined in the rejection, use of robotic systems have continually been incorporated with surgical tools/devices such that such instruments can be driving remotely as outlined. Dachs II provides a teaching of such a robotic system. It is respectfully asserted that one of ordinary skill in the art at the time the invention was effectively filed would have been readily motivated to modify the instrument/system of Smith to be capable of use with a robot (i.e. utilizing a mount and housing) and replacing the drive motor of Smith with a robotic motor output such as taught by Dachs II as outlined above) to gain such benefits of a robotic system.
Further, it has been held that: the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As outlined above, Dachs II is relied upon for teaching use of a robotic system with a surgical instrument and while the specific features thereof may not necessarily be incorporated into Smith, Dachs II provides sufficient teaching such that one of ordinary skill in the art would have been motivated to modify Smith to be capable of use with such a robotic system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. see “Notice of References Cited”.
-Caillouette (US Patent 5,556,401) discloses manual actuators (193, 194; Figure 5) rotatable to override motors and control drive shafts.
-Choi (KR 100978222 B1) discloses a hybrid surgical robot system which can be controlled by a robot and a human operator.
-Won (WO 2011/115387) discloses a manual override for controlling manipulation of the robotic system.
-Wenderow (US PGPUB 2010/0069833) discloses a manual override for a robotic catheter system.
-Kirschenman (US PGPUB 2009/0247943) discloses a manual override (450) for a robotic manipulator.
-Tovey (US Patent 6,231,565-previously cited) and Jinno (US PGPUB 2004/0092912) discloses further motivations toward using instruments with a robotic system
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 9/1/2026
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