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 .
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.
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.
Claims 1, 7, 8, and 11-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Definis et al. (US Pat. Pub. 2022/0249182 A1).
Regarding claim 1, Definis provides for an apparatus comprising:
(a) an end effector configured to manipulate tissue (see figure 13 with 1304),
(b) a shaft assembly extending proximally from the end effector (see figure 13 with shaft 1302),
(c) an instrument base (1306 as in figure 13; see [0110], wherein a portion of the shaft assembly located proximally relative to the end effector extending through the instrument base (as in figure 13), wherein the instrument base comprises at least one input assembly configured to operatively engage an output assembly of a robotic arm (via the attachment interface at 1314 having the mechanical inputs 1316), wherein the at least one input assembly is configured to actuate to thereby control movement of the end effector, wherein the output assembly for the robotic arm is configured to drive actuation of the at least one input assembly (see at least [0110] and [0111] discussing the actuation of the end effector), and
(d) a bailout assembly (assembly having the various components as shown in figure 18 and described in at least [0158]), wherein the bailout assembly comprises: (i) an actuating body configured to acuate relative to the instrument base from a pre-bailout position, an engaged position, and a bailout position (1802 functioning to rotate relative to the body from a first position forming the pre-bailout position as in figure 21A, a second position forming the engaged position as in figure 21B and a third position forming the bailout position as in figure 21C), and (ii) a driving assembly configured to actuate from a first position toward a second position to drive the output assembly of the robotic arm out of engagement with the at least one input assembly of the instrument base in response to the actuating body actuating from the engaged position into the bailout position (via the pin 1820 and the cam plate formed by the slot in 1814a; see [0179] and [0180] describing the removal of engagement between the input from the robotic arm to the claimed apparatus), wherein the driving assembly is configured to remain in the first position while the actuating body is in the pre-bailout position (via 1802 being functionally/structurally arranged to not be rotated in the pre-bailout position).
Regarding claim 7, Definis provides that the end effector comprises a knife member configured to actuate between a pre-fired position and a fired position (see [0139] providing for “a cutting element of knife” with such being translatable from a pre-fired to a fired position).
Regarding claim 8, Definis provides for an automatic knife retraction assembly configured to drive the knife member toward the pre-fired position in response to the driving assembly actuating from a first position toward a second position (assembly coupled to 1624c as in figure 19A for driving the knife as in at least [0160]; the Examiner is of the position that the pre-fired position can be considered a position proximal to the distal-most position of the knife and wherein the fired position can be considered the distal-most translation of the knife).
Regarding claims 11-13, Definis provides for a shaft insertion lockout assembly configured to inhibit distal movement of the shaft assembly once the driving assembly reaches the second position (carriage 1626 functions to inhibit the distal movement of the shaft upon reaching the second position). Definis further provides that the shaft insertion lockout assembly comprises a biased locking body slidably coupled to a chassis assembly of the instrument base (via carriage 1626 being slidable relative to the base) as well as an annular array of locking teeth fixed to a first input assembly of the at least one input assembly (see [0142] providing for the teeth via either the lead screw thread or the nut thread in [0143]) .
Regarding claim 14, Definis provides for a shaft clocking assembly configured to rotational fix the shaft assembly relative to the instrument base about a longitudinal axis of the shaft assembly (carriage 1626 functions to rotationally fix the shaft relative to the base; see [0142] and [0143]).
Regarding claim 15, Definis provides that the shaft clocking assembly is configured to inhibit disassembly of the instrument base unless the shaft assembly is in a predetermined retracted position or the driving assembly is in the second position (via the carriage functioning to provide a visual indication to not dissemble the device when the shaft is longitudinally advanced [such as within a patient]; and to indicate ability to be disassembled in a retracted position [such as when the end effector in retracted from use within the patient]).
Regarding claim 16, Definis provides for an apparatus comprising:
(a) an end effector configured to manipulate tissue (see figure 13 with 1304),
(b) a shaft assembly extending proximally from the end effector (see figure 13 with shaft 1302),
(c) an instrument base (1306 as in figure 13; see [0110]), wherein a portion of the shaft assembly located proximally relative to the end effector extending through the instrument base (as in figure 13), wherein the instrument base comprises at least one input assembly configured to operatively engage an output assembly of a robotic arm (via the attachment interface at 1314 having the mechanical inputs 1316), wherein the at least one input assembly is configured to actuate to thereby control movement of the end effector, wherein the output assembly for the robotic arm is configured to drive actuation of the at least one input assembly (see at least [0110] and [0111] discussing the actuation of the end effector), and
(d) a two-stage bailout assembly configured to drive the output assembly of the robotic arm out of engagement with the at least one input assembly of the instrument base (assembly having the various components as shown in figure 18 and described in at least [0158]), wherein the two-stage bailout assembly comprises a user-input feature configured to actuate through a first range of motion to render the two-stage bailout assembly operable, wherein the user-input feature is configured to actuate through a second range of motion to drive the output assembly of the robotic arm out of engagement with the at least one input assembly of the instrument base (1802 functioning to rotate relative to the body through a first range to the position as in figure 21A, and then a second range of motion to the position as in figure 21C).
Regarding claim 17, Definis provides that the end effector comprises a pair of jaws (See the jaws at 1304 as in figure 13).
Regarding claim 18, Definis provides that the two-stage bailout assembly is associated with the instrument base (the based formed by 1306 is associated with the assembly as relied on in the rejection of claim 16 having the various components as shown in figure 18 via at least the structural interrelationships between the two).
Regarding claim 19, Definis provides that the at least one input assembly comprises a pair of input assemblies configured to drive a knife member of the end effector via the attachment interface at 1314 having the mechanical inputs 1316; see further 1636a as in [0145] driving the carriage forward/backward to laterally translate the knife forward/backward and see 1624c forming a second as in [0148] to specifically advance/retract the knife).
Regarding claim 20, Definis provides for an apparatus comprising:
(a) an end effector configured to manipulate tissue (see figure 13 with 1304),
(b) a shaft assembly extending proximally from the end effector (see figure 13 with shaft 1302),
(c) an instrument base slidably housing the shaft assembly (1306 as in figure 13; see [0110]), wherein the instrument base comprises at least one input assembly configured to operatively engage an output assembly of a robotic arm (via the attachment interface at 1314 having the mechanical inputs 1316),
wherein the at least one input assembly is configured to actuate to thereby control movement of the end effector (one of 1316 functioning in light of [0146] to provide for the opening/closing of the end effector), and
wherein the output assembly for the robotic arm is configured to drive actuation of the at least one input assembly (via the outputs 1208 as in figure 12) and
(d) a two-stage bailout assembly (assembly having the various components as shown in figure 18 and described in at least [0158]) configured to remain inoperable until a first condition is satisfied (inoperable until a first portion of rotation is completed to achieve the position as in figure 21B), wherein the two-stage bailout assembly is configured to drive the output assembly of the robotic arm out of engagement with the at least one input assembly of the instrument base in response to a second condition being satisfied after the first condition is satisfied (via the pin 1820 achieving a position in the ring 1814b; see [0179] and [0180] describing the removal of engagement between the input from the robotic arm to the claimed apparatus).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Definis et al. (US Pat. Pub. 2022/0249182 A1) as applied to claim 1 above, and further in view of Stahler et al. (US Pat. Pub. 2009/0024141 A1).
Regarding claim 2, while Definis provides for a cam plate and a pin (see figure 20 with the pin at 1820 and the plate formed by the guide slot 1818). Definis fails, however, to specifically provide that the pin is a pogo pin. Stahler, however, provides for a spring-loaded pin akin to a pogo pin that follows a rotational and vertical guide path within a device (see spring 335 in figures 25A-D). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a pogo pin for the pin 1820 of Definis in view of the spring-loaded pin teaching in Stahler. A pogo pin is a known spring-loaded pin in the art akin to the pin of Stahler with such functioning to provide for a biased guide pin in the art that operates in a similar motion as the pin 1820 of Definis. The Examiner is further of the position that the use of a spring-loaded pin versus a solid pin would provide for a device that can adjust to manufacturing defects or misalignments between the various plates of the bailout of Definis thereby providing for a device that more effectively rotates through the various bailout positions in figures 21A-C.
Regarding claim 3, in view of the combination in the rejection of claim 2 above, Definis further provides that the cam plate is configured to drive the pogo pin in response to actuating from the first position toward the second position (via the slot in 1814a driving the pin in a vertical or slanted direction for future interaction with similar slots in 1814b/c).
Regarding claim 4, Definis provides for a bailout engagement feature slidably attached to the cam plate (plate 1814b that slides relative to 1814a).
Regarding claim 5, Definis provides that the bailout engagement feature is configured to couple with the actuating body in response to the actuating body reaching the engaged position (via 1802 moving the pin 1820 to be within the slot in 1814b when 1802 is in the engaged position).
Regarding claim 6, Definis provides that he bailout engagement feature is biased toward the actuating body (via the plate 1814b being held toward the body 1802 via the intermediary structure holding the plate 1814b toward the inner surface of 1802).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Definis et al. (US Pat. Pub. 2022/0249182 A1).
Regarding claims 9 and 10, while Definis provides for the automatic knife retraction assembly as in the rejection of claim 8 above, Definis fails to provide for a first sector gear associated with the driving assembly and a second sector gear associated with the at least one input assembly. Definis provides in a separate embodiment in figures 27A-C for an alternative manner of driving a knife retraction assembly wherein the assembly includes a first sector gear associated with the driving assembly (gear at 2704) and a second sector gear (gear at 2718). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a sector gear arrangement as in figures 27A-C of Definis as a driving arrangement in the embodiment in figures 18-21C of to provide for a manner of driving the bailout assembly to provide for a retraction of knife assembly as well as the opening of the jaw assembly. The embodiment in figures 27A-C is silent with respect to the manner in which such would provide a disengagement from the robotic drive and the Examiner is of the position that the combination with the embodiment in figures 18-21C with its various plates would provide for such a bailout system to allow for the easier, decoupled movement of the drive members.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794