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 .
Priority
The present application, filed 12 December 2023, claims foreign priority to German Patent App. No. DE102022134205.0, filed 20 December 2022.
Response to Amendment
Claims 1, 4, 6-8, 10, and 13 have been newly amended. Claims 3, 5, 14 and 15 have been newly canceled. Claims 18 and 19 have been newly added. Claims 1-2, 4, 6-13, and 16-19 remain pending in the present application.
Response to Arguments
Applicant’s arguments with respect to claim 1 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 Objections
Claim 2 is objected to because of the following informalities:
Regarding claim 2, Applicant claims: “The surgical instrument as set forth claim 1….” The examiner recommends amending this to recite: “The surgical instrument as set forth in claim 1….”
Appropriate correction is required.
Election/Restrictions
Newly submitted claim 18 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
a) The inventions as claimed do not overlap in scope, i.e., are mutually exclusive.
Specifically, the inventions as claimed in claim 1 and claim 18 are mutually exclusive, as the steering gear setup of newly submitted claim 18 (“wherein the steering gear has a spatially orientable swash plate and a steering ring coupled to the swash plate…”) would not infringe on the steering gear setup of claim 1 (“wherein the steering gear has a spatially orientable swash plate, the swash plate having a groove extending continuously along a circumference of the swash plate…”).
b) The inventions as claimed are not obvious variants.
Specifically, the examiner asserts that a person having ordinary skill in the art at the effective filing date of the present invention would recognize that the inventions as claimed in claims 1 and 18 are not obvious variants.
c) The inventions as claimed have a materially different mode of operation.
Specifically, the examiner asserts that the invention of claim 1 uses a plurality of ball heads affixed to respective slides, each slide coupled to a particular spindle drive, to adjust the orientation of the steering gear and the swash plate, while the invention of claim 18 uses a single, toothed steering gear which directly interfaces with each of the plurality of spindle drives.
Since Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 18 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should Applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
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 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper (US 20170281296 A1), hereafter Cooper, in view of Pedros (US 20190008600 A1), hereafter Pedros.
Regarding claim 1, Cooper discloses a surgical instrument, comprising:
A housing arranged at the proximal end of the surgical instrument (0135, FIG. 34 shows the gimbaled cable actuator 300 mounted on a lower housing member 380. FIG. 35 shows an upper housing member 382 mounted on the lower housing member 380. The upper housing member 382 includes pivots 384 for rotatably mounting the gear quadrants 314, 316. A cover plate 390 may be mounted over the actuator plate 302 by fasteners 392, as seen in FIGS. 27, 28, 31, 33, and 34.),
A steering gear arranged in the housing, wherein the steering gear has a spatially orientable swash plate, the swash plate having a groove extending continuously along a circumference of the swash plate (0131, The actuator plate 302 is moved by a first actuator link 304 and a second actuator link 306 to produce pitch and yaw rotations. The actuator links 304, 306 are rotatably coupled to a mounting member 308 disposed around the actuator plate 302. Examiner's note: the examiner is interpreting mounting member 308 as the claimed "groove" as they both are disposed "around the actuator plate"), and
A first drive and a second drive, the first drive and the second drive configured to drive the steering gear (0131, The actuator links 304, 306 are driven to move generally longitudinally by first and second follower gear quadrants 314, 316, respectively, which are rotatably coupled with the actuator links 304, 306 via pivot joints 318, 320, as shown in FIGS. 27 and 28. The gear quadrants 314, 316 are rotated by first and second drive gears 324, 326, respectively, which are in turn actuated by drive spools 334, 336, as best seen in FIGS. 34 and 35.);
A first slide mechanically coupled to the first drive, wherein a rotation of the first drive is translated into an axial displacement of the first slide (0131, The actuator links 304, 306 are driven to move generally longitudinally by first and second follower gear quadrants 314, 316, respectively, which are rotatably coupled with the actuator links 304, 306 via pivot joints 318, 320, as shown in FIGS. 27 and 28. The gear quadrants 314, 316 are rotated by first and second drive gears 324, 326, respectively, which are in turn actuated by drive spools 334, 336, as best seen in FIGS. 34 and 35.);
A second slide mechanically coupled to the second drive, wherein a rotation of the second drive is translated into an axial displacement of the second slide (0131, The actuator links 304, 306 are driven to move generally longitudinally by first and second follower gear quadrants 314, 316, respectively, which are rotatably coupled with the actuator links 304, 306 via pivot joints 318, 320, as shown in FIGS. 27 and 28. The gear quadrants 314, 316 are rotated by first and second drive gears 324, 326, respectively, which are in turn actuated by drive spools 334, 336, as best seen in FIGS. 34 and 35.);
A first ball head fixed to the first slide and disposed within the groove (0131, As best seen in FIG. 33, ball ends 310 are used for coupling the actuator links 304, 306 with the mounting member 308 to form ball-in-socket joints in the specific embodiment shown, but other suitable rotational connections may be used in alternate embodiments. Examiner's note: the examiner is interpreting mounting member 308 as the claimed "groove" as they both are disposed "around the actuator plate"); and
A second ball head fixed to the second slide and disposed within the groove, wherein the axial displacement of the first slide and the second slide adjust a position of the first ball head and the second ball head within the groove, adjusting an orientation of the swash plate (0131, The actuator links 304, 306 are rotatably coupled to a mounting member 308 disposed around the actuator plate 302. As best seen in FIG. 33, ball ends 310 are used for coupling the actuator links 304, 306 with the mounting member 308 to form ball-in-socket joints in the specific embodiment shown, but other suitable rotational connections may be used in alternate embodiments. Examiner's note: the examiner is interpreting mounting member 308 as the claimed "groove" as they both are disposed "around the actuator plate").
Cooper fails to explicitly disclose, however, wherein the surgical instrument includes:
An interface arranged on the housing for coupling to a drive unit,
Wherein the first and second drives are spindle drives; and
Wherein each spindle drive has an axis of rotation that is parallel to that of the other and parallel to a longitudinal axis of the surgical instrument.
Pedros, however, in an analogous field of endeavor, does teach a surgical instrument including:
An interface arranged on the housing for coupling to a drive unit (0049, Turning now to FIGS. 2-13, instrument drive assembly 200 is configured to engage instrument control unit 100 at a proximal end 201 thereof and couple to surgical instrument 1000 at a distal end 202 thereof, where surgical instrument 1000 extends distally from instrument drive assembly 200, as described herein. Instrument drive assembly 200 is configured to transfer rotational movement supplied by instrument control unit 100 (e.g., via motors “M”) into longitudinal movement of a drive member 380 (FIGS. 5A and 7-10) to effect various functions of surgical instrument 1000.),
Wherein the first and second drives are spindle drives (0052, Drive nut 350 includes a threaded aperture 352 extending longitudinally therethrough, which is configured to mechanically engage threaded portion 345 of drive screw 340.); and
Wherein each spindle drive has an axis of rotation that is parallel to that of the other and parallel to a longitudinal axis of the surgical instrument (0052, Drive nut 350 includes a threaded aperture 352 extending longitudinally therethrough, which is configured to mechanically engage threaded portion 345 of drive screw 340. That is, drive nut 350 and drive screw 340 are threadingly engaged with each other. Drive nut 350 includes a rail 353 extending longitudinally along an outer surface thereof and is configured to be slidably disposed in the longitudinally extending channel 206 formed in bore 207 of housing assembly 205 (FIGS. 6 and 9). Rail 353 of drive nut 350 cooperates with channel 206 of bore 207 to inhibit or prevent drive nut 350 from rotating about longitudinal axis “A” as drive screw 340 is rotated. Accordingly, drive nut 350 is configured to be positioned on drive screw 340 in a manner such that rotation of drive screw 340 causes longitudinal translation of drive nut 350. More specifically, rotation of proximal gear 310 in a first direction (e.g., clockwise) causes drive screw 340 to rotate in a corresponding first direction and drive nut 350 to translate in a first longitudinal direction (e.g., proximally) with respect to proximal gear 310, and rotation of proximal gear 310 in a second direction (e.g., counter-clockwise) causes drive screw 340 to rotate in a corresponding second direction and drive nut 350 to translate in a second longitudinal direction (e.g., distally) with respect to proximal gear 310. See also 0048-0049, as well as Fig. 1B).
Cooper and Pedros are analogous because they are in a similar field of endeavor, e.g., surgical robotic systems. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the present invention, with a reasonable expectation of success, to have included the drive means and interface of Pedros in order to provide a means of making the surgical instrument of Cooper modular. The motivation to combine is to increase the flexibility in use of the surgical instrument by allowing it to be placed-on and removed-from a modular surgical robot.
Regarding claim 2, the combination of Cooper and Pedros teaches the surgical instrument as set forth claim 1, and Pedros further teaches wherein the interface is arranged on a coupling surface of the housing extending perpendicular to the longitudinal axis of a shaft, the shaft passing through the coupling surface (0049, Turning now to FIGS. 2-13, instrument drive assembly 200 is configured to engage instrument control unit 100 at a proximal end 201 thereof and couple to surgical instrument 1000 at a distal end 202 thereof, where surgical instrument 1000 extends distally from instrument drive assembly 200, as described herein. Instrument drive assembly 200 is configured to transfer rotational movement supplied by instrument control unit 100 (e.g., via motors “M”) into longitudinal movement of a drive member 380 (FIGS. 5A and 7-10) to effect various functions of surgical instrument 1000.).
Cooper and Pedros are analogous because they are in a similar field of endeavor, e.g., surgical robotic systems. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the present invention, with a reasonable expectation of success, to have included the drive means and interface of Pedros in order to provide a means of making the surgical instrument of Cooper modular. The motivation to combine is to increase the flexibility in use of the surgical instrument by allowing it to be placed-on and removed-from a modular surgical robot.
Regarding claim 4, the combination of Cooper and Pedros teaches the surgical instrument as set forth in claim 2, and Pedros further teaches wherein the first spindle drive and the second spindle drive each have a drive plate arranged on the coupling surface (0051, With reference to FIGS. 3, 4 and 7, each inner drive assembly 300 includes a proximal gear 310, a proximal bearing 320, a distal bearing 330, a drive screw 340, and drive nut 350. Drive screw 340 includes a proximal portion 342, a proximal shaft 343, a threaded portion 345 and a distal shaft 344, and defines a longitudinal axis “A-A” extending through a radial center thereof (FIG. 7). Proximal gear 310 is configured to engage, directly or indirectly, with an instrument control gear (e.g., crown gear “CG” of motor “M”) of instrument control unit 100, such that rotation of crown gear “CG” causes a corresponding rotation of proximal gear 310. Proximal gear 310 may be a crown gear “CG” that is configured to mate with and/or mesh with crown gear “CG” of motor “M.”).
Cooper and Pedros are analogous because they are in a similar field of endeavor, e.g., surgical robotic systems. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the present invention, with a reasonable expectation of success, to have included the drive means and interface of Pedros in order to provide a means of making the surgical instrument of Cooper modular. The motivation to combine is to increase the flexibility in use of the surgical instrument by allowing it to be placed-on and removed-from a modular surgical robot.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cooper in view of Pedros, and further in view of Steger (US 20220000570 A1), hereafter Steger.
Regarding claim 16, the combination of Cooper and Pedros teaches the surgical instrument of claim 1, and Pedros further teaches a drive system for the surgical instrument, wherein the drive system comprises a drive unit, which can be attached to a robot arm, wherein the surgical instrument is coupled to the drive unit from the proximal direction via the interface (0048, Control device 4 may control a plurality of motors (e.g., “M1”-“M6”). Motors “M” may be part of instrument control unit 100 and/or disposed externally of instrument control unit 100. Motors “M” (e.g., motors “M” being located externally of instrument control unit 100) may be configured to rotate a crown gear “CG” (FIG. 1B), or the like, that is keyed to or non-rotatably supported on a rotatable shaft of at least some of motors “M,” or act on a cable to draw in or let out length of cable to actuate robot arms 2, 3. In use, as motors “M” are driven, the rotation of crown gear(s) “CG” effects operation, movement, and/or articulation of instrument drive assembly 200 of surgical instrument 1000, and an end effector attached thereto, as discussed below. It is further envisioned that at least one motor “M” receives signals wirelessly (e.g., from control device 4). It is contemplated that control device 4 coordinates the activation of the various motors (Motor 1 . . . n) to coordinate an operation, movement, and/or articulation of robot arms 2, 3 and/or surgical instrument 1000. It is envisioned that each motor may corresponds to a separate degree of freedom of robot arms 2, 3, and/or surgical instrument 1000 engaged with instrument control unit 100. It is further envisioned that more than one motor, including every motor (Motor 1 . . . n), is used for each degree of freedom.).
Cooper and Pedros are analogous because they are in a similar field of endeavor, e.g., surgical robotic systems. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the present invention, with a reasonable expectation of success, to have included the drive means and interface of Pedros in order to provide a means of making the surgical instrument of Cooper modular. The motivation to combine is to increase the flexibility in use of the surgical instrument by allowing it to be placed-on and removed-from a modular surgical robot.
The combination of Cooper and Pedros fails to explicitly teach, however, a sterile adapter plate, which is attached to the drive unit and at least partially covers an interface of the drive unit.
Steger, however, in an analogous field of endeavor, does teach a sterile adapter plate, which is attached to the drive unit and at least partially covers an interface of the drive unit (0023, FIGS. 5A-5C are an illustrative top perspective view (FIG. 5A) and bottom perspective view (FIG. 5B) and rear perspective view (FIG. 5C) of a sterile adapter 502 in accordance with some embodiments. The sterile adapter 502 includes a mechanical adapter interface 504, a first housing 506 that supports a first end portion of a first optical fiber 526, an integral protective pouch 508, and a planar flange drape 510. The mechanical adapter interface 504 and the support 506 are solid material structures. The pouch 508 and the flange drape 510 are flexible, foldable structures formed of durable materials such as polyethylene, polyurethane, polycarbonate, or mixtures thereof, for example.).
Cooper, Pedros, and Steger are analogous because they are in a similar field of endeavor, e.g., surgical robotic systems. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the present invention, with a reasonable expectation of success, to have included the sterile adapter plate of Steger in order to provide a means of connecting the surgical instrument in a sterile manner. The motivation to combine is to ensure that the surgical instrument can maintain sterility for use in a surgical procedure.
Claim 17 is similar in scope to claim 16, and is similarly rejected.
Allowable Subject Matter
Claims 6-13 and 19 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 6, the closest pieces of prior art are Cooper, Pedros, Thissen (US 20220061634 A1), Chassot (US 20180353252 A1), Bagwell (US 20190374277 A1), and Weitzner (US 20080188890 A1).
Cooper teaches an apparatus for pitch and yaw rotation of an elongate surgical tool, wherein the apparatus includes an actuator plate coupled to a plurality of actuators, wherein actuation of the plurality of actuators is operable to adjust the orientation of a swash plate in both pitch and yaw.
Pedros teaches a robotic surgical system having an elongated instrument, wherein a plurality of motors are used to rotate a plurality of drive screws, wherein the rotation of each drive screw effects a translational movement of a respective drive nut, wherein each of the respective drive nuts is coupled to a respective surgical instrument.
Thissen teaches a steering device for an elongated instrument, wherein the steering device comprises a locking plate with a coupling to which a steering plate of the instrument can secure, wherein the steering plate is oriented with two actuators.
Chassot teaches a translatable instrument interface for a surgical robot, wherein the interface has a sterile shield for separating the instrument interface from the sterile surgical environment.
Bagwell teaches a tissue ablation system, wherein reciprocal motion of an ablation device is generated through rotation of a swash plate housed within the ablation system.
Weitzner teaches an elongate surgical tool having a swash plate, wherein actuation of a handle by an operator is operable to adjust the orientation of the swash plate, which in turn adjusts the orientation of the elongate surgical tool.
No reference, however, as a whole or in combination, teaches, discloses, suggests, or otherwise renders obvious:
Wherein the steering gear has a clamp which is arranged on the swash plate, the clamp being recessed with respect to an outer surface of the swash plate so as to define the groove, wherein the first slide and the second slide are coupled to the clamp.
Claims 7-13 and 19 are dependent on claim 6, and are similarly allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE A WOOD whose telephone number is (571)272-6830. The examiner can normally be reached M-F, 8:00 AM to 4:30 PM Eastern.
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, Thomas Worden can be reached at (571) 272-4876. 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.
/BLAKE A WOOD/ Primary Examiner, Art Unit 3658
Prosecution Insights