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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 02/13/2024 and 05/23/2025 have been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see Remarks filed 02/12/2026, with respect to the rejection of claims 1, 6, 7, 11, 16, 17, and 20 under 35 USC 102 in view of Holop have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Holop and incorporated reference Cooper. Holop does not disclose each and every one of the amended limitations of a motor coupler assembly including a collar assembly non-rotatably coupled to the distal end of the rotatable shaft; a motor coupler non-rotatably and slidably coupled to the collar assembly, wherein the motor coupler is slidable along a rotation axis of the rotatable shaft; and a spring disposed between the collar assembly and the motor coupler. However, Cooper, which is incorporated by reference by Holop, does disclose these features. See 35 USC 103 rejection below.
Claim Rejections - 35 USC § 103
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.
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 1, 4-11, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Holop et al (US 20190223966 A1) in view of incorporated reference Cooper (US 20160184037 A1).
Regarding claims 1, 11, and 20 Holop teaches a robotic surgical system (200), comprising:
a motor block module supporting a motor assembly (see [0091-0092]; instrument manipulator assembly 440 having motor pack 446),
the motor assembly including a motor having a shaft assembly (see [0094-0096]; shaft assembly comprising drive output assembly 443 and drive output disk 445),
the shaft assembly including a rotatable shaft (see [0134]; controller 290 sends a signal to rotate drive output disk 445 via drive output assembly 443) and a motor coupler assembly secured to the rotatable shaft (see [0096]; drive output disk 445 has a drive interface including alignment elements which are regarded as the motor coupler assembly),
the motor coupler assembly including:
a motor coupler (445) and a spring engaged with the motor coupler (see [0095]; drive output assembly 443 includes a preload spring assembly and a drive output disk 445); and
a sterile adapter assembly (450) mounted to the motor block module (see [0121]; sterile adapter assembly 450 is mounted on instrument manipulator assembly 440) and supporting an adapter coupler (453) that is positioned to engage with the motor coupler (see [0127]; adapter 450 having intermediate disk assemblies 453 to interface with the drive output assemblies),
wherein the adapter coupler (453) is seated in an opening formed in the sterile adapter assembly (450), wherein the adapter coupler is rotatable within the opening and is translatable in a direction along the rotation axis of the rotatable shaft (see [0126]; adapter 450 includes a frame 451 and a movable manipulator-instrument interface plate 451C, which is mounted in frame 451 so that plate 451C can move in the proximal and distal directions within frame 451, a plurality of intermediate disks is mounted in plate 451C so that each of the plurality of disks can rotate relative to frame 451);
the adapter coupler positioned to impart axial force onto the motor coupler sufficient to compress the spring (see Fig. 4C, [0132]; preload spring assembly in each drive output assembly 443 is compressed which exerts force onto drive output disk 445 and corresponding adapter coupling interface) when the adapter coupler and the motor coupler are rotationally misaligned (see [0133]; when the adapter and the motor block are first mounted, the coupling elements may not be aligned),
the motor coupler being rotatable relative to the adapter coupler to rotationally align the motor coupler and the adapter coupler (see [0134]; if the coupling disks are not correctly mated, the controller will send a signal to lock adapter coupling disks 453 while motor block drive output disk 445 rotates until the disks are coupled), the spring positioned to move the motor coupler toward the adapter coupler when the motor coupler and the adapter coupler are rotationally aligned such that the adapter coupler and the motor coupler can rotate together (see [0134]; under partial coupling the disks remain coupled due to the corresponding interface of disks 445 and 455 so that they may rotate together, so it can be appreciated that the disks may also rotate together when they are fully aligned); and
a surgical instrument (460) securable to the adapter assembly, the surgical instrument including an instrument coupler that is positioned to engage with the adapter coupler (see [0142]; driven disk 464 of instrument assembly 460 interfaces with intermediate drive interface 456 of intermediate disk 453 of adapter assembly), the adapter coupler positioned to rotate relative to the instrument coupler when the instrument coupler and the adapter coupler are rotationally misaligned to rotationally align the adapter coupler with the instrument coupler (see [0145-0146]; when the instrument coupler 464 and the adapter coupler interface 456 of coupler 453 are not aligned, the rotation of instrument coupler disk 464 is prevented and adapter coupler disk 453 rotates until they reach alignment).
Holop is silent regarding the motor coupler assembly including a collar assembly non-rotatably coupled to the distal end of the rotatable shaft;
a motor coupler non-rotatably and slidably coupled to the collar assembly, wherein the motor coupler is slidable along a rotation axis of the rotatable shaft; and
a spring disposed between the collar assembly and the motor coupler.
It can be appreciated that Holop incorporates the art of Cooper, with reference to the disclosed motor pack and drive units (Holop [0096]), wherein Cooper teaches a surgical system having an adapter assembly coupled to a motor assembly (drive output assembly 543) including:
a motor coupler assembly including a collar assembly (544) non-rotatably coupled to the distal end of the rotatable shaft (see Cooper fig. 16A, [0225-0228]; low backlash coupler 544 is coupled to the drive unit and may transmit torque from the drive unit);
a motor coupler (545) non-rotatably and slidably coupled to the collar assembly (see Cooper fig. 16A, [0228]; coupler 544 and drive output disk 545 are coupled by two pins), wherein the motor coupler is slidable along a rotation axis of the rotatable shaft (see Cooper [0177]; each drive output assembly 543 is spring loaded and is automatically positioned so that a preload force is exerted against drive output disk 545); and
a spring disposed between the collar assembly and the motor coupler (see annotated Cooper fig. 16A below wherein spring 1601 is disposed at least partially between collar 544 and motor coupler 545).
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the motor pack and drive units taught by Cooper as incorporated by Holop with the adapter assembly taught by Holop. One of ordinary skill in the art would have been motivated to make this modification in order to securely and safely couple a motor pack having a plurality of drive units to a sterile adapter assembly for use in a surgical application.
Regarding claims 4 and 14, Holop and Cooper teach the robotic surgical systems of claims 1 and 11. Holop is silent regarding wherein the spring is supported on a fastener that secures the motor coupler to the collar assembly.
It can be appreciated that Holop incorporates the art of Cooper, with reference to the disclosed motor pack and drive units (Holop [0096]), wherein Cooper teaches the spring supported on a fastener that secures the motor coupler to the collar assembly (see Cooper Fig. 16a, [0225-0228]; preload spring 1601 has one end affixed to a proximal side of drive output disk 545 wherein drive output disk 545 and coupler 544 may be regarded as the fastener devices securing one another as they are connected via pins).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate the motor assembly having a spring supported on a fastener as taught by Cooper into the adapter assembly taught by Holop. One of ordinary skill in the art would have been motivated to make this modification in order to couple the drive units and the motor coupler so that force transmitted by the spring can be transferred to the drive output disk acting as the motor coupler (Cooper [0020]).
Regarding claims 5 and 15, Holop and Cooper teach the system of claims 4 and 14. Holop further teaches wherein the motor coupler is axially movable along the fastener and relative to the collar assembly as the spring moves between a compressed position and an expanded position. It can be appreciated that the motor coupler 445 is axially movable relative to the collar assembly as the spring moves between a compressed and expanded position because the collar assembly attached to drive units 441 may move between different preload states (Holop [0130]) which exerts pressure on the preload spring causing it to compress (Holop [0132]), where the motor coupler extends from the distal face of the motor assembly (Holop [0098]).
Regarding claims 6 and 16, Holop and Cooper teach the robotic surgical systems of claims 1 and 11. Holop further teaches wherein the sterile adapter assembly includes an adapter body and an adapter plate that support the adapter coupler therebetween (see Holop [0126]; sterile adapter 450 includes frame 451 which may be regarded as the adapter body and interface plate 451C having a plurality of mounted intermediate disks).
Regarding claims 7 and 17, Holop and Cooper teach the robotic surgical system of claims 6 and 16. Holop further teaches wherein the adapter body includes an anti-rotation feature selectively engageable with an anti-rotation feature of the adapter coupler to prevent the adapter coupler from rotating when the motor coupler and the adapter coupler are misaligned (see [0134]; when disks are misaligned, the controller sends a signal to inhibit the rotation of adapter disks 453) and the adapter coupler is moved to a distal-most position in the opening of the sterile adapter assembly. Holop is silent regarding wherein the anti-rotation feature is located in the body of the sterile adapter assembly and projecting proximally from a distal wall of the adapter body.
Cooper teaches wherein the adapter body (651/651C) includes an anti-rotation feature (1761) located in the opening of the sterile adapter assembly and projecting proximally from a distal wall of the adapter body (see Cooper Fig. 17B where hard stop 1761 projects proximally from a distal wall of the adapter body 651C),
the anti-rotation feature of the adapter body (1761) selectively engageable with an anti-rotation feature of the adapter coupler (1767) to prevent the adapter coupler from rotating when the motor coupler and the adapter coupler are misaligned and the adapter coupler is moved to a distal-most position in the opening of the sterile adapter assembly (see Cooper [0253-0254]; in Fig. 17A intermediate disk 653 is in the most distal position, intermediate disk 653 has a tab 1767 extending from an outer side surface of disk 653 and extending from the proximal end surface of disk 653, wherein tab 1767 can contact hard stop 1761 and upon contact, rotation of intermediate disk 653 is stopped).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the anti-rotation features disclosed by Cooper with the sterile adapter assembly of Holop, wherein Holop incorporated the prior art of Cooper by reference. One of ordinary skill in the art would have been motivated to make this modification in order to selectively inhibit the rotation of an intermediate disk of the adapter assembly while the motor coupler assembly is rotated until the two assemblies are mated together (Cooper [0179]).
Regarding claims 8 and 18, Holop and Cooper teach the surgical system of claims 1 and 11. Holop teaches the motor block module includes a tongue (see Holop [0096]; distal end of drive output disk 445 has drive interface including drive dogs and alignment elements extending in a distal direction for interfacing with the adapter), and the adapter assembly supports a distal end cap (see Holop [0095-0096]; drive output assembly 443 having drive output disk 445 at the distal end, which may be considered as a distal end cap), the distal end cap defining a locking groove that is positioned to receive the tongue of the motor block module to secure the motor block module to the distal end cap (see Holop [0127]; adapter interface 455 includes a first alignment receptable and drive dog receptables).
Holop is silent regarding wherein the adapter assembly includes a tongue and the motor block module supports a distal end cap having a locking groove. Holop teaches wherein the sterile adapter assembly includes a tongue which interfaces with another drive interface having a distal end cap with a complementary locking groove (see Holop [0127]; intermediate driven interface 455 includes a first alignment receptable and drive dog receptables, intermediate drive interface 456 includes drive dogs and an engagement structure). Cooper also teaches in paragraph [0140], surgical device interface 450 having tongues on one end positioned in grooves in instrument manipulator assembly housing 448.
It can be appreciated that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to swap/reconfigure the coupling structures as taught by Holop to reflect that of the claimed invention in order to securely couple the motor block module and the adapter. It has been held that a reversal and/or rearrangement of parts of an invention involves only routine skill in the art as the reversal/rearrangement of the coupling structures does not result in any unexpected or novel results. See MPEP 2144.04(VI), In re Gazda 104 USPQ 400, In re Japikse 86 USPQ 70.
Regarding claims 9 and 19, Holop and Cooper teach the systems of claims 1 and 11. Holop teaches wherein the adapter coupler includes a drive channel on a distal end portion thereof (see Holop [0127]; adapter interface 455 includes a first alignment receptable and drive dog receptables) and the motor coupler includes a proximal cleat that is positioned to be received within the drive channel of the adapter coupler when the motor coupler and the adapter coupler are rotationally aligned (see Holop [0096]; distal end of drive output disk 445 has drive interface including drive dogs and alignment elements extending in a distal direction for interfacing with the adapter).
Holop is silent regarding wherein the motor coupler includes a drive channel on the distal end and the adapter coupler includes a cleat. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to swap the coupling structures as taught by Holop to reflect that of the claimed invention in order to securely couple the motor coupler and the adapter coupler. It has been held that a reversal and/or rearrangement of parts of an invention involves only routine skill in the art as the reversal/rearrangement of the coupling structures does not result in any unexpected or novel results. See MPEP 2144.04(VI), In re Gazda 104 USPQ 400, In re Japikse 86 USPQ 70.
Regarding claim 10, Holop and Cooper teach the robotic surgical system of claim 9. Holop further teaches wherein the adapter coupler includes a distal cleat (see Holop [0127]; intermediate drive interface 456 includes drive dogs and an engagement structure) that is configured to engage with an instrument coupler of a surgical instrument (see Holop [0142]; driven disk 464 of instrument assembly 460 interfaces with intermediate drive interface 456 of intermediate disk 453 of adapter assembly).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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