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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 29 October 2025. As directed by the amendment: Claims 1, 4, 22, and 23 have been amended, claims 2, 5-11, 17, and 21 are cancelled, claims 13-16, 18-20, and 25 stand withdrawn, and claims 26-29 are newly added. Claims 1, 3, 4, 12-16, 18-20, and 22-29 currently stand pending in the application.
The claim amendments are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn.
Response to Arguments
Applicant's arguments filed 29 October 2025 have been fully considered but they are not persuasive. Applicant contends that Mikus (US 2002/0087152) fails to disclose a sleeve extending along a first axis and at least one spike extending along a second axis offset from the first axis, as recited by the amended claims 1 and 22. Applicant contends that the sleeve (1020) and the spike (1024) are illustrated as extending along the same axis, particularly since the distal end 1024 is an integrally formed, tapered end of the sleeve/dilator 1020. Examiner respectfully submits that the sleeve 1020 in Mikus extends along a multitude of axes, including but not limited to the central longitudinal axis, any axis extending through the lumen, any axis along one of its sides, etc., any of which may be interpreted as the first axis. In the interpretation below, the first axis is the central longitudinal axis extending through a center of the lumen 1026. Similarly, the spike, or distal end 1024, also extends along a multitude of axes, including but not limited to the central longitudinal axis, any axis extending through the lumen, any axis along one of the sides of the spike, etc., any of which may be interpreted as the second axis. In the interpretation below, the second axis is the axis extending along a side of the spike, i.e. along one sidewall of 1024. Since the sidewall is offset from the center of the lumen, the first and the second axes are offset from each other. Additionally, since the spike at 1024 is tapered, its axis, taken along its side, may be at an angled offset from the central longitudinal axis.
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.
Claims 1, 3, 4, 12, 22-24, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2002/0087152 to Mikus et al. (hereinafter, “Mikus”) in view of U.S. Patent No. US 8,795,188 to Maschke and U.S. Patent Application Publication No. US 2014/0324062 to Heuer et al. (hereinafter, “Heuer”).
As to claim 1, Mikus discloses a tool assembly for robotic-assisted surgery (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of such intended use), the tool assembly comprising: a dilator (1020 and 1030) comprising a sleeve (1020) defining a lumen (1026) (par. [0035]), FIG. 1B, the sleeve extending along a first axis (central longitudinal axis extending through a center of the lumen 1026); and at least one spike (one spike, commonly understood to mean a pointed portion, comprises a distal end portion of the dilator at 1024) coupled to the sleeve (coupled to a rest of the sleeve) and fully capable of penetrating bone (interpreted as language of intended use; the spike is fully capable of penetrating bone if positioned against bone and pushed with sufficient force), the at least one spike extending along a second axis (axis extending along a side of the spike, i.e. along one sidewall of 1024) offset from the first axis; a working tool (1010) comprising a shank (proximal portion), and a cutting member (distal end 1014 including sharpened distal tip 1016) coupled to the shank (par. [0034]), FIG. 1B, the working tool sized to be coaxially movable within the lumen of the dilator, FIGS. 2-5; and a locking mechanism (1044) to prevent axial movement of the working tool relative to the dilator such that the working tool supports the dilator (par. [0038]), wherein the locking mechanism is configured to receive an input (twisting) to permit axial movement of the working tool within the lumen of the dilator (par. [0038]).
As to claim 3, Mikus discloses the tool assembly of claim 1, wherein the sleeve (1020) is an inner sleeve defining the lumen, the dilator further comprising an outer sleeve (1030) coaxially disposed over the inner sleeve, wherein the inner sleeve is movably coupled to the outer sleeve, FIGS. 2-4.
As to claim 4, Mikus discloses the tool assembly of claim 3, wherein the inner sleeve has an inner sleeve length defined between the locking mechanism and a distal end of the inner sleeve, and the outer sleeve has an outer sleeve length defined between opposing proximal and distal ends of the outer sleeve, wherein the inner sleeve length is greater than the outer sleeve length, FIG. 1A; and wherein the working tool has a tool length configured to align the cutting member (1014) to the distal end of the inner sleeve when the locking mechanism is engaged, FIG. 1A.
Mikus is silent as to a robotic manipulator including an end effector; the working tool shank removably coupled to and supported by the end effector of the robotic manipulator; the working tool supports the dilator when the working tool is coupled to the robotic manipulator (claim 1); wherein the end effector is configured to provide a torque to impart rotational movement to the working tool (claim 27); wherein the robotic manipulator further comprises a robotic arm, and further comprising a robotic controller configured to control the robotic arm to control at least one of a position and an orientation of the working tool (claim 28); wherein the robotic manipulator further comprises a robotic arm, and further comprising a robotic controller configured to control the robotic arm to constrain the end effector (claim 29).
Maschke teaches a robotic manipulator (22) including an end effector (23), FIG. 1; a working tool (2) comprising a shank removably coupled to and supported by the end effector of the robotic manipulator (col. 6 / lines 28-46); wherein the end effector is fully capable of providing a torque to impart rotational movement to the working tool (because the end effector is coupled to the working tool, any movement of the end effector imparts movement to the working tool; guiding of the working tool by the end effector to the destination point is fully capable of comprising rotational movement, where rotational movement of the end effector would provide a torque to impart rotational movement to the working tool; even rotation of the entire system including the robotic manipulator would result in providing a torque to the working tool so that it also rotates); wherein the robotic manipulator further comprises a robotic arm (22) (col. 6 / lines 28-33), FIG. 1, and further comprising a robotic controller (24) configured to control the robotic arm to control at least one of a position and an orientation of the working tool (col. 6 / lines 51-55), FIG. 1; wherein the robotic manipulator further comprises a robotic arm (22) (col. 6 / lines 28-33), FIG. 1, and further comprising a robotic controller (24) configured to control the robotic arm to constrain the end effector (since the end effector is on an end of the controlled robotic arm and would be constrained to move with the robotic arm).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Mikus’ assembly, a robotic manipulator including an end effector, as taught by Maschke, that removably couples to and supports Mikus’ working tool so that the robotic manipulator can accurately and automatically guide the working tool to a destination point based on preoperative patient image information obtained during the planning phase, as taught by Maschke, therefore reducing the chance of user error and incorrect positioning. Both Mikus and Maschke disclose that the working tool is a biopsy needle (Mikus, par. [0040]; Maschke, col. 4 / lines 54-59), and therefore the biopsy needle of Mikus would be effectively supported and guided by the robotic manipulator taught by Maschke. Because Mikus discloses that the working tool supports the dilator when locked together by the locking mechanism, and the working tool can be coupled to the end effector of the robotic manipulator at the proximal end of the working tool that protrudes proximally when engaged to the dilator, the working tool would also support the dilator when the working tool is coupled to the robotic manipulator.
Mikus is silent as to the locking mechanism comprising an actuator defining a bore sized to removably receive the shank, a slot in the actuator configured to releasably engage a necked portion of the shank under bias by a biasing element, wherein the actuator is configured to receive an input to disengage the slot from the necked portion (claim 1); wherein the necked portion of the shank defines two stepped surfaces and the slot of the actuator is configured to engage with one of the stepped surfaces of the necked portion (claim 12).
Heuer teaches a tool assembly comprising a dilator (20, 30) comprising a sleeve (20) defining a lumen; a working tool (10) comprising a shank (10), the working tool sized to be coaxially movable within the lumen of the dilator (par. [0034], [0037]); and a locking mechanism comprising an actuator (40) defining a bore (42) sized to removably receive the shank (par. [0034]), a slot (41) in the actuator configured to releasably engage a necked portion (140) of the shank under bias by a biasing element (49) (par. [0034], [0037], [0038]) to prevent axial movement of the working tool relative to the dilator such that the working tool supports the dilator, wherein the actuator is configured to receive an input (pushed against the force of the biasing element) to disengage the slot from the necked portion and permit axial movement of the working tool within the lumen of the dilator (par. [0037]); wherein the necked portion of the shank defines two stepped surfaces (one stepped surface at the transition from the larger distal circumference to a bottom of 140, and another stepped surface at the transition from the larger proximal circumference to a top of 140) and the slot of the actuator is configured to engage with one of the stepped surfaces of the necked portion (the slot engages both stepped surfaces or can abut either one of the stepped surfaces, depending on the relative size of the actuator).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mikus/Maschke to have a locking mechanism as taught by Heuer, with Mikus’ working tool shank comprising a necked portion defining two stepped surfaces and Mikus’ sleeve comprising a spring biased button actuator that passes through and is held by the sleeve to receive the shank through a bore of the actuator, with a slot in the actuator biased by the biasing element into engagement with the necked portion, with the button actuator able to be pushed against the spring force such that the slot moves out of engagement from the necked portion of the shank to allow relative axial movement of the shank and the sleeve, since the simple substitution of one known element for another (one locking mechanism for another) to obtain predictable results (releasable locking) is within the ordinary skill in the art, and providing a spring biased button that can be released by pushing force does not require relative twisting of the shank and the sleeve as disclosed by Mikus which could cause undesirable tissue damage. The locking mechanism comprising the actuator and the necked portion of the shank would be located at the proximal locations on the sleeve and the shank as required by Mikus and for ease of access by the practitioner, so that the inner sleeve length would be defined between the actuator and a distal end of the inner sleeve, and the cutting member is aligned to the distal end of the inner sleeve when the slot of the actuator and the necked portion are engaged.
As to claim 22, Mikus discloses a tool assembly for robotic-assisted surgery (interpreted as language of intended use and deemed anticipated by the prior art if said prior art is capable of such intended use), the tool assembly comprising: a dilator (1020 and 1030) (par. [0035]) comprising an inner sleeve (1020) extending along a first axis (central longitudinal axis extending through a center of the lumen 1026), defining a lumen (1026), and comprising at least one spike (one spike, commonly understood to mean a pointed portion, comprises a distal end portion of the dilator at 1024), FIG. 1B, extending along a second axis (axis extending along a side of the spike, i.e. along one sidewall of 1024) offset from the first axis, the dilator further comprising an outer sleeve (1030) coaxially disposed over the inner sleeve, wherein at least one of the inner sleeve and the outer sleeve is movable from an initial configuration in which the at least one spike is recessed within the outer sleeve (during assembly, when the outer sleeve is moved onto and over a distal end of the inner sleeve, the spike is recessed within the outer sleeve at least when the outer sleeve is positioned over the spike), and a deployed configuration in which the at least one spike extends beyond the outer sleeve, FIG. 1A, fully capable of penetrating bone (interpreted as language of intended use; the spike is fully capable of penetrating bone if positioned against bone and pushed with sufficient force); a working tool (1010) comprising a shank (proximal portion), and a cutting member (distal end 1014 including sharpened distal tip 1016) coupled to the shank (par. [0034]), FIG. 1B, the working tool sized to be slidably and coaxially movable within the lumen of the inner sleeve, FIGS. 2-5; and a locking mechanism (1044) releasably coupling the working tool and the dilator (par. [0038]), FIG. 1B.
As to claim 24, Mikus discloses the tool assembly of claim 22, wherein the inner sleeve has an inner sleeve length defined between opposing proximal and distal ends of the inner sleeve, and the outer sleeve has an outer sleeve length defined between opposing proximal and distal ends of the outer sleeve, wherein the inner sleeve length is greater than the outer sleeve length, FIG. 1A.
Mikus is silent as to a robotic manipulator including an end effector; the working tool shank removably coupled to and supported by the end effector of the robotic manipulator.
Maschke teaches a robotic manipulator (22) including an end effector (23), FIG. 1; a working tool (2) comprising a shank removably coupled to and supported by the end effector of the robotic manipulator (col. 6 / lines 28-46).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Mikus’ assembly, a robotic manipulator including an end effector, as taught by Maschke, that removably couples to and supports Mikus’ working tool so that the robotic manipulator can accurately and automatically guide the working tool to a destination point based on preoperative patient image information obtained during the planning phase, as taught by Maschke, therefore reducing the chance of user error and incorrect positioning. Both Mikus and Maschke disclose that the working tool is a biopsy needle (Mikus, par. [0040]; Maschke, col. 4 / lines 54-59), and therefore the biopsy needle of Mikus would be effectively supported and guided by the robotic manipulator taught by Maschke.
Mikus is silent as to the locking mechanism comprising an actuator defining a bore sized to removably receive the working tool, a slot in the actuator configured to releasably engage a necked portion of the working tool under bias by a biasing element (claim 22); wherein the necked portion of the working tool is located on the shank and defines two stepped surfaces, and the actuator is positioned for releasable engagement with one of the stepped surfaces (claim 23).
Heuer teaches a tool assembly comprising a dilator (20, 30) comprising an inner sleeve (20) defining a lumen; a working tool (10) comprising a shank (10), the working tool sized to be slidably and coaxially movable within the lumen of the dilator (par. [0034], [0037]); and a locking mechanism releasably coupling the working tool and the dilator the locking mechanism comprising an actuator (40) defining a bore (42) sized to removably receive the working tool (par. [0034]), a slot (41) in the actuator configured to releasably engage a necked portion (140) of the working tool under bias by a biasing element (49) (par. [0034], [0037], [0038]); wherein the necked portion of the working tool is located on the shank and defines two stepped surfaces (one stepped surface at the transition from the larger distal circumference to a bottom of 140, and another stepped surface at the transition from the larger proximal circumference to a top of 140), and the actuator is positioned for releasable engagement with one of the stepped surfaces (the slot engages both stepped surfaces or can abut either one of the stepped surfaces, depending on the relative size of the actuator).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Mikus/Maschke to have a locking mechanism as taught by Heuer, with Mikus’ working tool shank comprising a necked portion defining two stepped surfaces and Mikus’ sleeve comprising a spring biased button actuator that passes through and is held by the sleeve to receive the shank through a bore of the actuator, with a slot in the actuator biased by the biasing element into engagement with the necked portion, with the button actuator able to be pushed against the spring force such that the slot moves out of engagement from the necked portion of the shank to allow relative axial movement of the shank and the sleeve, since the simple substitution of one known element for another (one locking mechanism for another) to obtain predictable results (releasable locking) is within the ordinary skill in the art, and providing a spring biased button that can be released by pushing force does not require relative twisting of the shank and the sleeve as disclosed by Mikus which could cause undesirable tissue damage. The locking mechanism comprising the actuator and the necked portion of the shank would be located at the proximal locations on the sleeve and the shank as required by Mikus and for ease of access by the practitioner.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Mikus in view of Maschke and Heuer (hereinafter, “Mikus/Maschke/Heuer”), as applied to claims 1, 3, 4, 12, 22-24, and 27-29 above, and further in view of U.S. Patent Application Publication No. US 2017/0238983 to Kukla et al. (hereinafter, “Kukla”).
Mikus/Maschke/Heuer are silent as to wherein the end effector includes a hex nut and a collet, wherein the hex nut is configured to compress the collet to facilitate coupling of the shank to the end effector.
Kukla teaches a locking mechanism comprising a hex nut (on the right in FIG. 17) and a collet (on the left in FIG. 17), wherein the hex nut is configured to compress the collet (par. [0086]-[0092]) to facilitate coupling to a shank.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in the end effector in Mikus/Maschke/Heuer a hex nut and a collet as taught by Kukla, wherein the hex nut is configured to compress the collet to facilitate coupling of the working tool shank, that extends through the hex nut and collet, to the end effector, by uniformly compressing the collet against the shank to securely position the shank in the end effector so that the shank/working tool does not inadvertently disconnect from the end effector and robotic manipulator, which would result in inaccurate tool guidance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775