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
The amendment filed on May 27, 2026 has been entered. Claims 1-15 and 32-36 remain pending in the application. Applicant’s amendments to the drawing, specification, and claim objections previously set forth in the Non-Final Office Action mailed May 27, 2026 have overcome each and every objection.
Response to Arguments
Drawing Objections
Applicant amended the drawings to add a missing reference number from originally filed drawings. This successfully overcomes the previous drawing objection and the objection is withdrawn.
Specification Objections
Applicant amended the specification to eliminate incorrect references to Figures from originally filed specification. This successfully overcomes the previous specification objections and the objections are withdrawn.
Claim Objections
Applicant amended claim 36 to eliminate informalities from originally filed claim 36. This successfully overcomes the previous claim objection and the objection is withdrawn.
35 U.S.C. § 102 and 103
Applicant’s arguments, see pg. 16-19, filed May 27, 2026, with respect to claim 1 have overcome the 35 U.S.C. 102 rejection with respect to Clayton from the February 27, 2026 Office Action. A new 35 U.S.C. 103 rejection below is being applied using Clayton in light of the amendments to the claim.
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, 2, 5, 9-13, 15, 33-34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Clayton et. al, (US 6434507 B1, published 08/13/2002, hereinafter known as Clayton) in view of Dicorleto et al. (US 8961500 B2, published 2/24/2015, hereinafter known as Dicorleto).
Regarding claim 1, Clayton discloses a tracker attachment for a high-speed drill device (200 in Fig. 1 and “instrument 200 may be a drill” in Col. 6, lines 17-37 and “high speed drill” in Col. 1, line 47), the tracker attachment (270 in Fig. 3) comprising: an attachment body (270 in Fig. 3) extending from a proximal end to a distal end, wherein the proximal end is configured for engaging a distal end of a motor body of the high-speed drill device (Col. 6, lines 23-28); and a cantilever arm coupled to the attachment body and extending in a proximal direction (210 and 220 in Fig. 3, Col. 6, lines 23-25), wherein a proximal end of the cantilever arm is positioned proximally of the proximal end of the attachment body (as shown below in Fig. 3).
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Clayton does not disclose a tool chuck supported by the attachment body and configured to receive a material removal tool arranged at a working end of the high-speed drill device; a driveshaft supported in the attachment body and operably coupled to the tool chuck to transfer power from the high-speed drill device to the material removal tool.
However, Dicorleto teaches a stabilizer for use with a trackable surgical instrument can include a first member, a second member and a retaining member (Abstract). The proximal end of instrument tip can be positioned though a passage (132 in FIG. 4) in guide member, (passage 132 can also be referred to as a chuck, Col. 4, lines 43-44). The internal groove can be configured to receive an o-ring (276) or similar member to aid in retaining second member in engagement with housing portion, as generally shown in FIG. 5 with reference to FIG. 2. The instrument tip could alternatively engage a drive shaft associated with guide member (Col. 4, lines 58-59). Since Dicorleto in view of Clayton teaches the structure as recited in claim 1, the prior art is capable of teaching that the driveshaft is used to transfer power from the high-speed drill device to the material removal tool.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the tool chuck, driveshaft, and ring of Dicorleto with the tracker attachment of Clayton because this orientation allows for the transfer of power and force between the drill and the attachment.
Regarding claim 2, Clayton discloses the cantilever arm coupled to the attachment body using an interference fit (“the tool body 130 is inserted into cage 210 and locked in place by ring 270” Col. 6, lines 54-58 and annotated Fig. 2 shows attachment body covering the proximal end of 210).
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Regarding claim 5, Clayton discloses the cantilever arm comprises an accessory mount (210 in Fig. 5A) comprising: a trunk portion having a top surface and defining a clamping hole in the top surface (Col. 7 lines 10-15); and a first lateral wing portion and a second lateral wing portion protruding from opposing sides of the trunk portion transverse to the top surface wherein the first lateral wing portion has a first lateral face, and the second lateral wing portion has a second lateral face (219 in Fig. 5A), wherein the first lateral face and the second lateral face are symmetrically angled about a longitudinal plane of the high-speed drill device (as shown in annotated Fig. 5A below).
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Regarding claim 9 Clayton discloses a system for tracking a position of a rotary cutting tool (Col. 2, lines 38-40), the system comprising: a rotary cutting tool (Col. 4, lines 24-29); a surgical handpiece including a motor body (Col. 6, lines 23-28); a surgical instrument attachment comprising (Col. 6, lines 23-26)): an attachment body extending from a proximal end to a distal end (270 in Fig. 3), wherein the proximal end is configured for engaging the motor body (Col. 6, lines 26-31); and a cantilever arm coupled to the attachment body and extending in a proximal direction to an accessory mount (220 in Fig. 3, Col. 6, lines 46-48), and wherein the tracker frame radially surrounds the surgical handpiece when the tracker frame is engaged with the accessory mount (Col. 7, lines 6-12).
However, Clayton does not disclose that the accessory mount is arranged proximally of the proximal end of the attachment body and spaced from the surgical handpiece; a tracker comprising: a tracker frame; an accessory socket coupled to the tracker frame and configured to engage the accessory mount; at least three optical markers coupled to the tracker frame; and wherein the at least three optical markers are arranged proximally of the attachment body when the accessory socket is engaged with the accessory mount.
Dicorleto teaches the guide member can include distal end, a proximal end and the tracking array spaced at the proximal end (Col. 4, lines 62-63); a tracker (62 in Fig. 4), comprising a tracking array (Col. 3, lines 58-60), with the tracking array affixed to guide member in either a removable or permanent fashion (64 in Fig. 4, Col. 4, lines 30-32), in which the tracking array can include more than three emitters (Col. 3, lines 60-62), and the three or more emitters are proximal to the tracking array (68 in Fig. 2).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the tracker of Dicorleto with the system for tracking a position of a rotary cutting tool of Clayton because a real-time position of the surgical instrument can be tracked via a tracking system in conjunction with the tracking array, and the surgical instrument can be guided along a desired trajectory using at least position data generated by the tracking system (Dicorleto, Col. 2, lines 24-28).
Regarding claim 10, Clayton discloses the tracker spaced from the surgical handpiece when the tracker frame is engaged with the accessory mount (Col. 4, lines 43-50).
Regarding claim 12, Clayton discloses the system for tracking a position of a rotary cutting tool as described in claim 9.
However, Clayton does not disclose that the tracker frame defines an instrument aperture, and wherein the surgical handpiece is disposed in the instrument aperture when the tracker frame is engaged with the accessory mount.
Dicorleto teaches that the stabilizer attachment can include a first member and a second member. First member can define a distal end of stabilizer configured to removably engage guide member and second member can define a proximal end configured to engage driving device (Col. 5, lines 36-41).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the stabilizer attachment configuration of Dicorleto with the tracker attachment of Clayton because it frees up one of the surgeon's hands while using instrument in an associated procedure (Dicorleto, Col. 5, lines 24-25).
Regarding claims 13 and 34, Clayton discloses that the surgical instrument attachment further comprises a tool chuck supported in the attachment body (270 in Fig. 3) and configured to receive the rotary cutting tool and a driveshaft supported in the attachment body and operably coupled to the tool chuck (Col. 6, lines 58-67).
Regarding claims 14 and 35, Clayton and Dicorleto disclose the system for tracking a position of a rotary cutting tool as described in claims 9 and 32, wherein the attachment body (270 in Fig. 3) comprises a coupling portion arranged at the proximal end of the attachment body and engageable with the motor body (230a and 210 in Fig. 3, Col. 6, lines 60-62), and wherein the cantilever arm (210 and 220 in Fig. 3) is coupled to the attachment body distal to the coupling portion (Col. 7, lines 28-35).
Regarding claim 15, Clayton discloses the system for tracking a position of a rotary cutting tool as described in claim 9, wherein the accessory mount is spaced radially from the surgical handpiece at a second distance (Col. 3, lines 33-38).
However, Clayton does not disclose that the accessory mount is spaced proximally of the proximal end of the attachment body at a first distance, wherein the first distance is greater than the second distance.
Dicorleto discloses guide member can include distal end, a proximal end and the tracking array spaced at the proximal end (Col. 4, lines 62-63), where the length of the stabilizer can be greater than a distance between post and projection (Col. 7, lines 5-10), as shown in annotated Fig. 4 below.
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the tracking array spaced at the proximal end of the device, with a first distance greater than the second distance of Dicorleto with the radial spacing of the surgical handpiece at a second distance of Clayton because the tracking array and guide member, if not constrained, can rotate with or relative to instrument tip (Col. 4, lines 63-65).
Regarding claim 33, Clayton discloses the system for tracking a position of a rotary cutting tool as described in claim 32.
However, Clayton does not disclose that the tracker is spaced from the surgical handpiece when the tracker frame is engaged with the accessory mount.
Dicorleto teaches that the array can be positioned in various angular orientations relative to instrument and a position of detector (Col. 5, lines 26-27).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the positioning of the array of Dicorleto with the tracker attachment of Clayton because it can provide more flexibility for the surgeon during the procedure (Dicorleto, Col. 5, lines 27-34).
Regarding claim 34, Clayton discloses the system for tracking a position of a rotary cutting tool as described in claim 32, wherein the surgical instrument attachment further comprises a tool chuck supported in the attachment body and configured to receive the rotary cutting tool and a driveshaft supported in the attachment body and operably coupled to the tool chuck (Col. 6, lines 46-49 and 55-58).
Regarding claim 36, Clayton discloses the system for tracking a position of a rotary cutting tool as described in claim 32, wherein the tracker frame is arranged between the accessory socket and optical markers (Col. 7, lines 29-34).
However, Clayton does not teach at least three optical markers.
Dicorleto teaches a tracking array which can include more than three emitters (68 in Fig. 2, Col. 3, lines 60-62).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of more than three emitters of Dicorleto with the tracker frame arrangement of Clayton because the detector can receive and triangulate the signals generated by emitters and tracking array in order to identify during the procedure the relative position of each of the reference points and the instrument (Dicorleto, Col. 4, lines 7-10).
Claims 3-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Clayton in view of Dicorleto (hereinafter known as modified Clayton), and further in view of Barnes et al. (US 10709508 B2, published 07/14/2020, hereinafter known as Barnes).
Regarding claim 3, modified Clayton discloses the tracker attachment as described in claim 1.
However, modified Clayton does not disclose the cantilever arm welded to the attachment body.
Barnes teaches a system to engage one or more tools, including a powered drill, in which a tracking device may be used to track a location of at least a portion of the tool (Abstract). Fixation mechanisms may be provided to fix the tracking devices to the motor housing, such as by molding and/or welding (Col. 6, lines 57-60). The secondary locking assembly may assist in rotationally fixing the attachment and/or the tool relative to the motor housing having the tracking device fixed thereto (Col. 9, lines 28-31).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the method of welding the tracking device to the motor housing and fixing the tool relative to the motor housing with the tracker attachment as described by modified Clayton because fixing the components together would eliminate substantial rotation of the attachment relative to the tracking device (Barnes, Col. 11, lines 65-66).
Regarding claim 4, modified Clayton discloses the tracker attachment as described in claim 1.
However, modified Clayton does not disclose that the cantilever arm has an arcuate profile.
Barnes teaches the tool attachment may also include a second portion that extends along the second axis, which may be formed at an angle relative to the longitudinal axis. The angle may be any appropriate angle such as about 1° to about 179°, or any appropriate angle (162” in Fig. 10A, Col. 12, lines 42-47).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the angled attachment unit of Barnes with the cantilever arm of modified Clayton because the angle may assist in positioning the working end of the tool at a selected position for performing a procedure, (Barnes, Col. 12, lines 54-56).
Regarding claim 6, modified Clayton discloses the tracker attachment as described in claim 5.
However, modified Clayton does not disclose that the accessory mount further comprises one or more alignment pegs protruding from the top surface.
Barnes teaches various trackable markers or portions that may be interconnected with the array; the markers may be connected with the array via one or more pins (30 in Fig. 3, Col. 6, lines 42-43).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the variable markers of Barnes with the tracker attachment of modified Clayton because the trackable portions can be fixed relative to the array through the pins both axially and rotationally (Barnes, Col. 6, lines 49-50).
Regarding claim 7, modified Clayton discloses the tracker attachment as described in claim 5.
However, modified Clayton does not disclose that the cantilever arm and the accessory mount are integrally formed.
Barnes teaches the array, having trackable portions thereon, is fixedly and rigidly connected to the housing (Col. 6, lines 32-35).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the connection of the array and housing of Barnes with the cantilever arm and accessory mount of modified Clayton because this allows for accurate tracking of the powered drill assembly (Barnes, Col. 6, lines 33-34).
Regarding claim 8, modified Clayton discloses the tracker attachment as described in claim 1.
However, modified Clayton does not disclose that the attachment body further comprises a coupling portion arranged at the proximal end of the attachment body and engageable with the motor body of the high-speed drill device and mount flange.
Barnes teaches the working end may be tracked by the connection of the tracking device to the motor housing which is connected to the collet assembly, which is connected to the attachment, which is connected to the tool. The tool may be driven through the angled attachment via a first attachment drive shaft that is coupled to a second attachment drive shaft through an angled coupling (Fig. 10A, Col. 13, lines 9-16). The setting the angle may assist in positioning the tool during the surgical procedure (Col. 12, lines 49-56).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the connection of the tracker with the motor body and engagement of the tool with the motor body of Barnes with the tracker attachment of modified Clayton because setting the angle may assist in positioning the tool during the surgical procedure.
Claims 11 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Clayton in view of Dicorleto (hereinafter known as modified Clayton), and further in view of Friedrich et al. (US 20180132839 A1, published 05/17/2018, hereinafter known as Friedrich).
Regarding claim 11, Clayton does not disclose the tracker includes one or more tracked faces coupled to the tracker frame, and each of the at least three optical markers is coupled to one of the one or more tracked faces (Col. 7, lines 6-12).
However, Dicorleto teaches the guide member can include distal end, a proximal end and the tracking array spaced at the proximal end (Col. 4, lines 62-63); a tracker (62 in Fig. 4), comprising a tracking array (Col. 3, lines 58-60), with the tracking array affixed to guide member in either a removable or permanent fashion (64 in Fig. 4, Col. 4, lines 30-32), in which the tracking array can include more than three emitters (Col. 3, lines 60-62), and the three or more emitters are proximal to the tracking array (68 in Fig. 2).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the tracker of Dicorleto with the system for tracking a position of a rotary cutting tool of Clayton because a real-time position of the surgical instrument can be tracked via a tracking system in conjunction with the tracking array, and the surgical instrument can be guided along a desired trajectory using at least position data generated by the tracking system (Dicorleto, Col. 2, lines 24-28).
Further, Clayton in view of Dicorleto (modified Clayton) does not disclose that the trackers are oriented non-parallel to one another.
However, Friedrich teaches a surgical robot system includes a robot having a robot base and a robot arm coupled to the robot base, and a surgical retractor (Abstract). The tracking array may be attached to an instrument and may comprise tracking markers, these tracking markers (804 as shown in Fig. 8), are oriented non-parallel to one another [0076].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the non-parallel formation of the trackers of Friedrich with the tracker attachment of modified Clayton because the reason for asymmetric alignment is so that it is unambiguous which marker corresponds to a particular location on the rigid body and whether markers are being viewed from the front or back, i.e., mirrored (Friedrich [0104]).
Regarding claim 32 Clayton discloses a system for tracking a position of a rotary cutting tool (Col. 2, lines 38-40), the system comprising: a rotary cutting tool (Col. 4, lines 24-29); a surgical handpiece including a motor body (Col. 6, lines 23-28); a surgical instrument attachment comprising (Col. 6, lines 23-26)): an attachment body extending from a proximal end to a distal end (270 in Fig. 3), wherein the proximal end is configured for engaging the motor body (Col. 6, lines 26-31); and a cantilever arm coupled to the attachment body and extending in a proximal direction to an accessory mount (220 in Fig. 3, Col. 6, lines 46-48), the cantilever arm comprises an accessory mount (210 in Fig. 5A) comprising: a trunk portion having a top surface and defining a clamping hole in the top surface (Col. 7 lines 10-15); and a first lateral wing portion and a second lateral wing portion protruding from opposing sides of the trunk portion transverse to the top surface wherein the first lateral wing portion has a first lateral face, and the second lateral wing portion has a second lateral face (219 in Fig. 5A), wherein the first lateral face and the second lateral face are symmetrically angled about a longitudinal plane of the high-speed drill device (as shown in annotated Fig. 5A); and one or more alignment pegs protruding from the top surface (bores 212 as shown in Fig. 3).
However, Clayton does not disclose that the accessory mount is arranged proximally of the proximal end of the attachment body and spaced from the surgical handpiece; a tracker comprising: a tracker frame; an accessory socket coupled to the tracker frame and configured to engage the accessory mount.
Dicorleto teaches the guide member can include distal end, a proximal end and the tracking array spaced at the proximal end (Col. 4, lines 62-63); a tracker (62 in Fig. 4), comprising a tracking array (Col. 3, lines 58-60), with the tracking array affixed to guide member in either a removable or permanent fashion (64 in Fig. 4, Col. 4, lines 30-32), with the tracking array affixed to guide member in either a removable or permanent fashion (64 in Fig. 4, Col. 4, lines 30-32), in which the tracking array can include more than three emitters (Col. 3, lines 60-62), and the three or more emitters are proximal to the tracking array (68 in Fig. 2).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the tracker of Dicorleto with the system for tracking a position of a rotary cutting tool of Clayton because a real-time position of the surgical instrument can be tracked via a tracking system in conjunction with the tracking array, and the surgical instrument can be guided along a desired trajectory using at least position data generated by the tracking system (Dicorleto, Col. 2, lines 24-28).
Further, Clayton in view of Dicorleto (modified Clayton) does not disclose the accessory socket comprising:
a clamp surface defining a fastener hole;
one or more alignment channels recessed in the clamp surface and configured to complementarily engage the one or more alignment pegs;
a first socket wall extending from the clamp surface and having a first rail surface spaced from the clamp surface and a first ramp surface extending between the first rail surface and the clamp surface, the first ramp surface arranged to engage the first lateral face; and
a second socket wall extending from the clamp surface and having a second rail surface spaced from the clamp surface and a second ramp surface extending between the second rail surface and the clamp surface, the second ramp surface arranged to engage the second lateral face (shown in annotated Figs. 9A-9C, [000085] & [0086]); and
a clamp fastener disposed in the fastener hole and engageable with the clamping hole,
wherein the clamp fastener is configured to bias the top surface of the trunk portion toward the clamp surface of the accessory socket such that the one or more alignment pegs engage the one or more alignment channels.
However, Friedrich teaches clamp 1204 defining a fastener hole as shown in annotated Figs. 9A-9C [0083]. Through the magnetic attraction of clamp and robot arm, balls become seated into respective depressions as shown in FIG. 9A [0085]. The first and second socket walls extending from the clamp surface and having a first and second rail surfaces spaced from the clamp surface and a first and second ramp surfaces extending between the first and second rail surfaces and the clamp surfaces are shown in annotated Figs. 9A-9C, [0085] & [0086]. Closing clamp handle may fasten end-effector to robot arm as lip and lip engage clamp in a manner to secure end-effector and robot arm [0086].
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the clamp structure of Friedrich with the tracker attachment of modified Clayton because this aids in a more effective device in which the linkage between end-effector and robot arm may provide for a sterile barrier between end-effector and robot arm without impeding fastening of the two couplings (Friedrich [0087]).
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 FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/F.M.K./ Patent Examiner, Art Unit 3792
/ALLEN PORTER/ Primary Examiner, Art Unit 3796
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