DETAILED ACTION
For the purposes of examination, reference to the original disclosure has been made using the USPG Publication version of this application.
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 .
Status of Claims
Claims 1-15 and 32-36 are currently pending and under consideration.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 252. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Specification
The disclosure is objected to because of the following informalities: Reference to Fig. 13 in [0054] when all of the reference numerals in [0054] are not illustrated in Fig. 13. The examiner will assume that this is a typo for Fig. 14.
Appropriate correction is required.
Claim Objections
Claim 36 objected to because of the following informalities: “the” is missing from the phrase “arranged between accessory socket”. Appropriate correction to “arranged between the accessory socket” is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2 and 5 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Clayton et al., (US 6434507 B1, published 08/13/2002, hereinafter known as Clayton).
Regarding claim 1, Clayton teaches 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); a tool chuck (260 in Fig. 3, Col. 6, lines 55-58) 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 (216 in Fig. 5 and col. 7, lines 6-15) supported in the attachment body and operably coupled to the tool chuck (); 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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Regarding claim 2, Clayton teaches 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 teaches 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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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.
Claims 3-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Clayton in view of Barnes et al. (US 10709508 B2, published 07/14/2020, hereinafter known as Barnes).
Regarding claim 3, Clayton teaches the tracker attachment as described in claim 1.
However, Clayton does not teach 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 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, Clayton teaches the tracker attachment as described in claim 1.
However, Clayton does not teach 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 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, Clayton teaches the tracker attachment as described in claim 5.
However, Clayton does not teach 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 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, Clayton teaches the tracker attachment as described in claim 5.
However, Clayton does not teach 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 Clayton because this allows for accurate tracking of the powered drill assembly (Barnes, Col. 6, lines 33-34).
Regarding claim 8, Clayton teaches the tracker attachment as described in claim 1.
However, Clayton does not teach 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 Clayton because setting the angle may assist in positioning the tool during the surgical procedure.
Claims 9-13, 15, 32-34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Clayton in view of Dicorleto et al. (US 8961500 B2, published 2/24/2015, hereinafter known as Dicorleto).
Regarding claims 9 and 32, Clayton teaches 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).
However, Clayton does not teach 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 a stabilizer for use with a trackable surgical instrument can include a first member, a second member and a retaining member (Abstract). 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 teaches the tracker spaced from the surgical handpiece when the tracker frame is engaged with the accessory mount (Col. 4, lines 43-50).
Regarding claim 11, Clayton teaches the tracker frame radially surrounds the surgical handpiece when the tracker frame is engaged with the accessory mount (Col. 7, lines 6-12).
Regarding claim 12, Clayton teaches the system for tracking a position of a rotary cutting tool as described in claim 9.
However, Clayton does not teach 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 teaches 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 teach 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 teaches 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 teach 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 teaches 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 teaches the system for tracking a position of a rotary cutting tool as described in claim 32.
However, Clayton does not teach 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 teaches 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 teaches 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).
Conclusion
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
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792