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
According to the amendment filed January 22, 2026, claims 1, 4, 8 and 24 have been amended, claims 3, 9 and 23 have been canceled, and new claims 26-28 have been added. Claims 1, 4-6, 8, 11-18, 21-22 and 24-28 currently pending in this application, where claims 11-18 remain withdrawn from consideration.
Response to Arguments
Applicant’s arguments filed January 22, 2026, with respect to claim(s) 1 and 4 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claim 24 (currently rewritten as an independent claim incorporating the limitations of amended claim 1), specifically regarding the Examiner’s application of Palmatier (US 2017/0209286 A1) cited in the previous Office Action based on its disclosure of fiducials/sensor array, have been fully considered but they are not persuasive.
Examiner respectfully disagrees with Applicant’s statement that “there is no permissible motivation for one of ordinary skill to look to Palmatier” because Palmatier is directed towards fiducials detected by a sensor, where Applicant submits that the amended claim prevents such an interpretation. Palmatier teaches a surgical system with an implant and an applicator instrument substantially similar to the claimed system, where a controller is used to detect the position of the first shaft relative to the second shaft to determine a position of the implant for real-time tracking during implantation thereof (described in detail in the rejection of claims 21-22 and 24-28 below). Further, as noted below, while the “sensor” in the embodiment of Palmatier described above includes an array of fiducials/markers for identification by imaging systems associated with the controller, Palmatier also contemplates other types of systems for generating a signal representative of positions of the instrument components including “one or more components that generate acoustic signals, magnetic signals, electro-magnetic signals and/or radiologic signals” (see para. 0045, 0049 and 0054). Thus, one of ordinary skill in the art would reasonably incorporate a controller such as Palmatier’s for receiving signals from another type of sensor disposed on the applicator instrument for the claimed functions related to implant positioning during implantation, because Palmatier recognizes the advantages of real-time tracking to aid a medical practitioner in moving the instrument and implant to a desired location within a patient’s anatomy.
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, 4-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 2008/0077241 A1) in view of Geebelen (WO 2013/104682 A1) and Clauda (US 2018/0146976 A1).
Regarding Claim 1, Nguyen teaches a surgical system, comprising:
an applicator (100; Figs. 1-2, 6-7; para. 0049) having a first shaft (104; Figs. 1-2, 6-7) and a parallel second shaft (106; Figs. 1-2, 6-7) slidably disposed on the first shaft, the second shaft adapted to move with respect to the first shaft along an axis defined by a longitudinal axis of the applicator (second shaft 106 “may move or translate relative to” first shaft 104, as recited in at least para. 0050 and 0068, due to rotation of knob 110; Figs. 1-2, 6-7);
an implant (300; Figs. 5-7) having:
a pivot point (defined by instrument slot 118; Figs. 6-7; para. 0053) for pivotably and detachably coupling to the first shaft (pivot point/slot 118 configured for pivotably and detachably coupling with shaped end portion 140 of first shaft 104; Figs. 6-7; para. 0058); and
a pin (defined by projection 128; Figs. 4-7; para. 0055) eccentric to the pivot point (118, as shown; Fig. 6) of the implant for engaging the second shaft (via shaped end portion 142 of second shaft 106; Figs. 6-7; para. 0059), wherein pivoting of the implant results in an offset of the second shaft along the axis (as shown; Figs. 15A-17C; para. 0070-0078).
Nguyen does not disclose the system comprising a sensor for determining the offset, wherein the sensor is a Hall effect sensor, a stress sensor, a strain sensor, a spring sensor, a piezoelectric sensor, a pneumatic pressure sensor, or a hydraulic pressure sensor.
Geebelen is considered analogous to the claimed invention because it is directed towards a surgical system for inserting an intervertebral disc implant (see Figs. 1-4), where a positioning tool shaft is moved relative to a guide to rotate the implant with respect to the positioning tool (shaft 110 of positioning tool 100 is rotated relative to guide 300, which rotation is translated into rotation of implant 200 with respect to the positioning tool; Figs. 1-4; page 21, line 4 – page 22, line 18). Geebelen discloses the system is “provided with a position monitor determining the position of said positioning tool relative to said guiding tool” (see page 3, lines 7-13) and also teaches that the position indicator/detector “may be regarded as a first and a second reference feature provided on the positioning tool and guiding tool or part thereof” (see page 13, lines 4-9).
Further, Geebelen notes that the position monitor refers to any device that permits position measurement and “may include short range distance sensors that enable the measurement of the positioning tool relative to the guiding tool” (see page 11, line 24 – page 12, line 11). However, Geebelen is generally silent on the specific type of short range distance sensors beyond stating that the “position monitor may be an electronic, electrical, optical or mechanical position monitoring system” (see page 11, lines 28-30)
Clauda, in analogous art, is directed towards a surgical instrument (surgical instrument 10 illustrated in Figs. 1-2, having end effector shaft assembly 14; para. 0060) comprising a first shaft element (outer tubular sheath 56; Figs. 2-5; para. 0077) and a parallel second shaft element (reciprocating inner tubular member 58; Figs. 2-5; para. 0077), the second shaft element adapted to move with respect to the first shaft along an axis defined by a longitudinal axis of the instrument (as represented by arrows 60A and 60B; Fig. 2; para. 0077, 0088), and a sensor for determining offset of the second shaft element along the axis, wherein the sensor is a Hall effect sensor (para. 0090 teaches that the position of outer tubular sheath 56 relative to reciprocating inner tubular member 58 “measured by a Hall-effect sensor and magnet combination”, which is described in at least para. 0009 as a Hall-effect sensor positioned on the outer tube and a magnet positioned on the inner tube, schematically depicted in Fig. 12, described in para. 0140, and in Fig. 31 at blocks 3202/3208/3210, described in para. 0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s device, where the offset between Nguyen’s first and second shafts results in rotation of the implant, to include Geebelen’s distance sensor provided in the manner taught by Clauda, e.g. with a magnet positioned on Nguyen’s second shaft and a hall effect sensor positioned on the first shaft for measuring the offset of the second shaft relative to the first shaft as claimed, because Geebelen recognizes that such a system provides information about the relative position of two elements that directly correlates to the position of the implant advantageously enables the surgeon to continuously monitor the position of the implant without relying on imaging techniques such as fluoroscopy, reducing the number of images taken during the surgery to one single image checking the final position of the implant (see Geebelen, page 8, lines 6-11), and Clauda discloses that a Hall-effect sensor and magnet combination is a suitable distance sensor configuration for measuring offset between a first element and a reciprocating second element (see Clauda, para. 0009 and 0090).
Regarding Claims 4-6 and 8, Nguyen teaches a surgical system, comprising:
an applicator (100; Figs. 1-2, 6-7; para. 0049) having a first shaft (104; Figs. 1-2, 6-7) and a parallel second shaft (106; Figs. 1-2, 6-7) slidably disposed on the first shaft, the second shaft adapted to move with respect to the first shaft along an axis defined by a longitudinal axis of the applicator (second shaft 106 “may move or translate relative to” first shaft 104, as recited in at least para. 0050 and 0068, due to rotation of knob 110; Figs. 1-2, 6-7);
an implant (300; Figs. 5-7) having:
a first member (defined by instrument slot 118; Figs. 6-7; para. 0053) defining a pivot point of the implant (as shown; Figs. 6-7, 17A-C) for pivotably and detachably coupling to the first shaft (pivot point/slot 118 configured for pivotably and detachably coupling with shaped end portion 140 of first shaft 104; Figs. 6-7; para. 0058); and
a second member (defined by projection 128; Figs. 4-7; para. 0055) for converting rotational motion of the implant to a translational offset of the second shaft (second member/projection 128 is engaged by shaped end portion 142 of second shaft 106, so that rotational movement of the implant 100 involves translational offset of second shaft 106 relative to first shaft 104; Figs. 6-7 and 15A-17C; para. 0059, 0070-0078); and
[Claim 5] wherein the second member (128; Figs. 6-7) is eccentric to the pivot point of the implant (as shown, eccentric to first member/slot 118 defining the pivot point; Figs. 6-7);
[Claim 6] wherein the second member (128; Figs. 6-7) engages the second shaft (106, as shown; Figs. 6-7), and wherein pivoting of the implant results in movement of the second shaft along the axis (as shown; Figs. 6-7, 15A-17C);
[Claim 8] wherein the second member is a pin (second member/projection 128 is a pin; Figs. 6-7), and wherein the pin is eccentric to the pivot point of the implant (as shown in at least Figs. 6-7, pin 128 eccentric to pivot point defined by slot 118).
Nguyen does not disclose [in Claim 4] the system comprising at least one of a sensor for determining the offset, wherein the sensor is a Hall effect sensor, a stress sensor, a strain sensor, a spring sensor, a piezoelectric sensor, a pneumatic pressure sensor, or a hydraulic pressure sensor, or an indicator for indicating the offset, provided that the indicator is not a protrusion located at an end of the applicator.
Geebelen is considered analogous to the claimed invention because it is directed towards a surgical system for inserting an intervertebral disc implant (see Figs. 1-4), where a positioning tool shaft is moved relative to a guide to rotate the implant with respect to the positioning tool (shaft 110 of positioning tool 100 is rotated relative to guide 300, which rotation is translated into rotation of implant 200 with respect to the positioning tool; Figs. 1-4; page 21, line 4 – page 22, line 18). Geebelen discloses the system is “provided with a position monitor determining the position of said positioning tool relative to said guiding tool” (see page 3, lines 7-13) and also teaches that the position indicator/detector “may be regarded as a first and a second reference feature provided on the positioning tool and guiding tool or part thereof” (see page 13, lines 4-9).
Further, Geebelen notes that the position monitor refers to any device that permits position measurement and “may include short range distance sensors that enable the measurement of the positioning tool relative to the guiding tool” (see page 11, line 24 – page 12, line 11). However, Geebelen is generally silent on the specific type of short range distance sensors beyond stating that the “position monitor may be an electronic, electrical, optical or mechanical position monitoring system” (see page 11, lines 28-30)
Clauda, in analogous art, is directed towards a surgical instrument (surgical instrument 10 illustrated in Figs. 1-2, having end effector shaft assembly 14; para. 0060) comprising a first shaft element (outer tubular sheath 56; Figs. 2-5; para. 0077) and a parallel second shaft element (reciprocating inner tubular member 58; Figs. 2-5; para. 0077), the second shaft element adapted to move with respect to the first shaft along an axis defined by a longitudinal axis of the instrument (as represented by arrows 60A and 60B; Fig. 2; para. 0077, 0088), and a sensor for determining offset of the second shaft element along the axis, wherein the sensor is a Hall effect sensor (para. 0090 teaches that the position of outer tubular sheath 56 relative to reciprocating inner tubular member 58 “measured by a Hall-effect sensor and magnet combination”, which is described in at least para. 0009 as a Hall-effect sensor positioned on the outer tube and a magnet positioned on the inner tube, schematically depicted in Fig. 12, described in para. 0140, and in Fig. 31 at blocks 3202/3208/3210, described in para. 0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s device, where the offset between Nguyen’s first and second shafts results in rotation of the implant, to include Geebelen’s distance sensor provided in the manner taught by Clauda, e.g. with a magnet positioned on Nguyen’s second shaft and a hall effect sensor positioned on the first shaft for measuring the offset of the second shaft relative to the first shaft as claimed, because Geebelen recognizes that such a system provides information about the relative position of two elements that directly correlates to the position of the implant advantageously enables the surgeon to continuously monitor the position of the implant without relying on imaging techniques such as fluoroscopy, reducing the number of images taken during the surgery to one single image checking the final position of the implant (see Geebelen, page 8, lines 6-11), and Clauda discloses that a Hall-effect sensor and magnet combination is a suitable distance sensor configuration for measuring offset between a first element and a reciprocating second element (see Clauda, para. 0009 and 0090).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 2008/0077241 A1) in view of Geebelen (WO 2013/104682 A1) and Clauda (US 2018/0146976 A1), as applied to claim 4 above, further in view of Palmatier (US 2017/0209286 A1).
Regarding claims 21-22, the combined disclosures of Nguyen, Geebelen and Clauda teach the system of claim 4.
However, in the combination described above, Nguyen, Geebelen and Clauda do not specifically disclose [Claim 21] the system further comprising a controller for: receiving data from the sensor regarding the offset of the second shaft along the axis; determining an angle of the implant in a patient using dimensions of the implant and the offset; and causing a display to display a current position of the implant relative to patient anatomy; and [Claim 22] wherein the controller is further configured for determining if a desired position of the implant has been reached and, if so, displaying a notification on the display.
Palmatier is analogous to the claimed invention because it is directed towards a surgical system (system 10 shown in Fig. 10, including inserter/applicator 12 and implant 150; para. 0029-0035) comprising:
an applicator (10; Fig. 1) having a first shaft (shaft 24; Fig. 1; para. 0051) and a second shaft (rod 102; Fig. 1) adapted to move with respect to the first shaft along a longitudinal axis of the applicator (second shaft/rod 102 is “configured for translation relative to first shaft 24 as spinal implant 150 is moved and/or rotated for positioning with tissue to provide indicia and/or display of an amount of manipulation, movement, translation and/or rotation of spinal implant 150” as recited in para. 0052; Figs. 1-10);
an implant (150; Fig. 1) pivotably and detachably coupled to the applicator (implant 150 is pivotably and detachably coupled with distal end of applicator 10; Figs. 1-9; para. 0051), wherein pivoting of the implant results in an offset of the second shaft relative to the first shaft along the longitudinal axis (as described in at least para. 0052, quoted above, pivoting of implant 150, e.g. for positioning implant within tissue, results in translation of second shaft 102 relative to first shaft 24 along the longitudinal axis, creating an offset between the first and second shafts; Figs. 1-9); and
a sensor for determining the offset (sensor array 202 shown in Fig. 10, detects signals from emitting array 82 comprising fiducials 84 on the first shaft 24 and navigation component 108 with fiducial 110 disposed on the second shaft/rod 102, identified in at least Fig. 1, where the sensor array 202 is configured to determine the offset between the first and second shafts by imaging the fiducials 84 and 110 to determine position/orientation of implant 150; Figs. 1-10; para. 0049, 0054, 0063),
[Claim 21] the system further comprising a controller (surgical navigation computer 220; Fig. 10; para. 0069) for: receiving data from the sensor regarding the offset of the second shaft along the axis (computer 220, in navigation system 200, receives signals from sensor array 202 which, as described above, sends signals relating to the offset; para. 0070); determining an angle of the implant in a patient using dimensions of the implant and the offset (where signals from sensor array 202 are used to provide a two dimensional position of the ends of first and second shafts of the inserter instrument and/or of the spinal implant, as recited in at least para. 0063 and 0077, the computer/controller 220 can determine an angle of the implant using dimensions and the offset between the shafts; Figs. 1-10); and causing a display to display a current position of the implant relative to patient anatomy (via monitor 222; Fig. 10; para. 0063-0069, 0075);
[Claim 22] wherein the controller is further configured for determining if a desired position of the implant has been reached and, if so, displaying a notification on the display (controller/computer 220 is programmed with software modules to determine the position of the inserter 12 and implant 150 relative to the patient’s anatomy and sends the information to monitor 222 to allow the medical practitioner to move the inserter and implant to a desired location, as described in para. 0070-0071, so that the controller is understood to be capable of determining if a desired position has been reached and displaying information via a notification on monitor 222; Fig. 10).
Examiner notes that while the “sensor” in the embodiment of Palmatier described above includes fiducials/markers for identification by imaging systems of the controller, Palmatier also contemplates other types of systems for generating a signal representative of positions of the instrument components including “one or more components that generate acoustic signals, magnetic signals, electro-magnetic signals and/or radiologic signals” (see para. 0045, 0049 and 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s surgical system, modified to include Geebelen’s distance sensor in the form of Clauda’s Hall effect sensor and magnet combination for monitoring the relative position of the first and second shafts which corresponds to the orientation of the implant, to further include the controller and monitor of Palmatier’s surgical system for receiving data from the distance sensor (i.e. the Hall effect sensor and magnetic combination of Clauda implemented with Nguyen’s surgical system) and for determining and displaying implant position relative to the patient’s anatomy as claimed, because Palmatier teaches that such a system, receiving and processing data from a sensor regarding the position of an implant inserter instrument and/or an implant, provides for real-time tracking of the applicator/inserter instrument and the implant to allow the medical practitioner to move the instrument and implant to a desired location within the patient’s anatomy (see Palmatier, para. 0070).
Claims 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 2008/0077241 A1) in view of Geebelen (WO 2013/104682 A1), Clauda (US 2018/0146976 A1), and Palmatier (US 2017/0209286 A1).
Regarding Claims 24-28, Nguyen teaches a surgical system comprising:
an applicator (100; Figs. 1-2, 6-7; para. 0049) having a first shaft (104; Figs. 1-2, 6-7) and a parallel second shaft (106; Figs. 1-2, 6-7) slidably disposed on the first shaft, the second shaft adapted to move with respect to the first shaft along an axis defined by a longitudinal axis of the applicator (second shaft 106 “may move or translate relative to” first shaft 104, as recited in at least para. 0050 and 0068, due to rotation of knob 110; Figs. 1-2, 6-7);
an implant (300; Figs. 5-7) having:
a pivot point (defined by instrument slot 118; Figs. 6-7; para. 0053) for pivotably and detachably coupling to the first shaft (pivot point/slot 118 configured for pivotably and detachably coupling with shaped end portion 140 of first shaft 104; Figs. 6-7; para. 0058); and
a pin (defined by projection 128; Figs. 4-7; para. 0055) eccentric to the pivot point (118, as shown; Fig. 6) of the implant for engaging the second shaft (via shaped end portion 142 of second shaft 106; Figs. 6-7; para. 0059), wherein pivoting of the implant results in an offset of the second shaft along the axis (as shown; Figs. 15A-17C; para. 0070-0078).
Nguyen does not disclose:
[Claim 24] the system comprising: a sensor; and a controller for: receiving data from a sensor for determining the offset of the second shaft along the axis, wherein the sensor is a Hall effect sensor, a stress sensor, a strain sensor, a spring sensor, a piezoelectric sensor, a distance sensor, a pneumatic pressure sensor, or a hydraulic pressure sensor; determining an angle of the implant in a patient using dimensions of the implant and the offset; and causing a display to display a current position of the implant relative to patient anatomy;
[Claim 25] wherein the controller is further configured for determining if a desired position of the implant has been reached and, if so, displaying a notification on the display;
[Claim 26] wherein the controller is further configured for: receiving updated data from the sensor; determining an updated offset of the second shaft along the axis; and determining an updated angle of the implant in the patient, thereby tracking progress of the implant in real time;
[Claim 27] wherein the controller is further configured for modeling placement of the implant in the patient; and
[Claim 28] wherein the controller is further configured for using the updated offset data to calculate a percentage of pivoting required before a predetermined position is achieved.
(I) Regarding the “sensor” of claim 24 noted above, Geebelen is considered analogous to the claimed invention because it is directed towards a surgical system for inserting an intervertebral disc implant (see Figs. 1-4), where a positioning tool shaft is moved relative to a guide to rotate the implant with respect to the positioning tool (shaft 110 of positioning tool 100 is rotated relative to guide 300, which rotation is translated into rotation of implant 200 with respect to the positioning tool; Figs. 1-4; page 21, line 4 – page 22, line 18). Geebelen discloses the system is “provided with a position monitor determining the position of said positioning tool relative to said guiding tool” (see page 3, lines 7-13) and also teaches that the position indicator/detector “may be regarded as a first and a second reference feature provided on the positioning tool and guiding tool or part thereof” (see page 13, lines 4-9).
Further, Geebelen notes that the position monitor refers to any device that permits position measurement and “may include short range distance sensors that enable the measurement of the positioning tool relative to the guiding tool” (see page 11, line 24 – page 12, line 11). However, Geebelen is generally silent on the specific type of short range distance sensors beyond stating that the “position monitor may be an electronic, electrical, optical or mechanical position monitoring system” (see page 11, lines 28-30).
Clauda, in analogous art, is directed towards a surgical instrument (surgical instrument 10 illustrated in Figs. 1-2, having end effector shaft assembly 14; para. 0060) comprising a first shaft element (outer tubular sheath 56; Figs. 2-5; para. 0077) and a parallel second shaft element (reciprocating inner tubular member 58; Figs. 2-5; para. 0077), the second shaft element adapted to move with respect to the first shaft along an axis defined by a longitudinal axis of the instrument (as represented by arrows 60A and 60B; Fig. 2; para. 0077, 0088), and a sensor for determining offset of the second shaft element along the axis, wherein the sensor is a Hall effect sensor (para. 0090 teaches that the position of outer tubular sheath 56 relative to reciprocating inner tubular member 58 “measured by a Hall-effect sensor and magnet combination”, which is described in at least para. 0009 as a Hall-effect sensor positioned on the outer tube and a magnet positioned on the inner tube, schematically depicted in Fig. 12, described in para. 0140, and in Fig. 31 at blocks 3202/3208/3210, described in para. 0138).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s device, where the offset between Nguyen’s first and second shafts results in rotation of the implant, to include Geebelen’s distance sensor provided in the manner taught by Clauda, e.g. with a magnet positioned on Nguyen’s second shaft and a hall effect sensor positioned on the first shaft for measuring the offset of the second shaft relative to the first shaft as claimed, because Geebelen recognizes that such a system provides information about the relative position of two elements that directly correlates to the position of the implant advantageously enables the surgeon to continuously monitor the position of the implant without relying on imaging techniques such as fluoroscopy, reducing the number of images taken during the surgery to one single image checking the final position of the implant (see Geebelen, page 8, lines 6-11), and Clauda discloses that a Hall-effect sensor and magnet combination is a suitable distance sensor configuration for measuring offset between a first element and a reciprocating second element (see Clauda, para. 0009 and 0090).
(II) Regarding the “controller” limitations of claims 24-28 noted above, Palmatier is analogous to the claimed invention because it is directed towards a surgical system (system 10 shown in Fig. 10, including inserter/applicator 12 and implant 150; para. 0029-0035) comprising:
[Claim 24] an applicator (10; Fig. 1) having a first shaft (shaft 24; Fig. 1; para. 0051) and a second shaft (rod 102; Fig. 1) adapted to move with respect to the first shaft along a longitudinal axis of the applicator (second shaft/rod 102 is “configured for translation relative to first shaft 24 as spinal implant 150 is moved and/or rotated for positioning with tissue to provide indicia and/or display of an amount of manipulation, movement, translation and/or rotation of spinal implant 150” as recited in para. 0052; Figs. 1-10); an implant (150; Fig. 1) pivotably and detachably coupled to the applicator (implant 150 is pivotably and detachably coupled with distal end of applicator 10; Figs. 1-9; para. 0051), wherein pivoting of the implant results in an offset of the second shaft relative to the first shaft along the longitudinal axis (as described in at least para. 0052, quoted above, pivoting of implant 150, e.g. for positioning implant within tissue, results in translation of second shaft 102 relative to first shaft 24 along the longitudinal axis, creating an offset between the first and second shafts; Figs. 1-9); and a sensor for determining the offset (sensor array 202 shown in Fig. 10, detects signals from emitting array 82 comprising fiducials 84 on the first shaft 24 and navigation component 108 with fiducial 110 disposed on the second shaft/rod 102, identified in at least Fig. 1, where the sensor array 202 is configured to determine the offset between the first and second shafts by imaging the fiducials 84 and 110 to determine position/orientation of implant 150; Figs. 1-10; para. 0049, 0054, 0063); and
a controller (surgical navigation computer 220; Fig. 10; para. 0069) for: receiving data from the sensor regarding the offset of the second shaft along the axis (computer 220, in navigation system 200, receives signals from sensor array 202 which, as described in the combination above, sends signals relating to the offset of Nguyen’s second shaft along the axis; para. 0070); determining an angle of the implant in a patient using dimensions of the implant and the offset (where signals from sensor array 202 are used to provide a two dimensional position of the ends of first and second shafts of the inserter instrument and/or of the spinal implant, as recited in at least para. 0063 and 0077, the computer/controller 220 can determine an angle of the implant using dimensions and the offset between the shafts; Figs. 1-10); and causing a display to display a current position of the implant relative to patient anatomy (via monitor 222; Fig. 10; para. 0063-0069, 0075);
[Claim 25] wherein the controller is further configured for determining if a desired position of the implant has been reached and, if so, displaying a notification on the display (controller/computer 220 is programmed with software modules to determine the position of the inserter 12 and implant 150 relative to the patient’s anatomy and sends the information to monitor 222 to allow the medical practitioner to move the inserter and implant to a desired location, as described in para. 0070-0071, so that the controller is understood to be capable of determining if a desired position has been reached and displaying information via a notification on monitor 222; Fig. 10);
[Claim 26] wherein the controller is further configured for: receiving updated data from the sensor; determining an updated offset of the second shaft along the axis; and determining an updated angle of the implant in the patient, thereby tracking progress of the implant in real time (where para. 0070-0071 describe using computer/controller 220 “for real-time tracking of inserter 12 and spinal implant 150” by receiving data from the sensor array 202, the controller is understood to receive updated data from the sensor to determine an updated offset and an updated angle of the implant in the manner described above; Fig. 10);
[Claim 27] wherein the controller is further configured for modeling placement of the implant in the patient (where para. 0070-0071 describe using computer/controller 220 “for real-time tracking of inserter 12 and spinal implant 150” and a processor sending the information “to monitor 222, which provides a visual representation of the position of inserter 12 and spinal implant 150 relative to the patient’s anatomy”, the controller is capable for modeling placement of the implant in the patient); and
[Claim 28] wherein the controller is further configured for using the updated offset data to calculate a percentage of pivoting required before a predetermined position is achieved (where para. 0070-0071 describe using computer/controller 220 “for real-time tracking of inserter 12 and spinal implant 150” and a processor sending the information “to monitor 222, which provides a visual representation of the position of inserter 12 and spinal implant 150 relative to the patient’s anatomy to allow the medical practitioner to move inserter 12 and spinal implant 150 to a desired location within the patient’s anatomy”, the controller is understood to be capable for using updated data in real-time tracking to calculate a percentage of pivoting of the implant required before the desired, i.e. predetermined, position is achieved).
Examiner notes that while the “sensor” in the embodiment of Palmatier described above includes fiducials/markers for identification by imaging systems of the controller, Palmatier also contemplates other types of systems for generating a signal representative of positions of the instrument components including “one or more components that generate acoustic signals, magnetic signals, electro-magnetic signals and/or radiologic signals” (see para. 0045, 0049 and 0054).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nguyen’s surgical system, modified to include Geebelen’s distance sensor in the form of Clauda’s Hall effect sensor and magnet combination for monitoring the relative position of the first and second shafts which corresponds to the orientation of the implant, to further include the controller and monitor of Palmatier’s surgical system for receiving data from the distance sensor (i.e. the Hall effect sensor and magnetic combination of Clauda implemented with Nguyen’s surgical system), where the controller is configured in the claimed manner noted above, because Palmatier teaches that such a system, receiving and processing data from a sensor regarding the position of an implant inserter instrument and/or an implant, provides for real-time tracking of the applicator/inserter instrument and the implant to allow the medical practitioner to move the instrument and implant to a desired location within the patient’s anatomy (see Palmatier, para. 0070).
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 ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights