DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the Request for Continued Examination (RCE) received on 24 August 2026. Claims 1-7 and 18-20 are currently pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24 August 2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
In lines 18-19, it appears that the phrase “one or more screws wherein” should read “one or more screws, wherein.”
In line 20, it appears that the phrase “the surgical rod” should read “the rod” for consistency.
In line 23, it appears that the phrase “the manipulation” should read “manipulation.”
In line 25, it appears that the phrase “the rod bending device” should read “the bending device” for consistency.
In line 25, it appears that the phrase “and the moved” should read “and moved.”
Claim 2 is objected to because of the following informalities:
In lines 22-24, it appears that the phrase “one or more screws wherein” should read “one or more screws, wherein.”
In line 28, it appears that the phrase “the manipulation” should read “manipulation.”
In line 30, it appears that the phrase “and the moved” should read “and moved.”
Claim 18 is objected to because of the following informalities:
In line 1, it appears that the phrase “the rod bender” should read “the bending device” for consistency.
In line 2, it appears that the phrase “the location” should read “the position.”
Claim 20 is objected to because of the following informalities:
In line 1, it appears that the phrase “the rod bending instructions” should read “rod bending instructions.”
In line 2, it appears that the phrase “the surgical rod” should read “the rod.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claim 19 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 19 requires “a first motor,” “a second motor,” and “a third motor.” As claimed, these motors are not tied to the “motor” as required by claim 18. It is therefore unclear as to if the motors required by claim 19 are further defining the motor required by claim 18.
Note: It appears that amending line 1 of claim 18 to read “wherein the bending device includes at least one motor” and lines 1-3 of claim 19 to read “wherein the at least one motor includes a first motor that is a linear translator motor, a second motor that is a rotational motor, and a third motor that causes angular bends of the surgical rod” would overcome this rejection. For examination purposes, claims 18 and 19 will be treated as such.
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.
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 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Roger et al. (International Publication WO 2015/003224) in view of Anderson et al. (U.S. Patent Application Publication 2010/0191088), further in view of Dankowicz et al. (U.S. Patent Application Publication 2005/0262911), and further in view of Isaacs (U.S. Patent 7,957,831).
Roger et al. disclose (as to part of claim 1) a system for global alignment of a spine during spinal surgery (see Figure 7, and paragraph 0057), the system comprising an imaging device (12); a spatial tracking system (i.e. system defined by 15, 17 and 102); a device (i.e. analyser / computer processor, 14) capable of calculating one or more spinal parameters (e.g. parameters corresponding to a degree of rod bending and rod length selection, see paragraphs 0096-0097) based on identification of spinal markers (17, 18 and 19) in a preoperative image (see paragraphs 0059, 0070, 0084-0086 and 0089) (see Note below regarding functional language with respect to the phrase “configure to calculate one or more spinal parameters...the one or more spinal parameters comprising one or more of T1 vertebra slope, cervical lordosis, the T1 vertebra slope minus the cervical lordosis, or cervical sagittal vertical axis”); a control unit (31) capable of receiving a planned target value of the one or more spinal parameters (see paragraphs 0044 and 0097), and capture, via the imaging device and the spatial tracking system, one or more intraoperative images (i.e. provided via 12); and a bending device (32), wherein the control unit is capable of instructing the bending device to bend a rod (see paragraphs 0096-0097) based upon the target value of the one or more spinal parameters and an intraoperative value based upon the one or more intraoperative image of the one or more spinal parameters (see paragraphs 0044 and 0097), wherein the one or more spinal parameters is capable of being a desired correlation in at least one of a sagittal alignment and a coronal alignment (see paragraph 0026 referring to multiple fiduciary screws (i.e. markers) being aligned with different anatomical planes for use in correlating images for location identification), wherein the intraoperative value is capable of being a measurement of a location of one or more screws (e.g. 20, see paragraph 0096 referring to using a line connecting pedicle screw heads for a desired degree of rod bending), wherein (as to claim 20) rod bending instructions (i.e. instructions provided by the control unit) are used as a template (i.e. a guide) to bend the rod (see paragraphs 0088 and 0096-0097) (see Figures 1-10, and paragraphs 0044 and 0058-0103).
Roger et al. disclose wherein the device capable of calculating one or more spinal parameters based on identification of spinal markers in a preoperative image comprises a processor and/or other appropriate electronic circuitry (see paragraphs 0070 and 0087-0088); however, fail to explicitly disclose wherein (as to part of claim 1) the device is a mobile hand held communication device.
Anderson et al. teach the use of a system (10) for use during a spinal surgery (see paragraph 0119) comprising an imaging device (i.e. used in step 24, see Figure 5 and paragraph 0065); a tracking system (i.e. using sensors in step 24, see paragraph 0066); a mobile hand held communication device (see paragraphs 0104 and 0109) capable of executing instructions and acts (see paragraph 0103); and a control unit (e.g. defined by a computer) (see Figures 1-7, and paragraphs 0090-0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. with wherein the device is a mobile hand held communication device in view of Anderson et al. in order to provide an alternative, well-known and obvious means for executing instructions and acts producing a desired and predictable result.
Roger et al. disclose capturing one or more intraoperative images (e.g. via a computer tomography device, an MRI, an X-ray device, or any other means of generating a scaleable image) into the control unit; however, Roger et al. in view of Anderson et al. fail to explicitly disclose wherein (as to part of claim 1) the intraoperative images are captured via fluoroscopy.
Dankowicz et al. teach the use of a commonly used imaging apparatus (e.g. fluoroscopy) during surgery on a spine (see paragraphs 0044 and 0105-0106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. with wherein the intraoperative images are captured via fluoroscopy in view of Dankowicz et al. in order to provide an alternative, well-known and obvious means for providing intraoperative images to yield predictable results.
Roger et al. disclose the use of a generic, automated bending device (32, see Figure 5, and paragraph 0042 referring to the bending device being controlled by control unit 31); however, Roger et al. in view of Anderson et al. further in view of Dankowicz et al. fail to explicitly disclose wherein (as to the remainder of claim 1) the bending device includes a first lever and a second lever, a mandrel and moving die and a fixed die, the rod is moved through the mandrel and in between the moving die and the fixed die, wherein the bending device includes gauges, and at least one angle gauge, allowing for manipulation of the rod in order to determine bend position, bend angle, and bend rotation, wherein the rod is held within the bending device by a collet, and moved via a sliding slide block, wherein the angle gauge includes a ratchet mechanism having ratchet teeth spaced apart at intervals indicating five degrees of bend angle.
Isaacs teaches the use of a bending device (70) capable of being automated (see column 12, lines 32-35), wherein the bending device includes a first lever (71) and a second lever (72), a mandrel (80) and moving die (81) and a fixed die (82), a rod (10) is moved through the mandrel and in between the moving die and the fixed die (see column 13, lines 50-51), wherein the bending device includes gauges (i.e. gauges defined by 77, 85 and 91), and at least one angle gauge (85), allowing for manipulation of the rod in order to determine bend position (i.e. via 77), bend angle (i.e. via 85), and bend rotation (i.e. via 91) (see column 13, lines 51-53), wherein the rod is held within the bending device by a collet (90), and moved via a sliding slide block (76), wherein the angle gauge includes a ratchet mechanism (i.e. mechanism defined by 85) having ratchet teeth (86) spaced apart at intervals indicating five degrees of bend angle (see column 13, lines 62-63) (see Figured 7-10, column 12, lines 32-35, and column 13, line 36 – column 14, line 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. further in view of Dankowicz et al. with wherein the bending device includes a first lever and a second lever, a mandrel and moving die and a fixed die, the rod is moved through the mandrel and in between the moving die and the fixed die, wherein the bending device includes gauges, and at least one angle gauge, allowing for manipulation of the rod in order to determine bend position, bend angle, and bend rotation, wherein the rod is held within the bending device by a collet, and moved via a sliding slide block, wherein the angle gauge includes a ratchet mechanism having ratchet teeth spaced apart at intervals indicating five degrees of bend angle in view of Isaacs in order to provide a bending device requiring less manual manipulation of the rod and forming a rod in a more accurate and quicker technique taking into account the spinal parameters for the specific rod to yield predictable results.
Note: Regarding functional language, "[a]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (see MPEP 2114(II)).
Claims 2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Roger et al. (International Publication WO 2015/003224) in view of Anderson et al. (U.S. Patent Application Publication 2010/0191088), further in view of Isaacs (U.S. Patent 7,957,831).
Regarding claims 2 and 6, Roger et al. disclose (as to part of claim 2) a system for use during a surgical procedure (see Figure 7, and paragraph 0057), the system comprising an imaging device (12); a spatial tracking system (i.e. system defined by 15, 17 and 102); a rod bending device (32); a device (i.e. analyser / computer processor, 14) capable of calculating one or more spinal parameters (e.g. parameters corresponding to a degree of rod bending and rod length selection, see paragraphs 0096-0097) based on identification of spinal markers (17 and 18) in a preoperative image (see paragraphs 0059, 0070, 0084-0086 and 0089) (see Note above regarding functional language with respect to the phrase “configure to calculate one or more spinal parameters...the one or more spinal parameters comprising one or more of T1 vertebra slope, cervical lordosis, the T1 vertebra slope minus the cervical lordosis, or cervical sagittal vertical axis”); a control unit (31) capable of obtaining one or more preoperative measurements of (i.e. via 12 and 14) an anatomical parameter (i.e. representations of the anatomy of a patient) of a patient and the one or more spinal parameters (see paragraphs 0059 and 0072); obtaining one or more planned target measurements of (i.e. via 12 and 14) the anatomical parameter (i.e. for degree of rod bending and rod length selection, see paragraphs 0096-0097); obtaining an intraoperative image from (i.e. displayed via 11) the imaging device (see paragraphs 0058-0059 and 0072); measuring an intraoperative measurement of (i.e. corresponding to degree of rod bending and rod length selection) the anatomical parameter (see paragraphs 0096-0097); and calculating an instruction for bending a surgical rod based upon a comparison of the intraoperative measurements, the one or more planned target measurements, and the one or more spinal parameters (see paragraphs 0088 and 0096-0097), wherein the one or more spinal parameters is capable of being a desired correlation in at least one of a sagittal alignment and a coronal alignment (see paragraph 0026 referring to multiple fiduciary screws (i.e. markers) being aligned with different anatomical planes for use in correlating images for location identification), wherein the intraoperative measurement is capable of being a measurement of a location of one or more screws (e.g. 20, see paragraph 0096 referring to using a line connecting pedicle screw heads for a desired degree of rod bending) (see Figures 1-10, and paragraphs 0044 and 0058-0103).
Roger et al. disclose wherein the device capable of calculating one or more spinal parameters based on identification of spinal markers in a preoperative image comprises a processor and/or other appropriate electronic circuitry (see paragraphs 0070 and 0087-0088); however, fail to explicitly disclose wherein (as to part of claim 2) the device is a mobile hand held communication device, and wherein (as to claim 6) the anatomical parameter is a parameter correlated to a health related quality of life score.
Anderson et al. teach the use of a system (10) for use during a spinal surgery (see paragraph 0119) comprising an imaging device (i.e. used in step 24, see Figure 5 and paragraph 0065); a tracking system (i.e. using sensors in step 24, see paragraph 0066); a mobile hand held communication device (see paragraphs 0104 and 0109) capable of executing instructions and acts (see paragraph 0103); and a control unit (e.g. defined by a computer), and obtaining a health related quality of life score regarding a desired patient outcome after a spinal surgery (see paragraph 0057) (see Figures 1-7, and paragraphs 0090-0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. with wherein the device is a mobile hand held communication device, and wherein the anatomical parameter is a parameter correlated to a health related quality of life score in view of Anderson et al. in order to provide an alternative, well-known and obvious means for executing instructions and acts producing a desired and predictable result, and to provide a well-known, obvious parameter accounting for a patient’s desired quality of life outcome correction after a spinal surgery.
Roger et al. disclose the use of a generic, automated bending device (32, see Figure 5, and paragraph 0042 referring to the bending device being controlled by control unit 31); however, Roger et al. in view of Anderson et al. fail to explicitly disclose wherein (as to the remainder of claim 2) the bending device includes a first lever and a second lever, a mandrel and moving die and a fixed die, the rod is moved through the mandrel and in between the moving die and the fixed die, wherein the bending device includes gauges, and at least one angle gauge, allowing for manipulation of the rod in order to determine bend position, bend angle, and bend rotation, wherein the rod is held within the bending device by a collet, and moved via a sliding slide block, wherein the angle gauge includes a ratchet mechanism having ratchet teeth spaced apart at intervals indicating five degrees of bend angle.
Isaacs teaches the use of a bending device (70) capable of being automated (see column 12, lines 32-35), wherein the bending device includes a first lever (71) and a second lever (72), a mandrel (80) and moving die (81) and a fixed die (82), a rod (10) is moved through the mandrel and in between the moving die and the fixed die (see column 13, lines 50-51), wherein the bending device includes gauges (i.e. gauges defined by 77, 85 and 91), and at least one angle gauge (85), allowing for manipulation of the rod in order to determine bend position (i.e. via 77), bend angle (i.e. via 85), and bend rotation (i.e. via 91) (see column 13, lines 51-53), wherein the rod is held within the bending device by a collet (90), and moved via a sliding slide block (76), wherein the angle gauge includes a ratchet mechanism (i.e. mechanism defined by 85) having ratchet teeth (86) spaced apart at intervals indicating five degrees of bend angle (see column 13, lines 62-63) (see Figured 7-10, column 12, lines 32-35, and column 13, line 36 – column 14, line 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. with wherein the bending device includes a first lever and a second lever, a mandrel and moving die and a fixed die, the rod is moved through the mandrel and in between the moving die and the fixed die, wherein the bending device includes gauges, and at least one angle gauge, allowing for manipulation of the rod in order to determine bend position, bend angle, and bend rotation, wherein the rod is held within the bending device by a collet, and moved via a sliding slide block, wherein the angle gauge includes a ratchet mechanism having ratchet teeth spaced apart at intervals indicating five degrees of bend angle in view of Isaacs in order to provide a bending device requiring less manual manipulation of the rod and forming a rod in a more accurate and quicker technique taking into account the spinal parameters for the specific rod to yield predictable results.
Regarding claim 7, Roger et al. in view of Anderson et al. further in view of Isaacs disclose the claimed invention except for wherein the anatomical parameter is a parameter correlated to an alignment of a patient's head over the patient's pelvis.
Roger et al. teach the system running software identifying key features of bony anatomy (i.e. anatomical parameter) to be linked with a line assembled on the display, wherein the results would indicate a required angular correction that would be entered into the system (see paragraph 0035). Although Roger et al. do not explicitly list a patient’s head or pelvis, one of ordinary skill in the art would recognize the importance of including these bony features (i.e. head and pelvis) during global alignment of a spine during spinal surgery.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. further in view of Isaacs with wherein the anatomical parameter is a parameter correlated to an alignment of a patient's head over the patient's pelvis in order to provide well-known, obvious bony features (e.g. head and pelvis) as parameters for global alignment of a spine during spinal surgery.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Roger et al. (International Publication WO 2015/003224) in view of Anderson et al. (U.S. Patent Application Publication 2010/0191088), further in view of Isaacs (U.S. Patent 7,957,831), as applied to claim 2 above, and further in view of Suk et al. (“Significance of Chin-Brow Vertical Angle in Correction of Kyphotic Deformity of Ankylosing Spondylitis Patients”).
Roger et al. in view of Anderson et al. further in view of Isaacs disclose the claimed invention except for wherein (as to claim 3) the anatomical parameter is a chin brow vertical angle, and wherein (as to claim 4) the chin brow vertical angle is an angle of a patient's gaze relative to a horizontal position.
Suk et al. teach the importance of obtaining a chin brow vertical angle for alignment of a spine during a spinal surgery, wherein the chin brow vertical angle is an objective index for evaluating a patient’s horizontal gaze (see pages 2001-2004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. further in view of Isaacs with wherein the anatomical parameter is a chin brow vertical angle, and wherein the chin brow vertical angle is an angle of a patient's gaze relative to a horizontal position in view of Suk et al. in order to provide a well-known, obvious parameter accounting for a patient’s horizontal gaze for planning correction/alignment of a spine.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Roger et al. (International Publication WO 2015/003224) in view of Anderson et al. (U.S. Patent Application Publication 2010/0191088), further in view of Isaacs (U.S. Patent 7,957,831), and further in view of Suk et al. (“Significance of Chin-Brow Vertical Angle in Correction of Kyphotic Deformity of Ankylosing Spondylitis Patients”), as applied to claim 4 above, and further in view of Frank et al. (U.S. Patent 7,570,791).
Roger et al. in view of Anderson et al. further in view of Isaacs and further in view of Suk et al. disclose the claimed invention except for wherein the control unit displays to a user a color indication of the angle of the gaze.
Frank et al. teach the use of a system (10) utilizing color to indicate a parameter (e.g. center of a vertebra) on a display (12) (see Figure 1, and column 16, line 52 – column 17, line 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. further in view of Isaacs and further in view of Suk et al. with wherein the control unit displays to a user a color indication of the angle of the gaze in view of Frank et al. in order to provide a well-known, obvious means for providing a clear, identifiable indication of a parameter (e.g. angle) to a user to yield predictable results.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Roger et al. (International Publication WO 2015/003224) in view of Anderson et al. (U.S. Patent Application Publication 2010/0191088), further in view of Dankowicz et al. (U.S. Patent Application Publication 2005/0262911), and further in view of Isaacs (U.S. Patent 7,957,831), and further in view of Scholl et al. (International Publication WO 2015/195843).
Roger et al. disclose the use of a generic, automated bending device (32, see Figure 5, and paragraph 0042 referring to the bending device being controlled by control unit 31). Dankowicz et al. teaches the use of a bending device (200) capable of being motorized (see paragraph 0053). Isaacs teaches the use of a bending device (70) capable of being automated (see column 12, lines 32-35).
However, Roger et al. in view of Anderson et al. further in view of Dankowicz et al. and further in view of Isaacs fail to explicitly disclose wherein (as to claim 18) the bending device includes at least one motor which automatically adjusts the position, rotation and the bend angle of the rod, and wherein (as to claim 19) the at least one motor includes a first motor that is a linear translator motor, a second motor that is a rotational motor, and a third motor that causes angular bends of the surgical rod.
Scholl et al. teach the use of a bending device (18) including a first lever (106) and a second lever (110), a mandrel (118) and moving die (120) and a fixed die (122), a rod is moved through the mandrel and in between the moving die and the fixed die (see page 47, lines 13-14), wherein the bending device includes gauges (i.e. gauges defined by 130, 132 and 134), and at least one angle gauge (132), allowing for manipulation of the rod in order to determine bend position (i.e. via 130), bend angle (i.e. via 132), and bend rotation (i.e. via 134), wherein the rod is held within the bending device by a collet (134), and moved via a sliding slide block (128), wherein the angle gauge includes a ratchet mechanism (i.e. mechanism defined by 132) having ratchet teeth (116) spaced apart at intervals indicating five degrees of bend angle (see column 13, lines 62-63), wherein the bending device includes at least one motor which automatically adjusts the position, rotation and the bend angle of the rod (see page 48, lines 5-6), and wherein the at least one motor includes a first motor that is a linear translator motor, a second motor that is a rotational motor, and a third motor that causes angular bends of the surgical rod (see Figure 53, and page 48, lines 6-13) (see page 46, line 24 – page 48, line 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Roger et al. in view of Anderson et al. further in view of Dankowicz et al. and further in view of Isaacs with wherein the bending device includes at least one motor which automatically adjusts the position, rotation and the bend angle of the rod, and wherein the at least one motor includes a first motor that is a linear translator motor, a second motor that is a rotational motor, and a third motor that causes angular bends of the surgical rod in view of Scholl et al. in order to provide a well-known, obvious motor configuration allowing for automatic adjustments to the location, rotation and bend angle of the rod to yield predictable results.
Response to Arguments
The applicant’s arguments with respect to claim 1-7 and 18-20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
