DETAILED ACTION
The Amendment filed on 08/18/2026 is acknowledged and has been entered. Claims 1, 4, & 9 have been amended. Claims 1-13 are rejected. Claims 14-20 are withdrawn. Presently, Claims 1-20 remain pending and are hereinafter examined on the merits.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/18/2026 has been entered.
Response to Arguments
Previous claim objections are withdrawn in view of the amendments filed on 08/18/2026.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2018/0280092 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10) applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new grounds of rejection now relies on Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2008/0015602 A1) in view of Fleig et al (US 20170007353 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 1, “the corresponding positions among the keyed based coupler features”. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes corresponding positions of the keyed based coupler features. Accordingly, proper antecedent basis is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 3, 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2008/0015602 A1) in view of Fleig et al (US 20170007353 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10).
Claim 1: Malackowski discloses: A computer-aided surgical navigation system comprising: an image processor adapted to generate navigational reference information regarding position and orientation of a body part of a patient within a three-dimensional (3-D) coordinate system; (¶0065, ¶0071, ¶0080, ¶0093, ¶0094)
a tracking device (tracker 44/46, FIG. 4, ¶0017-0019) configured to be mounted to the patient (Claim 13, ¶0072,) comprising a tracking frame (tracking head 212, FIG. 4)
a coupler base (Connector assembly 214, FIG. 4-6) configured to be removably fastenable to a bone in a fixed position and orientation (¶0103, ¶0111-0112)
a sensor (localizer 34, ¶0067) configured to identify a fixed position of the tracking frame relative to the coupler base (¶0085, ¶0096-0097);
a processor (navigation processor 52); and
a non-transitory, computer-readable medium storing instructions that, when executed, cause the processor to: (navigation computer 26, ¶0071)
receive the navigational reference information from the image processor; (¶0085)
receive the fixed position of the tracking frame from the sensor; (¶0085)
display one or more of the navigational reference information and information associated with the position and orientation of the at least one surgical reference (¶0066, ¶0088, ¶0098-0099, ¶0183, ¶0189, Claim 27-29).
Malackowski fails to disclose wherein the tracking frame comprises a keyed tracking frame coupler feature; &
that the coupler base [has] a plurality of planar mounting surfaces, wherein each of the plurality of planar mounting surfaces comprises a keyed base coupler feature matingly complementary to the keyed tracking frame coupler feature and configured to orient the tracking frame relative to the coupler base;
wherein the tracking frame is configured to selectively and alternatively engage each of the plurality of planar mounting surfaces in one of a plurality of locations such that the keyed tracking frame coupler feature engages the keyed base coupler feature and prevents translation and rotation of the tracking frame relative to the coupler base;
However, Axelson in the context of navigation systems for surgical bone procedures discloses:
a tracking device (112) mounted to the patient comprising a tracking frame (the structure of the tracker 112) wherein the tracking frame comprises a keyed tracking frame coupler feature (spring loaded ball like structures); (¶0003, ¶0032-0034);
-Axelson teach a dynamic reference frame or tracker device 112 that attaches to patient body parts (i.e., bones) and surgical instruments to communicate position information to the system, ¶0003, ¶0032-0034. ¶Abstract. Under the broadest reasonable interpretation, the structure of the tracker is a tracking frame, while the tacker is a tracking device. The trackers feature a keyed tracking coupler feature (i.e., the spring loaded ball like structure on their mounting end, ¶0032-0034. Alternatively, they may feature such as another shape or design, for example, an opening of non-circular shape or a projection or a mechanical detail of suitable geometry and construction may also be used for attaching a tracker, ¶0034.
a coupler base (cutting block serves as a coupler base and is fixed to the bone using pins, ¶Abstract, ¶0038) having a plurality of planar mounting surfaces (the flat two-dimensional surface that also includes the attachment holes), wherein each of the plurality of planar mounting surfaces comprises a keyed base coupler feature matingly complementary (the holes have corresponding small openings to accommodate the trackers spring loaded balls, acting as the matingly complementary coupler feature. ¶0032-0034.) to the keyed tracking frame coupler feature and configured to orient the tracking frame relative to the coupler base; (¶Abstract, ¶0007-0008, ¶0029-0031, ¶0032-0034, ¶0038)
-Axelson teaches a cutting block. See block 20, 54, or 78. This cutting block is anchored to the bones using pins, ¶Abstract, ¶0038. Because the tracker couples to this block to navigate it, the cutting block serves as the coupler base. This cutting block connects its top via flat outwardly facing walls. These walls are 26, 28, 30, and 32, see ¶0029-0031. Under the broadest reasonable interpretation, these flat walls represent a plurality of planar mounting walls. Each of the block’s walls feature an attachment hole. These holes are 34, 36, 38, & 40. These holes contain small openings. These small holes can be non-circular shape, see ¶0032-0034. Upon review of reading ¶0032-0034, the small openings are designed to accommodate the tracker’s spring loaded ball like structures aiding in attachment. This interface is matingly complementary and ensures the tacker is locked in a precise predetermined orientation.
wherein the tracking frame is configured to selectively and alternatively engage each of the plurality of planar mounting surfaces in one of a plurality of locations such that the keyed tracking frame coupler feature engages the keyed base coupler feature and prevents translation and rotation of the tracking frame relative to the coupler base; (¶0032, ¶0034, ¶0037)
-The tracker is designed to be relocated during surgery, ¶0032, ¶0037. A surgeon will selectively plug the tracker into hole 34 to navigate one cut, then move it to another hole and so forth. ¶0032, ¶0039., This teaches the selective and alternative engagement across a plurality of locations. Regarding the prevention of translation and rotation, the mating of the spring loaded balls into the small opening or the non-circular projections into a non-circular hole physically precents the tracker from spinning (i.e., rotating) or sliding (i.e.., translating) relative to the cutting block hole, ¶0032-0034. Axelson even states, ¶0037, “accurate positional information on all 6 degrees-of-freedom”. Because tracking all 6 DOF would require a complete fixed relationship, the keyed interface must prevent all translation and all rotation of the tracker relative to the block.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the tracking device and coupler base of Malackowski in view of the teachings of Axelson. The motivation to do this yield predictable results such as improving minimally invasive surgery, as suggested by Axelson, ¶0044.
Malackowski fails to disclose:
and one or more coupler magnets configured to magnetically couple to one or more frame magnetics;
However, Fleig in the context of detachable tracking devices in the field of surgical tracking systems, discloses, and one or more coupler magnets of a coupler base (base member 2) configured to magnetically couple to one or more frame magnetics of a tracking device/tracking frame (¶Abstract – tracking reference with the trackers on is a tracking device. The reference is a frame that the tracking markers are held by (i.e., a tracking frame));
-¶0008, ¶0010, ¶0012, ¶0014, ¶0029, ¶0032, Claim 1-“wherein the interface comprises magnetic means which generate a force at the reference array, wherein the force is directed away from the supporting surface and wherein the magnetic means are formed by at least one permanent magnet”, The reference array features an arrangement of tracking marks to be detected by a tracking system. The reference array features magnetic means. The tracking reference is formed by at least one permanent magnetic 6, ¶0029. The base member 2 features its own complementary shaped interface with magnetic means, ¶0008, ¶0010, ¶0014, Claims 3, ‘a base member comprising an interface which is complementarily shaped with respect to the reference array interface and comprises magnetic means which generate a force at the reference array’ & Claim 4, “wherein the magnetic means of the base member interface are formed by at least one permanent magnet”. ¶0030, ‘a base member 2 in accordance with the invention, comprising an interface 4B which forms a recess within the body of the base member 2. The bottom of the recess is formed as a flat surface 7 which exhibits a magnetic means,’. Accordingly, ¶0014, ‘the attachment connection between the reference array and the base member is established and maintained solely by the magnetic means of the reference array and base member, respectively.’
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify coupler base and tracking frame of modified Malackowski to incorporate one or more coupler magnets configured to magnetically couple to one or more frame magnetics, respectively as taught by Fleig. The motivation to do this yield predictable results such as providing tracking system which is inexpensive to produce and easy to use and suitable for a wide range of different applications, as suggested by Fleig, ¶0006.
Malackowski fails to disclose:
identify the fixed position of the tracking frame relative to the coupler base as one of a plurality of predetermined potential locations based on stored characteristics of the coupler base and the corresponding positions among the keyed based coupler features;
However, Van Beek in the context of modular tracking frames and bases discloses,
identify the fixed position of the tracking frame relative to the coupler base as one of a plurality of predetermined potential locations based on stored characteristics of the coupler base and the corresponding positions among the keyed based coupler features; (¶0106, ¶0110-0111, ¶0115-0122, when the tracker utilizes a symmetric fixation to allow it to be attached to the base in multiple predetermined positions, to navigate using this steep, the computer generated separate 3D volumes representing each of the potential positions of the tracker relative to the base, such as a left position and right position. In order to determine the real position of the tracker relative to the base (i.e., identifying whether it is in a left or right predetermined location), the user places the tip of a tracked tool so it contract a reference point on the base. The computer then compares the tracked position of the tool tip against the known position of the reference point to select the correct referential. The reference features includes the reference point on the base as well as the tracker which are known to the system. Reference features are stored in the memory of the computer. For the computer to resolve which position the tracker is in, it must know the layout of the base. (i.e., the spatial relationship between the cylindrical openings 12’ and the reference finger 13 defined as the base’s reference features), ¶0070, ¶0117-0122.)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of modified Malackowski such that it identifies the position of the tracking frame relative to the coupler base as one of a plurality of predetermined potential locations based on stored characteristics of the coupler base as taught by Van Beek. The motivation to do this yield predictable results such as allowing the surgical team to easily adapt the tracker’s orientation to accommodate the camerea setup and spatial constraints of the operating room, as suggested by Van Beek, ¶0070, ¶0110-0111.
Malackowski fails to disclose:
determine a position and orientation of at least one surgical reference with respect to the body part based on the navigational reference information and the position of the tracking frame; and
However, Nielsen in the context of hip replacement navigation systems discloses:
determine a position and orientation of at least one surgical reference with respect to the body part based on the navigational reference information and the position of the tracking frame; and (¶0266, ¶0267) Note; Nielsen also discloses, display one or more of the navigational reference information and information associated with the position and orientation of the at least one surgical reference (¶0011, ¶0018, ¶0025, ¶0033, ¶0035, ¶0208-0209, ¶0211, ¶0267, ¶0291, ¶0313-0314).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the navigation system of modified Malackowski to be configured to determined determine a position and orientation of at least one surgical reference with respect to the body part based on the navigational reference information and the position of the tracking frame as taught by Nielsen. The motivation to do this yields predictable results such as providing a valid anatomical plane to guide cup placement, Nielsen ¶0267.
Claim 3: Malackowski as modified discloses all the elements above in claim 1, Malackowski fails to disclose, wherein each of the keyed base coupler features comprise a divot.
However, Van Beek is relied upon teaches wherein each of the keyed base coupler features (cylindrical openings 12’ (i.e., the opening/recess of the cylindrical opening 12)) comprise a divot.
-The surface at the base of each recess is considered the seat at the bottom of the recess is considered the divot.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify each of the keyed base coupler features of modified Malackowski to include a divot as taught by Van Beek. The motivation to do this yields predictable results such as improving the relative position and fixation of the tracker relative to the base to generate accurate a navigational 3D volume, as suggested by Van Beek, ¶0102, ‘Since the tracker has known position and fixation relative to the base (noted RFtracker), the computer implements an algorithm to generate the above-mentioned 3D volume in the referential of the tracker. This 3D volume is referred to as Vtracker.’.
Claim 9: Malackowski as modified discloses all the elements above in claim 1, Malackowski discloses, wherein the navigational reference information relates to the bone of the patient. (Claim 13, ‘13. A navigation system as set forth in claim 1 wherein said tracking device is attachable to bone.’; ¶0072, ‘Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Pat. No. 7,725,162, hereby incorporated by reference […] the trackers 44, 46 could be mounted to other tissue types or parts of the anatomy.’)
Claim 10: Malackowski as modified discloses all the elements above in claim 9, Malackowski discloses, wherein the tracking device is mounted to the bone. (Claim 13, ‘13. A navigation system as set forth in claim 1 wherein said tracking device is attachable to bone.’; ¶0072, ‘Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Pat. No. 7,725,162, hereby incorporated by reference […] the trackers 44, 46 could be mounted to other tissue types or parts of the anatomy.’), a tissue (Claim 13, ‘13. A navigation system as set forth in claim 1 wherein said tracking device is attachable to bone.’; ¶0072, ‘Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Pat. No. 7,725,162, hereby incorporated by reference […] the trackers 44, 46 could be mounted to other tissue types or parts of the anatomy.’; ¶0091, ‘Navigation system 20 monitors the positions of the femur F and tibia T of the patient by monitoring the position of bone trackers 44, 46 firmly attached to bone. Femur coordinate system is FBONE and tibia coordinate system is TBONE, which are the coordinate systems of the bones to which the bone trackers 44, 46 are firmly attached.’)
Claim 12: Malackowski as modified discloses all the elements above in claim 1, Malackowski fails to disclose, wherein the at least one surgical reference is an anterior pelvic plane.
However, Nielsen discloses, wherein the at least one surgical reference is an anterior pelvic plane. (¶0267, ‘As described herein, the system 600 can determine a reference plane. The plane can be uniquely determined by any of the following: three non-collinear points, a line and non-collinear point, two distinct but intersecting lines, or two parallel lines. In some methods of use, the Anterior Pelvic Plane is calculated based on three non-collinear points. In some methods of use, the Anterior Pelvic Plane is calculated based on ipsilateral ASIS, contralateral ASIS, and the anterior surface of the pubic symphysis. In some methods of use, the orientation of the Anterior Pelvic Plane can be a baseline for placement of the cup portion of a hip prosthesis. The surgical orientation device 172 can display information with respect to the Anterior Pelvic Plane. In some methods of use, the abduction and anteversion angles in cup placement in total hip arthroplasty can be with respect to the Anterior Pelvic Plane. The Anterior Pelvic Plane is cited in literature as a valid anatomical plane to guide cup placement. In some embodiments, the Anterior Pelvic Plane is determined by the surgical orientation device 172 and/or the orientation sensing device 204. In some embodiments, a reference frame is established by the Anterior Pelvic Plane. The Anterior Pelvic Plane reference frame is a three dimensional reference frame. The Anterior Pelvic Plane reference frame is a reference frame that contains the Anterior Pelvic Plane. In some embodiments, the surgical orientation device 172 and/or the orientation sensing device 204 can provide orientation and/or position data related to the Anterior Pelvic Plane reference frame. In some embodiments, the surgical orientation device 172 can display orientation and/or position data relative to the Anterior Pelvic Plane reference frame.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the surgical reference of modified Malackowski to be configured such that the at least one surgical reference is the anterior pelvic plane as taught by Nielsen. The motivation to do this yields predictable results such as providing a valid anatomical plane to guide cup placement, Nielsen ¶0267.
Claims 2, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2008/0015602 A1) in view of Fleig et al (US 20170007353 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10), alternatively, in view of McCombs (US 2005/0197569 A1).
Claim 2: Malackowski as modified discloses all the elements above in claim 1, Malackowski discloses, further comprising a monitor configured to receive and display the one or more of the navigational reference information (¶0065, ‘The navigation system 20 tracks these objects for purposes of displaying their relative positions and orientations to the surgeon and, in some cases, for purposes of controlling or constraining movement of the surgical instrument 22 relative to a predefined path or anatomical boundary.’; ¶0066, ‘The navigation system 20 includes a computer cart assembly 24 that houses a navigation computer 26. A navigation interface is in operative communication with the navigation computer 26. The navigation interface includes a first display 28 adapted to be situated outside of a sterile field and a second display 29 adapted to be situated inside the sterile field. The displays 28, 29 are adjustably mounted to the computer cart assembly 24.’) and the position and orientation of the at least one surgical reference.
Alternatively, McCombs in the context of providing patient-mounted surgical navigational sensors, discloses, further comprising a monitor configured to receive and display the one or more of the navigational reference information and the position and orientation of the at least one surgical reference. (Claim 13, ‘displaying the position and orientation of the at least one surgical reference with respect to the body part in combination with at least some of the navigational reference information.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify monitor of modified Malckowski such that it is configured to receive and display the one or more of the navigational reference information and the position and orientation of the at least one surgical reference as taught by McCombs. The motivation to do this yields predictable results such as surgeon is able to see into the body to navigate the position item properly, ¶0034 of McCombs.
Claim 6: Malackowski as modified discloses all the elements above in claim 1, Malackowski discloses, wherein the sensor (localizer 34, ¶0067, ‘A localizer 34 communicates with the navigation computer 26. In the embodiment shown, the localizer 34 is an optical localizer and includes a camera unit 36 (also referred to as a sensing device). The camera unit 36 has an outer casing 38 that houses one or more optical position sensors 40. In some embodiments at least two optical sensors 40 are employed, preferably three.’) is adapted to sense at least one of the following: an electrical signal, a magnetic field, an electromagnetic field, a sound, a physical body, radio frequency, an x-ray, light (¶0067), an active signal (¶0139), or a passive signal (¶0146).
Alternatively, McCombs in the context of providing patient-mounted surgical navigational sensors, discloses, wherein the sensor is adapted to sense at least one of the following: an electrical signal, a magnetic field, an electromagnetic field, a sound, a physical body, radio frequency, an x-ray, light, an active signal, or a passive signal. (Claim 2, ‘wherein the sensor is adapted to sense at least one of the following: an electrical signal, a magnetic field, an electromagnetic field, a sound, a physical body, radio frequency, an x-ray, light, an active signal, or a passive signal.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify sensor of modified Malackowski such that the sensor is adapted to sense at least one of the following: an electrical signal, a magnetic field, an electromagnetic field, a sound, a physical body, radio frequency, an x-ray, light, an active signal, or a passive signal as taught by McCombs. The motivation to do this yields predictable results such as improving visualization of navigational guidance.
Claim 8: Malackowski as modified discloses all the elements above in claim 1, Malackowski discloses, wherein the body part is at least one of a bone (Claim 13, ‘13. A navigation system as set forth in claim 1 wherein said tracking device is attachable to bone.’; ¶0072, ‘Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Pat. No. 7,725,162, hereby incorporated by reference […] the trackers 44, 46 could be mounted to other tissue types or parts of the anatomy.’), a tissue (Claim 13, ‘13. A navigation system as set forth in claim 1 wherein said tracking device is attachable to bone.’; ¶0072, ‘Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Pat. No. 7,725,162, hereby incorporated by reference […] the trackers 44, 46 could be mounted to other tissue types or parts of the anatomy.’), a femur (¶0065, ‘Such objects include, for example, a surgical instrument 22, a femur F of a patient, and a tibia T of the patient’; ¶0072, ‘Navigation system 20 includes a plurality of tracking devices 44, 46, 48, also referred to herein as trackers. In the illustrated embodiment, one tracker 44 is firmly affixed to the femur F of the patient and another tracker 46 is firmly affixed to the tibia T of the patient. Trackers 44, 46 are firmly affixed to sections of bone. Trackers 44, 46 may be attached to the femur F and tibia T in the manner shown in U.S. Pat. No. 7,725,162, hereby incorporated by reference’), and a head of the patient.
Alternatively, McCombs in the context of providing patient-mounted surgical navigational sensors, discloses, wherein the body part is at least one of a bone, a tissue, a femur, and a head of the patient. (Claim 4, ‘wherein the body part is at least one of the following: a bone, a tissue, a patient's femur, a patient's head.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the body part modified Malackowski such the body part is at least one of a bone, a tissue, a femur, and a head of the patient as taught by McCombs. The motivation to do this yields predictable results such as improving surgical navigational guidance.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2008/0015602 A1) in view of Fleig et al (US 20170007353 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10), as applied to claim 3 above, in further view of Carson (US 2005/0113846 A1).
Claim 4: Malackowski as modified discloses all the elements above in claim 3, Malackowski fails to disclose, further comprising a tracking probe, wherein the sensor is further configured to identify a position of the tracking probe, and wherein the instructions, when executed, further cause the processor to; receive the position of the tracking probe, and determine whether the tracking probe is located in the divot of one of the plurality of planar mounting surfaces.
However, Carson in the context of surgical navigation system, discloses, further comprising a tracking probe (probe 26, FIG. 11, ¶0081, ‘computer functionality 18 can track any point in the position/orientation sensor 16 field such as by using a designator or a probe 26.), wherein the sensor is further configured to identify a position of the tracking probe, and wherein the instructions, when executed, further cause the processor to; receive the position of the tracking probe, and (¶0088, ‘FIG. 11 shows a technician designating with probe 26 an item 22 such as an instrument component to which fiducial 14 is attached. The sensor 16 “sees” the position and orientation of the fiducial 14 attached to the item 22 and also the position and orientation of the fiducial 14 attached to the probe 26 whose tip is touching a landmark on the item 22.')
determine whether the tracking probe is located in the divot of one of the plurality of surfaces (¶0081, ‘The probe also can contain or be attached to a fiducial 14.’, ¶0083, ‘Such systems also use at least one probe 26 which the surgeon can use to select, designate, register, or otherwise make known to the system a point or points on the anatomy or other locations by placing the probe as appropriate and signaling or commanding the computer to note the location of, for instance, the tip of the probe.’;).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the surgical navigation system of modified Malackowski to further comprise a tracking probe, wherein the sensor is further configured to identify a position of the tracking probe as taught by Carson. The motivation to do this yields predictable results such as provide functionality information relating to the body part such as rotational axes, Carson ¶0015.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of modified Malackowski such that wherein the instructions, when executed, further cause the processor to; receive the position of the tracking probe, and determine whether the tracking probe is located in the divot of one of the plurality of surfaces as taught by Carson for the advantage of providing an improved apparatus with such an apparatus being able to ensuring that the computer knows which part, item, or construct corresponds to the tracking frame and how to position and orientation of the body part is related to the position and orientation of its corresponding tracking frame, Carson ¶0088.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2008/0015602 A1) in view of Fleig et al (US 20170007353 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10), as applied to claim 1 above, in further view of Moctezuma de la Barrera et al (US 2016/0242858 A1).
Claim 5: Malackowski as modified discloses all the elements above in claim 1, Malackowski discloses, further comprising a robotic arm (the surgical instrument 22 of the robotic manipulator 56 equates to a robotic arm), wherein the instructions, when executed, further cause the processor to notify a user to when a line of sight obstructed between the sensor to the tracking frame. (¶0139, ‘The optical sensors 40 of the navigation system 20 are configured to receive signals from the LEDs 50. The navigation system 20 controls activation of the LEDs 50, as previously described, so that the navigation system 20 can anticipate when a signal should be received. When an anticipated signal from an LED 50 is not received one possibility is that the signal path is obstructed and the signal is blocked from being sent to the camera unit 36.’; ¶0140, ‘In either case, when the navigation system 20 determines that there is an error based on the failure of one or more sensors 40 to receive signals from one or more LEDs 50, an error signal is generated by the navigation computer 26. An error message then appears on displays 28, 29. The navigation computer 26 also transmits an error signal to the tracker controller 62.’; ¶0173, ‘The navigation system 20 is configured to assist with positioning of the tracker 44 by the surgeon or other medical personnel. This assistance helps to place the tracking head 212 (or tracking heads 312, 412) in a desired orientation that provides line-of-sight between the LEDs 50 and the optical sensors 40 and helps to reduce line-of-sight errors that may otherwise be encountered during a surgical procedure.)
Malackowski fails to disclose, to notify a user to reposition the tracking frame when the robotic arm obstructs a line of sight of the sensor to the tracking frame
However, Moctezuma de la Barrera in the context of navigation systems for reducing tracking interruptions during a surgical procedure discloses, notify a user to reposition the tracking frame when the robotic arm obstructs a line of sight of the sensor to the tracking frame. (¶0087, ‘Referring to FIG. 9, the feedback generator 122, in response to detecting the collision, may also cause the displays 28, 29 to display a message to the user including instructions to reposition particular anatomy of the patient. The particular anatomy may include the anatomy to which the bone tracker 44, 46 about to be obstructed is attached. For instance, if the tool virtual object 22′ representing the surgical tool 22 was found to have collided with the virtual line-of-sight boundary 108 associated with the bone tracker 46 on the tibia T, the navigation processor 52 may cause the displays 28, 29 to display a message to the user to “move the tibia.’) -The tracker corresponds to the tibia of the patient. When user moves the tibia, the tracker would also be repositioned.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the processor of modified Malackowski to include notifying a user to reposition the tracking frame when the robotic arm obstructs a line of sight of the sensor to the tracking frame as taught by Moctezuma de la Barrera. The motivation to do this yields predictable results such as avoided collisions and line of sight errors, ¶0087 and Moctezuma de la Barrera.
Claims 7, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Malackowski et al (US 2017/0119478 A1, herein Malackowski) in view of Axelson (US 2008/0015602 A1) in view of Fleig et al (US 20170007353 A1) in view of Van Beek et al (US 2018/0280092 A1) in view of Nielsen et al (US 2018/0296365 A10), as applied to claim 1 above, in further view of McCombs (US 2005/0197569 A1).
Claim 7: Malackowski as modified discloses all the elements above in claim 1, Malackowski discloses, wherein the sensor comprises at least two optical tracking cameras for sensing the body part of the patient (localizer 34, ¶0067, ‘A localizer 34 communicates with the navigation computer 26. In the embodiment shown, the localizer 34 is an optical localizer and includes a camera unit 36 (also referred to as a sensing device). The camera unit 36 has an outer casing 38 that houses one or more optical position sensors 40. In some embodiments at least two optical sensors 40 are employed, preferably three.’).
Malackowski fails to disclose, wherein the sensor comprises at least two optical tracking cameras for sensing the at least one surgical reference associated with body part of the patient.
However, McCombs in the context of providing patient-mounted surgical navigational sensors, discloses, wherein the sensor comprises at least two optical tracking cameras for sensing the at least one surgical reference associated with body part of the patient. (Claim 3, ‘wherein the sensor comprises: (a) at least two optical tracking cameras for sensing at least one surgical reference associated with a body part of a patient’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the sensor of modified Malackowski to be configured such that the sensor comprises at least two optical tracking cameras for sensing the at least one surgical reference associated with body part of the patient as taught by McCombs. The motivation to do this yields predictable results such as providing multiple viewing positions of the surgical references, ¶0030 of McCombs.
Claim 11: Malackowski as modified discloses all the elements above in claim 1, Malackowski fails to disclose, wherein the navigational reference information is a mechanical axis of the body part.
However, McCombs in the context of providing patient-mounted surgical navigational sensors, discloses, wherein the navigational reference information is a mechanical axis of the body part. (Claim 6, ‘wherein the navigational reference information includes at least one of a mechanical axis of a femur and a mechanical axis of the body part.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the navigational reference information modified Malackowski to be configured such that it is a mechanical axis of the body part as taught by McCombs. The motivation to do this yields predictable results such as improving navigational guidance, ¶0034 of McCombs.
Claim 13: Malackowski as modified discloses all the elements above in claim 1, Malackowski fails to disclose, further comprising an imager for obtaining an image of the body part of the patient, and wherein the processor is adapted to store the image.
However, McCombs in the context of providing patient-mounted surgical navigational sensors, discloses, further comprising an imager for obtaining an image of the body part of the patient, and wherein the processor is adapted to store the image. (Claim 5, ‘further comprising an imager for obtaining an image of the body part of the patient, and wherein the computer is adapted to store the image in addition to the at least some of the navigational reference information, and the monitor is adapted to display the image and the at least some of the navigational reference information.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the navigational reference information modified Malackowski comprising an imager for obtaining an image of the body part of the patient, and wherein the processor is adapted to store the image as taught by McCombs. The motivation to do this yields predictable results such as improving navigational guidance, ¶0052-¶0055 of McCombs.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
van der Walt et al (US 2016/0242934 A1) discloses, ¶0330, ‘The orientation sensing device 204 can track any movement of the pelvis during the procedure. There is no need for registration of landmarks in this technique because the position and orientation of the impactor 300B and/or orientation sensing device 204 relative to the acetabulum and/or to the anterior pelvic plane are known from the pre-operative imaging. From the known orientation of the orientation sensing device 204 with respect to the pelvis, the system can calculate the orientation of the surgical orientation device 172 with respect to the pelvis.’
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/N.A.R./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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