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 .
Status of Claims
This Office Action is responsive to the claims filed on 08/13/2025. Claims 1, 6, and 11 have been amended. Claim 16 is newly presented. Claims 1-16 are presently pending in this application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “emitting device” in claim 4, line 3, claim 9, line 3, and claim 14, line 3.
The corresponding structure for the “emitting device” defined within the specification is “emitting coils” (Pg. 9, Line 16) and any functional equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kang (US 20140180341) in view of Krause (US 20040068187), Uhde (US 20230293235), de la Barrera (US 20140276855) and Quist (US 20240122671).
Regarding claim 1, Kang teaches a computer-assisted surgical method for osteotomy (Paragraph [0011]; a computer-readable storage medium having instructions thereon that, when executed by a processing circuit, aid in the planning or performance of an open wedge osteotomy) of a first bone of a lower limb (Paragraph [0027]; bone 10 is a tibia, Fig. 2A and Fig. 6) to correct a misalignment of the lower limb (Paragraph [0029]; methods and systems can be utilized for osteotomy procedures on any bone of the body to correct a variety of joint alignment issues) by moving a first bone portion of the first bone (Paragraph [0032]; a distal portion 10b of bone 10, Figs. 5A-B) and a second bone portion of the first bone (Paragraph [0032]; Figs. 5A-B, a proximal portion 10a of bone 10) away from or toward each other about a bony hinge (Paragraph [0027]-[0028]; opening and closing wedge, Fig. 2A-B) to reach a targeted deformed configuration of the first bone (Paragraph [0027]-[0028]; The angle between the resected surfaces 12, 14 is then increased to a desired angle) achieving a corrected alignment of the lower limb (Paragraph [0027]-[0028]; FIG. 2A illustrates a completed high tibial, open wedge osteotomy, term "desired" means a planned or ideal outcome to be achieved by the surgical method or system), the first bone portion and the second bone portion being created after cutting the first bone (Paragraph [0035]; FIG. 5A illustrates a single cut 36 through the bone 10; a wedge-shaped opening created between the proximal portion 10a and the distal portion 10b of the bone 10), the lower limb comprising the first bone and a second bone articulated with the first bone (Paragraph [0049]; tibia and femur; Figs. 5-6 shows the first (tibia) and second bone (femur)), the method comprising:
fixing a first tracker to the first bone portion of the first bone (Paragraphs [0043]-[0045]; navigation marker 46, Fig. 6 first marker on lower bone; Paragraph [0045]; After creation of a cut 36 in bone 10 during an osteotomy procedure, navigation marker 46 will be located on one side of cut 36) and a second tracker to the second bone (Paragraphs [0043]-[0045]; navigation marker 46, Fig. 6 second marker on upper bone);
based on tracked poses of the first tracker and of the second tracker (Paragraph [0044]; calculates a pose of the tracked object based on the trackable elements' positions; Paragraph [0047]; computer 50 is configured to communicate with the navigation system 42), computing the targeted deformed configuration of the first bone achieving the corrected alignment of the lower limb (Paragraph [0048]; Based on the patient's current femoral-tibial angle and the desired femoral-tibial alignment angle to be achieved by the osteotomy procedure, the computer 50 is programmed to calculate the desired correction angle), at least one cutting plane (Paragraph [0049]; correction angle can represent any angular measurement utilized for planning… a cut to be made through at least a portion of a bone; Paragraph [0055]-[0056]; Virtual boundary 72 representing a cut through a portion of the bone may have an essentially planar shape) and an optimal placement of an implant to maintain the first bone in the targeted deformed configuration (Paragraph [0052]; Alternatively, the computer 50 may develop the surgical plan, including the planned virtual boundaries, prior to fixation plate selection. In this case, the fixation plate 24 may be selected (e.g. input, chosen, or designed) based at least in part on the planned virtual boundaries… execution of the surgical plan will result in alignment of the first and second holes 30, 32 in the bone 10 with the first and second apertures 26, 28 of the fixation plate 24);
fixing a tracker to the second bone portion of the first bone (Paragraph [0045]; Another option to overcome an inability to track both portions 10a and 10b during an osteotomy procedure is to have a navigation marker on each side of the planned location of cut 36.);
drilling a plurality of screw holes in the first bone (Paragraph [0032]; Holes are created in the patient's bone to accommodate the fasteners (step 302), Fig. 3) on either side of the at least one computed cutting plane (Paragraph [0032]; both the first hole 30 and the second hole 32 will be created on the bone 10 in accordance with a preoperative plan, Figs. 5A-B and 7A-B show the holes are on either side of the cutting plane);
after drilling the plurality of screw holes, performing at least one partial cut in the first bone along the at least one computed cutting plane to create the first bone portion and the second bone portion (Paragraph [0035]; a cut (i.e. resection) is made through at least a portion of the bone (step 304), Fig. 3; Paragraph [0050]; the computer 50 is used to develop a surgical plan… virtual boundaries, shown in FIG. 7A, represent holes and/or cuts to be made in a bone 10 during an osteotomy procedure);
wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion (Paragraph [0035]; a cut (i.e. resection) is made through at least a portion of the bone (step 304). In the case of an open wedge osteotomy, the cut can be a single planar cut… the first resected surface 38 and the second resected surface 40 each face a wedge-shaped opening created between the proximal portion 10a and the distal portion 10b of the bone 10);
based on tracked poses of the first, second, (Paragraph [0039]; In one approach, the haptic device slowly pushes the tool between the surfaces, automatically stopping once the desired correction angle between the first and second resected surfaces has been reached; Paragraph [0042]; The navigation system tracks the patient's bone, as well as surgical tools utilized during the surgery, to allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure) moving the first bone portion and the second bone portion away or toward each other to reach the targeted deformed configuration (Paragraph [0038]-[0040]; steps 305 and 306 illustrate different paths… step 305, the bone is distracted such that the first resected surface 38 and the second resected surface 40 move relative to each other until the second aperture 28 of the fixation plate 24 is aligned with the second hole 32 of the bone 10; step 306, wedge-shaped opening created in the bone is closed); and
fixing the implant in the optimal placement to the first bone portion and the second bone portion with a plurality of screws in the plurality of respective screw holes to maintain the first bone in the targeted deformed configuration (Paragraph [0033]; a fastener 34 through the first aperture 26 and into the first hole 30 (step 303); Paragraph [0041]; step 307, the first portion of fixation plate 24 is coupled to the bone 10 with fastener 34 prior to coupling the second portion of fixation plate 24 to bone 10 (e.g. by inserting a fastener through second aperture 28 and into second hole 32), Fig. 3); and
a 3D model of the first bone from tracked poses of the first tracker and the second tracker (Paragraph [0048]; The scan data is then segmented to obtain a three-dimensional representation of the patient's anatomy… Using the three-dimensional representation and as part of the planning process, femoral and tibial landmarks can be selected, and the patient's femoral-tibial alignment angle is calculated; Paragraph [0054]; the physical anatomy is registered using known registration techniques).
Kang does not explicitly teach fixing a third tracker to a predetermined pose;
after fixing the third tracker, drilling a plurality of screw holes;
determining the predetermined pose of the third tracker on the second bone portion of the first bone from:
the 3D model and a 3D forbidden region comprising:
a first 3D region around the at least one computed cutting plane, wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion;
a second 3D region representing a volume of the implant at the optimal placement to maintain the first bone in the targeted deformed configuration, wherein the volume of the implant comprises a volume occupied by the implant inside the first bone and an area covered by a portion of the implant outside the first bone;
a third 3D region representing a volume of the plurality of screws in the plurality of respective screw holes; and
a 3D anatomical region of the first bone, wherein the 3D anatomical region comprises:
a 3D joint region adjacent to the second bone portion of the first bone; and
a 3D vascular region of the first bone,
wherein the predetermined pose is outside the 3D forbidden region.
Krause, however, teaches in a similar field of endeavor a computer-assisted surgical method for osteotomy of a first bone of a lower limb to correct a misalignment of the lower limb (Paragraph [0029]; computer assisted orthopedic surgery planner software), the method comprising fixing a third tracker to the second bone portion of the first bone to a predetermined pose (Paragraph [0174]; During surgery, radio opaque multifunctional markers 2110 are preferably attached to the patient's bone; The multifunctional marker is considered to be a third tracker as understood in its broadest reasonable interpretation; Paragraph [0169]; computer may provide an exact preferable location in which to place the markers 2110, or the computer may offer a suggested range of marker positions, Fig. 23; The lower marker 2110 is on a second portion of the bone and is considered to be a third tracker at a predetermined pose as understood in its broadest reasonable interpretation);
after fixing the third tracker (Paragraphs [0178]-[0181]; After the markers 2110 are attached, the new or "final" surgical plan is calculated, the surgeon is ready to actually perform the osteotomy), drilling a plurality of screw holes (Paragraph [0193]-[0196]; the fixation plate 2240 is secured to the open wedge-side of the bone 2100; this example includes more than one cut, the other parts of the bone may be opened at this time; open bone wedge 2102 is filled and the fixation plate 2240 is secured);
based on tracked poses of the third trackers, moving the first bone portion and the second bone portion away or toward each other to reach the targeted deformed configuration (Paragraph [0189]; the bone is ready to be bent, rotated, twisted, and/or repositioned into the proper alignment according to the updated surgical plan… this part of the surgical plan has been "updated" based on the actual position of the multifunctional markers); and
determining the predetermined pose of the third tracker on the second bone portion of the first bone from the 3D model (Paragraph [0169]; computer-based planning software places multifunctional markers 2110 near the suggested osteotomy location 2102 on the computerized 3D patient bone model 2100 (see, FIG. 23C)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Kang to have included further fixing the tracker of Krause to the bone thus resulting in fixing a third tracker to a predetermined pose; and after fixing the third tracker, drilling a plurality of screw holes, and determining the predetermined pose of the third tracker on the second bone portion of the first bone from the 3D model as taught by Krause because it would have allowed re-calculating the pre-surgical plan for performing the osteotomy and improve the overall accuracy and thereby effectiveness of the operation; and further improve accuracy in making cuts during the procedure and improve the ease of performing complicated surgeries (Krause, Paragraphs [0180]-[0183], Paragraph [0206]).
The method of Kang in view of Krause does not explicitly teach determining the predetermined pose of the third tracker on the second bone portion of the first bone from a 3D forbidden region comprising:
a first 3D region around the at least one computed cutting plane, wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion;
a second 3D region representing a volume of the implant at the optimal placement to maintain the first bone in the targeted deformed configuration, wherein the volume of the implant comprises a volume occupied by the implant inside the first bone and an area covered by a portion of the implant outside the first bone;
a third 3D region representing a volume of the plurality of screws in the plurality of respective screw holes; and
a 3D anatomical region of the first bone, wherein the 3D anatomical region comprises:
a 3D joint region adjacent to the second bone portion of the first bone; and
a 3D vascular region of the first bone,
wherein the predetermined pose is outside the 3D forbidden region.
Uhde, however, teaches in a similar field of endeavor a computer-assisted surgical method (Paragraph [0009]; a computer-implemented medical method of planning a position of a tracking reference device for referencing (i.e. defining and/or marking) a position in a medical environment) comprising determining the predetermined pose of the third tracker on the second bone portion of the first bone (Paragraph [0066]; an improved or optimal position of the tracking device can also be suggested to the user as displayed visual information) from a 3D forbidden region (Paragraph [0017]; The avoidance region constitutes a region in which the position of the tracking reference device described by the reference position data must not lie; Paragraph [0016]; the avoidance region comprises or consists of the envelope (for example, the volume defined by the envelope)) comprising:
a first 3D region around the at least one computed cutting plane (Paragraph [0013]; the medical instrument is a navigated drill or a navigated screwdriver or a navigated guide sleeve. For example, the envelope surrounds the position, i.e. the shape, of the instrument along the trajectory of the instrument when it is used on the anatomical body part; Paragraph [0064]; by a navigated drill sleeve having a marker device 7 attached to it is planned and that an envelope 5 is determined which surrounds the medical instrument 6 throughout the movement at least as long as at least a part of the medical instrument is disposed outside of the anatomical body part 1.; Paragraph [0054], Fig. 4 shows an envelope around a medical instrument which covers the implantation trajectory),;
a second 3D region representing a volume of the implant at the optimal placement to maintain the first bone in the targeted deformed configuration (Paragraph [0016]; Paragraph [0014]-[0016]; The envelope is then determined for two or more implants or implant positions and combined from the respective individual envelopes) wherein the volume of the implant comprises a volume occupied by the implant inside the first bone (Paragraph [0013]; the instrument envelope data describes a position and a shape of a three-dimensional envelope around the shape of the instrument… The envelope is then determined such that it encloses all positions of the rotational body determined in such a manner. The area in which all those positions lie is also called rotational cone or implantation cone of the medical instrument; Paragraph [0063]; FIG. 3 shows that an implantation cone 18 around the paths 3 are considered to account for the greater deviation from a back projection used for planning the paths 3 with increasing distance from the implant 2) and an area covered by a portion of the implant outside the first bone (Paragraph [0015]; the envelope for example is or has been determined to enclose… a rotational cone of the medical instrument for example in relation to one or more implants or implant positions; Fig. 3 shows the rotational cone around the implant includes part of the bone and an area covered by a portion of the implant outside the first bone), and
a third 3D region representing a volume of the plurality of screws in the plurality of respective screw holes (Paragraph [0062]; shows implants 2, for example screws, which are placed in anatomical body parts 1; Paragraph [0016]; the tracking reference device should or must not be positioned within the envelope and/or on its boundary because the volume defined by the envelope should or must be kept free of mechanical interference, for example… and/or implant; Fig. 2 shows the implant is screw);
wherein the predetermined pose is outside the 3D forbidden region (Paragraph [0066]; Boxes 11 and 12 indicate regions in which the tracking reference device can be positioned without causing any problem for tracking it or for tracking the instrument tracking reference device. These regions are called for example acceptance regions and can in the framework of the method according to the first aspect also be displayed as visual information to a user, Fig. 6 shows the acceptance regions are outside avoidance region 13 and 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Kang in view of Krause such that determining the predetermined pose of the third tracker on the second bone portion of the first bone from a 3D forbidden region comprising: a first 3D region around the at least one computed cutting plane, wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion; a second 3D region representing a volume of the implant at the optimal placement to maintain the first bone in the targeted deformed configuration, wherein the volume of the implant comprises a volume occupied by the implant inside the first bone and an area covered by a portion of the implant outside the first bone; a third 3D region representing a volume of the plurality of screws in the plurality of respective screw holes; wherein the predetermined pose is outside the 3D forbidden region as taught by Uhde because it would prevent the tracking reference device from being positioned within the envelope and/or on its boundary because the volume defined by the envelope should or must be kept free of mechanical interference, for example collisions, between the tracking reference device on the one hand and a medical instrument and/or implant and/or instrument tracking reference device attached to the medical instrument on the other hand (Uhde, Paragraph [0016]).
Together Kang in view of Krause and Uhde do not explicitly teach the 3D forbidden region further comprises a 3D anatomical region of the first bone, wherein the 3D anatomical region comprises:
a 3D joint region adjacent to the second bone portion of the first bone; and
a 3D vascular region of the first bone.
de la Barrera, however, teaches a method (Paragraph [0009]; a method for arranging a plurality of objects in an operating room using a guidance station) comprising determining the predetermined pose of the third tracker on the second bone portion of the first bone (Paragraph [0068]; one exemplary embodiment of instructions provided by the guidance station 20 for placing the trackers 44, 46 is shown in FIG. 8) from a 3D forbidden region further comprises a 3D anatomical region of the first bone (Paragraph [0050]; The guidance station 20 provides instructions on the arrangement of the objects to facilitate procedural efficiency and to reduce possible obstructions to navigation during the surgical procedure; Paragraph [0053]; The design includes the type of implant, the size/shape of the implant, and the location on the bones to which the implant is to be fixed; Paragraph [0088]; relate to checking for obstructions or other interference… surgical personnel are instructed to place trackers of the navigation system with respect to the patient's anatomy; Paragraph [0087]; the term predefined boundary is understood to include predefined trajectory, volume, line, other shapes or geometric forms, and the like), wherein the 3D anatomical region comprises:
a 3D joint region adjacent to the second bone portion of the first bone (Paragraph [0068]; based on distance from the knee joint, for example, or distances from certain anatomical landmarks associated with the knee joint (e.g, distances from patella, tibial tubercle, etc.); Fig. 5D).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the forbidden region of Kang in view of Krause and Uhde to have further included a 3D anatomical region of the first bone, wherein the 3D anatomical region comprises a 3D joint region adjacent to the second bone portion of the first bone as taught by de la Barrera because it would have allowed proper placement of the tracker to allow measurement of joint angles, thereby improving the tracking and performance of the operation (Paragraphs [0070] and [0080]).
Together Kang in view of Krause, Uhde, and de la Barrera do not explicitly teach the 3D anatomical region comprises a 3D vascular region of the first bone.
Quist, however, teaches a method (Paragraph [0017]; a method is disclosed for determined visualization of a location of vasculature within anatomical structures, such that vascular structure can be leveraged to enable and/or guide surgical actions and/or decision making during the surgical procedures) comprising determining the predetermined pose of the third tracker on the second bone portion of the first bone (Paragraph [0006]; OTS trackers also typically require additional skin incisions to be rigidly attached to bone; Paragraph [0060]; In Step 312, engine 200 determines a placement of at least one location marker) from a 3D forbidden region further comprises a 3D anatomical region (Paragraph [0057]-[0060]; specific parts of the patient's body related to a surgical procedure, specific parts of the patient's body to avoid) comprises a 3D vascular region of the first bone (Paragraph [0057]; the spatial reference can be configured as a 3D or 2D modelling; Paragraph [0060]; a spatial reference can have associated therewith a plurality of markers so as to delineate the proximity to focus on and/or avoid within the vascular structure of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the anatomical region of Kang in view of Krause, Uhde, and de la Barrera to have further included a 3D vascular region of the first bone as taught by Quist because it would have allowed the tracker to be anchored in good quality bone as placing the anchors near vasculature via implementation of the disclosed framework can enhance the likelihood of these anchors remaining secure as the surrounding bone heals after the procedure (Paragraph [0083]), while ensuring the tracker is placed to avoid the vasculature tissue and cause unnecessary blood loss (Paragraph [0059]).
Regarding claim 2, together Kang, Krause, Uhde, de la Barrera, and Quist teach all of the limitations of claim 1 as noted above.
Kang further teaches displaying the 3D model of the first bone (Paragraph [0042]; visualize the bone and tools on a display 56 during the osteotomy procedure; Paragraph [0055]; virtual representation of the bone 10… include a surface or surfaces that fully enclose and surround a three-dimensional volume).
Kang does not explicitly teach displaying the 3D forbidden region.
Uhde, however, further teaches displaying the 3D forbidden region (Paragraph [0036]; comprises a step of displaying the display data for displaying the position of at least one of the avoidance region, the envelope or the medical instrument; Paragraph [0013]; a shape of a three-dimensional envelope around the shape of the instrument).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the method of Kang in view of Krause and Uhde to have included displaying the 3D forbidden region as taught by Uhde because it would have allowed the surgeon to see exactly on the body where not to place the trackers, thereby ensuring trackers are placed properly thus improving the surgical method.
Regarding claim 3, together Kang, Krause, Uhde, de la Barrera, and Quist teach all of the limitations of claim 1 as noted above.
Kang further teaches displaying the first portion and the second portion in the 3D model (Paragraph [0042]; allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure; Paragraph [0055]; virtual representation of the bone 10… representing a cut 36 through at least a portion of the bone; Fig. 7A shows the bone with the planned cut including first and second portion of the bones around the cut).
Regarding claim 4, together Kang, Krause, Uhde, de la Barrera, and Quist teach all of the limitations of claim 1 as noted above.
Kang discloses the invention as claimed and discussed above, but fails to explicitly disclose the first tracker, the second tracker, and the third tracker are respectively configured to receive an electromagnetic field, the electromagnetic field being emitted by an emitting device, and tracked poses of the first tracker, the second tracker, and the third tracker are computed based on the received electromagnetic field.
Uhde, however, further teaches trackers are respectively configured to receive an electromagnetic field (Paragraph [0022]; markers may be magnetic field sensors; the tracking reference device is an electromagnetic reference device), the electromagnetic field being emitted by an emitting device (Paragraph [0022]; emitting electromagnetic coils), and tracked poses of the trackers are computed based on the received electromagnetic field (Paragraph [0017]; magnetic tracking sensor when the tracking reference device attains the reference position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the trackers of Kang in view of Krause, Uhde, de la Barrera, and Quist with the electromagnetic trackers taught by Uhde such that the first tracker, the second tracker, and the third tracker are respectively configured to receive an electromagnetic field, the electromagnetic field being emitted by an emitting device, and tracked poses of the first tracker, the second tracker, and the third tracker are computed based on the received electromagnetic field because it would have been a simple substitution of well-known surgical tracking components that further would have improved the surgical procedure by reducing the constraints of needing to maintain line of sight between the trackers and optical system during the surgical procedure.
Regarding claim 5, together Kang, Krause, Uhde, de la Barrera, and Quist teach all of the limitations of claim 1 as noted above.
Kang further teaches obtaining a 2D image or a 3D image (Paragraph [0058]-[0059]; The individual images of the patient's anatomy… are then segmented and used to create a three-dimensional representation) comprising:
the first bone; the implant; the plurality of screws; and the plurality of respective screw holes (Paragraph [0059]; to improve surgical planning In this embodiment, holes and/or cuts are planned and the model is manipulated to represent the patient's bone after performance of the osteotomy procedure; created of the patient's bone after performance of an open wedge osteotomy, during which the resected surfaces have been distracted, a bone graft has been added, and the fixation plate has been coupled to the bone); and
controlling from the 2D image or from the 3D image the pose of the implant and the pose of the plurality of screws (Paragraph [0059]; The structural integrity of the post-operative bone is analyzed to determine whether the patient's bone will be structurally sound post-operatively. If the analysis uncovers structural weaknesses, the surgical plan can be modified to achieve a desired post-operative structural integrity; Paragraph [0051]-[0052]; the surgical plan includes the position and alignment of the fixation plate).
Regarding claim 6, Kang teaches a computer-assisted surgical method for osteotomy (Paragraph [0011]; a computer-readable storage medium having instructions thereon that, when executed by a processing circuit, aid in the planning or performance of an open wedge osteotomy) of a first bone of a lower limb (Paragraph [0027]; bone 10 is a tibia, Fig. 2A and Fig. 6) to correct a misalignment of the lower limb (Paragraph [0029]; methods and systems can be utilized for osteotomy procedures on any bone of the body to correct a variety of joint alignment issues) by moving a first bone portion of the first bone (Paragraph [0032]; a distal portion 10b of bone 10, Figs. 5A-B) and a second bone portion of the first bone (Paragraph [0032]; Figs. 5A-B, a proximal portion 10a of bone 10) away from or toward each other about a bony hinge (Paragraph [0027]-[0028]; opening and closing wedge, Fig. 2A-B) to reach a targeted deformed configuration of the first bone (Paragraph [0027]-[0028]; The angle between the resected surfaces 12, 14 is then increased to a desired angle) achieving a corrected alignment of the lower limb (Paragraph [0027]-[0028]; FIG. 2A illustrates a completed high tibial, open wedge osteotomy, term "desired" means a planned or ideal outcome to be achieved by the surgical method or system), the first bone portion and the second bone portion being created after cutting the first bone (Paragraph [0035]; FIG. 5A illustrates a single cut 36 through the bone 10; a wedge-shaped opening created between the proximal portion 10a and the distal portion 10b of the bone 10), the lower limb comprising the first bone and a second bone articulated with the first bone (Paragraph [0049]; tibia and femur; Figs. 5-6 shows the first (tibia) and second bone (femur)), the method comprising:
fixing a first tracker to the first bone portion of the first bone (Paragraphs [0043]-[0045]; navigation marker 46, Fig. 6 first marker on lower bone; Paragraph [0045]; After creation of a cut 36 in bone 10 during an osteotomy procedure, navigation marker 46 will be located on one side of cut 36) and a second tracker to the second bone (Paragraphs [0043]-[0045]; navigation marker 46, Fig. 6 second marker on upper bone);
based on tracked poses of the first tracker and the second tracker (Paragraph [0044]; calculates a pose of the tracked object based on the trackable elements' positions; Paragraph [0047]; computer 50 is configured to communicate with the navigation system 42), computing the targeted deformed configuration of the first bone achieving the corrected alignment of the lower limb (Paragraph [0048]; Based on the patient's current femoral-tibial angle and the desired femoral-tibial alignment angle to be achieved by the osteotomy procedure, the computer 50 is programmed to calculate the desired correction angle), at least one cutting plane (Paragraph [0049]; correction angle can represent any angular measurement utilized for planning… a cut to be made through at least a portion of a bone; Paragraph [0055]-[0056]; Virtual boundary 72 representing a cut through a portion of the bone may have an essentially planar shape) and an optimal placement of an implant to maintain the first bone in the targeted deformed configuration (Paragraph [0052]; Alternatively, the computer 50 may develop the surgical plan, including the planned virtual boundaries, prior to fixation plate selection. In this case, the fixation plate 24 may be selected (e.g. input, chosen, or designed) based at least in part on the planned virtual boundaries… execution of the surgical plan will result in alignment of the first and second holes 30, 32 in the bone 10 with the first and second apertures 26, 28 of the fixation plate 24);
drilling a plurality of screw holes in the first bone (Paragraph [0032]; Holes are created in the patient's bone to accommodate the fasteners (step 302), Fig. 3) on either side of the at least one computed cutting plane (Paragraph [0032]; both the first hole 30 and the second hole 32 will be created on the bone 10 in accordance with a preoperative plan, Figs. 5A-B and 7A-B show the holes are on either side of the cutting plane);
fixing a tracker to the second bone portion of the first bone (Paragraph [0045]; Another option to overcome an inability to track both portions 10a and 10b during an osteotomy procedure is to have a navigation marker on each side of the planned location of cut 36);
performing at least one partial cut in the first bone along the at least one computed cutting plane to create the first bone portion and the second bone portion (Paragraph [0035]; a cut (i.e. resection) is made through at least a portion of the bone (step 304), Fig. 3; Paragraph [0050]; the computer 50 is used to develop a surgical plan… virtual boundaries, shown in FIG. 7A, represent holes and/or cuts to be made in a bone 10 during an osteotomy procedure);
wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion (Paragraph [0035]; a cut (i.e. resection) is made through at least a portion of the bone (step 304). In the case of an open wedge osteotomy, the cut can be a single planar cut… the first resected surface 38 and the second resected surface 40 each face a wedge-shaped opening created between the proximal portion 10a and the distal portion 10b of the bone 10);
based on tracked poses of the first, second, (Paragraph [0039]; In one approach, the haptic device slowly pushes the tool between the surfaces, automatically stopping once the desired correction angle between the first and second resected surfaces has been reached; Paragraph [0042]; The navigation system tracks the patient's bone, as well as surgical tools utilized during the surgery, to allow the surgeon to visualize the bone and tools on a display 56 during the osteotomy procedure) moving the first bone portion and the second bone portion away or toward each other to reach the targeted deformed configuration (Paragraph [0038]-[0040]; steps 305 and 306 illustrate different paths… step 305, the bone is distracted such that the first resected surface 38 and the second resected surface 40 move relative to each other until the second aperture 28 of the fixation plate 24 is aligned with the second hole 32 of the bone 10; step 306, wedge-shaped opening created in the bone is closed); and
fixing the implant in the optimal placement to the first bone portion and the second bone portion with a plurality of screws in the plurality of respective screw holes to maintain the first bone in the targeted deformed configuration (Paragraph [0033]; a fastener 34 through the first aperture 26 and into the first hole 30 (step 303); Paragraph [0041]; step 307, the first portion of fixation plate 24 is coupled to the bone 10 with fastener 34 prior to coupling the second portion of fixation plate 24 to bone 10 (e.g. by inserting a fastener through second aperture 28 and into second hole 32), Fig. 3); and
a 3D model of the first bone from tracked poses of the first tracker and the second tracker (Paragraph [0048]; The scan data is then segmented to obtain a three-dimensional representation of the patient's anatomy… Using the three-dimensional representation and as part of the planning process, femoral and tibial landmarks can be selected, and the patient's femoral-tibial alignment angle is calculated; Paragraph [0054]; the physical anatomy is registered using known registration techniques).
Kang does not explicitly teach after drilling the plurality of screw holes, fixing a third tracker to a predetermined pose;
after fixing the third tracker, performing the at least one partial cut in the first bone;
determining the predetermined pose of the third tracker on the second portion of the first bone from:
the 3D model and a 3D forbidden region comprising:
a first 3D region around the at least one computed cutting plane, wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion;
a second 3D region representing a volume of the implant at the optimal placement to maintain the first bone in the targeted deformed configuration, wherein the volume of the implant comprises a volume occupied by the implant inside the first bone and an area covered by a portion of the implant outside the first bone;
a third 3D region representing a volume of the plurality of screws in the plurality of respective screw holes;
a 3D anatomical region of the first bone, wherein the 3D anatomical region comprises:
a 3D joint region adjacent to the second bone portion; and
a 3D vascular region of the first bone,
wherein the predetermined pose is outside the 3D forbidden region.
Krause, however, teaches in a similar field of endeavor a computer-assisted surgical method for osteotomy of a first bone of a lower limb to correct a misalignment of the lower limb (Paragraph [0029]; computer assisted orthopedic surgery planner software), the method comprising after drilling a plurality of screw holes (Paragraph [0174]; mounting the markers to the bone and a screw acceptor (threaded hole)), fixing a third tracker to a predetermined pose (Paragraph [0174]; During surgery, radio opaque multifunctional markers 2110 are preferably attached to the patient's bone; the multifunctional marker is considered to be a third tracker as understood in its broadest reasonable interpretation; Paragraph [0169]; computer may provide an exact preferable location in which to place the markers 2110, or the computer may offer a suggested range of marker positions, Fig. 23; The lower marker 2110 is on a second portion of the bone and is considered to be a third tracker at a predetermined pose as understood in its broadest reasonable interpretation);
after fixing the third tracker (Paragraphs [0178]-[0181]; After the markers 2110 are attached, the new or "final" surgical plan is calculated, the surgeon is ready to actually perform the osteotomy), performing the at least one partial cut in the first bone (Paragraph [0193]-[0196]; the fixation plate 2240 is secured to the open wedge-side of the bone 2100; this example includes more than one cut, the other parts of the bone may be opened at this time; open bone wedge 2102 is filled and the fixation plate 2240 is secured);
based on tracked poses of the third trackers, moving the first bone portion and the second bone portion away or toward each other to reach the targeted deformed configuration (Paragraph [0189]-[0192]; the bone is ready to be bent, rotated, twisted, and/or repositioned into the proper alignment according to the updated surgical plan… this part of the surgical plan has been "updated" based on the actual position of the multifunctional markers); and
determining the predetermined pose of the third tracker on the second bone portion of the first bone from the 3D model (Paragraph [0169]; computer-based planning software places multifunctional markers 2110 near the suggested osteotomy location 2102 on the computerized 3D patient bone model 2100 (see, FIG. 23C)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Kang to have included further fixing the tracker of Krause to the bone thus resulting in, after drilling the plurality of screw holes, fixing a third tracker to a predetermined pose; and after fixing the third tracker, performing the at least one partial cut in the first bone, and determining the predetermined pose of the third tracker on the second bone portion of the first bone from the 3D model as taught by Krause because it would have allowed re-calculating the pre-surgical plan for performing the osteotomy and improve the overall accuracy and thereby effectiveness of the operation; and further improve accuracy in making cuts during the procedure and improve the ease of performing complicated surgeries (Krause, Paragraphs [0180]-[0183], Paragraph [0206]).
The method of Kang in view of Krause does not explicitly teach determining the predetermined pose of the third tracker on the second bone portion of the first bone from a 3D forbidden region comprising:
a first 3D region around the at least one computed cutting plane, wherein the at least one partial cut in the first bone is performed along the at least one computed cutting plane to create the first bone portion and the second bone portion;
a second 3D region representing a volume of the implant at the optimal placement to maintain the first bone in the targeted deformed configuration, wherein the volume of the implant comprises a volume occupied by the implant inside the first bone and an area covered by a portion of the implant outside the first bone;
a third 3D region representing a volume of the plurality of screws in the plurality of respective screw holes; and
a 3D anatomical region of the first bone, wherein the 3D anatomical region comprises:
a 3D joint region adjacent to the second bone portion of the first bone; and
a 3D vascular region of the first bone,
wherein the predetermined pose is outside the 3D forbidden region.
Uhde, however, teaches in a similar field of endeavor a computer-assisted surgical method (Paragraph [0009]; a computer-implemented medical method of planning a position of a tracking reference device for referencing (i.e. defining and/or marking) a position in a medical environment) comprising determining the predetermined pose of the third tracker on the second bone portion of the first bone (Paragraph [0066]; an improved or optimal position of the tracking device can also be suggested to the user as displayed visual information) from a 3D forbidden region (Paragraph [0017]; The avoidance region constitutes a region in which the position of the tracking reference device described by the reference position data must not lie; Paragraph [0016]; the avoidance region comprises or consists of the envelope (for example, the volume defined by the envelope)) comprising:
a first 3D region around the at least one computed cutting plane (Paragraph [0013]; the medical instrument is a navigated drill or a navigated screwdriver or a navigated guide sleeve. For example, the envelope surrounds the position, i.e. the shape, of the instrument along the trajectory of the instrument when it is used on the anatomical body part; Paragraph [0064]; by a navigated drill sleeve having a marker device 7 attached to it is planned and that an envelope 5 is determined which surrounds the medical instrument 6 throughout the movement at least as long as at least a part of the medical instrument is disposed outside of the anatomical body part 1.; Paragraph [0054], Fig. 4 shows an envelope around a medical instrument which covers the implantation trajectory),;
a second 3D region representing a volume of the implant at the optimal placement to