Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1-19 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 04/08/2026.
Response to Arguments
Applicant’s arguments filed 06/22/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Given the amendments to claim 1, reference to Perez is being relied upon to teach dependent claim 6-11 and 13-14 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Ma is being relied upon to teach dependent claim 12 more-consistently with the instant claim language, as shown below.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 6-11, 13-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (US 20190388159 A1, published December 26, 2019) in view of Bonutti (US 20120221017A1, published August 30, 2012) and Gotte et al. (US 20090005783 A1, published January 1, 2009), hereinafter referred to as Perez, Bonutti, and Gotte, respectively.
Regarding claim 1, Perez teaches a method of intraoperatively tracking a patella of a knee of a patient, the method comprising:
percutaneously attaching a tracking assembly to an anterior surface of the patella (Fig. 2; see para. 0041 – “First tracker 102 [tracking assembly] has a distal tip 106 configured to contact bone, such as a patella 16 as shown [at anterior surface of patella], and a plurality of fiducials 110 at a proximal end.”),
the tracking assembly comprising one or more tracking elements that are configured to be tracked by a tracking system (Fig. 2; see para. 0041 – “First tracker 102 [tracking assembly] has a distal tip 106 configured to contact bone, such as a patella 16 as shown, and a plurality of fiducials 110 [tracking elements] at a proximal end. Fiducials 110 are spherical-shaped markers configured to be identified by position capturing device 210 [tracking system].”),
wherein the tracking assembly is configured to be converted between a first configuration wherein the one or more tracking elements are in a first pose and a second configuration wherein the one or more tracking elements are in a second pose that differs from the first pose (Fig. 2; see para. 0043 – “Tracking the location and movement of fiducials 110, 112 [of first tracker 102, tracking assembly] through flexion and extension allows tracking system 200 to accurately record and display precise position and orientation of distal tip 106, and therefore, patella 16 through knee flexion-extension cycle [different poses of tracking elements during range of motion of knee].”);
tracking, via the tracking system, the tracking assembly as the knee is moved through a range of motion (Fig. 2; see para. 0043 – “Tracking the location and movement of fiducials 110, 112 through flexion and extension allows tracking system 200 to accurately record and display precise position and orientation of distal tip 106, and therefore, patella 16 through knee flexion-extension cycle.”);
intraoperatively collecting data associated with the patella (see para. 0044 – “Referring now to FIGS. 3 and 4, there is shown a display 220 with patellar tracking information captured by image capture device 210. Display 220 depicts virtual bone models of femur 12′ and tibia 14′. The virtual bone models can be preoperatively captured and displayed on display 220, or can be intraoperatively captured during bone tracking. As shown in FIG. 3, distal tip 106 placed on an unresected patella 16 is tracked at four different positions 224, 226, 228 and 230 of unresected patella 116 as it moves from flexion to extension.”).
Perez teaches performing knee surgery, where the steps of making an incision to open a joint capsule of the knee and everting the patella is inherent and known in the art (Fig. 6; see para. 0050 – “In step 320, a surgeon performs a patellar resection based on a predetermined resection depth…Once a suitable patellar trial is identified and verified to simulate natural or a desired patellar kinematics, a corresponding patellar implant is selected in step 350 and then implanted.”), but does not explicitly teach making an incision to open a joint capsule of the knee and everting the patella.
Whereas, Bonutti, in an analogous field of endeavor, teaches:
making an incision to open a joint capsule of the knee (see para. 0162 "...a limited incision 114 (FIG. 6) is formed in the knee portion 76 of the leg 70."; see para. 0169 "While the leg70 is in the extended condition, the incision 114 (FIG. 7) is elastically expanded [joint capsule] using suitable retractors.");
everting the patella (see para. 0170 "After the incision 114 has been elastically expanded, a patella 120 and tissue on the lateral side of the incision may be everted in a manner illustrated in FIG. 7. Thus, the patella 120 is moved from the normal orientation of FIG. 6 to the everted or flipped orientation of FIG. 7, preferably while the leg 70 of the patient is in the extended orientation of FIG. 7.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified performing knee surgery, as disclosed in Perez, by making an incision to open a joint capsule of the knee and everting the patella during knee surgery, as disclosed in Bonutti. One of ordinary skill in the art would have been motivated to make this modification in order to perform surgery on a patella to install a patellar implant, as taught in Bonutti (see para. 0336).
Perez in view of Bonutti teaches a tracking assembly on a patella moving from a first configuration to a second configuration as the knee is moved through a range of motion, but does not explicitly teach reconfiguring the tracking assembly from the first configuration to the second configuration to reorient the tracking elements relative to the patella.
Whereas, Gotte, in an analogous field of endeavor, teaches reconfiguring the tracking assembly from the first configuration to the second configuration to reorient the tracking elements (see para. 0050 "Turning to FIG. 3, a computational unit 30 of the navigation system 17 can virtually define or select a base coordinate system B that is connected to the pre-adjusting device 20 [tracking assembly] such that a rotation of one of the joints 21, 22 causes a rotation of the base coordinate system B. The reference star 24 [tracking elements] may be arranged on the pre-adjusting device 20 until the base coordinate system B has been rotated or aligned as desired.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a tracking assembly on a patella moving from a first configuration to a second configuration as the knee is moved through a range of motion, as disclosed in Perez in view of Bonutti, by also reconfiguring the tracking assembly from the first configuration to the second configuration to reorient the tracking elements, as disclosed in Gotte. One of ordinary skill in the art would have been motivated to make this modification in order for the navigation system to assist the surgeon by ascertaining, monitoring and displaying the change in the flexion/extension, the varus/valgus angle and the resection, while the setting elements are being adjusted, such that the surgeon can quickly set the desired values, as taught in Gotte (see para. 0056).
Furthermore, regarding claim 2, Gotte further teaches wherein the tracking assembly comprises a rotatable joint that is configured to allow the tracking assembly to be converted from the first configuration to the second configuration (see para. 0050 "Turning to FIG. 3, a computational unit 30 of the navigation system 17 can virtually define or select a base coordinate system B that is connected to the pre-adjusting device 20 [tracking assembly] such that a rotation of one of the joints 21, 22 causes a rotation of the base coordinate system B. The reference star 24 [tracking elements] may be arranged on the pre-adjusting device 20 until the base coordinate system B has been rotated or aligned as desired [from a first configuration to a second configuration].”).
Furthermore, regarding claim 6, Perez further teaches wherein the first pose and the second pose have a known relationship with respect to each other (Fig. 2; see para. 0043 – “Tracking the location and movement of fiducials 110, 112 [of first tracker 102, tracking assembly] through flexion and extension allows tracking system 200 to accurately record and display precise position and orientation of distal tip 106, and therefore, patella 16 through knee flexion-extension cycle [different poses of tracking elements during range of motion of knee].”).
Furthermore, regarding claim 7, Perez further teaches wherein the tracking assembly can comprise an electromagnetic tracking assembly or an optical tracking assembly (Fig. 2; see para. 0041 – “Fiducials 110 [ of first tracker 102, tracking assembly] are spherical-shaped markers configured to be identified by position capturing device 210. The number, shape and properties of markers can be varied depending on the type of the position capturing device being utilized and the nature of bone being tracked. For example…, whereas markers with reflectors can be used with a camera position capturing device [of an optical tracking assembly].”).
Furthermore, regarding claim 8, Perez further teaches wherein the intraoperatively collected data comprises a patellar surface or a patellar shape of the patella relative to the tracking assembly attached thereto (see para. 0044 – “As shown in FIG. 3, distal tip 106 placed on an unresected patella 16 [patellar surface] is tracked at four different positions 224, 226, 228 and 230 of unresected patella 116 as it moves from flexion to extension.”).
Furthermore, regarding claim 9, Perez further teaches determining movement of the patellar surface or the patellar shape relative to one or more other bones of the patient (see para. 0044 – “As shown in FIG. 3, distal tip 106 placed on an unresected patella 16 [patellar surface] is tracked at four different positions 224, 226, 228 and 230 of unresected patella 116 as it moves from flexion to extension.”).
Furthermore, regarding claim 10, Perez further teaches determining, using the determined movement of the patellar surface or the patellar shape relative to the one or more other bones, a surgical place to replace a surface of the one or more other bones or the patellar surface (Fig. 6; see para. 0050 – “Once a suitable patellar trial is identified and verified to simulate natural or a desired patellar kinematics [determined movement of the patellar surface], a corresponding patellar implant is selected in step 350 and then implanted. Final testing can be done to ensure proper kinematics of the permanent implant.”).
Furthermore, regarding claim 11, Perez further teaches wherein the tracking assembly weights from about 1 ounce to about 4 ounces (Fig. 2; see para. 0041 – “Fiducials 110 [ of first tracker 102, tracking assembly] are spherical-shaped markers configured to be identified by position capturing device 210. The number, shape and properties of markers can be varied depending on the type of the position capturing device being utilized and the nature of bone being tracked.” So the tracking assembly weigh from about 1 ounce to about 4 ounces).
Furthermore, regarding claim 13, Perez further teaches determining a change to a surgical plan for the knee of the patient based on the intraoperatively collected data (Fig. 7; see para. 0050 – “Once a suitable patellar trial is identified and verified to simulate natural or a desired patellar kinematics [intraoperatively collected data], a corresponding patellar implant is selected in step 350 and then implanted.” Selecting an implant as a change to a surgical plan for the knee).
Furthermore, regarding claim 14, Perez further teaches wherein a surgical computer system determines the change to the surgical plan (Fig. 4, display 220 of surgical system 10; see para. 0046 – “An optimal path 225 representing the desired patellar path is also displayed to assist the surgeon in selecting the appropriate patellar implant [change in surgical plan].”).
Furthermore, regarding claim 16, Gotte further teaches wherein reconfiguring the tracking assembly comprises reorienting the one or more tracking elements relative to the patella or the tracking system (see para. 0050- "Turning to FIG. 3, a computational unit 30 of the navigation system 17 can virtually define or select a base coordinate system B that is connected to the pre-adjusting device 20 [tracking assembly] such that a rotation of one of the joints 21, 22 causes a rotation of the base coordinate system B. The reference star24 [tracking elements] may be arranged on the pre-adjusting device 20 until the base coordinate system B has been rotated or aligned as desired [from a first configuration to a second configuration].").
Furthermore, regarding claim 17, Gotte further teaches wherein reconfiguring the tracking assembly comprises folding the tracking assembly such that the one or more tracking elements transition from the first pose to the second pose (see para. 0050 "Turning to FIG. 3, a computational unit 30 of the navigation system 17 can virtually define or select a base coordinate system B that is connected to the pre-adjusting device 20 [tracking assembly] such that a rotation [folding] of one of the joints 21, 22 causes a rotation of the base coordinate system B. The reference star 24 [tracking elements] maybe arranged on the pre-adjusting device 20 until the base coordinate system B has been rotated or aligned as desired [from a first pose to a second pose].").
Furthermore, regarding claim 18, Gotte further teaches wherein the tracking assembly is configured to reconfigure automatically or via electromechanical control (see para. 0050 "Turning to FIG. 3, a computational unit 30 of the navigation system 17 [automatic or electromechanical control] can virtually define or select a base coordinate system B that is connected to the pre-adjusting device 20 [tracking assembly] such that a rotation of one of the joints 21, 22 causes a rotation of the base coordinate system B. The reference star24 [tracking elements] may be arranged on the pre-adjusting device 20 until the base coordinate system B has been rotated or aligned as desired [from a first configuration to a second configuration].").
Furthermore, regarding claim 19, Gotte further teaches wherein the tracking assembly is configured to be reconfigured manually (Fig. 2; see para. 0049 "A setting element, for example, a hand wheel setting screw23, of the pre-adjusting device 20 [tracking assembly] is connected to each of the joints 21, 22 respectively and can be adjusted and rotated by a user [reconfigured manually], such that changing a setting element causes a rotation or movement about whichever one of the joints 21, 22 to which the setting element is connected.”).
The motivation for claims 2 and 16-19 was shown previously in claim 1.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of Bonutti and Gotte, as applied to claim 1 above, and in further view of Stone (US20070162142 A1, published July 12, 2007), hereinafter referred to as Stone.
Regarding claim 3, Perez in view of Bonutti and Gotte teaches all of the elements disclosed in claim 1 above.
Perez in view of Bonutti and Gotte teaches a tracking assembly at the patella, but does not explicitly teach the tracking assembly is configured to be percutaneously affixed to the patella via a fastener.
Whereas, Stone, in an analogous field of endeavor, teaches wherein the tracking assembly is configured to be percutaneously affixed to the patella via a single fastener (Fig. 7A-7C; see para. 0053 "…the guidance clamp 10 [fastener] is placed onto and clamped to the patella 11 (block 104)...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified tracking assembly at the patella, as disclosed in Perez in view of Bonutti and Gotte, by having the tracking assembly configured to be percutaneously affixed to the patella via a fastener, as disclosed in Stone. One of ordinary skill in the art would have been motivated to make this modification in order to improve the placement and resection of the patella to avoid complications associated with malalignment, as taught in Stone (see para. 0026).
Furthermore, regarding claim 4, Stone further teaches wherein the tracking assembly is configured to be percutaneously affixed to the patella via two or more fasteners (Fig. 7A-7C; see para. 0053 "...the guidance clamp 10 [fastener] is placed onto and clamped to the patella 11 (block 104)...").
Furthermore, regarding claim 5, Stone further teaches wherein the tracking assembly is configured to be percutaneously affixed to the patella via a squeeze clamp attachment (Fig. 7A-7C; see para. 0053 " the guidance clamp 10 is placed onto and clamped to the patella 11 (block 104)...").
The motivation for claims 4-5 was shown previously in claim 3.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of Bonutti and Gotte, as applied to claim 1 above, and in further view of Ma et al. (WO 2021098177 A1, published May 27, 2021), hereinafter referred to as Ma.
Regarding claim 12, Perez in view of Bonutti and Gotte teaches all of the elements disclosed in claim 1 above.
Perez in view of Bonutti and Gotte teaches a tracking assembly at the patella, but does not explicitly teach using a robotic arm to affix the tracking assembly to the patella.
Whereas, Ma, in an analogous field of endeavor, teaches wherein the tracking assembly is percutaneously affixed to a bone using a robotic arm (Fig. 1; see pg. 12, para. 2 – “After the robotic arm 2 locates the osteotomy [bone] plane through the tool target 3 and moves to a predetermined position, the robotic arm 2 enters the holding state (ie, does not move). ), after that, the operator can use a surgical tool 5 such as a swing saw or an electric drill to perform osteotomy and/or drilling operations through the osteotomy guide tool 4.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a tracking assembly at the patella, as disclosed in Perez in view of Bonutti and Gotte, by using a robotic arm to affix the tracking assembly to the patella, as disclosed in Ma. One of ordinary skill in the art would have been motivated to make this modification in order for the operator to not need to use additional bone screws to fix the guide tool on the bones, reducing the traumatic surface of the patient and shortening the operation time, as taught in Ma (see pg. 12, para. 3).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Perez in view of Bonutti and Gotte, as applied to claim 13 above, and in further view of Sheffer et al. (US 20070270680 A, published November 22, 2007), hereinafter referred to as Sheffer.
Regarding claim 15, Perez in view of Bonutti and Gotte teaches all of the elements disclosed in claim 13 above.
Perez in view of Bonutti and Gotte teaches determining a change to a surgical plan for the knee of the patient based on the intraoperatively collected data, but does not explicitly teach providing an alteration to a target model for the knee of the patient.
Whereas, Sheffer, in an analogous field of endeavor, teaches wherein the change to the surgical plan comprises an alteration to a target model for the knee of the patient (Fig. 14; see para. 0062 -"To accomplish this, an image of the implant 802 to be surgically inserted is displayed on the warped femoral model 620. By utilizing these landmark points, the surgeon can manipulate the orientation of the femoral model to view surgical information such as the planned distal resection plane 804, the planned posterior resection plane 806, as well as various femoral implant rotation data 808…By having this information, the surgeon can intra-operatively adjust the planned femoral orientation data [surgical plan] as needed based upon the points acquired during landmark registration...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified determining a change to a surgical plan for the knee of the patient based on the intraoperatively collected data, as disclosed in Perez in view of Bonutti and Gotte, by also providing an alteration to a target model for the knee of the patient, as disclosed in Sheffer. One of ordinary skill in the art would have been motivated to make this modification in order to conduct femoral component orientation and planning, such as implant sizing and rotation, as taught in Sheffer (see para. 0062).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lindequist (US 6387100 B1, published May 14, 2002) discloses positioning a robot to drill in marked pin/screw positions at femoral neck.
Hampp et al. (US 20170281202 A1, published October 5, 2017) discloses a patella clamp includes a tracker, which intraoperatively informs the surgeon where to place the clamp on the patella such that the position and orientation of the resection plane can be made with either manual instrumentation or via a robotic cutting arm.
Sheffer et al. (US 20090183740 A1, published July 23, 2009) discloses the cameras of the optical locator detect the position of the patella array assembly in space by using triangulation methods, which reference the position of the array assembly as it moves with respect to the rigid reference arrays and, which are fixably attached to the tibia and femur of the patient, respectively. The relative location of the patella array assembly with respect to the patient's leg may then be shown as a real-time image on a computer display during the surgical procedure.
Bailey (US 20220183758 A1, published June 16, 2022 with a priority date of December 14, 2020) discloses providing robotic guidance to a user in resecting along the interface during a surgery, and using a robotically-assisted alignment guide to position the prosthetic component.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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