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 .
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, 6-7, 11-12, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti (US 20120221017 A1, published August 30, 2012) in view of Gotte et al. (US 20090005783 A1, published January 1, 2009), hereinafter referred to as Bonutti and Gotte, respectively.
Regarding claim 1, Bonutti teaches a method of intraoperatively tracking a patella of a knee of a patient, the method comprising:
percutaneously attaching a tracking assembly to the patella, the tracking assembly comprising one or more tracking elements that are configured to be tracked by a tracking system, wherein the tracking assembly is configured to be converted between a first configuration where the one or more tracking elements are in a first pose and a second configuration where the one or more tracking elements are in a second pose that differs from the first pose (Fig. 31; see para. 0777 – “Patellar tracking may be checked by the positioning of one or more transducers 930 and/or 932 [tracking elements] between the patella 120 and the distal end portion 124 of the femur 126...Output signals from a transducer 930 will vary as a function of variations in force transmitted between the patella 120 and femur 126 during bending of the leg [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. 31; see para. 0777 – “Patellar tracking may be checked by the positioning of one or more transducers 930 and/or 932 [tracking elements] between the patella 120 and the distal end portion 124 of the femur 126...Output signals from a transducer 930 will vary as a function of variations in force transmitted between the patella 120 and femur 126 during bending of the leg [different poses of tracking elements during range of motion of knee].”);
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 leg 70 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.”); and
intraoperatively collecting data associated with the patella (Fig. 34-35; see para. 0317 – “Video images [data] are transmitted from the control unit 362 to a video screen 364 which is viewable by the surgeon 106 during surgery [intraoperatively] on the knee portion 76 [includes patella 120] of the leg 70. A continuous display of images is projected in rapid succession on the screen illustrating the knee portion 76 of the leg 70 when the lower portion 68 of the leg is in various positions relative to the upper portion of the leg.”).
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 relative to the patella (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 Bonutti, by also reconfiguring the tracking assembly from the first configuration to the second configuration to reorient the tracking elements relative to the patella, as disclosed in Gotte. One of ordinary skill in the art would have been motivated to make this modification in order to 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, Bonutti further teaches wherein the first pose and the second pose have a known relationship with respect to each other (Fig. 31; see para. 0777 – “Patellar tracking may be checked by the positioning of one or more transducers 930 and/or 932 [tracking elements] between the patella 120 and the distal end portion 124 of the femur 126...Output signals from a transducer 930 will vary as a function of variations in force transmitted between the patella 120 and femur 126 during bending of the leg [different poses of tracking elements during range of motion of knee].”).
Furthermore, regarding claim 7, Gotte further teaches wherein the tracking assembly can comprise an electromagnetic tracking assembly or an optical tracking assembly (see para. 0049 – “For example, the navigation system 17 can detect a position of a reference star 24 or other registration element arranged on the adjusting device 10 and the pre-adjusting device 20 by means of infrared cameras 25 [optical tracking assembly].”).
Furthermore, regarding claim 11, Bonutti further teaches wherein the tracking assembly weights from about 1 ounce to about 4 ounces (see para. 0400 – “Although the illustrated transducers 596 and 598 (FIGS. 41 and 42) are of the pneumatic type, it is contemplated that a different type of transducer could be utilized if desired.” So the tracking assembly (transducers 596 and 598) can weigh from about 1 ounce to about 4 ounces).
Furthermore, regarding claim 12, Bonutti further teaches wherein the tracking assembly is percutaneously affixed to the patella using a robotic arm (see para. 0332 – “Computer controls which respond to the locating devices provide information to the surgeon about cutting tools and/or other instruments [tracking system] being moved by the articulate arms.”).
Furthermore, regarding claim 16, Gotte further teaches wherein reconfiguring the tracking assembly comprises reorient 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 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 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] 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 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 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 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 screw 23, 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, 7, and 16-19 was shown previously in claim 1.
Claims 3-5 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti in view of Gotte, as applied to claim 1 above, and in further view of Stone (US 20070162142 A1, published July 12, 2007), hereinafter referred to as Stone.
Regarding claim 3, Bonutti in view of Gotte teaches all of the elements disclosed in claim 1 above.
Bonutti in view of 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 Bonutti in view of 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)…”).
Furthermore, regarding claim 8, Stone 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 (Fig. 7A-7C; see para. 0054 – “The knee is then flexed throughout the full range of motion (block 132) and the tracking of the patella 11 within the patello-femoral groove can be evaluated using the navigation device (block 136).”).
Furthermore, regarding claim 9, Stone further teaches determining movement of the patellar surface or the patellar shape relative to one or more other bones of the patient (Fig. 7A-7C; see para. 0054 – “The navigation systems can track and measure the movement of the patella 11 throughout the full range of motion of the knee.”).
Furthermore, regarding claim 10, Stone 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. 7A-7C; see para. 0006 – “…surgically resecting the patella to remove the posterior portion of the bone, leaving a planar bony surface to which a patellar prosthesis is affixed.”; see para. 0055 – “If the tracking [of patella 11] is deemed optimal, the posterior guide 52 is reattached to the docking mechanism 46 (blocks 140-148), the position marked (by drill, marking pen, bovie, etc. as know[n] in the art) (block 152) and the resection procedure continues as proscribed in the art (blocks 156-160).”).
The motivation for claims 4-5 and 8-10 was shown previously in claim 3.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti in view of Gotte, as applied to claim 1 above, and in further view of Sheffer et al. (US 20070270680 A, published November 22, 2007), hereinafter referred to as Sheffer.
Regarding claim 13, Bonutti in view of Gotte teaches all of the elements disclosed in claim 1 above.
Bonutti in view of Gotte teaches intraoperatively collecting data, but does not explicitly teach determining a change to a surgical plan for the knee of the patient based on the intraoperatively collected data.
Whereas, Sheffer, in an analogous field of endeavor, teaches determining a change to a surgical plan for the knee of the patient based on the intraoperatively collected data (see para. 0062 – “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 intraoperatively collecting data, as disclosed in Bonutti in view of Gotte, by also determining a change to a surgical plan for the knee of the patient based on the intraoperatively collected data, 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).
Furthermore, regarding claim 14, Sheffer further teaches wherein a surgical computer system determines the change to the surgical plan (Fig. 2; see para. 0034 – “Application data 136 [of computer 112] is data that is generated or used by application program 132, such as implant geometries, instrument geometries, surgical defaults, patient landmarks, and the like.”).
Furthermore, regarding claim 15, Sheffer further 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 – “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…”).
The motivation for claims 14-15 was shown previously in claim 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Plaskos et al. (US 20170042557 A1, published February 16, 2017) discloses guiding resurfacing operations on at least a portion of a joint of at least one bone is provided and uses a guide with actuators (motors) controlled by a computer to position a cutting tool relative to a bone so that the bone Surface can be cut in a flexible and accurate manner.
Couture et al. (US 20170360512 A1, published December 21, 2017) discloses robotic controller may determine soft tissue balance using information from a tracking system, such as a position of a first tracker affixed to the bone.
Chappuis et al. (US 20210315590 A1, published October 14, 2021) discloses resecting a knee joint using a navigated pin guide driver system.
Lang (US 20210192759 A1, published June 24, 2021) discloses displaying, placing, fitting, sizing, selecting, aligning, moving a virtual implant on a physical anatomic structure of a patient and, optionally, modifying or changing the displaying, placing, fitting, sizing, selecting, aligning, moving, for example based on kinematic information.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.C./Examiner, Art Unit 3798