DETAILED ACTION
This action is pursuant to claims filed on 02/10/2025. Claims 11-14, 16-24, 27-28, 30-33, and 51 are pending. A first action on the merits of claims 11-14, 16-24, 27-28, 30-3,3 and 51 is as follows.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: the International Application PCT/IB2023/058203 (filed on 2/22/2024) to which the present application is the National Stage was filed more than 12 months from the filing date of the provisional application 63/398049 (filed on 8/15/2022) according to PTO records. As a result, the Applicant does not receive the benefit of the prior-filed application 63/398049 (filed on 8/15/2022).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the third sensor from claim 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters has been used to designate multiple components.
Reference character “94” has been used to designate both “server” in paragraph [0059] of the specification and “an implant system” in Figure 8
Reference character “144” has been used to designate both “memory” in paragraph [0058] in the specification and “suture” in Figures 11A-11B
Reference character “152” has been used to designate both “suture passer” in Figure 11A and “bone” in paragraph [0075]
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-14, 16-24, 27-28, 30-33, and 51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 11, the claim recites the limitation “a common coordinate system” in line 6. The limitation “common” is unclear, as this is a vague term with no clear distinction. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any type of coordinate system will teach on this limitation. Claims 12-14 and 16-24 are also rejected due to their dependence on claim 11.
Regarding claim 12, the claim limitation “wherein the movement is identified as a change in a fixation state of the at least one surgical accessory to the anatomical structure” in lines 1-2 is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). Also, it is not clear what structure, if any, of the apparatus related to this action step. Claim 13 is rejected by virtue of its dependence from claim 12.
Regarding claim 14, the claim recites the limitation “the change in the spatial relationship is identified in response to a change in the kinematic profile resulting from one of the first position or the second position changing relative to the anatomical structure” in lines 3-5, which renders the claim indefinite. First, it is not clear if this identification of the change in the spatial relationship is the same as or different from “detect a change in the spatial relationship” in claim 11, line 10. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear. Second, if they are different, the recitation of claim 14 reads as an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). Third, if they are different, it is not clear what structure, if any, of the apparatus related to this action step.
Regarding claim 21, the claim recites the limitation “the at least one fixation device” in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear what this limitation is meant to refer to, as no fixation device has been introduced. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any type of fixation device incorporated anywhere in the device will teach on this limitation.
Regarding claim 27, the claim recites the limitation “a common coordinate system” in line 7. The limitation “common” is unclear, as this is a vague term with no clear distinction. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any type of coordinate system will teach on this limitation. Claims 28 and 30-33 are also rejected due to their dependence on claim 27.
Regarding claim 31, the claim recites the limitation “the first surgical accessory” in line 2, but it is not clear if this limitation is referring “a first accessory” in claim 27, lines 3-4 or “a surgical assembly” in claim 27, line 11 or a new surgical accessory.
Regarding claim 51, the claim recites the limitation “the at least one surgical accessory” in line 9. There is insufficient antecedent basis for this limitation of “at least one” surgical accessory in the claim. It is unclear if this limitation is meant to refer to the first surgical accessory from line 3, the second surgical accessory from line 3, both surgical accessories, or different surgical accessories. If it is meant to refer to any of the previously introduced surgical accessories, it needs to refer back to it. If it is meant to refer to different surgical accessories, it needs to be distinguished from the previously introduced surgical accessories. For purposes of examination, it is being interpreted as referring to any of the previously introduced surgical accessories.
Further regarding claim 51, the claim recites the limitation “a common coordinate system” in line 10. The limitation “common” is unclear, as this is a vague term with no clear distinction. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, any type of coordinate system will teach on this limitation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-14, 16-24, and 51 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 11 recites “at least one surgical accessory that connects to at least one anatomical structure, the at least one surgical accessory comprising a first sensor and a second sensor connected to spatially separated portions of the at least one anatomical structure” in lines 2-4, which improperly includes a human being as part of the claimed invention. Claims 12-14 and 16-24 are rejected by virtue of their dependence from claim 11.
Claim 16 recites “wherein the first sensor and the second sensor are rigidly attached to the anatomical structure” in lines 1-2, which improperly includes a human being as part of the claimed invention.
Claim 17 recites “wherein the anatomical structure is a continuous rigid structure” which improperly includes a human being as part of the claimed invention.
Claim 19 recites “wherein the first surgical accessory and the second surgical accessory are independently attached to the at least one anatomical structure” in lines 1-2, which improperly includes a human being as part of the claimed invention.
Claim 51 recites “an orthopedic surgical assembly in connection with at least one anatomical structure comprising a first surgical accessory interconnected to a second surgical accessory, wherein: the first surgical accessory comprises a first sensor and is in connection with a first portion of the at least one anatomical structure, and the second surgical accessory comprises a second sensor and is in connection with a second portion of the at least one anatomical structure spatially separated from the first portion” in lines 2-8, which improperly includes a human being as part of the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 11, 14, 16-21, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over McIntosh (US 20110160738) in view of Hladio (US 20150182292).
Regarding independent claim 11, McIntosh teaches an apparatus for orthopedic surgery ([0028]: “Embodiments in accordance with the present disclosure provide an apparatus and method of assisted guidance navigation for surgical assisted alignment”) comprising:
at least one surgical accessory that connects to at least one anatomical structure ([0096]: “FIG. 4B depicts a block diagram of an exemplary sensor 201-204 suitable for use in the portable assisted guidance system 200 of FIG. 4A. With respect to FIG. 4A, each sensor 201-204 in the system 200 may contain more or less than the number of components shown depending on function. For instance, Sensor 201 and Sensor 203 may contain only an ultrasonic sensor with a transceiver for strictly disposable use. Sensors 202 and 204 may contain all the components shown in FIG. 4B. The sensor can be waterproof and shock absorbent”; [0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery”. The system 200 containing the sensors is the at least one surgical accessory, wherein each sensor is attached to at least one anatomical structure.), the at least one surgical accessory comprising a first sensor (Sensor 202) and a second sensor connected to spatially separated portions of the at least one anatomical structure (Sensor 204; Fig. 4A shows the sensors disposed on different bones, which are separate portions of the at least one anatomical structure (the knee)); and
a controller in communication with the at least one surgical accessory ([0093]: “The system 200 comprises a group of sensors 201-204 communicatively coupled to an acquisition system 205 by way of a wired or wireless connection. The group of sensors 201-204 can be individually hermetically sealed for clean room conditions during surgery. The acquisition system 205 can comprise a custom control board (CC) a DSP board and a laptop, although, in other embodiments, the CC and DSP can operate internally from a customized laptop using electronic processing resources therein (e.g., processor, memory, converters, etc.)”. The acquisition system is the controller in communication with the surgical accessory.) and configured to:
detect a first position of the first sensor in a common coordinate system ([0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.);
detect a second position of the second sensor in the common coordinate system ([0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.).
However, McIntosh does not teach identifying a spatial relationship between the first position and the second position; detecting a change in the spatial relationship; and outputting an indication reporting the change in the spatial relationship indicating a movement of a portion of the surgical accessory relative to the at least one anatomical structure.
Hladio discloses systems and methods to assist joint replacement surgery. Specifically, Hladio teaches identifying a spatial relationship between the first position and the second position ([0007]: “the sensor coupled to a first bone, the first beacon coupled to the first bone via a patient specific jig (PSJ) configured to mate with the first bone, the second beacon coupled to the object, which object comprises one of a second bone and a surgical tool, the method comprising: receiving positional information from the sensor at an intra-operative computing unit in communication with the sensor; measuring a pose of the first beacon when coupled to the first bone via the PSJ to establish a positional relationship between the sensor and the PSJ; calculating poses of the second beacon with respect to an anatomical coordinate frame utilizing pre-operative data representing the PSJ and the positional relationship between the sensor and the PSJ; and displaying positional information for the object in real time”. The positional relationship between the sensor and the PSJ and calculating the poses of the second beacon is the spatial relationship between the first position and the second position.);
detecting a change in the spatial relationship ([0069]: “The position of the femur sensor may be determined, calculated, or otherwise identified based in part by a positional relationship between the first surface and the second surface of the patient-specific femoral jig. The position of the femur sensor may alternatively be determined, calculated, or otherwise identified based in part on a pre-operative formation of the patient-specific femoral jig. The change in leg position may be determined, calculated, or otherwise identified based in part on the a pre-operative three-dimensional image reconstruction of the patient's pelvis and femur”); and
outputting an indication reporting the change in the spatial relationship indicating a movement of a portion of the surgical accessory relative to the at least one anatomical structure ([0067]: “display the change in leg position”. The display step includes outputting an indication reporting the change, which indicates movement of a portion of the surgical accessory relative to the anatomical structure.). McIntosh and Hladio are analogous art as they are related to the same field of endeavor of assisting orthopedic surgeries.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection of a change in relationship between the two sensors and attributing it to the motion of the surgical accessory from Hladio into the device from McIntosh as it allows the device to monitor the distance between the sensors and use it to determine how the sensor moves. This allows the device to monitor the movement of the device and detect any important changes, which can assist in determining the location of the device and its use during a surgery.
Regarding claim 14, the McIntosh/Hladio combination teaches the apparatus according to claim 11,wherein the spatial relationship defines a kinematic profile defining the relationship of the first position to the second position over a range of motion (Hladio, [0067]: “display the change in leg position”. The display of the change in leg position in real-time is a kinematic profile defining the relationship of the positions.) and the change in the spatial relationship is identified in response to a change in the kinematic profile resulting from one of the first position or the second position changing relative to the anatomical structure (Hladio, [0069]: “The position of the femur sensor may be determined, calculated, or otherwise identified based in part by a positional relationship between the first surface and the second surface of the patient-specific femoral jig. The position of the femur sensor may alternatively be determined, calculated, or otherwise identified based in part on a pre-operative formation of the patient-specific femoral jig. The change in leg position may be determined, calculated, or otherwise identified based in part on the a pre-operative three-dimensional image reconstruction of the patient's pelvis and femur”).
Regarding claim 16, the McIntosh/Hladio combination teaches the apparatus according to claim 11, wherein the first sensor and the second sensor are rigidly attached to the anatomical structure (McIntosh, [0040]: “One threaded end couples to sensor 101 the remaining threaded end couples to a bone, cutting block, jig or other structure for supporting the device. A taper threaded region would be used to screw the mounting structure 120 into bone similar to an orthopedic screw. It is not limited to the embodiments disclosed herein and others are attachment methods are contemplated.”. The method of attaching a sensor to the bone can be applied to all sensors using the described methods which are rigidly attached methods.).
Regarding claim 17, the McIntosh/Hladio combination teaches the apparatus according to claim 11, wherein the anatomical structure is a continuous rigid structure (McIntosh, [0040]: “One threaded end couples to sensor 101 the remaining threaded end couples to a bone, cutting block, jig or other structure for supporting the device. A taper threaded region would be used to screw the mounting structure 120 into bone similar to an orthopedic screw. It is not limited to the embodiments disclosed herein and others are attachment methods are contemplated.” The anatomical structure is the top layer of bone, which is a continuous rigid structure.).
Regarding claim 18, the McIntosh/Hladio combination teaches the apparatus according to claim 11,wherein the at least one surgical accessory comprises a first surgical accessory comprising the first sensor (McIntosh, [0096]: “Sensors 202 and 204 may contain all the components shown in FIG. 4B”. Sensor device 202 is the first surgical accessory containing the first sensor (sensor unit 12 from figure 4B)) and a second surgical accessory comprising the second sensor (McIntosh, [0096]: “Sensors 202 and 204 may contain all the components shown in FIG. 4B”. Sensor device 204 is the second surgical accessory containing the second sensor (sensor unit 12 from figure 4B)).
Regarding claim 19, the McIntosh/Hladio combination teaches the apparatus according to claim 18, wherein the first surgical accessory and the second surgical accessory are independently attached to the at least one anatomical structure (McIntosh, Fig. 4A shows sensor 202 and sensor 204 attached independently.).
Regarding claim 20, the McIntosh/Hladio combination teaches the apparatus according to claim 19, wherein the first surgical accessory and the second surgical accessory are interconnected by an orthopedic surgical assembly (McIntosh, [0093]: “FIG. 4A depicts another exemplary embodiment of a portable assisted guidance system 200 similar in function to the sensor-wand configuration of FIG. 1A. The system 200 comprises a group of sensors 201-204 communicatively coupled to an acquisition system 205 by way of a wired or wireless connection. The group of sensors 201-204 can be individually hermetically sealed for clean room conditions during surgery. The acquisition system 205 can comprise a custom control board (CC) a DSP board and a laptop, although, in other embodiments, the CC and DSP can operate internally from a customized laptop using electronic processing resources therein (e.g., processor, memory, converters, etc.)”. Portable assisted guidance system 200 is the orthopedic surgical assembly.).
Regarding claim 21, the McIntosh/Hladio combination teaches the apparatus according to claim 11,wherein the at least one fixation device comprises at least one of a pin, a button, a screw, an anchor, and a nail (McIntosh, [0073]: “a tibial pin can be pinned in the proximal tibia or midway on the tibia”; [0003]: “a button may also be added under the kneecap surface”; [0045]: “The mount can comprise a rod or fastener on or extending from the housing of wand 102 that can screw into or attach to a structure”).
Regarding claim 23, the McIntosh/Hladio combination teaches the apparatus according to claim 11, further comprising: a third sensor in connection with a surgical instrument (McIntosh, Fig. 4A, sensor 203), wherein the controller is further configured to identify a third position in the common coordinate system (McIntosh, [0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.).
Regarding claim 24, the McIntosh/Hladio combination teaches the apparatus according to claim 23, wherein each of the first sensor and the second sensor are configured to communicate with the controller via a wireless communication circuit and the controller is further configured to distinguish first data communicated by the first sensor from second data communicated by the second sensor in response to a distinct signal characteristic or identification communicated to a receiver of the controller (McIntosh, [0093]: “The system 200 comprises a group of sensors 201-204 communicatively coupled to an acquisition system 205 by way of a wired or wireless connection. The group of sensors 201-204 can be individually hermetically sealed for clean room conditions during surgery. The acquisition system 205 can comprise a custom control board (CC) a DSP board and a laptop, although, in other embodiments, the CC and DSP can operate internally from a customized laptop using electronic processing resources therein (e.g., processor, memory, converters, etc.)”; [0096]: “FIG. 4B depicts a block diagram of an exemplary sensor 201-204 suitable for use in the portable assisted guidance system 200 of FIG. 4A. With respect to FIG. 4A, each sensor 201-204 in the system 200 may contain more or less than the number of components shown depending on function. For instance, Sensor 201 and Sensor 203 may contain only an ultrasonic sensor with a transceiver for strictly disposable use. Sensors 202 and 204 may contain all the components shown in FIG. 4B. The sensor can be waterproof and shock absorbent.”. Each sensor has their own transceiver for transmitting data to the controller. Since the controller uses data from different sensors for different measurements, it is obvious that each sensor has its own distinct identification.).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the McIntosh/Hladio combination as applied to claim 11 above, and further in view of Lion (“Linear Position and Displacement Measurement with Capacitive and Eddy-Current Sensors”).
Regarding claim 12, the McIntosh/Hladio combination teaches the apparatus according to claim 11.
However, the McIntosh/Hladio combination does not teach wherein the movement is identified as a change in a fixation state of the at least one surgical accessory to the anatomical structure.
Lion discloses methods of measuring a position change of an object. Specifically, Lion teaches wherein the movement is identified as a change in a fixation state of the at least one accessory to the structure (Page 3: “As bearings and slides wear, non-contact displacement measurements of the moving parts will indicate increased movement in unintended directions. Rotary motions will show increasing displacements in the X, Y, and Z axes as the object turns. Linear slides will show increasing displacements in the two axes perpendicular to the direction of travel … Linear non-contact displacement measurements are relative measurements and indicate the change of an object’s position from an initial location in one or more linear axes”. This limitation states that as objects change from their initial fixation state, there will be an increased amount of displacement (the movement).). Hladio and Lion are analogous art as they are related to solving the same problem of measuring displacement between two objects.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the movement being identified as a change in a fixation state from Lion into the McIntosh/Hladio combination as it allows the device to determine if the accessory is not in the correct location, and therefore indicate that the device needs to be fixed before the procedure continues. This ensures that the device is in the correct spot for the procedure and is functioning correctly, ensuring that the device can perform its intended functions.
Regarding claim 13, the McIntosh/Hladio/Lion combination teaches the apparatus according to claim 12, wherein the change in the fixation state is a separation of the portion of the surgical accessory from the anatomical structure (Lion, Page 3: “As bearings and slides wear, non-contact displacement measurements of the moving parts will indicate increased movement in unintended directions. Rotary motions will show increasing displacements in the X, Y, and Z axes as the object turns. Linear slides will show increasing displacements in the two axes perpendicular to the direction of travel … Linear non-contact displacement measurements are relative measurements and indicate the change of an object’s position from an initial location in one or more linear axes”. This limitation states that as objects change from their initial fixation state (indicating a separation from the anatomical structure), there will be an increased amount of displacement (the movement).).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over the McIntosh/Hladio combination as applied to claim 11 above, and further in view of Lopez (US 20210338228).
Regarding claim 22, the McIntosh/Hladio combination teaches the apparatus according to claim 11.
However, the McIntosh/Hladio combination does not teach wherein the surgical accessory comprises a suture or a flexible connecting element.
Lopez discloses surgical fixation device and methods. Specifically, Lopez teaches wherein the surgical accessory comprises a suture or a flexible connecting element ([0149]: “The sutures are threaded around the crossbars of the anchor. Next, the suture is passed through soft tissue of a subject, and the suture is temporarily secured within the notch of the suture anchor for stability”). McIntosh, Hladio, and Lopez are analogous art as they are related to the same field of endeavor of devices to assist during surgeries.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the suture from Lopez into the McIntosh/Hladio combination as it allows the combination to include sutures to close the site after surgery, which is an important step to ensure the surgery is performed accurately and closed.
Claims 27-28, 30-31, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over McIntosh in view of Hladio and Lion.
Regarding independent claim 27, McIntosh teaches a method for detecting a condition of an orthopedic assembly ([0028]: “Embodiments in accordance with the present disclosure provide an apparatus and method of assisted guidance navigation for surgical assisted alignment”), the method comprising:
attaching the orthopedic assembly to a first portion of an anatomical structure ([0096]: “FIG. 4B depicts a block diagram of an exemplary sensor 201-204 suitable for use in the portable assisted guidance system 200 of FIG. 4A. With respect to FIG. 4A, each sensor 201-204 in the system 200 may contain more or less than the number of components shown depending on function. For instance, Sensor 201 and Sensor 203 may contain only an ultrasonic sensor with a transceiver for strictly disposable use. Sensors 202 and 204 may contain all the components shown in FIG. 4B. The sensor can be waterproof and shock absorbent”; [0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery”. The system 200 containing the sensors is the at least one surgical accessory, wherein each sensor is attached to at least one anatomical structure.) with a first accessory comprising a first sensor ([0096]: “Sensors 202 and 204 may contain all the components shown in FIG. 4B”. Sensor device 202 is the first surgical accessory containing the first sensor (sensor unit 12 from figure 4B));
attaching the orthopedic assembly to a second portion, spatially separated from the first portion of the anatomical structure (Sensor 204; Fig. 4A shows the sensors disposed on different bones, which are separate portions of the at least one anatomical structure (the knee)), with a second accessory comprising a second sensor ([0096]: “Sensors 202 and 204 may contain all the components shown in FIG. 4B”. Sensor device 204 is the second surgical accessory containing the second sensor (sensor unit 12 from figure 4B));
identifying a first position of the first sensor in a common coordinate system ([0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.);
identifying a second position of the second sensor in the common coordinate system ([0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.).
However, McIntosh does not teach identifying a spatial relationship between the first position and the second position; detecting a change in the spatial relationship; and outputting an indication reporting the change in the spatial relationship indicating a movement of a portion of the surgical accessory relative to the at least one anatomical structure.
Hladio discloses systems and methods to assist joint replacement surgery. Specifically, Hladio teaches determining a spatial relationship between the first position and the second position ([0007]: “the sensor coupled to a first bone, the first beacon coupled to the first bone via a patient specific jig (PSJ) configured to mate with the first bone, the second beacon coupled to the object, which object comprises one of a second bone and a surgical tool, the method comprising: receiving positional information from the sensor at an intra-operative computing unit in communication with the sensor; measuring a pose of the first beacon when coupled to the first bone via the PSJ to establish a positional relationship between the sensor and the PSJ; calculating poses of the second beacon with respect to an anatomical coordinate frame utilizing pre-operative data representing the PSJ and the positional relationship between the sensor and the PSJ; and displaying positional information for the object in real time”. The positional relationship between the sensor and the PSJ and calculating the poses of the second beacon is the spatial relationship between the first position and the second position.);
detecting a change in the spatial relationship ([0069]: “The position of the femur sensor may be determined, calculated, or otherwise identified based in part by a positional relationship between the first surface and the second surface of the patient-specific femoral jig. The position of the femur sensor may alternatively be determined, calculated, or otherwise identified based in part on a pre-operative formation of the patient-specific femoral jig. The change in leg position may be determined, calculated, or otherwise identified based in part on the a pre-operative three-dimensional image reconstruction of the patient's pelvis and femur”); and
detecting the change in the spatial relationship indicating a movement of a portion of the surgical accessory relative to the at least one anatomical structure ([0067]: “display the change in leg position”. The display step includes outputting an indication reporting the change, which indicates movement of a portion of the surgical accessory relative to the anatomical structure.). McIntosh and Hladio are analogous art as they are related to the same field of endeavor of assisting orthopedic surgeries.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection of a change in relationship between the two sensors and attributing it to the motion of the surgical accessory from Hladio into the method from McIntosh as it allows the method to monitor the distance between the sensors and use it to determine how the sensor moves. This allows the method to monitor the movement of the device and detect any important changes, which can assist in determining the location of the device and its use during a surgery.
However, the McIntosh/Hladio combination does not teach the movement of the surgical accessory indicating a change in fixation state of a surgical assembly.
Lion discloses methods of measuring a position change of an object. Specifically, Lion teaches wherein the movement is identified as a change in a fixation state of the at least one accessory to the structure (Page 3: “As bearings and slides wear, non-contact displacement measurements of the moving parts will indicate increased movement in unintended directions. Rotary motions will show increasing displacements in the X, Y, and Z axes as the object turns. Linear slides will show increasing displacements in the two axes perpendicular to the direction of travel … Linear non-contact displacement measurements are relative measurements and indicate the change of an object’s position from an initial location in one or more linear axes”. This limitation states that as objects change from their initial fixation state, there will be an increased amount of displacement (the movement).). Hladio and Lion are analogous art as they are related to solving the same problem of measuring displacement between two objects.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the movement being identified as a change in a fixation state from Lion into the McIntosh/Hladio combination as it allows the method to determine if the accessory is not in the correct location, and therefore indicate that the device needs to be fixed before the procedure continues. This ensures that the device is in the correct spot for the procedure and is functioning correctly, ensuring that the device can perform its intended functions.
Regarding claim 28, the McIntosh/Hladio/Lion combination teaches the method according to claim 27, wherein the change in the fixation state indicates that a connection of the surgical assembly has at least partially decoupled from the anatomical structure (Lion, Page 3: “As bearings and slides wear, non-contact displacement measurements of the moving parts will indicate increased movement in unintended directions. Rotary motions will show increasing displacements in the X, Y, and Z axes as the object turns. Linear slides will show increasing displacements in the two axes perpendicular to the direction of travel … Linear non-contact displacement measurements are relative measurements and indicate the change of an object’s position from an initial location in one or more linear axes”. This limitation states that as objects change from their initial fixation state, there will be an increased amount of displacement (the movement).).
Regarding claim 30, the McIntosh/Hladio/Lion combination teaches the method according to claim 27,wherein the anatomical structure is a continuous rigid structure (McIntosh, [0040]: “One threaded end couples to sensor 101 the remaining threaded end couples to a bone, cutting block, jig or other structure for supporting the device. A taper threaded region would be used to screw the mounting structure 120 into bone similar to an orthopedic screw. It is not limited to the embodiments disclosed herein and others are attachment methods are contemplated.” The anatomical structure is the top layer of bone, which is a continuous rigid structure.).
Regarding claim 31, the McIntosh/Hladio/Lion combination teaches the method according to claim 27, wherein the first surgical accessory is at least one of a pin, a button, a screw, an anchor, and a nail (McIntosh, [0073]: “a tibial pin can be pinned in the proximal tibia or midway on the tibia”; [0003]: “a button may also be added under the kneecap surface”; [0045]: “The mount can comprise a rod or fastener on or extending from the housing of wand 102 that can screw into or attach to a structure”).
Regarding claim 33, the McIntosh/Hladio/Lion combination teaches the method according to claim 27, wherein the anatomical structure comprises at least one of a bone, a tendon, a ligament, a joint, a cartilage, and a muscle tissue (McIntosh, Fig. 4B; [0040]: “One threaded end couples to sensor 101 the remaining threaded end couples to a bone, cutting block, jig or other structure for supporting the device. A taper threaded region would be used to screw the mounting structure 120 into bone similar to an orthopedic screw. It is not limited to the embodiments disclosed herein and others are attachment methods are contemplated.” The anatomical structure is the top layer of bone.).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over the McIntosh/Hladio/Lion combination as applied to claim 27 above, and further in view of Lopez.
Regarding claim 32, the McIntosh/Hladio/Lion combination teaches the method according to claim 27.
However, the McIntosh/Hladio combination does not teach wherein the surgical accessory comprises a suture or a flexible connecting element.
Lopez discloses surgical fixation device and methods. Specifically, Lopez teaches wherein the surgical accessory comprises a suture or a flexible connecting element ([0149]: “The sutures are threaded around the crossbars of the anchor. Next, the suture is passed through soft tissue of a subject, and the suture is temporarily secured within the notch of the suture anchor for stability”). McIntosh, Hladio, and Lopez are analogous art as they are related to the same field of endeavor of devices to assist during surgeries.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the suture from Lopez into the McIntosh/Hladio combination as it allows the combination to include sutures to close the site after surgery, which is an important step to ensure the surgery is performed accurately and closed.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over McIntosh in view of Hladio, Lion, Revie (US 20080269596), and Bono (US 20220096173).
Regarding independent claim 51, McIntosh teaches an apparatus for orthopedic surgery ([0028]: “Embodiments in accordance with the present disclosure provide an apparatus and method of assisted guidance navigation for surgical assisted alignment”) comprising:
an orthopedic surgical assembly in connection with at least one anatomical structure ([0096]: “FIG. 4B depicts a block diagram of an exemplary sensor 201-204 suitable for use in the portable assisted guidance system 200 of FIG. 4A. With respect to FIG. 4A, each sensor 201-204 in the system 200 may contain more or less than the number of components shown depending on function. For instance, Sensor 201 and Sensor 203 may contain only an ultrasonic sensor with a transceiver for strictly disposable use. Sensors 202 and 204 may contain all the components shown in FIG. 4B. The sensor can be waterproof and shock absorbent”; [0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery”. The system 200 containing the sensors is the at least one surgical accessory, wherein each sensor is attached to at least one anatomical structure.) comprising a first surgical accessory interconnected to a second surgical accessory (Fig. 4B; system 200 contains the first surgical accessory (sensor structure 202) and second surgical accessory (sensor 204)), wherein:
the first surgical accessory comprises a first sensor and is in connection with a first portion of the at least one anatomical structure ([0096]: “Sensors 202 and 204 may contain all the components shown in FIG. 4B”. Sensor device 202 is the first surgical accessory containing the first sensor (sensor unit 12 from figure 4B)), and
the second surgical accessory comprises a second sensor and is in connection with a second portion of the at least one anatomical structure ([0096]: “Sensors 202 and 204 may contain all the components shown in FIG. 4B”. Sensor device 204 is the second surgical accessory containing the second sensor (sensor unit 12 from figure 4B)) spatially separated from the first portion (Sensor 204; Fig. 4A shows the sensors disposed on different bones, which are separate portions of the at least one anatomical structure (the knee)); and
a controller in communication with the at least one surgical accessory ([0093]: “The system 200 comprises a group of sensors 201-204 communicatively coupled to an acquisition system 205 by way of a wired or wireless connection. The group of sensors 201-204 can be individually hermetically sealed for clean room conditions during surgery. The acquisition system 205 can comprise a custom control board (CC) a DSP board and a laptop, although, in other embodiments, the CC and DSP can operate internally from a customized laptop using electronic processing resources therein (e.g., processor, memory, converters, etc.)”. THE acquisition system is the controller in communication with the surgical accessory.) and configured to:
detect a first position of the first sensor in a common coordinate system ([0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.);
detect a second position of the second sensor in the common coordinate system ([0095]: “Each sensor 201-204 can be entirely sealed in a disposable plastic package. An adhesive can affix it to the patient prior to surgery. A sensor can also comprise one or more sensing elements (e.g., MEMS ultrasonic transducer, optical element, laser, camera) for permitting three-dimensional tracking, for example by way, of sound localization, optical line of sight, optical pattern recognition, or any combination thereof. The sensor can include other processing components in addition to just the sensing elements (e.g., acoustic transducers, optical elements, infra-red elements, etc.)”; [0049]: “In the alignment example, the display 150 shows patient alignment and the measured parameter from the sensor in real-time. The measured parameter can be a load magnitude and position of load on the articular surface of the insert.”. The three-dimensional tracking of the sensors is determining the position of the sensors in a common coordinate system.).
However, McIntosh does not teach identifying a spatial relationship between the first position and the second position; detecting a change in the spatial relationship; and outputting an indication reporting the change in the spatial relationship indicating a movement of a portion of the surgical accessory relative to the at least one anatomical structure.
Hladio discloses systems and methods to assist joint replacement surgery. Specifically, Hladio teaches identifying a spatial relationship between the first position and the second position ([0007]: “the sensor coupled to a first bone, the first beacon coupled to the first bone via a patient specific jig (PSJ) configured to mate with the first bone, the second beacon coupled to the object, which object comprises one of a second bone and a surgical tool, the method comprising: receiving positional information from the sensor at an intra-operative computing unit in communication with the sensor; measuring a pose of the first beacon when coupled to the first bone via the PSJ to establish a positional relationship between the sensor and the PSJ; calculating poses of the second beacon with respect to an anatomical coordinate frame utilizing pre-operative data representing the PSJ and the positional relationship between the sensor and the PSJ; and displaying positional information for the object in real time”. The positional relationship between the sensor and the PSJ and calculating the poses of the second beacon is the spatial relationship between the first position and the second position.);
detecting a change in the spatial relationship ([0069]: “The position of the femur sensor may be determined, calculated, or otherwise identified based in part by a positional relationship between the first surface and the second surface of the patient-specific femoral jig. The position of the femur sensor may alternatively be determined, calculated, or otherwise identified based in part on a pre-operative formation of the patient-specific femoral jig. The change in leg position may be determined, calculated, or otherwise identified based in part on the a pre-operative three-dimensional image reconstruction of the patient's pelvis and femur”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the detection of a change in relationship between the two sensors and attributing it to the motion of the surgical accessory from Hladio into the device from McIntosh as it allows the device to monitor the distance between the sensors and use it to determine how the sensor moves. This allows the device to monitor the movement of the device and detect any important changes, which can assist in determining the location of the device and its use during a surgery.
However, the McIntosh/Hladio combination does not teach comparing the change in spatial relationship to a kinematic relationship between the first sensor and the second sensor.
Lion discloses methods of measuring a position change of an object. Specifically, Lion teaches comparing the change in the relationship to a kinematic relationship between the first sensor and the second sensor, and in response to the change diverting from a known value, determining that the connection of the orthopedic assembly has at least partially decoupled from the at least one anatomical structure (Page 3: “As bearings and slides wear, non-contact displacement measurements of the moving parts will indicate increased movement in unintended directions. Rotary motions will show increasing displacements in the X, Y, and Z axes as the object turns. Linear slides will show increasing displacements in the two axes perpendicular to the direction of travel … Linear non-contact displacement measurements are relative measurements and indicate the change of an object’s position from an initial location in one or more linear axes”. This limitation states that as objects change from their initial fixation state, there will be an increased amount of displacement (the movement).). Hladio and Lion are analogous art as they are related to solving the same problem of measuring displacement between two objects.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the movement being identified as a change in a fixation state from Lion into the McIntosh/Hladio combination as it allows the method to determine if the accessory is not in the correct location, and therefore indicate that the device needs to be fixed before the procedure continues. This ensures that the device is in the correct spot for the procedure and is functioning correctly, ensuring that the device can perform its intended functions.
However, the McIntosh/Hladio/Lion combination does not disclose specifically using a known range for the comparison.
Revie discloses orthopedic monitoring systems and methods. Specifically, Revie teaches comparing the values to a known range ([0341]: “the surgeon can evaluate the success of the procedure for example by comparing the actual positions of the implants with the planned implant positions and/or articulating the joint and comparing the actual movement of the patient's limbs with a planned or theoretical movement or pre-operative range of motion of the patient's limbs”). McIntosh, Hladio, and Revie are analogous art as they are all related to the same field of endeavor of orthopedic monitoring devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the known range from Revie into the McIntosh/Hladio/Lion combination as the combination is silent on the specific values used in the comparison, and Revie discloses a suitable value in an analogous device.
However, the McIntosh/Hladio/Lion/Revie combination does not teach outputting a notification.
Bono discloses a surgical sensor anchor system. Specifically, Bono teaches outputting a notification ([0106]: “the user can define a boundary for movement of the fiducial marker that may trigger alarms stop the surgical procedure for realignment or recalibration, or may adjust the positioning and movements of the robot(s) to compensate for the monitored movement of the anatomy.”). McIntosh, Hladio, and Bono are analogous art as they are all related to orthopedic surgery management devices.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the notification from Bono into the McIntosh/Hladio/Lion/Revie combination as it allows the device to alert the user to any informalities or issues in the location of the device, which can allow for easy and quick correction.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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