DETAILED ACTION
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 7-10, 13, 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alva et al. (US 20230255794 A1).
In regard to claim 1, Alva teaches a system for detecting impingement or dislocation of a prosthetic implant installed within a patient (Alva, Para. 738, dislocation and impingement can be accurately calculated and predicted by assessing the lift-off in one direction, and comparing it to a pre-defined threshold), the prosthetic implant including an implant configured to receive a head component and installed into a first bone and an articulating component installed into a second bone (Alva, Para. 154, A joint implant according to this aspect, may include a first implant coupled to a first bone of a joint and a second implant coupled to a second bone of the joint), the system comprising: a trial head configured to be installed on the implant to engage with the articulating component, the trial head including: a sensor configured to generate a signal, the signal indicative of a distance between the trial head and the articulating component (Alva, Para. 154, The second implant may include at least one medial marker reader to identify a position of the medial markers and at least one lateral marker reader to identify a position of the lateral markers. The position of the medial markers and the position of the lateral markers may provide positional data of the first implant with respect to the second implant. The second implant may include a medial load sensor to measure medial load data between the first and second implants on a medial side of the joint implant, a lateral load sensor to measure lateral load data between the first and second implants on a lateral side of the joint implant. A processor may be operatively coupled to the medial marker reader, the lateral marker reader, the medial load sensor, and the lateral load sensor. The processor may simultaneously output the positional data, the medial load data, and the lateral load data to an external source); a memory including instructions; and a controller coupled to the memory including instructions, the instructions configured to, when executed by processing circuitry of the controller, cause the processing circuitry to perform operations including: receive the signal from the sensor; compare the signal from the sensor to a set threshold value (Alva, Para. 678, The initial vibration readings post-operation (or after the patient has had the time to properly heal), provide a threshold value that act as a baseline for determine the implant's position, as the implant likely experienced minimal shift post-operation. Subsequent readings may be taken at time intervals after the threshold readings are taken. For example, a patient may be tested annually. After the threshold readings have been collected, they may be stored in the processor's memory system as vibration signatures 7960 such that they can later be compared with measured values); and communicate an alert on condition that the signal exceeds the set threshold value, the alert indicative of an impingement between the trial head and the second bone or the articulating component or a dislocation between the trial head and the articulating component (Alva, Para. 738, For example, dislocation and impingement can be accurately calculated and predicted by assessing the lift-off in one direction, and comparing it to a pre-defined threshold. Measurements such as flexion-extension, abduction-adduction, internal-external rotation, lift-off, the direction vector of the lift-off, etc., can be readily monitored and evaluated in order to determine whether an excursion of the position has passed a predetermined threshold. If this is detected, warnings can be transmitted to alert the user or the HCP of the possibility of dislocation or impingement).
In regard to claim 4, Alva teaches the system of claim 1, wherein the sensor is passive and requires no power to operate (Alva, Para. 556, Hip implant 1600 includes a charging coil 1610 located on stem 1602 as shown in FIG. 30. Charging coil 1610 charges a battery 1612 via a connector 1624 to power the various sensors located in hip implant 1600).
In regard to claim 7, Alva teaches the system of claim 1, wherein the alert can include one or more of an audible alert, a visual indicia, or a haptic response (Alva, Para. 688, an external source 8126 such as a computer or smartphone app may show the graphs and allow a clinician to interpret the data to the patient. The external source 8126 may also create alerts such as an audio alert or a visual alert when implant detachment is detected).
In regard to claim 8, Alva teaches the system of claim 1, wherein the instructions cause the processing circuitry to perform operations including: generate a record of the signal obtained from the sensor; and save the record of the signal obtained from the sensor in a database (Alva, Para. 566, Upon identifying the relevant activity and switching over to the high-power mode, various sensors in the knee joint implant record and store sensor measurements on the device (step 2512). This data can be transferred from the patient to a home station when the patient is in the vicinity of the home station or a smart device (step 2514). The data is then transferred from the home station or the smart device to the cloud 5850 to be reviewed and analyzed by the software 5860 or virtual machines and/or by experts (steps 2518, 2520). Relevant information for patient rehabilitation and recovery uncovered from the sensor data is sent back to the patient (steps 2523, 2522) via the client portal 5856).
In regard to claim 9, Alva teaches the system of claim 8, wherein the database includes a patient record database, the patient record database including patient-specific medical information including at least the signal obtained from the sensor during a range of motion test (Alva, Para. 686, After the baseline movement data 8140 is determine post-operation, a patient may perform identical range of motion tests at given time intervals to determine a new data point 8142 after potential loosening has occurred. For example, a patient may undergo a range of motion test annually, and the tenth annual test may indicate implant detachment compared to the reference movement data 8140. Accordingly, it is imperative that each resulting data gained from each range of motion test is properly stored in a memory system to ensure that results can be compared over a long time period).
In regard to claim 10, Alva teaches a trial implant for detecting impingement or dislocation of a prosthetic implant installed within a patient intraoperatively during a range of motion test (Alva, Para. 685, After implantation, the patient undergoes a range of movement test to determine baseline movement data 8140 that can later be compared to other movement data. For example, the patient may perform an anterior-posterior drawer test to determine a range of motion. Alternatively, patients may perform other tests or potentially random range of motion tests as long as patient has a large range of motion), the trial implant including: a trial head of a ball and socket joint replacement prosthesis (Alva, Fig. 74), the ball and socket joint replacement prosthesis configured to attach to a stem component and engage with a socket portion of the ball and socket joint replacement prosthesis (Alva, Para. 596, Hip implant 5000 includes a stem 5002 and a ball joint 5004. Stem 5002 includes an energy generator 5008 electrically connected to an ultrasonic transducer 5018 via a wire 5016. Energy generator 5008 and ultrasonic transducer 5018 are sealed within a body 5006 of stem 5002 as shown in FIG. 74. Energy generator 5008 is an electromechanical energy generator configured to convert mechanical energy to electrical energy. Energy generator 5008 includes a plurality of magnets 5014 located on fixed and moveable columns 5012 configured to generate electricity via the relative motion of the magnets. The relative motion of magnets 5014 triggered by various activities of the patient including walking, standing, etc. results in electric energy generation. Biasing members such as spring 5010 in energy generator 5008 protect magnets 5014 during hard impacts experienced by stem 5002 and aid in relative magnet motion to increase energy generation) and a sensor embedded within the trial head, the sensor configured to generate a signal indicative of a distance between the trial head and the socket portion (Alva, (Alva, Para. 154, The second implant may include at least one medial marker reader to identify a position of the medial markers and at least one lateral marker reader to identify a position of the lateral markers. The position of the medial markers and the position of the lateral markers may provide positional data of the first implant with respect to the second implant. The second implant may include a medial load sensor to measure medial load data between the first and second implants on a medial side of the joint implant, a lateral load sensor to measure lateral load data between the first and second implants on a lateral side of the joint implant. A processor may be operatively coupled to the medial marker reader, the lateral marker reader, the medial load sensor, and the lateral load sensor. The processor may simultaneously output the positional data, the medial load data, and the lateral load data to an external source), the sensor including an inductive coil to detect the distance and generate the signal indicative of the distance (Alva, Para. 628, The reflected light from the surface of the femoral implant is read on a reading device to determine the relative distance between a tibial trial or implant and the femoral implant by comparing the detected pattern to target pattern. Thus, a surgeon can intra-operatively adjust the joint gap in real time for proper positioning of the joint implants).
In regard to claim 13, Alva teaches the trial implant of claim 10, wherein the sensor is passive and requires no power to operate (Alva, Para. 556, Hip implant 1600 includes a charging coil 1610 located on stem 1602 as shown in FIG. 30. Charging coil 1610 charges a battery 1612 via a connector 1624 to power the various sensors located in hip implant 1600).
In regard to claim 16, Alva teaches the trial implant of claim 10, comprising: a controller including processing circuitry and coupled to a memory, the memory including instructions that, when executed by the processing circuitry, cause the processing circuitry to: obtain the signal from the sensor (Alva, Para. 154, The second implant may include at least one medial marker reader to identify a position of the medial markers and at least one lateral marker reader to identify a position of the lateral markers. The position of the medial markers and the position of the lateral markers may provide positional data of the first implant with respect to the second implant. The second implant may include a medial load sensor to measure medial load data between the first and second implants on a medial side of the joint implant, a lateral load sensor to measure lateral load data between the first and second implants on a lateral side of the joint implant. A processor may be operatively coupled to the medial marker reader, the lateral marker reader, the medial load sensor, and the lateral load sensor. The processor may simultaneously output the positional data, the medial load data, and the lateral load data to an external source); compare the signal from the sensor to a set threshold value (Alva, Para. 678, The initial vibration readings post-operation (or after the patient has had the time to properly heal), provide a threshold value that act as a baseline for determine the implant's position, as the implant likely experienced minimal shift post-operation. Subsequent readings may be taken at time intervals after the threshold readings are taken. For example, a patient may be tested annually. After the threshold readings have been collected, they may be stored in the processor's memory system as vibration signatures 7960 such that they can later be compared with measured values); and communicate an alert on condition that the signal exceeds the set threshold value, the alert indicative of an impingement between the trial head and the socket portion or a bone of the patient, or a dislocation between the trial head and the socket portion (Alva, Para. 738, For example, dislocation and impingement can be accurately calculated and predicted by assessing the lift-off in one direction, and comparing it to a pre-defined threshold. Measurements such as flexion-extension, abduction-adduction, internal-external rotation, lift-off, the direction vector of the lift-off, etc., can be readily monitored and evaluated in order to determine whether an excursion of the position has passed a predetermined threshold. If this is detected, warnings can be transmitted to alert the user or the HCP of the possibility of dislocation or impingement).
In regard to claim 17, Alva teaches the trial implant of claim 16, wherein the alert can include one or more of an audible alert, a visual indicia, or a haptic response (Alva, Para. 688, an external source 8126 such as a computer or smartphone app may show the graphs and allow a clinician to interpret the data to the patient. The external source 8126 may also create alerts such as an audio alert or a visual alert when implant detachment is detected).
In regard to claim 18, Alva teaches the trial implant of claim 16, wherein the instructions cause the processing circuitry to: generate a record of the signal obtained from the sensor; and save the record of the signal obtained from the sensor in one or more databases (Alva, Para. 566, Upon identifying the relevant activity and switching over to the high-power mode, various sensors in the knee joint implant record and store sensor measurements on the device (step 2512). This data can be transferred from the patient to a home station when the patient is in the vicinity of the home station or a smart device (step 2514). The data is then transferred from the home station or the smart device to the cloud 5850 to be reviewed and analyzed by the software 5860 or virtual machines and/or by experts (steps 2518, 2520). Relevant information for patient rehabilitation and recovery uncovered from the sensor data is sent back to the patient (steps 2523, 2522) via the client portal 5856).
In regard to claim 19, Alva teaches the trial implant of claim 18, wherein the one or more databases includes a patient record database, the patient record database including patient-specific medical information including at least the signal obtained from the sensor during the range of motion test (Alva, Para. 686, After the baseline movement data 8140 is determine post-operation, a patient may perform identical range of motion tests at given time intervals to determine a new data point 8142 after potential loosening has occurred. For example, a patient may undergo a range of motion test annually, and the tenth annual test may indicate implant detachment compared to the reference movement data 8140. Accordingly, it is imperative that each resulting data gained from each range of motion test is properly stored in a memory system to ensure that results can be compared over a long time period).
In regard to claim 20, the claim is interpreted and rejected for the same reasons as stated in the rejection of claim 1 as stated above.
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.
Claim(s) 5-6 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alva et al. (US 20230255794 A1) in view of Bermudez Castel et al. (US 20180000599 A1).
In regard to claim 5, Alva do not specifically teach the system of claim 1, wherein the articulating component includes a liner, the liner including a conductive material.
However, the concept of having artificial joint with a liner made of Conductive material as taught by Bermudez Castel. Bermudez Castel teaches the first joint portion and the second joint portion comprise a conductive material and the intermediate portion comprises a non-conductive material and is arranged in between the first joint portion and the second joint portion such that the first joint portion is electrically isolated from the second joint portion. Preferably, at least the outer surfaces of the first joint portion and the second joint portion are electrically conductive. Further, preferably the first and second joint portions are formed from a conductive material. In a preferred embodiment, the conductive material is a metal such as a lightweight metal as used in the art. Preferably, the intermediate component is formed from a plastic material such as polyethylene. In a further preferred embodiment, the artificial joint is an artificial knee, the first joint portion is a femoral implant and the second joint portion is a tibial implant (Para. 8). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have artificial joint with conductive liner (as taught by Bermudez Castel) resulting in predictable result of having at least the outer surfaces of the first joint portion and the second joint portion are electrically conductive.
In regard to claim 6, Combination of Alva and Bermudez Castel teach the system of claim 5, wherein the sensor is configured to detect a distance between the trial head and the conductive material of the liner (Alva, Para. 154, The second implant may include at least one medial marker reader to identify a position of the medial markers and at least one lateral marker reader to identify a position of the lateral markers. The position of the medial markers and the position of the lateral markers may provide positional data of the first implant with respect to the second implant. The second implant may include a medial load sensor to measure medial load data between the first and second implants on a medial side of the joint implant, a lateral load sensor to measure lateral load data between the first and second implants on a lateral side of the joint implant. A processor may be operatively coupled to the medial marker reader, the lateral marker reader, the medial load sensor, and the lateral load sensor. The processor may simultaneously output the positional data, the medial load data, and the lateral load data to an external source).
In regard to claim 14, the claim is interpreted and rejected for the same reasons as stated in the rejection of claim 5 as stated above.
In regard to claim 15, the claim is interpreted and rejected for the same reasons as stated in the rejection of claim 6 as stated above.
Allowable Subject Matter
Claims 2-3 and 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regard to claims 2-3 and 11-12, Johannaber et al. (US 20180161168 A1) teaches rod 322 can include a magnet, such as a permanent magnet, disposed on a distal end of rod 322. In these examples, detector 324 can be a sensor configured to produce a sensor signal as a function of a sensed magnetic field, such as a hall sensor, disposed at a distal termination of bore 326 in stem 306. Detector 324 can be disposed in bore 326 in proximity to rod 322 and can be configured to produce a signal as a function of a detected magnetic field emitted by rod 322. In such cases, the displacement signal produce by detector 324 can be correlated to distance d between rod 322 and detector 324. In some other examples, the displacement signal be generated as a function of a sensed electric field, for example when capacitive displacement sensing is used as displacement sensor 318 (Para. 80) but does not teach wherein the sensor comprises: an inductive coil; and a capacitor connected to the inductive coil, the capacitor and the inductive coil configured to generate a resonant frequency, the resonant frequency is inversely related to the distance between the trial head and the articulating component such that the resonant frequency decreases as the distance between the trial head and the articulating component increases. Therefore, prior art of record neither anticipates nor renders obvious the claim limitations.
Conclusion
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/SHARMIN AKHTER/
Examiner, Art Unit 2689
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