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 § 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 1-21 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). Claims that depend directly or indirectly from claims 1 and 20 is/are also rejected due to said dependency.
In regard to claims 1 and 20, the claims 1 and 20 recite “a first implant coupled to a first bone of a joint, a second implant coupled to a second bone of the joint” and “an implant coupled to a patient”, respectively. The phrases should be read as “a first implant configured to be coupled to a first bone of a joint, a second implant configured to be coupled to a second bone of the joint” and “an implant configured to be coupled to a patient” to avoid improperly defining the apparatus in relation to a living being.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 20 and 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Forsell et al. (USPGPUB 2023/0355995). In regard to claim 20, Forsell discloses an implant system (Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions), comprising: an implant coupled to a patient (elements 100, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions; type of implants, [0059-0098], [0123-0163], [0293], [0458], [0611]), the implant comprising: a first communication module (elements 102/1091/1092/1281/1282, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions), and a memory to store authentication information (s4612/s4802/s4925a/s4926b/s5006/s5011/s5112/s5121/s5602/5702, Figs. 29, 39, 44-45, 54-55, 58-59, 88, and 93 and associated descriptions), an external device (element 200, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions) including a communication module (elements 203/1281/1282, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions) wherein the first communication module is configured to wirelessly transfer the authentication information to the communication module of an external device when the external device is placed adjacent the implant (Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions; a wireless communication channel (Radio), such as WLAN, Wi-Fi, cellular network, Bluetooth, NFC, RFID, [2719]; [2726]; [2965]; [3303-3311]).
In regard to claim 22, Forsell discloses a method for monitoring implant performance (referring to claim 200 above), the method comprising the steps of: placing an external device adjacent an implant coupled to patient to initiate a first communication between the implant and the external device (referring to claim 20 above; w1 or w2, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions); authenticating implant information via the first communication (referring to claim 20 above; Figs. 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions); initiating a second communication between the implant and the external device upon successful authentication of the first communication; and transferring implant data from the implant to the external device via the second communication (same or different communications between the implant and the external device, w1 and/or w2, with positive authentication, Figs. 54-55, 58-59, 65, 88 and 93 and associated descriptions; [1716]; [1818]; [3101-3103]; [3164-3169]; [3214-3216]; [3259]; “The external device 200 may be adapted to communicate with the implant 100 using two separate communication methods. A communication range of a first communication method W1 may be less than a communication range of a second communication method W2”, [3124]; “communication between an external device 200 and an implant 100 when implanted in a patient is provided. This is achieved by a first communication system (transmitting wireless communication W1) …from the external device 200 to the implant 100, and using a second, different, communication system (transmitting wireless communication W2) for receiving at the external device 200, data from the implant 100. By using different communication systems, a more flexible approach to transmission of data between the implant 100 and the external device 200 is provided. For example, different levels of security for transmissions to and from the implant 100 may be implemented, [3259]).
In regard to claim 23, Forsell discloses the first communication is an NFC communication and the second communication is a BLE communication (“The external device 200 may be adapted to communicate with the implant 100 using two separate communication methods. A communication range of a first communication method W1 may be less than a communication range of a second communication method W2”, [3124]; “communication between an external device 200 and an implant 100 when implanted in a patient is provided. This is achieved by a first communication system (transmitting wireless communication W1) …from the external device 200 to the implant 100, and using a second, different, communication system (transmitting wireless communication W2) for receiving at the external device 200, data from the implant 100. By using different communication systems, a more flexible approach to transmission of data between the implant 100 and the external device 200 is provided. For example, different levels of security for transmissions to and from the implant 100 may be implemented, [3259]; NFC and BLE, [0770], [0800], [0859]; [0975-0976], [2719], [3111-3116], and [3137]).
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over Forsell, in regard to claim 21, Forsell discloses the first communication module is configured to wirelessly transfer the authentication information to the communication module of an external device when the external device is placed adjacent the implant (Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions) but does not specifically discloses the communication module is configured to communicate with a cloud-based service such that the authentication information from the first communication module is authenticated on the cloud-based service. Forsell further discloses “The communication between the second external device 300 and the external device 200 may use a third communication method W3. The third communication method W3 may be a wireless communication method as those proposed for the first and second communication methods W1, W2”, [3233-3234] and “the second external device 300 may be considered to be or comprise the instruction provider 270… the instruction provider 270 may be adapted to receive authentication input from the caregiver, comprising at least one of a code and a parameter”, [3327]; “sensed parameters are transmitted from the implant/external device to the second external device 300, [3370] and the second external device 300 is cloud based ([3734]; [3988]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the location for authentication processing of sensed data/ authentication information at the external device with the cloud-based authentication processing at the second external device to yield predictable results, since sensed data/ authentication information can be transmitted to the cloud-based location and one of ordinary skill in the art would have recognized that the cloud-based location is an alternative equivalent location for authentication processing of sensed data/ authentication information and may reduce the processing power of the external device. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Claims 1-11 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa et al. (USPN 6,447,448 – applicant cited) in view of Forsell. In regard to claim 1, Ishikawa discloses a joint implant (Figs. 1-3) comprising: a first implant coupled to a first bone of a joint (element 304, Fig. 3 and associated descriptions); a second implant coupled to a second bone of the joint (elements 302/306/308/310/312, Fig. 3 and associated descriptions); a first communication module (element 150, Figs. 1-2 and associated descriptions), a memory to store measured information (element 1439, fig. 14 and associated descriptions), wherein the first communication module is configured to wirelessly transfer the measured information to a communication module of an external device (to element 244 of external device 200, Fig. 2 and associated descriptions).
Ishikawa does not specifically disclose a memory to store authentication information, wherein the first communication module is configured to wirelessly transfer the authentication information to a communication module of an external device
Forsell teaches an implant system comprises (Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions), comprising: an implant coupled to a patient (elements 100, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions; type of implants, [0059-0098], [0123-0163]; an implant for adjusting or replacing any bone part of a body of the patient, [0070]), the implant comprising: a first communication module (elements 102/1091/1092/1281/1282, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions), and a memory to store authentication information (s4612/s4802/s4925a/s4926b/s5006/s5011/s5112/s5121/s5602/5702, Figs. 29, 39, 44-45, 54-55, 58-59, 88, and 93 and associated descriptions), an external device (element 200, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions) including a communication module (elements 203/1281/1282, Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions) wherein the first communication module is configured to wirelessly transfer the authentication information to the communication module of an external device when the external device is placed adjacent the implant (Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions; a wireless communication channel (Radio), such as WLAN, Wi-Fi, cellular network, Bluetooth, NFC, RFID, [2719]; [2726]; [2965]; [3303-3311]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant (Ishikawa) to incorporate store and wireless transmission and associated elements/ functions of authentication information from the implant to the external device for authenticating/ establishing secure communication as taught by Forsell, since both devices are bone implant systems and one of ordinary skill in the art would have recognized that authentication information facilitate authenticating/ establishing secure communication between the implant and the external device (see Forsell). The rationale would have been to obtain secure wireless communications.
In regard to claim 2, Ishikawa as modified by Forsell discloses the first communication module is an NFC communication module, the NFC communication module configured to transfer the authentication information to the communication module of the external device via NFC (NFC, [2719]; [2726]; [2965]; [3303-3311] of Forsell).
In regard to claim 3, Ishikawa as modified by Forsell discloses at least one sensor to measure an interaction between the first and second implants (elements 314, Fig. 3 and associated descriptions of Ishikawa).
In regard to claim 4, Ishikawa as modified by Forsell discloses the authentication information include joint implant data or patient data (Figs. 1-2, 8-11, 18-21, 25, 29, 39, 44-45, 54-55, 58-59, 69, 88 and 93 and associated descriptions; [0786]; [0788]; [2724] of Forsell).
In regard to claim 5, Ishikawa as modified by Forsell discloses the joint implant is configured to change from a sleep mode to an advertising mode when the external device is placed adjacent the joint implant (receiving power from external element 220, Fig. 2 and associated descriptions; Col 5 line 44 – Col 6 line 29 of Ishikawa).
In regard to claim 6, Ishikawa as modified by Forsell discloses a second communication module (elements 1091/1092/1281/1282, Figs. 62, 65, 69-70, and 95-96 and associated descriptions of Forsell).
In regard to claims 7 and 8, Ishikawa as modified by Forsell discloses the second communication module is any of BLE, Z-wave or Zigbee module and wherein the second communication module is a BLE module (BLE, [0769], [0777], [0800], [0935], [0976] of Forsell).
In regard to claim 9, Ishikawa as modified by Forsell discloses the BLE module is configured to transfer the measured interaction between the first and second implants to the communication module of the external device via BLE in the advertising mode (referring to claims 1, 5 and 7-8 above).
In regard to claim 10, Ishikawa as modified by Forsell discloses the joint implant is configured to return to the sleep mode upon transferring the measured interaction (after transmission of data and remove the RF power/ external device, referring to claims 1 and 5 above).
In regard to claim 11, Ishikawa as modified by Forsell discloses the measured interaction is any of a load between the first and second implants and position of the first implant with respect to the second implant (strain gauges 314, Fig. 3 and associated descriptions of Ishikawa).
In regard to claim 16, Ishikawa as modified by Forsell discloses the external device is any of a smartphone, tablet, watch, and fob (smartphone/ tablet, [2732] and [3716]; [3733] of Forsell).
In regard to claim 17, Ishikawa as modified by Forsell discloses the joint implant is any of hip implant, shoulder implant, and ankle implant (fig. 3 and associated descriptions of Ishikawa).
Claims 12-15 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Ishikawa and Forsell as applied to claims 1-11 and 16-17 above, and further in view of Stein et al. (USPGPUB 2014/0275815). In regard to claim 12, Ishikawa as modified by Forsell discloses the sensor implant can be implanted in the knee portion (Fig. 6 and associated descriptions of Ishikawa) but does not specifically discloses the joint implant is a knee joint implant, the first implant being a femoral implant and the second implant being a tibial implant.
Stein teaches a knee joint implant (Figs. 1 and 31 and associated descriptions) comprises a first implant being a femoral implant (elements 104/2706/3102, Figs. 1, 27 and 31 and associated descriptions; [0065]) and the second implant being a tibial implant (elements 106/3100/3102/3104/3124, Fig. 1 and 31 and associated descriptions; [0065]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant (Ishikawa as modified by Forsell) to incorporate the configurations of knee joint implant and associated elements/ functions as taught by Stein, since both devices are implant systems with sensor(s) being placed between bones and one of ordinary skill on the art would have recognized that the configuration as taught by Stein is suitable for measurements at knee portion of a user (see Stein). The rationale would have been to obtain information at the knee portion(s) of the user.
In regard to claim 13, Ishikawa as modified by Forsell and Stein discloses the tibial implant includes a tibial insert (element 3100, Fig. 31 and associated descriptions of Stein) and a tibial stem (element 3124, Fig. 31 and associated descriptions of Stein), the first communication module, the second communication module and the memory being disposed within the tibial insert (referring to claims 1 and 6 above; electronics being disposed within element 3110, Figs. 31 and 38-40 and associated descriptions of Stein).
In regard to claim 14, Ishikawa as modified by Forsell and Stein discloses the position of the first implant with respect to the second implant includes any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, superior-inferior translation, anterior-posterior translation, and time derivatives thereof ([0188]; [0190] and [0276] of Stein).
In regard to claim 15, Ishikawa as modified by Forsell and Stein discloses the tibial insert includes any of a pH sensor, a temperature sensor and a pressure sensor operatively coupled to a processor ([0154]; [0188]; [0190]; [0243] of Stein).
In regard to claim 18, Ishikawa as modified by Forsell and Stein discloses the measured interaction includes patient activity data ([0188]; [0190]; [0276]; [0289] of Stein)
In regard to claim 19, Ishikawa as modified by Forsell and Stein discloses the patient activity data includes any of a patient's gait and a number of steps taken by the patient in a predetermined interval (walking, [0289] of Stein).
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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