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 .
Applicant’s amendments and remarks filed on 06/29/2026 have been fully considered.
Claims 1-2, 4-5 and 7-23 are pending for examination,
Claim Objections
Claim 20 is objected to because of the following informalities: In regard to claim 20, line 10, “an” should be set forth “the” . Appropriate correction is required.
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 20-21 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. Claims that depend directly or indirectly from claim 20 is/are also rejected due to said dependency. In regard to claim 21, the claim recites “the communication module is configured to transfer sensor data to the external device”. However, claim 20 recites “a first communication module, a second communication module and a communication module of the external module”. It is unclear which communication module the underlined limitation refers. Clarification is requested by amendments.
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.
Claims 1-2, 4-5, and 7-23 are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al. (USPGPUB 2014/0275815 – cited in previous action) and further in view of Hua et al. (USPGPUB 2022/0070666). In regard to claims 1, 20 and 22, Stein teaches a joint implant (Figs. 1 and 27-47 and associated descriptions) comprising a first implant configured to be coupled to a first bone of a joint (elements 104/2706/3102, Figs. 1, 27 and 31 and associated descriptions; [0065]); a second implant configured to be coupled to a second bone of the joint (elements 106/3100/3102/3104/3124, Fig. 1 and 31 and associated descriptions; [0065]); at least one sensor configured to measure an interaction between the first and second implants (elements 100-500, Figs. 1-5 and associated descriptions); a first communication module (Fig. 1 and associated descriptions; wired or wireless communications, [0069]); a memory (memory, [0225]; [0232]; [0260]) and an external device (element 110, Fig. 1 and associated descriptions).
Stein does not specifically disclose a second communication module; and a memory storing pre-determined authentication credentials, wherein the first communication module is configured to retrieve the pre-determined authentication credentials from the memory and wirelessly transfer the authentication credentials to a communication module of an external device when the external device is placed adjacent the joint implant, wherein the second communication module is configured to transfer the measured interaction to the external device via a communication protocol different from a communication protocol used by the first communication module only upon successful validation of the authentication credentials.
Hua teaches a sensor system and an associated method (Figs. 1-9 and associated descriptions) comprising a sensor configured to be coupled to a patient (element 110, Figs. 1-2, 5 and 7-9 and associated descriptions), the sensor comprising: a first communication module (element 240, Fig. 2 and associated descriptions; Near-Field Communication (“NFC”) chipset, [0030]), a second communication module (element 240, Fig. 2 and associated descriptions; Bluetooth Low-Energy (“BLE”) chipset, [0030]) and a memory (elements 220 and/or 230, Fig. 2 and associated descriptions) storing pre-determined authentication credentials (data used in the authentication and encryption security architecture. [0030]; UID/ identifying information/ serial number, [0060]; token/ identifying, [0098]), an external device (elements 120, 130, 140 and/or elements 710/715/720, Figs. 1, 3, 5 and 7-9 and associated descriptions) including a communication module (elements 340/341/342/345, Fig. 3 and associated descriptions), wherein the first communication module is configured to retrieve the pre-determined authentication credentials from the memory (data used in the authentication and encryption security architecture, [0030]; UID/ identifying information/ serial number, [0060]; token/ identifier, [0098-0100]) and wirelessly transfer the authentication credentials to the communication module of the external device when the external device is placed adjacent the sensor (NFC, [0030]; mutual authentication, Figs. 7A-7D and 8 and associated descriptions; [0042]), wherein the communication module is configured to transfer sensor data to the external device via a communication protocol different from a communication protocol used by the first communication module upon successful validation of the authentication credentials ([0007]; mutual authentication, Figs. 7A-7D and associated descriptions; [0039-0040]; [0050]; [0098-0100]).
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 and the method (Stein) to incorporate the elements, configurations and associated authentication and data transmission functions/steps as taught by Hua, since both devices are medical systems having sensor(s) and external devices and one of ordinary skill in the art would have recognized that the elements/ functions/ configurations as taught by Hua facilitate providing secure device authentication and medical data transmission. The rationale would have been to provide secure device authentication and medical data transmission.
In regard to claim 2, Stein as modified by Hua discloses the first communication module is an NFC communication module, the NFC communication module configured to transfer the authentication credentials to the communication module of the external device via NFC (referring to claim 1 above).
In regard to claim 4, Stein as modified by Hua discloses the authentication information credentials include joint implant data or patient data (implant, referring to claim 1 above; data used in the authentication and encryption security architecture, [0030]; UID/ identifying information/ serial number, [0060]; token/ identifying, [0098] of Hua).
In regard to claim 5, Stein as modified by Hua discloses the implant is configured to change from a sleep mode to an advertising mode when the external device is placed adjacent the joint implant (inherent properties of inductor, [0198]; [0210]; [0298] of Stein)
In regard to claim 7, Stein as modified by Hua discloses the second communication module is any of BLE, Z-wave or Zigbee module (BLE, referring to claim 1 above).
In regard to claim 8, Stein as modified by Hua discloses the second communication module is a BLE module (BLE, referring to claim 1 above).
In regard to claim 9, Stein as modified by Hua 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 and 5 above).
In regard to claim 10, Stein as modified by Hua discloses the joint implant is configured to return to the sleep mode upon transferring the measured interaction (after transmission of data and remove the power induction, referring to claim 5 above; inherent properties of inductor, [0198]; [0210]; [0298] of Stein).
In regard to claim 11, Stein as modified by Hua 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 ([0063]; [0146]; [0188] of Stein).
In regard to claim 12, Stein as modified by Hua discloses the joint implant is a knee joint implant, the first implant being a femoral implant and the second implant being a tibial implant (referring to claim 1 above).
In regard to claim 13, Stein as modified by Hua 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 (electronics being disposed within element 3110, Figs. 31 and 38-40 and associated descriptions of Stein).
In regard to claim 14, Stein as modified by Hua 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, Stein as modified by Hua discloses 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 16, Stein as modified by Hua discloses the external device is any of a smartphone, tablet, watch, and fob (smartphone, [0259] of Stein; tablet, [0027] of Hua).
In regard to claim 17, Stein as modified by Hua discloses the joint implant is any of hip implant, shoulder implant, and ankle implant ([0068] of Stein).
In regard to claim 18, Stein as modified by Hua discloses the measured interaction includes patient activity data ([0188]; [0190]; [0276]; [0289] of Stein)
In regard to claim 19, Stein as modified by Hua 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).
In regard to claim 21, Stein as modified by Hua discloses the communication module is configured to communicate with a cloud-based service such that the authentication credentials from the first communication module is authenticated on the cloud-based service (Figs. 7C and 7D and associated descriptions; [0105-0112] of Hua).
In regard to claim 23, Stein as modified by Hua discloses the first communication is an NFC communication and the second communication is a BLE communication (Figs. 1-9 and associated descriptions; NFC and BLE, [0007]; [0024] of Hua).
Response to Arguments
Applicant’s arguments, see page 6 of Remarks, filed on 06/29/2026, with respect to claims 1-21 have been fully considered and are persuasive. The 35 USC 101 rejection of claims 1-21 has been withdrawn.
Applicant’s amendment and argument with respect to claims 1, 20 and 22 filed on 06/29/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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