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 03/23/2026 have been fully considered.
Claims 1-20 are pending for examination.
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)(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.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deirmengian et al. (USPGPUB 2011/0098603). In regard to claim 1, Deirmengian discloses a sensing device configured for implantation on an outer surface of a bone of a patient (elements 206/316 and bone 212/312, Figs. 2-4 and associated descriptions), the sensing device comprising: a housing (elements 306/318, Figs. 3-4 and associated descriptions); one or more features configured to couple the housing against the outer surface of the bone of the patient (element 316, Figs. 3-4 and associated descriptions; [0015-0016]), wherein the sensing device is separate from an orthopedic implant (element 302, Fig. 3 and associated descriptions) and is configured for implantation directly on the outer surface of the bone (elements 206/316 and bone 212/312, Figs. 2-4 and associated descriptions), spaced from the orthopedic implant (Figs. 2-4 and associated descriptions); and onboard electronics carried by the housing ([0012]), the onboard electronics comprising: communication circuitry (interface for wireless connection, [0012]); one or more sensors configured to generate data regarding one or more characteristics of the patient (strain sensors, [0012]); and processing circuitry (PCB, [0012]) configured to activate the communication circuitry to send the generated data to a device outside the patient (an interface for wireless connection to a data collection device, [0012]).
In regard to claim 5, Deirmengian discloses the one or more sensors comprise one or more of a gyroscope, an accelerometer, a thermometer, a pH monitor or a force sensor (strain sensor, [0012]).
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 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Deirmengian. In regard to claims 6 and 8, Deirmengian discloses at least the housing and the one or more features are configured for implantation at a bone surface near the bone fracture(s) (Figs. 2-4 and associated descriptions) but does not specifically disclose implantation at one or more of: a biceps groove of a humerus; a medial to lesser tuberosity of the humerus; a lateral side of the humerus extending from adjacent a humeral head to a humeral neck; or a medial side of the humerus below an articular margin; and the outer surface is part of a metaphysis region of the bone. However, one of ordinary skill in the art would have recognized that when the bone fracture(s) is/are located at humerus, the bone screw configuration of the sensing device can be configured for implantation at any area(s)/ location(s) on the humerus. 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 sensing device to be configured and implanted at any area(s)/ location(s) on the humerus, including the a biceps groove of a humerus; a medial to lesser tuberosity of the humerus; a lateral side of the humerus extending from adjacent a humeral head to a humeral neck; or a medial side of the humerus below an articular margin; and the outer surface is part of a metaphysis region of the bone, when the bone fracture(s) is/are located at any location(s) of the humerus, in order to obtain more information near the bone fracture area(s).
Claims 2, 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Deirmengian as applied to claims 1, 5-6 and 8 above, and further in view of Windolf (USPGPUB 2018/0055444 – cited in previous action). In regard to claims 2 and 4, Deirmengian discloses the sensors comprise powered chips ([0012]) but does not specifically disclose the onboard electronics further include a battery configured to provide power to one or more of the one or more sensors and the processing circuitry, wherein the battery is configured for recharging by induction and the communication circuitry includes an antenna configured for communication over at least one of a frequency band approved for medical communication or another frequency band approved for wireless communication.
Windolf teaches a sensing device (element 1, Figs. 1-4 and associated descriptions) comprises a housing, (element 9, Figs. 1-4 and associated descriptions); onboard electronics carried by the housing (elements 2/3/4/16, Fig. 1 and associated descriptions), the housing includes one or more sensors (element 5, Figs. 1-4 and associated descriptions; [0034]; [0071]; [0079-0080]); a data processing device (element 2, Figs. 1-4 and associated descriptions); a data transmission device (element 4, Figs. 1-4 and associated descriptions) and a battery configured to provide power to one or more of the one or more sensors and the processing circuitry (element 3, Figs. 1 and 5 and associated descriptions), wherein the battery is configured for recharging by induction ([0024]; [0078]) and the communication circuitry includes an antenna configured for communication over at least one of a frequency band approved for medical communication or another frequency band approved for wireless communication (element 4, Fig. 1 and associated descriptions; [0021]; [0072]; [0075]).
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 sensing device (Deirmengian) to incorporate the battery and the antenna and associated elements/ configurations/ functions as taught by Windolf, since both devices are implantable sensing systems and one of ordinary skill would have recognized that the use of induction chargeable battery eliminates the need for replacing the battery and the antenna configured for communication over at least one of a frequency band approved for medical communication or another frequency band approved for wireless communication reduce possible interferences with other frequency bands. The rationale would have been to reduce the need for replacing the battery and reduce possible interferences with other frequency bands during wireless transmission.
In regard to claim 7, Deirmengian as modified by Windolf discloses the sensors are the same type of sensors (elements 204/206, Fig. 2 and associated descriptions of Deirmengian), wherein a sensor can be mounted on a bone implant (element 204, Fig. 2 and associated descriptions of Deirmengian) and the other one can be mounted directly on the bone (element 204, Fig. 2 and associated descriptions of Deirmengian) but does not specifically disclose the one or more features comprise arms each of the arms with an aperture configured to receive one or more of a suture, cable, bone screw or porous coating. Windolf further teaches the hermetically sealed housing comprises two arms each of the arms with an aperture configured to receive a screw (housing 9 with fixing tabs 11, each with a through hole 12 for receiving a screw, Figs. 1-2 and associated descriptions; [0073] of Windolf). 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 configurations of the housing of both sensors to incorporate the configurations of the hermetically sealed housing with fixing tabs and holes as taught by Windolf, since one of ordinary skill in the art would have recognized that hermetically sealed housing with fixing tabs and screw holes facilitate receiving screws for attachment to a desired places (see Windolf) and a bone screw can be utilized for attaching the sensor directly to the bone surface (see Deirmengian). The rationale would have been to better secure both sensors on desired locations.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Deirmengian as applied to claims 1, 5-6 and 8 above, and further in view of Hansen (USPN 6,357,438), In regard to claim 3, Deirmengian discloses all the claimed limitations except the communication circuitry is part of a transdermal lead.
Hansen teaches an implantable sensor (element 100, Figs. 1 and 3 and associated descriptions) comprises transdermal wires (element 332, Fig. 3 and associated descriptions; Col 4 lines 14-32) connect to an externally device for transmission of sensor data (element 105, Fig. 3 and associated descriptions; transdermal wire, Col 4 lines 14-32).
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 configuration of the wireless communication (Deirmengian) with the transdermal wires type communication as taught by Hansen to yield predictable results, since both devices are implantable systems and one of ordinary skill in the art would have recognized that the configuration as taught by Hansen is an alternative equivalent configuration for wireless communication of detected data (see Hansen). 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 9-13, 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Britton et al. (USPGPUB 2017/0007330 – cited in previous action). In regard to claim 9, Britton discloses a system configured to be implanted into a patient (Figs. 1-14 and associated descriptions), the system comprising: an orthopedic implant configured for coupling to a resected surface of a bone of the patient (elements 115/125/130, 215/225, and/or 125, Figs. 1-2 and 4 and associated descriptions), wherein the orthopedic implant is configured to replicate a portion of the bone that forms a joint of the patient (elements 115/130, 215/225, and/or 125,Figs. 1-2 and 4 and associated descriptions; [0003]; [0006]; [0009]); and a sensing device external of the orthopedic implant (position/ motion sensor 410, Fig. 4 and associated descriptions), wherein the sensing device is configured for implantation on an outer surface of the bone of the patient (attached to a humerus 120, Fig. 4 and [0044]; it is noted that the incorporated reference recited in [0044], Proulx et al. (USPGPUB 2009/0247863), teaches the position/ motion sensor and the tracking member is fixed/ secured to a bone, Figs. 1 and 3-4 and associated descriptions; bone, [0021] and [0045] ) and including one or more sensors configured to generate data regarding one or more characteristics of the patient ([0044]), wherein the sensing device is spaced from and not in contact with the orthopedic implant (Fig. 4 and associated descriptions) but does not specifically disclose herein the sensing device is subcutaneously implanted on the outer surface of the bone. However, one of ordinary skill in the art would have recognized that the sensing device is implanted from outside of the skin of the arm to the humerus bone. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try different implantation methods, including subcutaneously implantation, through experiments/ investigations, in order to find an optimal implantation method(s) for implanting/ securing the sensor on to humerus). The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007).
In regard to claim 10, Britton as modified discloses the sensor device is attached to a humerus ([0044] of Britton and Figs. 1 and 3-4 and associated descriptions; bone, [0021] and [0045] of incorporated reference Proulx) but does not specifically disclose the sensing device is configured for mounting to one or more of: a biceps groove of a humerus; a medial to lesser tuberosity of the humerus; a lateral side of the humerus extending from adjacent a humeral head to a humeral neck; or a medial side of the humerus below an articular margin. 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 mounting location(s) with a bone surface location near the humeral prosthesis, including any of the above mentioned location(s) of humerus, since one of ordinary skill in the art would have recognized that other bone surface location(s) near the humeral prosthesis is an alternative locations for obtaining position information of the humerus. 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.
In regard to claim 11, Britton as modified discloses the one or more sensors are configured to measure one or more of: acceleration, angular velocity, orientation, pH, force or temperature adjacent the orthopedic implant when implanted on the outer surface of a metaphysis region of the bone (position/ motion sensor 410, Fig. 4 and associated descriptions; [0044] of Britton).
In regard to claim 12, Britton as modified discloses the sensing device includes: communication circuitry ([0044] of Britton and Figs. 1 and 3-4 and associated descriptions; bone, transmitter, [0021] and [0029] of incorporated reference Proulx); and processing circuitry configured to activate the communication circuitry to send generated data to a device outside the patient ([0044] of Britton and Figs. 1 and 3-4 and associated descriptions; [0021] and [0029] of incorporated reference Proulx).
In regard to claim 13, Britton as modified discloses the communication circuitry comprises one of: a transdermal lead; or an antenna configured for wireless communication ([0044] of Britton and Figs. 1 and 3-4 and associated descriptions; bone, [0021] and wired or wireless, [0029] of incorporated reference Proulx).
In regard to claim 15, Britton as modified discloses the sensing device is configured for implantation on the outer surface of a metaphysis region of the bone in close proximity to the orthopedic implant and the joint (referring to claims 10 and 11 above).
In regard to claim 17, Britton as modified by discloses a patient-specific configuration to mate with and mount to the external surface at one of a biceps groove of a humerus, a medial to lesser tuberosity of the humerus, a lateral side of the humerus extending from adjacent a humeral head to ae humeral neck or a medial side of the humerus below an articular margin (Fig. 4 and associated descriptions of Britton and Figs. 1 and 3-4 and associated descriptions of incorporated reference Proulx).
In regard to claim 18, Britton as modified discloses a method of monitoring one or more characteristics of a patient (referring to claim 9 above), the method comprising: implanting an orthopedic implant to replicate a portion of a joint of a patient (referring to claim 9 above); implanting a sensing device spaced from the orthopedic implant on an outer surface of a metaphysis region of a bone adjacent the joint (referring to claims 9-11 above), wherein implanting the sensing device comprises subcutaneous implanting on the outer bone surface such that the sensing device is beneath a skin of the patient and directly adjacent the bone (referring to claim 9 above); operating the sensing device while implanted on the outer surface of the metaphysis region to generate data regarding the one or more characteristics of the patient (referring to claims 9-11 above); and communicating the generated data from the sensing device to a remote computing device external of the patient (referring to claims 9 and 12 above; ([0044] of Britton and Figs. 1 and 3-4 and associated descriptions; [0021] and [0029] of incorporated reference Proulx).
In regard to claim 19, Britton as modified discloses implanting the sensing device at one of: a biceps groove of a humerus; a medial to lesser tuberosity of the humerus; a lateral side of the humerus extending from adjacent a humeral head to a humeral neck; or a medial side of the humerus below an articular margin (referring to claims 9-11 above).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Britton as applied to claims 9-13, 15 and 17-19 above, and further in view of Windolf. In regard to claim 4, Britton as modified discloses all the claimed limitations except the sensing device includes a battery configured to provide power to the one or more sensors, wherein the battery is configured for recharging by induction.
Windolf teaches a sensing device (element 1, Figs. 1-4 and associated descriptions) comprises one or more sensors (element 5, Figs. 1-4 and associated descriptions; [0034]; [0071]; [0079-0080]); a data processing device (element 2, Figs. 1-4 and associated descriptions); a data transmission device (element 4, Figs. 1-4 and associated descriptions) and a battery configured to provide power to one or more of the one or more sensors (element 3, Figs. 1 and 5 and associated descriptions), wherein the battery is configured for recharging by induction ([0024]; [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modified the sensing device (Britton as modified) to incorporate the battery and associated function(s) as taught by Windolf, since both devices are implantable devices and one of ordinary skill would have recognized that the use of induction chargeable battery eliminates the need for replacing the battery or power source of the implantable device. The rationale would have been to reduce the need for replacing the battery.
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Britton as applied to claims 9-13, 15 and 17-19 above, and further in view of Deirmengian. In regard to claims 16 and 20, Britton as modified discloses all the claimed limitations except a suture configured to be received by the sensing device and configured to wrap around at least a portion of the bone; a suture anchor configured to anchor into the bone; a cable configured to be received by the sensing device and configured to wrap around at least a portion of the bone; a bone screw configured to be received by the sensing device and configured for fixation in the bone; or a porous coating on the sensing device, wherein the porous coating configured to promote on-growth of the bone for fixation of the sensing device with the bone; and suturing using a cerclage technique around a shaft of a humerus and/or the orthopedic implant, cabling using the cerclage technique around the shaft of the humerus and/or the orthopedic implant, fixating the sensing device to the outer surface with one or more bone screws or coupling with a porous coating.
Deirmengian teaches a bone implantable sensing device (elements 306/318, Figs. 3-4 and associated descriptions), wherein the sensing device is implanted/ fixed on the surface of a bone (bone 312, Figs. 3-4 and associated descriptions) using a received bone fixation element (element 316, Fig. 4 and associated descriptions; bone screw, [0015]).
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 fixation way of the sensing device to the surface of the bone (Britton as modified) with the bone screw based way as taught by Deirmengian to yield predictable results, since both devices are bone attached sensors and one or ordinary skill in the art would have recognized that bone screw(s) is an alternative equivalent fixing/ securing structure for attaching a sensor to the surface of a bone (see Deirmengian). 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.
Response to Arguments
Applicant’s amendment and argument with respect to claims 1, 3, 6, 8, 9, and 18 filed on 03/23/2026 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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