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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 June 2026 has been entered.
Claims 11, 13-14, 18, 20-22 and 24-37 are cancelled; claims 1-10, 12, 15-17, 19, 23 and 38-41 are pending.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 29 June 2026, with respect to the rejection(s) of claim(s) 1, 19, 23 and their dependent claims under Janna have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Khanal.
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.
Claims 1, 7-10, 12, 15, 19, 23 and 38-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanal et al (U.S. 2019/0060543). Khanal discloses (Figs 15A-E) a cage body including an upper surface and a channel disposed on the upper surface; a cage cover adapted to be engaged and/or fastened to the cage body, the cage cover including an inner surface and one or more recesses disposed on the inner surface; one or more sensor elements (1532, 1534) adapted to measure a force exerted on the surgical implant when implanted in a subject (par. 0171), each sensor element being at least partly disposed in a recess of the one or more recesses; a transmitter operably coupled to the one or more sensor elements and adapted to receive a mechanical data representative of the force therefrom and transmit said mechanical data to an external receiver; and a power supply operably coupled to the one or more sensor elements and the transmitter, the power supply capable of being inductively powered by an external power source and adapted to receive energy wirelessly from the external power source (par. 0176), wherein the surgical implant is able to be activated from an inactive state to an active state by positioning of the external power source proximate or adjacent thereto, and wherein the one or more sensor elements, the transmitter and/or the power supply are hermetically sealed within a space defined by the channel of the cage body and the one or more recesses of the cage cover upon engagement and/or fastening of the cage cover to the cage body.
Regarding claim 7, Khanal discloses (Figs. 15A-E) the one or more sensor elements, the transmitter and/or the power supply are disposed entirely within the surgical implant the cage body further includes: an opposed pair of planar side walls defining a longitudinal axis of the surgical implant; a pair of opposed planar end walls that extend perpendicular between and interconnect respective ends of the planar side walls; and a central inner wall that is parallel to the planar end walls and extends perpendicularly between inner central portions of the planar side walls, wherein the planar side walls, planar end walls, and central inner wall define first and second inner spaces.
Regarding claim 8, Khanal discloses (Figs. 15A-E) the cage body further includes: an outer lip that extends outwardly from the upper surface of the cage body and substantially around an outer edge defined by the pair of planar side walls and the pair of planar end walls; and a pair of inner lips that extend outwardly from the upper surface and around an inner edge defined by the first and second inner spaces, wherein the outer lip, the pair of inner lips and the upper surface define the channel.
Regarding claim 9, Khanal discloses (par. 0171) a processing unit operably coupled to the transmitter and the one or more sensor elements, wherein the processing unit is adapted to process the force measured by the one or more sensor elements into the mechanical data transmittable by the transmitter.
Regarding claim 10, Khanal discloses (par. 0171) the processing unit is disposed in the channel and hermetically sealed within a space defined by the channel of the cage body and the one or more recesses of the cage cover upon engagement and/or fastening of the cage cover to the cage body.
Regarding claim 12, Khanal discloses (par. 0176) the external power source is an inductive power source.
Regarding claim 15, Khanal discloses (par. 0176) the power supply does not include an incorporated power source, such as a battery unit.
Regarding claim 19, Khanal discloses (Figs. 15A-E) (a) a surgical implant comprising: a cage body including an upper surface and a channel disposed on the upper surface; a cage cover adapted to be engaged and/or fastened to the cage body, the cage cover including an inner surface and one or more recesses disposed on the inner surface; one or more sensor elements (1532, 1534) adapted to measure a pressure and/or a strain exerted on the surgical implant when implanted in a subject, each sensor element being disposed in a recess of the one or more recesses; a transmitter operably coupled to the one or more sensor elements and adapted to receive pressure and/or a strain data therefrom and transmit said data to an external receiver (par. 0171); and a power supply (par. 0176) operably coupled to the one or more sensor elements and the transmitter, the power supply capable of being inductively powered by an external power source and adapted to receive energy wirelessly from the external power source; and (b) a control unit comprising a receiver adapted to receive the pressure and/or the strain data from the transmitter of the surgical implant, wherein the surgical implant is able to be activated from an inactive state to an active state by positioning of the external power source proximate or adjacent thereto, and wherein the one or more sensor elements, the transmitter and/or the power supply are hermetically sealed within a space defined by the channel of the cage body and the one or more recesses of the cage cover upon engagement and/or fastening of the cage cover to the cage body.
Regarding claim 23, Khanal discloses (par. 0171) (a) obtaining the mechanical data from the one or more sensor elements; (b) transmitting the mechanical data by the transmitter; and (c) powering the one or more sensor elements and the transmitter with a power supply operably coupled thereto, wherein step (c) includes positioning the external power source proximate or adjacent the surgical implant to switch the surgical implant from the inactive state to the active state.
Regarding claim 38, Khanal discloses (par. 0171) a non-transitory computer-readable storage medium whose stored contents configure a computing system to perform the method.
Regarding claim 39, Khanal discloses (par. 0158) at least the integrity, alignment and/or positioning of the surgical implant in the subject.
Regarding claim 40, Khanal discloses (par. 0172) the step of processing the mechanical data is only performed when the surgical implant is in the active state.
Regarding claim 41, Khanal discloses (par. 0172) said method is performed at a plurality of time points, and processing the mechanical data includes detecting a change in the mechanical data between the plurality of time points.
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.
Claims 2-4 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Khanal et al (U.S. 2019/0060543) in view of Janna et al (U.S. 9,445, 720). Khanal discloses the claimed invention except for the one or more sensor elements are selected from the group consisting of a piezoelectric sensor, a piezoresistive sensor, a capacitive sensor and any combination thereof. Janna, however, discloses (Figures 10-11 and 20-21; col. 9, lines 21-49 and col. 17, lines 5-42; col. 10, lines 34-50) a surgical implant, including at least a piezoelectric sensor. Janna and Khanal both disclose implantable systems for transmitting mechanical data using a sensor. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing data of the claimed invention to modify Khanal’s cage sensors with Janna’s piezoelectric sensor in order to provide a specific type of MEMS (see Khanal’s par. 0171) for generating an electrical signal for the collected mechanical stress on the system.
Regarding claim 3, Janna discloses (col. 9, lines 21-49) the one or more sensor elements are operably coupled to a printed circuit board (PCB).
Regarding claim 4, Janna discloses (col. 9, lines 21-49) the PCB is a thin or flexible PCB.
Regarding claim 16, Janna discloses (col. 6, lines 34-59) the surgical implant is or comprises a fracture fixation device or a joint implant.
As to claim 17, the functional language and statement of intended use have been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Janna utilizes a nail for fixation into a bone as claimed by the applicant, Khanal and Janna’s system is therefore capable of being used in a spinal implant. In addition nothing prevents Khanal and Janna’s implant from being used for this purpose. Therefore, they are capable of use as a spinal implant.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Khanal et al (U.S. 2019/0060543) in view of Ledet et al (U.S. 9,662,066). Khanal discloses the claimed invention except for capacitive sensors. Ledet, however, discloses (Figures 1 and 8; col. 4, line 46-col. 5, line 10; col. 7, lines 39-51; col. 6, lines 22-38) a system including implantable and external components, including one or more capacitive sensors not operably coupled to a PCB. Therefore, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the MEMS as taught by Khanal, with the capacitive sensors, because the applicant has not disclosed the capacitive sensors provide an advantage, are used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected the applicant's invention to perform equally well with the variety of sensors as taught by Khanal, because Khanal’s system is able to accurately and safely place the system using the sensors provided. Therefore, it would have been an obvious matter of design choice to modify Khanal’s system to obtain the invention as specified in the claim.
Regarding claim 6, Ledet discloses (col. 5, lines 34-54) the one or more capacitive sensors comprises a biocompatible substrate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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