DETAILED ACTION
The Examiner acknowledges the amendments received 13 March 2026. Claims 11, 13-14, 18, 20-22 and 24-37 are cancelled; new claims 40-41 are entered; claims 1-10, 12, 15-17, 19, 23 and 38-41 are pending.
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 .
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 13 March 2026, with respect to the rejection(s) of claim(s) 1, 19, 23 and their depended claims under Ledet 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 Therefore, the rejection has been withdrawn.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 Janna.
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 1-4, 7-10, 12, 15-17, 19, 23 and 38-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janna et al (U.S. 9,445, 720). Janna discloses (Figures 10-11 and 20-21) one or more sensor elements disposed in and/or on the surgical implant and adapted to measure a force exerted on the surgical implant when implanted in a subject (col. 9, lines 21-49 and col. 17, lines 5-42) ; 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; a power supply operably coupled to the one or more sensor elements and the transmitter, the power supply capable of being powered by an external power source and adapted to receive energy wirelessly from the external power source, 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.
Regarding claim 2, Janna discloses (col. 10, lines 34-50) at least a piezoelectric sensor.
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 7, Janna discloses (col. 8, lines 39-58) the one or more sensor elements, the transmitter and/or the power supply are disposed entirely within the surgical implant.
Regarding claim 8, Janna discloses (col. 32, lines 3-21) the one or more sensor elements, the transmitter and/or the power supply are disposed at least partly on one or more outer surfaces of the implant.
Regarding claim 9, Janna discloses (Figures 10-11 and 20-21) 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, Janna discloses (Figures 10-11 and 20-21) the processing unit is disposed in and/or on the surgical implant.
Regarding claim 12, Janna discloses (col. 9, lines 21-49) the external power source is an inductive power source.
Regarding claim 15, Janna discloses (col. 9, lines 21-49) the power supply does not include an incorporated power source, such as a battery unit.
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, Janna’s system is therefore capable of being used in a spinal implant. In addition nothing prevents Janna’s implant from being used for this purpose. Therefore, they are capable of use as a spinal implant.
Regarding claim 19, Janna discloses (Figures 10-11 and 20-21) (a) a surgical implant comprising (col. 9, lines 21-49; col. 17, lines 5-42): one or more sensor elements disposed in or on the surgical implant and adapted to measure a pressure and/or a strain exerted on the surgical implant when implanted in a subject; 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; 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; and (b) a control unit comprising a receiver adapted to receive the pressure and/or a strain data from the transmitter of the surgical implant, wherein the surgical implant is able to be activated from in active state to an active state by positioning of the external power source proximate or adjacent thereto.
Regarding claim 23, Janna discloses (Figures 10-11 and 20-21) (a) obtaining a mechanical data from one or more sensor elements that are disposed in or on the surgical implant and adapted to measure a force exerted thereon (col. 9, lines 21-49 and col. 17, lines 5-42); (b) transmitting the mechanical data by a transmitter operably coupled to the one or more sensor elements and adapted to receive data therefrom to a receiver external to the surgical implant and the subject; and (c) powering the one or more sensor elements and the transmitter with a power supply operably coupled thereto, wherein the power supply is inductively powered by an external power source and adapted to receive energy wirelessly from the external power source, wherein step (c) includes positioning the external power source proximate or adjacent the surgical implant to switch the surgical implant from an inactive state to an active state.
Regarding claim 38, Janna discloses (col. 17, lines 5-42) a non-transitory computer-readable storage medium whose stored contents configure a computing system to perform the method.
Regarding claim 39, Janna discloses (col. 2, lines 55-64) processing the mechanical data to determine at least a degree of healing of a bone fracture in the subject.
Regarding claim 40, Janna discloses (col. 17, lines 5-42) the step of processing the mechanical data is only performed when the surgical implant is in the active state.
Regarding claim 41, Janna discloses (col. 15, lines 45-55) 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 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Janna et al (U.S. 9,445, 720) in view of Ledet et al (U.S. 9,662,066). Janna 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 force or piezoelectric sensors as taught by Janna, 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 Janna, because Janna’s system is able to diagnose healing of the system using the sensors provided. Therefore, it would have been an obvious matter of design choice to modify Janna’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
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
Prosecution Insights