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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21, 24, 26-27, 31-32, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over US20060052782A1 (Morgan et. al), as cited by Applicant and hereto referred as Morgan, and in view of US20220176108A1 (Linden et. al), hereto referred as Linden.
As to claims 21 and 31, Morgan teaches a medical system comprising: a first medical device, comprising: a plate configured to couple to a musculoskeletal system (Morgan, [0028], "multiple sensors 50 may be provided for a single fixation device to monitor different segments of the fixation device or to monitor different types of sensors (e.g. strain"), including:
a first electronic circuitry (Morgan, [0005], " one or more microchips (ie., integrated circuits)"); and
a strain gauge coupled to the first electronic circuitry, wherein the strain gauge is configured to measure strain applied to the plate (Morgan, [0012], "One of said sensors may be selected from at least one of the group consisting of a pressure transducer, a thermocouple, a strain gauge and a cycle counter."; Fig. 1, sensors 50); and
at least one screw configured to couple the plate to a bone (Fig. 2, screw 90)
wherein the electronic circuitry is configured to transmit strain measurements from the strain gauge (Morgan, [0039], "a transmitter 130 or transmitting the information received from the sensor or sensors."),
a second medical device comprising at least one second screw (Fig. 2, screw 90), the at least one second screw including a sensor and a second electronic circuitry (Morgan, [0053], “A microchip may be installed within the bone screw with one or more sensors located at different locations on the bone screw to monitor stress, strain, temperature and pressure”).
However, Morgan does not teach a patch device configured to transmit a radio frequency signal to power the first medical device and the second medical device. Linden teaches relevant art of implantable medical devices (Linden, abstract). Linden teaches a patch device configured to transmit a radio frequency signal to power the first medical device and the second medical device (Linden, [0209], " In some embodiments, one or more external devices 500 are further configured to receive data from one or more implantable devices 200"; [0468], “Housing 510 of external device 500 can comprise one or more adhesive patches, 515.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morgan in view of Linden to include a patch device configured to transmit a radio frequency signal to power the first medical device and the second medical device because Morgan already contemplates an external device (Morgan, [0013], “external receiving device”; [0039], “The microchip may also contain a signal conditioner 110 for powering the sensor”), and Linden supplies further details of an external device as a patch so that the external device can be conveniently placed on a subject.
As to claims 24 and 32, Morgan-Linden teaches the plate further comprises: one or more therapy devices coupled to the first electronic circuitry, wherein the one or more therapy devices are configured to deliver therapy to the musculoskeletal system (Morgan, [0031], "Opening 65 may also hold a pharmaceutically active agent, such as a bolus of antibiotics, chemotherapy agents, pain medication and/or other therapeutic agents. The agent may be released by the implant in response to a signal conveyed by the treating physician or the patient, or may be dispensed automatically by the implant when an elevated temperature or other data signaling a need for the agent is recorded by one or more of sensors 50.").
As to claim 26, Morgan-Linden teaches the screw (Morgan, [0053], "FIG. 7 shows a pedicle screw 210, having threads 212 and an upper portion 214 for connection to a fixation rod 216. Pedicle screw 210 includes one or more microchips 40 and sensors 50. which function as described above with reference to implant 10")
comprises a second electronic circuitry (Morgan, [0053], “A microchip may be installed within the bone screw with one or more sensors located at different locations on the bone screw to monitor stress, strain, temperature and pressure”; [0059], "One or more microchips 40 and sensors 50 can record and transmit data concerning the fixation system to physicians and patients") and
a pressure sensor configured to measure pressure applied to the screw (Morgan, [0012], "One of said sensors may be selected from at least one of the group consisting of a pressure transducer, a thermocouple, a strain gauge and a cycle counter.")
As to claim 27, Morgan-Linden teaches the second electronic circuitry is configured to transmit pressure measurements from the pressure sensor (Morgan, [0056], “one or more sensors 50 for the collection and transmission of strain”; [0059], "One or more microchips 40 and sensors 50 can record and transmit data concerning the fixation system to physicians and patients").
As to claim 34, Morgan-Linden teaches the plate further comprises a force sensor coupled to the electronic circuitry, the force sensor configured to measure force applied to the plate (Morgan, [0033], "Thus, sensors 50 disposed between the edges or rails of the plate and the bone surface may detect the compression force between the bone and the plate at those sensor locations.")
As to claim 35, Morgan-Linden teaches a screw configured to couple the plate to the bone, the screw comprising: a screw head (Fig. 7, upper portion 214);
a threaded screw body extending from the screw head (Fig. 7, threads 212); and
a pressure sensor configured to measure pressure applied to the screw (Fig. 7, sensor 50).
As to claim 36, Morgan-Linden teaches the screw further comprises second electronic circuitry (Fig. 7, microchips 40) configured to transmit pressure measurements from the pressure sensor (Morgan, [0056], “the pedicle screw 210, pedicle hook 220 and/or fixation rod 216, 222 may contain one or more microchips 40 and one or more sensors 50 for the collection and transmission of strain, temperature, pressure”).
Claims 22-23, 28-30, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan and Linden as applied to claims 21 and 31 above, and further in view of US20140312834A1 (Tanabe et. al), cited by Applicant and hereto referred as Tanabe.
As to claims 22-23, Morgan-Linden teaches that the first electronic circuitry is configured to harvest energy (Morgan, [0046], "the microchip may be powered using the principle of induction"), and wherein the energy harvested by the first electronic circuitry enables operation of the first electronic circuitry to perform at least one task wherein the at least one task comprises transmitting strain measurements from the strain gauge (Morgan, [0046], "the microchip may be powered using the principle of induction"; Fig. 7, microchip 100 contains transmitter 130; examiner notes, the at least one task is transmitting data).
However, Morgan-Linden does not teach the plate further includes a first antenna and that the harvest energy is received by the first antenna. Tanabe teaches a solution to a relevant problem of powering devices (Tanabe, abstract). Tanabe teaches a first antenna and energy harvested by the first antenna (Tanabe, [0061], “FIG. 30 illustrates the matching circuit for receiving power using NFC antenna”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morgan in view of Tanabe to include a first antenna and harvest energy received by the first antenna because Morgan already contemplates a method of receiving energy through induction and Tanabe supplies the detailed description of a component that allows for energy harvesting.
As to claims 28 and 37, Morgan-Linden teaches the second electronic circuitry (Morgan, [0053], “A microchip may be installed within the bone screw with one or more sensors located at different locations on the bone screw to monitor stress, strain, temperature and pressure”; [0059], "One or more microchips 40 and sensors 50 can record and transmit data concerning the fixation system to physicians and patients") is powered by harvested energy (Morgan, [0046], "the microchip may be powered using the principle of induction").
However, Morgan-Linden does not necessarily teach that the second electronic circuitry is powered by energy harvested from radio frequency signals. Tanabe teaches the electronic circuitry is powered by energy harvested from radio frequency signals (Tanabe, [0061], “FIG. 30 illustrates the matching circuit for receiving power using NFC antenna”; the examiner notes, NFC uses radio frequency). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morgan in view of Tanabe to include energy harvested from radio frequency signals because Morgan already contemplates powering the electronic circuitry through harvested energy and Tanabe supplies the detailed description of the type of harvested energy, which is from radio frequency signals.
As to claims 29 and 38, Morgan-Linden-Tanabe teaches the first antenna of the plate is a dual band antenna and comprises a first intermediate antenna and a second intermediate antenna (Tanabe, [0093], “FIG. 5 illustrates an embodiment of a dual-band antenna 52 using an asymmetrical dipole, where the length of each dipole arm 53 or 54 is about one-quarter wavelength of an operating frequency, such as about 2.4 GHz.”).
As to claims 30 and 39, Morgan-Tanabe teaches the first intermediate antenna operates at a first frequency band and the second intermediate antenna operates at a second frequency band (Tanabe, [0093], “multi-turn loop 55 functions for the NFC frequency band. The matching circuit 56 tunes the self-inductances of both the Bluetooth and the NFC antenna elements.”).
Claims 25 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Morgan and Linden as applied to claims 24 and 32 above, and further in view of US20120059433A1 (Cowan et. al), hereto referred as Cowan.
As to claims 25 and 33, Morgan-Linden does not teach that the therapy device comprise at least one of: a transducer configured to deliver ultrasonic signals; or a light source configured to deliver light. However, Cowan teaches a relevant art of implantable medical device (Cowan, abstract). Cowan teaches an implantable device with a therapy device comprising delivering ultrasonic signal (Cowan, [0032], FIGS. 2 a and 2 b). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morgan-Linden in view of Cowan to include a plate comprising an ultrasound transducer because Morgan-Linden already contemplates a therapy device embedded in the plate, and Cowan teaches a similar implant device (Cowan, Fig. 5a) that employs a known type of therapy, which is the ultrasound stimulation, in a predictable manner.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Morgan, in view of Cowan, and in view of Linden.
As to claim 40, Morgan teaches a plate configured to couple to a bone (Morgan, Fig. 1, bone plate 10),
the plate including:
a strain gauge coupled to the electronic circuitry on a first side of the plate (Morgan, Fig. 1, sensor 50), the strain gauge configured to measure strain applied to the plate (Morgan, [0012], "One of said sensors may be selected from at least one of the group consisting of a pressure transducer, a thermocouple, a strain gauge and a cycle counter."); and
one or more therapy devices coupled to the electronic circuitry on a second side of the plate (Morgan, [0031], “Opening 65 may also hold a pharmaceutically active agent, such as a bolus of antibiotics, chemotherapy agents, pain medication and/or other therapeutic agents. The agent may be released by the implant in response to a signal conveyed by the treating physician or the patient”).
However, Morgan does not teach a patch device configured to transmit a radio frequency signal to power the first medical device and the second medical device. Linden teaches relevant art of implantable medical devices (Linden, abstract). Linden teaches a patch device configured to transmit a radio frequency signal to power the first medical device and the second medical device (Linden, [0209], " In some embodiments, one or more external devices 500 are further configured to receive data from one or more implantable devices 200"; [0468], “Housing 510 of external device 500 can comprise one or more adhesive patches, 515.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morgan in view of Linden to include a patch device configured to transmit a radio frequency signal to power the first medical device and the second medical device because Morgan already contemplates an external device (Morgan, [0013], “external receiving device”; [0039], “The microchip may also contain a signal conditioner 110 for powering the sensor”), and Linden supplies further details of an external device as a patch so that the external device can be conveniently placed on a subject.
Additionally, Morgan does not teach that the one or more therapy devices is configured to deliver ultrasound signals for therapy. (Cowan, [0032], FIGS. 2 a and 2 b). Cowan teaches an implantable device with a therapy device comprising delivering ultrasonic signal (Cowan, [0032], FIGS. 2 a and 2 b). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Morgan in view of Cowan to include a plate comprising an ultrasound transducer because Morgan already contemplates a therapy device embedded in the plate, and Cowan teaches a similar implant device (Cowan, Fig. 5a) that employs a known type of therapy, which is the ultrasound stimulation, in a predictable manner.
Response to Arguments
Applicant’s arguments filed 3/23/2026, with respect to the 112 and art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of art rejection are made in view of Linden, necessitated by the amendments.
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 ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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