DETAILED ACTION
Note: 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 arguments filed in the reply on March 9, 2026 were received and fully considered. Claim 1 was amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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 1-3, 7-12, 15, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Kessel (US PG Pub. No. 2016/0128572 A1), Radziemski et al. (US PG Pub. No. 2017/0319858 A1) (hereinafter “Radziemski”), Mi et al. (US PG Pub. No. 2010/0317929 A1) (hereinafter “Mi”), and in further view of Krasnow et al. (US PG Pub. No. 2016/0256106 A1) (hereinafter “Krasnow”).
Van Kessel, Radziemski, and Mi were applied in the previous office action.
With respect to claims 1 and 12, Van Kessel teaches a subcutaneous sensor system and method positioned in an implant (Fig. 2 depicts a device placed under the patient’s skin; see also par.0024 “external transducer against the patient's skin in order to read or otherwise interact with the implant/dermal acoustic computing element”) comprising: a biocompatible housing defining a longitudinal axis (par.0018 “encapsulated in a biocompatible material”; par.0034 “acoustic computing element 200 is fully immersed in a biocompatible encapsulant 218 to isolate its component parts from the patient and prevent irritation and rejection”); a subcutaneous sensor disposed within the biocompatible housing and configured to couple to and sense data (sensor 214 in Fig. 2; see also par.0032 “Sensor 214 measures parameters that include, but are not limited to temperature, pressure, force, magnetic field, electric field and chemical potential”); a circuit board disposed within the biocompatible housing and coupled to the sensor (input rectification and conditioning circuit 204 is disposed within encapsulant 218 as depicted in Fig. 2; see also par.0029 “circuit 204 rectifies the alternating signal from acoustic input transducer 202 and produces a direct current source at a desired voltage”); a controller disposed within the biocompatible housing (signal processor 206 is disposed within encapsulant 218 as depicted in Fig. 2); and an ultrasound transmitter disposed within the biocompatible housing and including a piezoelectric transducer, wherein the subcutaneous sensor system is configured to wirelessly and transcutaneously transmit the sensed data by the ultrasound transmitter (par.0019 “having a transmitter/receiver that excites a piezoelectric material to emit or detect acoustic vibration, which is typically ultrasonic acoustic vibration that has been modulated or otherwise encoded with data and instructions”; par.0021 “RF transmissions… carrying data from inside a patient to an external device… restricted to subcutaneous use” is understood to be wireless; par.0028 “Preferably, acoustic input transducer 202 is a piezoelectric material”; Fig. 2 depicts piezoelectric transducer 202 extends longitudinally along the longitudinal axis).
However, Van Kessel does not teach a piezo phased array (PPA) disposed externally of the biocompatible housing and adapted to generate a focused ultrasonic wave for receipt by the piezoelectric transducer for powering the controller; wherein the subcutaneous sensor contacts a force-load coupler configured to interface between the implant and the subcutaneous sensor, the force-load coupler having a surface that is complementary to a contacted surface of the subcutaneous sensor where the coupler and the subcutaneous sensor interface such that the subcutaneous sensor and the coupler resist lateral movement, and wherein the force-load coupler has a cam integrally formed with the force-load coupler and positioned on a side opposite of the surface that is complementary to the contacted surface of the subcutaneous sensor and wherein one or more thrust bearings are disposed on opposite sides of the cam.
Radziemski teaches a piezo phased array (PPA) disposed externally of the biocompatible housing and adapted to generate a focused ultrasonic wave for receipt by the piezoelectric transducer for powering the controller (abstract “providing energy to a bio-implantable medical device includes… generates acoustic energy with a multi-dimensional array of transmitting electroacoustical transducers… ultrasound energy transmitter”; par.0062 “phased array of ultrasound piezo transmitters”; see also par.0056 “narrow piezo elements 510 in a row”, 0071-72 “array of 3 mm square piezoelectric elements 731”).
Mi teaches wherein the subcutaneous sensor contacts a force-load coupler configured to interface between the implant and the subcutaneous sensor, the force-load coupler having a surface that is complementary to a contacted surface of the subcutaneous sensor where the coupler and the subcutaneous sensor interface such that the subcutaneous sensor and the coupler resist lateral movement (see Fig. 2; and par.59-60+ “a sensor module 56 coupled to an anchor assembly 58… adapted to radially expand such that it contacts and frictionally engages the vessel walls, securing and stabilizing the IMD 16 at the target location”).
Krasnow teaches wherein the force-load coupler has a cam integrally formed with the force-load coupler and positioned on a side opposite of the surface that is complementary to the contacted surface of the subcutaneous sensor and wherein one or more thrust bearings are disposed on opposite sides of the cam (par.0067 “The injector could include one or more magnets and/or cams configured to translate a force between the one or more magnets and other elements of the device 100 to produce driving and/or retracting force(s) that could be applied to the hollow needle 120 and/or elements of the reservoir 150”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Van Kessel to incorporate PPA in the manner claimed to provide power to the implantable device/controller from the outside, thereby reducing the need to remove the implant for battery replacement, as evidence by Radziemski (par.0004-0005). Additionally, PHOSITA would have had predictable success modifying Van Kessel and Radziemski to incorporate a force-load coupler (anchor assembly) in order to secure and stabilize the sensor at the target location (resist lateral movement), as evidence by Mi (par.0059-60; Fig. 2). Moreover, Van Kessel, Radziemski, and Mi all relate to the same narrow field of endeavor (securing implantable piezoelectric sensors, elements, etc. within the patient), thereby providing PHOSITA added motivation when the invention was filed to combine the teachings. Examiner also cites additional references that teach a force-load coupler and resisting lateral movement of the sensor, thereby demonstrating the known nature of utilizing force-load couplers in the manner recited. Please see prior art of record section at the end of the current office action for more example teachings. Finally, PHOSITA would have had predictable success modifying Van Kessel, Radziemski, and Mi to incorporate a cam, in the manner recited, for the purpose of apply driving and/or retracting force(s) directly to the hollow needle 120 and/or reservoir 150, as evidence by Krasnow (par.0067). Examiner also cites additional references that teach utilizing a cam in a subcutaneous sensor assembly, further demonstrating the known nature of utilizing a cam in the manner recited. Please see prior art of record section at the end of the current office action for more example teachings.
With respect to claim 2, Van Kessel modified by Radziemski suggest the piezoelectric transducer is a radially propagating transducer (piezoelectric transducer 202 is understood to sense in all directions as depicted in Van Kessel’s Fig. 2).
With respect to claim 3, Van Kessel modified by Radziemski suggest the piezoelectric transducer has 360 degrees of radial propagation coverage relative to the longitudinal axis (piezoelectric transducer 202 is understood to sense in all directions as depicted in Van Kessel’s Fig. 2).
With respect to claim 7, van Kessel does not explicitly teach the piezoelectric transducer is a 2.4 GHz to 2.485 GHz transmitter. Instead, van Kessel teaches transmitting in the ultrasonic range (see par.0029). Examiner argues that further modification of van Kessel such that the piezoelectric transducer is a 2.4 GHz to 2.485 GHz transmitter would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves
only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claim 8, van Kessel teaches the subcutaneous sensor includes at least one of: a capacitive sensor, a resistive sensor, a strain gauge, a micro-mechanical sensor, or a piezoelectric sensor (par.0028).
With respect to claim 9, van Kessel teaches a battery or a capacitor in electrical communication with the ultrasound transmitter (energy storage element 208 is in communication with ultrasound transmitter 202; see par.0029 “element 208, which may be implemented as… a battery”; see Fig. 2).
With respect to claim 10, van Kessel teaches the battery or the capacitor is coupled to the ultrasound transmitter such that the battery or the capacitor can store power received from the ultrasound transmitter; and wherein the battery or capacitor is coupled to the circuit board or the subcutaneous sensor such that the battery or capacitor can provide stored power to the circuit board or the subcutaneous sensor (par.0029; Fig. 2).
With respect to claim 11, van Kessel teaches the biocompatible housing includes a sealed compartment containing the circuit board, the controller, and the ultrasound transmitter (encapsulant 218 is biocompatible and seals circuit 204, controller 206, and ultrasound transmitter 202; see Fig. 2).
With respect to claim 15, van Kessel modified by Radziemski suggest transmitting the ultrasound data signal includes radially propagating the data signal with 360 degrees of coverage relative to the longitudinal axis (see rejection of claim 3 above).
With respect to claim 16, van Kessel teaches detecting the ultrasound data signal with a receiver external to a patient that received the implanted device (par.0016 “capable of transmitting RF data from inside a patient to an external device capable of reading the transmitted signal”).
With respect to claim 18, van Kessler modified by Radziemski suggest further comprising: with the piezoelectric transducer, wirelessly and transcutaneously transmitting sensed data by short-wavelength ultra-high frequency radio waves in a medial radio band from 2.4 GHz to 2.485 GHz (see rejection of claim 7 above), wherein sensing data with the subcutaneous sensor of the implanted device to create the sensed data includes creating: capacitance data, resistive data, strain gauge data, micromechanical sensor data, piezoelectric sensor data, force data, temperature data, electricity data, pH data, distance data, pressure data, or biomolecule data (see van Kessler, par.0020 “sensor to measure and/or detect… a temperature, a pressure, a force, a magnetic field, an electric field…”).
With respect to claim 19, van Kessler teaches the implanted device has an ultrasound couplant such that the implanted device has a single resonance frequency (par.0018, 0029).
With respect to claim 20, van Kessler teaches adjusting the implanted device in vivo, wherein sensing the data with a subcutaneous sensor occurs in vivo (par.0020).
Claims 4, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Van Kessel, Radziemski, Mi, and Krasnow, as applied to claims 1 and 12, in further view of Bailey et al. (US PG Pub. No. 2019/0192072 A1) (hereinafter “Bailey”).
Bailey was applied in the previous office action.
With respect to claims 4, 5, and 17, Van Kessel, Radziemski, Mi, and Krasnow teach a subcutaneous sensor system and method as established above.
However, Van Kessel, Radziemski, Mi, and Krasnow do not explicitly teach the limitations further recited in claims 4, 5, and 17.
Regarding claim 4, Bailey teaches the biocompatible housing includes a spinal rod housing (abstract, par.0004).
Regarding claim 5, Bailey teaches the biocompatible housing includes an intramedullary nail housing (abstract, par.0013).
Regarding claim 17, Bailey teaches the implanted device includes a spinal rod housing or an intramedullary nail housing (abstract, par.0004, 0013).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Van Kessel, Radziemski, Mi, and Krasnow such that the biocompatible housing includes spinal rod housing or an intramedullary nail housing in order to take measurements from a spine or leg, as evidence by Bailey (abstract, par.0004, 0013).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Van Kessel, Radziemski, Mi, and Krasnow, as applied to claim 12 above, in further view of Hedberg (WO 2008/039116 A1).
Hedberg was applied in the previous office action.
With respect to claim 13, Van Kessel, Radziemski, Mi, and Krasnow teach a method including a piezoelectric transducer, as established above.
However, Van Kessel, Radziemski, Mi, and Krasnow do not teach the piezoelectric transducer is tubular in shape.
Hedberg teaches an implantable tubular piezoelectric transducer (pg. 4, lines 21-25 “the sensor itself will have a tubular form, preferably cylindrical”; see also claim 6 “the piezoelectric layers are arranged in a tubular form”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Van Kessel, Radziemski, Mi, and Krasnow such that the piezoelectric transducer has a tubular form in order to enhance the strength and ease of manufacturing of the sensor, as evidence by Hedberg (pg. 4, lines 20+). Moreover, tubular piezoelectric transducers have been widely set forth in the prior art. See prior art cited at the end of the previous office action with mailing date January 3, 2025 for further example teachings.
With respect to claim 14, Van Kessel modified by Radziemski and Hedberg teach transmitting the ultrasound data signal includes propagating the data signal radially from the tubular piezoelectric transducer (Van Kessel’s piezoelectric transducer 202 is understood to sense in all directions, as depicted in Van Kessel’s Fig. 2).
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section above for more detail, updated citations (new Krasnow reference), and updated obviousness rationale.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Newly cited:
US PG Pub. No. 2013/0079599 A1, see at least par.682, 1159
Cited previously:
US PG Pub. No. 2018/0103860 A1, see Fig. 2
US PG Pub. No. 2017/0105635 A1, see Fig. 1
Conclusion
No claim is allowed.
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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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