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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-21 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 18 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 18 requires the target substrate and the disclosure and claim 19 clarify this is meant to be the heart. Thus, these claims include a human within the scope and are non-statutory. The examiner suggests using the phrase "adapted to be located" when referring to the location of the sensor device in relation to the heart. Dependent claims inherit the same deficiencies. The examiner notes claim 4 requires the implantation depth which also requires a human to obtain the depth of implantation.
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.
Claim(s) 1-10, 13-14, and 17-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Almarri et al (N. ALMARRI, et al., "Self-Powered Piezoelectric Biosensing Harvester for Intracardiac Monitoring", 2023 IEEE Biomedical Circuits and Systems Conference (BioCAS), 10/19/23-10/21/2023, 4 pgs.) cited in IDS date 6/23/2025.
Referring to Claim 1, Almarri et al teaches a self-powered sensor device comprising: a harvester module having a power harvesting element, the power harvesting element being arranged and disposed to harvest power from induced mechanical strain (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3); a sensor module having a sensor element (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3); a controller module having circuitry operably connected to the harvester module and the sensor module, the controller module being configured to receive power from the power harvesting element, to receive sensor signals from the sensor element, and to wirelessly communicate an output signal corresponding to the sensor signal (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3; and a sub nW communication module (Section VII)); wherein the controller module is powered continuously with power harvested from the power harvesting element to generate and communicate the output signal (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3 and Figures 1 and 2a explicitly note the battery-less device).
Referring to Claim 2, Almarri et al teaches the device of claim 1, wherein the sensor device is devoid of batteries (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3 and Figures 1 and 2a explicitly notes the battery-less device).
Referring to Claim 3, Almarri et al teaches the device of claim 1, wherein the sensor device is powered only by mechanical cardiac motion (e.g. abstract, and Figures 2a and 5 ).
Referring to Claim 4, Almarri et al teaches the device of claim 1, wherein the harvester module, the sensor module, and the controller module are mounted on a flexible carrier (e.g. Section IV(A) on left column of page 3 discloses flexible polyimide substrate).
Referring to Claim 5, Almarri et al teaches the device of claim 1, wherein the power harvesting element includes one or more piezoelectric elements selected from the group consisting of poly(vinylidene fluoride) barium titanate (PVDF-BaTiO.sub.3) fibers, poly(vinylidene fluoride) (PVDF) fibers, poly(vinylidene fluoride) (PVDF) films, polymethyl methacrylate (PMMA), lead zirconate titanate (PZT) films, and combinations thereof (e.g. page 1 left column last paragraph to right column, section III right column and section V first paragraph).
Referring to Claim 6, Almarri et al teaches the device of claim 1, wherein the power harvesting element includes a hybrid triboelectric-piezoelectric system (e.g. Section III left column, page 2).
Referring to Claim 7, Almarri et al teaches the device of claim 1, wherein the sensor element comprises at least one piezoelectric microelectromechanical system (MEMS) sensor (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3).
Referring to Claim 8, Almarri et al teaches the device of claim 1, wherein the sensor element includes a spatial sensing array (e.g. abstract and Figure 1).
Referring to Claim 9, Almarri et al teaches the device of claim 1, wherein the circuitry includes a power harvesting submodule comprising a maximum power point tracking (MPPT) control circuit and power conversion circuitry configured to regulate harvested electrical energy for continuous system operation at ultra-low power levels (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3).
Referring to Claim 10, Almarri et al teaches the device of claim 1, wherein the circuitry includes a signal acquisition submodule operable to process biomechanical sensor signals and extract physiological cardiac metrics (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3 and Section VII).
Referring to Claim 13, Almarri et al teaches the device of claim 1, wherein the signal acquisition submodule includes multiple sensing channels configured to collect spatially distributed measurements for one or more of ejection fraction, cardiac output or stiffness determination (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3).
Referring to Claim 14, Almarri et al teaches the device of claim 1, wherein the circuitry further comprises a capacitively coupled amplifier operably connected to the sensor module for ultra-low noise signal amplification (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3).
Referring to Claim 17, Almarri et al teaches the device of claim 1, wherein the harvester module generates between about 10μW and 150μW from cardiac motion under physiological operating conditions (e.g. Section VII page 4 left column).
Referring to Claim 18, Almarri et al teaches a monitoring system comprising: a target substrate (e.g. Figure 1); a sensor device according to claim 1, the sensor device being mounted on a flexible carrier (e.g. Figures 2a and 5 and Section IV); a signal receiver configured to receive the output signal from the sensor device (e.g. Section IV and Section VII); wherein the sensor device and flexible carrier are positioned on the target substrate (e.g. Figure 1).
Referring to Claim 19, Almarri et al teaches the monitoring system of claim 18, wherein the target substrate is a heart (e.g. Figure 1).
Referring to Claim 20, Almarri et al teaches the monitoring system of claim 19, wherein the sensor device provides real-time stiffness measurements with an accuracy of up to 96.7% (e.g. Figures 2a and 5 and Section IV).
Referring to Claim 21, Almarri et al teaches the monitoring system of claim 18, wherein the sensor is at an implantation depth of at least 4 cm (e.g. Figures1, 2a, and 5 and Section IV).
Referring to Claim 22, Almarri et al teaches an implantable cardiac sensor comprising: a biocompatible flexible carrier configured for implantation on a myocardial surface (e.g. Figures 2a and 5 and Section IV); a harvesting module comprising a power harvesting element including one or more piezoelectric elements selected from the group consisting of poly(vinylidene fluoride) barium titanate (PVDF-BaTiO.sub.3) fibers, poly(vinylidene fluoride) (PVDF) fibers, poly(vinylidene fluoride) (PVDF) films, polymethyl methacrylate (PMMA), lead zirconate titanate (PZT) films, and combinations thereof (e.g. page 1 left column last paragraph to right column, section III right column and section V first paragraph); a sensor module having a sensor element, the sensor element comprising piezoelectric MEMS sensors configured to detect myocardial deformation (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3); a controller module having circuitry operably connected to the harvester module and the sensor module, the controller module being configured to receive power from the power harvesting element, to receive sensor signals from the sensor element, and to wirelessly communicate an output signal corresponding to the sensor signal, the controller module being powered continuously with power harvested from the power harvesting element to generate and communicate the output signal (.g. Figures 2a and 5 and Section IV(A) on left column of page 3 and Section VII); wherein the circuitry includes maximum power point tracking (MPPT) control circuitry and power conversion circuitry configured to regulate harvested electrical energy for continuous battery-free system operation at ultra-low power levels and derive one or more of ejection fraction, cardiac stiffness and cardiac output parameters to communicate as data in the output signal (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3).
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.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almarri et al (N. ALMARRI, et al., "Self-Powered Piezoelectric Biosensing Harvester for Intracardiac Monitoring", 2023 IEEE Biomedical Circuits and Systems Conference (BioCAS), 10/19/23-10/21/2023, 4 pgs.) cited in IDS date 6/23/2025 in view of Babakhani et al (US Publication 2022/0158497).
Referring to Claims 11-12, Almarri et al teaches the device of claim 1, including a sub NW communication module, but does not explicitly disclose wherein the circuitry includes a data transmission submodule comprising an On-Off Keying (OOK) transmitter, configured to wirelessly transmit acquired cardiac data to an external receiver; and wherein the data transmission submodule achieves energy efficiency of at least picojoules per bit at data transmission rates of up to 10 Mbps while radiating at −33 dBm or less. Babakhani et al teaches that it is known to use a data transmission submodule comprising an On-Off Keying (OOK) transmitter, wherein the data transmission submodule achieves energy efficiency of at least picojoules per bit at data transmission rates of up to 10 Mbps while radiating at −33 dBm or less as set forth in Figure 21 and Paragraphs [0097]-[0098] to provide a known technique for power-efficient short range communication module. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Almarri et al, with data transmission submodule comprising an On-Off Keying (OOK) transmitter, wherein the data transmission submodule achieves energy efficiency of at least picojoules per bit at data transmission rates of up to 10 Mbps while radiating at −33 dBm or less as taught by Babakhani et al, since such a modification would provide the predictable results of a known technique for power-efficient short range communication module.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almarri et al (N. ALMARRI, et al., "Self-Powered Piezoelectric Biosensing Harvester for Intracardiac Monitoring", 2023 IEEE Biomedical Circuits and Systems Conference (BioCAS), 10/19/23-10/21/2023, 4 pgs.) cited in IDS date 6/23/2025 in view of Skinner et al (US Publication 2021/0016074).
Referring to Claim 15, Almarri et al teaches the device of claim 1, except wherein the circuitry further comprising a CMOS-based temperature sensor. Skinner et al teaches that it is known to use CMOS analog temperature sensor in an implantable device as set forth in Paragraph [0108] to provide improved determination of physiological performance with low power consumption. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Almarri et al, with wherein the circuitry further comprising a CMOS-based temperature sensor as taught by Skinner et al, since such a modification would provide the predictable results of improved determination of physiological performance with low power consumption.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almarri et al (N. ALMARRI, et al., "Self-Powered Piezoelectric Biosensing Harvester for Intracardiac Monitoring", 2023 IEEE Biomedical Circuits and Systems Conference (BioCAS), 10/19/23-10/21/2023, 4 pgs.) cited in IDS date 6/23/2025 in view of Babakhani et al (US Publication 2022/0158497) and Skinner et al (US Publication 2021/0016074).
Referring to Claim 16, Almarri et al teaches the device of claim 1, wherein the circuitry includes a maximum power point tracking (MPPT) control circuitry (e.g. Figures 2a and 5 and Section IV(A) on left column of page 3), a capacitively coupled amplifier (e.g. Figures 2a and 5 and Section IV(B) on right column of page 3). However, Almarri et al does not explicitly disclose a CMOS-based temperature sensor, and an On-Off Keying (OOK) oscillating transmitter connected to a dual-loop antenna. Skinner et al teaches that it is known to use CMOS analog temperature sensor in an implantable device as set forth in Paragraph [0108] to provide improved determination of physiological performance with low power consumption. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Almarri et al, with wherein the circuitry further comprising a CMOS-based temperature sensor as taught by Skinner et al, since such a modification would provide the predictable results of improved determination of physiological performance with low power consumption.
Babakhani et al teaches that it is known to use On-Off Keying (OOK) oscillating transmitter connected to a dual-loop antenna as set forth in Figure 21 and Paragraphs [0069], [0097]-[0098] to provide a known technique for power-efficient short range communication module. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Almarri et al, with On-Off Keying (OOK) oscillating transmitter connected to a dual-loop antenna as taught by Babakhani et al, since such a modification would provide the predictable results of a known technique for power-efficient short range communication module.
Claim(s) 1, 3-4, 7-8, 10, and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al (US Publication 2024/0164642).
Referring to Claim 1, Hunter et al teaches a self-powered sensor device comprising: a harvester module having a power harvesting element, the power harvesting element being arranged and disposed to harvest power from induced mechanical strain (e.g. Figure 1, Element 24); a sensor module having a sensor element (e.g. Figure 1, Element 14); a controller module having circuitry operably connected to the harvester module and the sensor module, the controller module being configured to receive power from the power harvesting element, to receive sensor signals from the sensor element, and to wirelessly communicate an output signal corresponding to the sensor signal (e.g. Figure 1, Element 52); wherein the controller module is powered continuously with power harvested from the power harvesting element to generate and communicate the output signal (e.g. Figure 1, Element 24).
Referring to Claim 3, Hunter et al teaches the device of claim 1, wherein the sensor device is powered only by mechanical cardiac motion (e.g. Figure 1 and Paragraph [0188]).
Referring to Claim 4, Hunter et al teaches the device of claim 1, wherein the harvester module, the sensor module, and the controller module are mounted on a flexible carrier (e.g. Paragraph [0012]).
Referring to Claim 7, Hunter et al teaches the device of claim 1, wherein the sensor element comprises at least one piezoelectric microelectromechanical system (MEMS) sensor (e.g. Paragraph [0101]).
Referring to Claim 8, Hunter et al teaches the device of claim 1, wherein the sensor element includes a spatial sensing array (e.g. Paragraph [0101]).
Referring to Claim 10, Hunter et al teaches the device of claim 1, wherein the circuitry includes a signal acquisition submodule operable to process biomechanical sensor signals and extract physiological cardiac metrics (e.g. Paragraph [0094] and Figures 1 , Elements 16 and 18).
Referring to Claim 13, Hunter et al teaches the device of claim 1, wherein the signal acquisition submodule includes multiple sensing channels configured to collect spatially distributed measurements for one or more of ejection fraction, cardiac output or stiffness determination (e.g. Figures 1 and 2).
Referring to Claim 14, Hunter et al teaches the device of claim 1, wherein the circuitry further comprises a capacitively coupled amplifier operably connected to the sensor module for ultra-low noise signal amplification (e.g. Figure 1, Element 42).
Referring to Claim 15, Hunter et al teaches the device of claim 1, wherein the circuitry further comprising a CMOS-based temperature sensor (e.g. Paragraph [0016]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al (US Publication 2024/0164642).
Referring to Claim 2, Hunter et al teaches the device of claim 1, except wherein the sensor device is devoid of batteries.
The examiner notes that capacitors are used to store energy and that it would have been an obvious substitution of one known element for another (to replace the batteries of Hunter et al with capacitors as is known in the art) to provide the predictable results of longer cycle life.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Li et al (US Publication 2023/0149720) discloses an intracardiac energy harvesting device with sensors which can emit electrical energy such that a detected low heart rate will have the device generate current to the heart tissue to stimulate heartbeat.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
