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.
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(s) 4-14 are 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(s) 4-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim describes human powered implantable device. Since the human body is positively recited in the claim, non-statutory subject matter has been claimed. See also Commissioner Quigg's notice at 1077 OG 24 (April 21, 1987).
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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Webster et al. (US 20190009083) in view of Li (US 20160204717).
Regarding claim 1, Webster discloses an implant assembly 10 (Fig. 1, section 0021), comprising:
a housing 21 configured to store components 200 that generate biomechanically activated electrical energy (Fig. 2A-C, section 0022);
a first electrode 40 positioned on an external surface of the housing 21 (Fig. 2C, section 0022); and
a second electrode 40 positioned on an external surface of the housing 21 and isolated from the first electrode (Fig. 2C, section 0022), the components comprising:
and delivered through the first and second electrode to a healing site when an anatomical force is applied to the implant surfaces that make contact with two bony surfaces (Section 0020, 0029).
However Webster does not specfically disclose a force activated piezogenerator electrically connected to an impedance matched rectifying circuit and digital microcontroller, wherein the piezogenerator transduces a mechanical load to an electrical signal that is passed through the impedance matched rectifying circuit.
Li discloses a force activated piezogenerator electrically connected to an impedance matched rectifying circuit and digital microcontroller, wherein the piezogenerator transduces a mechanical load to an electrical signal that is passed through the impedance matched rectifying circuit (Fig. 1, section 0002, 0028). This allows for proper piezoelectric energy to be harvested into AC energy. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Webster by adding a force activated piezogenerator electrically connected to an impedance matched rectifying circuit and digital microcontroller as taught by Li in order to facilitate proper piezoelectric energy to be harvested into AC energy.
Regarding claim 2, Webster in view of Li, specfically Li discloses the implant assembly of claim 1 wherein
the piezogenerator converts dynamic load to an alternating current (AC) electrical signal (section 0002, 0036), which is passed through the impedance matched rectifying circuit to generate a pulsed negative direct current (DC) electrical signal that is passed through internal electrical connections to the first and second electrode (section 0002, 0036). This allows for proper piezoelectric energy to be harvested into AC energy.
Regarding claim 3, Webster in view of Li, specfically Li discloses the implant assembly of claim 2 wherein
the piezogenerator and the impedance matched rectifying circuit are disposed within the housing 21 such that there is an open cavity that extends from the second electrode to the first electrode (Section 0027).
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.
Claim(s) 4-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Webster et al. (US 20190009083).
Regarding claim 4, Webster discloses a human powered implantable device comprising:
a first electrode 40 positioned on an exterior surface of a housing 21 (Fig. 2C, section 0022);
a second electrode 40 positioned on an exterior surface of the housing and isolated from the first electrode 40 (Fig. 2C, section 0022);
a microcontroller; and
piezoelectric materials 200 within the housing to generate load-induced power and run a measurement and storage function (Section 0022, 0024-0025), the power configured to generate electrical stimulation to promote bone growth and support data collection related to load, impedance, acceleration, temperature, and other physiologic signals (Sections 0020, 0029).
Regarding claim 5, Webster discloses the human powered implantable device of claim 4 wherein
the generated power delivers stimulation via mechanically synced electrical stimulation (MSES) (Section 0020, 0024).
Regarding claim 6, Webster discloses the human powered implantable device of claim 5 wherein
the generated power activates measurement and storage function to collect and store data during discrete periods of time for later transmission to an external data acquisition system (Section 0022).
Regarding claim 7, Webster discloses the human powered implantable device of claim 6 wherein
the data is selected from one or more of AC voltage from the piezoelectric materials (Section 0029), local temperature from the microcontroller (Section 0040), impedance between first and second electrode, and acceleration for gait analysis.
Regarding claim 8, Webster discloses the human powered implantable device of claim 7 further comprising
an external device 30, (Fig. 1, Abstract, section 0021).
Regarding claim 9, Webster discloses The human powered implantable device of claim 8 wherein
the data is transmitted to the external device (Fig. 1, Abstract, section 0021).
Regarding claim 10, Webster discloses the human powered implantable device of claim 9 wherein
the external device is configured to monitor trends of activity (Fig. 1, Abstract, section 0021, 0024).
Regarding claim 11, Webster discloses The human powered implantable device of claim 10 wherein
the trends comprise prediction of post-operative fusion mass formation, device loosening, and biological activity to indicate infection and trending (Section 0029).
Allowable Subject Matter
Claims 15-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Regarding independent claim 15, Regarding independent claim 15, for A system comprising: an external circuit; and an implant, the implant comprising: a piezo construct; an analog circuit, the piezo construct linked to the analog circuit; a solid state battery, the solid state battery linked to the digital circuit; a near field communication (NFC) antenna; and a Bluetooth Low Energy (BLE) antenna, the NFC antenna and the BLE antenna linked to the digital circuit. has not been suggested or disclosed in the prior art when combined with the rest of the claim limitations of independent claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796 /J.C.M/Primary Examiner, Art Unit 3796
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