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 pages 7 - 8, filed 04/21/2026, with respect to the claim rejection of 35 U.S.C. 112(b) have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of 01/30/2026 has been withdrawn.
Applicant’s arguments with respect to claim rejection under 35 U.S.C. 103 of all pending claims have been considered but are moot because the new ground of rejection does not rely on all reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
Claim(s) 1 – 7, 10 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0022427 A1 to Maharbiz et al. (hereinafter “Maharbiz”) in view of U.S. Patent Application Publication No. 2019/0044459 A1 to Degertekin et al. (hereinafter “Degertekin”).
Regarding Claim 1, Maharbiz teaches an implantable wireless sensor apparatus (see abstract, paragraph [0004], [0069] – [0070], [0086], [0094] describing an implantable device which is capable of being wirelessly powered and wirelessly transmitting information to an interrogator, see the implantable device at Fig. 4) comprising:
a transducer unit having at least one ultrasonic transducer (see paragraph [0069] which states “The implantable device described herein includes a miniaturized ultrasonic transducer (such as a miniaturized piezoelectric transducer) and a physiological sensor”, see also the implantable device at Fig. 4 which is a miniaturized ultrasonic transducer, hence reading on the invention as claimed);
at least one body sensor coupled to the transducer unit (see paragraph [0069] which states “The implantable device described herein includes a miniaturized ultrasonic transducer (such as a miniaturized piezoelectric transducer) and a physiological sensor”, thus the physiological sensor is considered as the claimed body sensor which is included in the implantable device, see also the implantable device at Fig. 4 which illustrates both the ultrasonic transducer and the sensor, see also paragraph [0094], hence reading on the invention as claimed); and
wherein the transducer unit is configured to generate backscattered ultrasonic waves (see Fig. 4 which illustrates backscattered ultrasonic waves being generated by implantable device, paragraph [0094] which states “Depending on the physiological condition detected by the sensor, information relating to the physiological condition can alter the current, which in turns modulates the backscatter from the miniaturized ultrasonic transducer”, and further states “Thus, the sensor system modulates the electrical impedance presented to the transducer to effect backscatter communication. The backscatter is then received by an external ultrasonic transceiver (which may be the same or different from the external ultrasonic transceiver that transmitted the initial ultrasonic waves). The information from the sensor can thus be encoded by changes in amplitude, frequency, or phase of the backscattered ultrasound waves”, thus the implantable device which includes the ultrasonic transducer generates the backscattered ultrasound waves as claimed) having a ring-down part such that body sensor data is wirelessly acquired from the ring-down part (see paragraph [0094] which states “The backscatter waves can be detected by the interrogator, and can be deciphered to determine the physiological condition or a change in the physiological condition”, see also paragraph [0096] and Figs. 5A – 5E, in particular to Figs. 5D and 5E which illustrates analyses of the ultrasonic backscatter wave received from the implantable device which includes the “responsive backscatter” and “non-responsive backscatter” which are identified in the different regions of the backscatter waves, thus including the claimed “ring-down” portion as illustrated at Fig. 5E, hence reading on the invention as claimed).
Even though Maharbiz teaches choosing a resonant frequency of the miniaturized ultrasonic transducer as described at paragraph [0097], Maharbiz does not explicitly state that the electrical resonance frequency of the apparatus is within a mechanical resonance frequency bandwidth of the transducer unit.
Degertekin, in the field of electrical transducers used in implantable devices as described for example at paragraphs [0016], [0018], teaches that it is known to use a device with electrical resonance frequency of the apparatus is within the bandwidth of mechanical resonance frequency of the ultrasonic unit (see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, thus reading on the invention as claimed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the arrangement of Degertekin into Maharbiz, in order to improve efficiency of the miniaturized ultrasonic transducer by allowing efficient energy conversion. The modification further ensures higher sensitivity, stability and robustness of the implantable device.
Regarding Claim 2, Maharbiz in view of Degertekin as modified above teaches wherein the at least one ultrasonic transducer is a diaphragm type ultrasonic transducer (see paragraph [0008], [0094], [0102] of Maharbiz describing the implantable device including a miniaturized ultrasonic transducer such as a piezoelectric transducer or a piezoelectric micro-machined ultrasonic transducer (PMUT), hence comprising a diaphragm type material, and/or see thin membranes of the micromachined capacitor ultrasonic transducer (CMUT) unit as described at paragraphs [0068], [0070] of Degertekin).
Regarding Claim 3, Maharbiz in view of Degertekin as modified above teaches wherein the diaphragm type ultrasonic transducer is a piezoelectric micro-machined ultrasonic transducer (PMUT) (see paragraph [0008], [0094], [0102] of Maharbiz describing the implantable device including a miniaturized ultrasonic transducer such as a piezoelectric transducer or a piezoelectric micro-machined ultrasonic transducer (PMUT), hence comprising a diaphragm type material, and/or see paragraphs [0014], [0070], [0071], [0075], [0079] of Degertekin describing the use of piezoelectric transducers).
Regarding Claim 4, Maharbiz in view of Degertekin as modified above teaches wherein diaphragm surface area and/or diaphragm thickness of the ultrasonic transducers and/or nominal capacitance of the sensors are arranged such that electrical resonance frequency of the apparatus is within a mechanical resonance frequency bandwidth of the transducer unit (see modification of claim 1 above, see paragraphs [0018], [0022], [0029] of Degertekin describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, hence reading on the invention as claimed).
Regarding Claim 5, Maharbiz in view of Degertekin as modified above teaches wherein the at least one ultrasonic transducer is a piezoelectric ceramic ultrasonic transducer (see paragraphs [0079], [0108] of Maharbiz describing piezoelectric transducer being a type of ultrasonic transceiver comprising piezoelectric material such as a ceramic, hence reading on the invention as claimed).
Regarding Claim 6, Maharbiz in view of Degertekin as modified above teaches wherein number of ceramics, ceramic surface area and/or ceramic thickness of the ultrasonic transducers and/or nominal capacitance of the sensors are arranged such that electrical resonance frequency of the apparatus is within a mechanical resonance frequency bandwidth of the transducer unit (see modification of claims 1 and 5 above, see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, of Degertekin hence reading on the invention as claimed).
Regarding Claims 7, 14, 15, 16, 17 and 18, Maharbiz in view of Degertekin as modified above teaches wherein the at least one body sensor is a capacitive, inductive or resistive sensor (see paragraphs [0011] – [0016], [0094], [0120] - [0121] of Maharbiz describing the implantable device includes one or more sensors that sense conditions such as temperature, oxygen concentration, pH, strain or pressure, thus reading on the invention as claimed since for instance temperature can be sensed using thermistor (see paragraph [0014]), strain can be sensed by utilizing changes in resistance (see paragraph [0146]) etc.).
Regarding Claim 10, Maharbiz in view of Degertekin as modified above teaches wherein ultrasonic transducers are in the form of an ultrasonic transducer array (see paragraphs [0004], [0021] and Figs. 1 – 3A of Maharbiz describing and illustrating a neural motes and/or plurality of implantable devices (i.e., arrays) which communicate with the transducer array, and/or see paragraphs [0068] – [0069] of Degertekin)
Regarding Claim 11, Maharbiz in view of Degertekin as modified above teaches at least two implantable wireless sensor apparatus (see paragraph [0099] of Maharbiz describing an interrogator communicating with a plurality of implantable devices) wherein each transducer unit has a different mechanical resonance frequency bandwidth in order to provide a different transmitting channel to each body sensors coupled to the corresponding transducer unit (see paragraph [0099] of Maharbiz which states “an interrogator communicates with a plurality of implantable devices. This can be performed, for example, using multiple-input, multiple output (MIMO) system theory. For example, communication between the interrogator and the plurality of implantable devices using time division multiplexing, spatial multiplexing, or frequency multiplexing”, and further states “ The interrogator focuses the transmitted ultrasonic waves to a first implantable device, receives backscatter from the first implantable device, focuses transmitted ultrasonic waves to a second implantable device, and receives backscatter from the second implantable device. In some embodiments, the interrogator transmits ultrasonic waves to a plurality of implantable devices, and then receives ultrasonic waves from the plurality of implantable devices”, hence reading on the invention as claimed).
Regarding Claim 12, Maharbiz in view of Degertekin as modified above teaches an ultrasonic actuator used for sending ultrasonic waves to and receiving ultrasonic waves from the implantable wireless sensor apparatus according to claim 1 (see paragraphs [0021], [0069], [0086] – [0090] of Maharbiz describing the system comprising one or more implantable devices and an interrogator comprising one or more ultrasonic transducers configured to transmit ultrasonic waves to the one or more implantable devices or receive ultrasonic backscatter from the one or more implantable devices, hence reading on the invention as claimed).
Regarding Claim 13, Maharbiz in view of Degertekin as modified above teaches wherein diaphragm surface area and/or diaphragm thickness of the ultrasonic transducers and/or nominal capacitance of the sensors are arranged such that electrical resonance frequency of the apparatus is within a mechanical resonance frequency bandwidth of the transducer unit (see modification of claims 1 and 3 above, see paragraphs [0018], [0022], [0029] describing capacitor having a “mechanical resonance frequency equal to about twice an electrical resonance frequency of the electronic device”, of Degertekin hence reading on the invention as claimed).
Claim(s) 8, 9, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Maharbiz in view of Degertekin and further in view of U.S. Patent No. 11,980,498 B2 to Reiche et al. (hereinafter “Reiche”).
Regarding Claims 8, 19 and 20, Maharbiz in view of Degertekin as modified above teaches wherein the transducer unit and/or the at least one body sensor are made of biodegradable materials (see for instance paragraphs [0018], [0106] of Maharbiz describing biocompatible polymer material encapsulating the implantable device).
Even though Maharbiz teaches a polymer based capacitive ultrasonic device as described above, Maharbiz in view of Degertekin is silent regarding the transducer unit and/or the at least one body sensor being made of biodegradable materials. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use biodegradable materials, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). The modification eliminates the need for secondary removal surgeries, reducing infection rates and preventing long-term foreign body reactions.
In addition, Reiche, in the field of implantable and biodegradable smart resonators with ultrasound readout, teaches that it is known to use a device with the transducer unit and/or the body sensor made of biodegradable materials (see Col. 15, line 27 – Col. 16, line 29 describing the biodegradable smart hydrogel sensor device used in the system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use biodegradable materials of Reiche into Maharbiz in view of Degertekin, in order to eliminate the need for a subsequent surgery/removal of the sensor structure.
Regarding Claim 9, Maharbiz in view of Degertekin in view of Reiche as modified above further comprising a triggered biodegradation layer which is coated on the biodegradable materials in order to initiate biodegrading of the materials by a controlled effect (see Col. 15, line 27 – Col. 16, line 29 of Reiche describing use of hydrogels for the biodegradable and implantable sensor structures, hence reading on the invention as claimed).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form accompanying this office action which includes the following relevant prior art:
Palti (U.S. 2015/0045669 A1) teaches an apparatus having an implanted section (200) including a transducer formed with an ultrasound reflecting surface.
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 MARRIT EYASSU whose telephone number is (571)270-1403. The examiner can normally be reached M - F: 9:00AM - 6:00PM.
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/MARRIT EYASSU/Primary Examiner, Art Unit 2855